A Study of ASP1002 in Adults for Treatment of Solid Tumors

NCT05719558 | Recruiting Phase 1 FDA Drug

• 2 other identifiers: 1002-CL-01012024-512410-18-00
• Study Type: interventional
• Target: 798
• Locations: 1 country
• Sites: 15

Brief Summary

ASP1002 is being studied in people with tumors that have spread to nearby tissue (locally advanced) that cannot be removed by surgery (unresectable) or tumors that have spread to other parts of the body (metastatic). Claudin 4 protein, or CLDN4, is a protein found on tumors in different parts of the body. ASP1002 is thought to work by attaching to the CLDN4 protein in the tumor. This switches on the body's immune system to attack the tumor. Before ASP1002 can be used, researchers need to collect information about the safety of ASP1002 and how people with tumors tolerate it. In this study, ASP1002 will be given to humans for the first time. It will either be given by itself or together with other cancer treatments. These include standard chemotherapies (mFOLFOX6, FOLFIRI, TAS-102, pemetrexed, carboplatin, and docetaxel) and immunotherapies (bevacizumab, pembrolizumab, and ramucirumab). Immunotherapy is a treatment that works with the body's immune system to treat tumors. This is an early development study. These studies are mostly about safety, but also to find the most suitable dose. Other aims are to learn if ASP1002 shows signs of slowing down tumor growth, to learn how the body processes ASP1002, and to check if there are changes in the CLDN4 protein or the immune system after treatment. The main aims of the study are to check the safety of ASP1002 by itself and given with standard chemotherapies and immunotherapies in people with solid tumors and how well they tolerate the study treatments, and to find a suitable dose of ASP1002 by itself and in combination with standard chemotherapies and immunotherapies. People in this study will be adults with tumors that have spread to nearby tissue (locally advanced) that cannot be removed by surgery (unresectable) or tumors that have spread to other parts of the body (metastatic). They will have been previously treated with available standard therapies, or they will have refused to receive those treatments. The key reasons people cannot take part are if they have symptoms of cancer in the brain or nervous system, have recently had other cancers that required treatment, or have diseases that affect the immune system or the heart. This study will be in 2 parts. In Part 1, different small groups of people will receive lower to higher doses of ASP1002 by itself and given with chemotherapies and immunotherapies. Any medical problems will be recorded at each dose. This is done to find suitable doses of ASP1002 to use in Part 2 of the study. In Part 2, other different small groups of people will receive doses of ASP1002, the chemotherapies and immunotherapies that worked the best in Part 1. In both parts of the study, ASP1002 will be given by itself and with standard chemotherapies and immunotherapies to people slowly through a tube into a vein. This is called an infusion. This will happen every 2 to 4 weeks, in treatment cycles. Treatment cycles may be 21 or 28 days long. People will continue to receive study treatment for up to 2 years or until their cancer gets worse, they can't tolerate the study treatment, they start other cancer treatments, or the doctor decides the person should stop receiving study treatment, or sadly, they pass away. They can also choose to stop taking the study treatment at any time without giving a reason. During the study, people will visit the clinic several times for a health check. This includes standard safety checks and reporting any medical problems. Every 2 months, the study doctors will check if each person's cancer has stayed the same, shrunk or disappeared over time. This will be done by scans (CT or MRI scans). Tumor samples will be taken during the study, and people will have the option of giving a tumor sample after study treatment has finished. People will have follow-up health checks for up to 1 year after their last dose of study treatment or until they start a different study treatment on a new study, whichever happens first.

Conditions

Advanced Solid Tumors

Keywords

microsatellite stable metastatic colorectal cancer (MSS-mCRC); Solid Tumor;; Malignancy;; Metastasis;; cancer;; ASP1002;; Pharmacokinetics

Outcome Measures

Primary Outcomes (8)

• Incidence of Dose Limiting Toxicities (DLTs) for ASP1002

  A DLT is defined as any of the following AEs that the investigator (or sponsor) cannot clearly attribute to a cause other than study intervention.

  Up to 24 months

• Number of participants with Adverse Events (AEs)

  Adverse events (AEs) will be coded using MedDRA. An AE is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention.

  Up to 25 months

• Number of participants with Serious Adverse Events (SAEs)

  A Serious Adverse event (SAE) is defined as any untoward medical occurrence that, at any dose: results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, or other medically important event.

  Up to 27 months

• Number of participants with laboratory value abnormalities and/or adverse events (AEs)

  Number of participants with potentially clinically significant laboratory values.

  Up to 27 months

• Number of participants with vital sign abnormalities and/or adverse events (AEs)

  Number of participants with potentially clinically significant vital sign values.

  Up to 27 months

• Number of participants with electrocardiogram (ECG) abnormalities and/or Adverse Events (AEs)

  Number of participants with potentially clinically significant ECG values.

  Up to 27 months

• Number of participants with physical exam abnormalities and/or Adverse Events (AEs)

  Number of participants with potentially clinically significant physical exam values.

  Up to 24 months

• Number of participants at each grade of Eastern Cooperative Oncology Group (ECOG) performance status scores

  The ECOG scale will be used to assess performance status. Grades range from 0 (fully active) to 4 (completely disabled). Negative change scores indicate an improvement. Positive scores indicate a decline in performance.

  Up to 27 months

Secondary Outcomes (15)

• Pharmacokinetics (PK) of ASP1002 in serum: Area under the concentration-time curve from time zero to time of the last measurable concentration (AUC0-tlast)

  Up to 12 months

• Pharmacokinetics (PK) of ASP1002 in serum: Cmax

  Up to 12 months

• Pharmacokinetics (PK) of ASP1002 in serum: Ctrough

  Up to 12 months

• Pharmacokinetics (PK) of ASP1002 in serum: tmax

  Up to 12 months

• Objective Response Rate (ORR) per Immune Response Evaluation Criteria in Solid Tumors (iRECIST)

  Up to 28 months

Study Arms (18)

Monotherapy Dose Escalation (Part 1)

EXPERIMENTAL

Participants will receive sequentially escalating doses of ASP1002. Each dose level will open sequentially based upon sponsor review of emerging data.

Drug: ASP1002

Monotherapy Dose Expansion (Part 2) in microsatellite stable metastatic colorectal cancer(MSS-mCRC)

EXPERIMENTAL

Participants will receive ASP1002 with dose/regimen selected from dose escalation (Part 1).

Drug: ASP1002

Monotherapy Dose Expansion (Part 2) in microsatellite stable prostate cancer(MSS-Pca)

EXPERIMENTAL

Participants will receive ASP1002 with dose/regimen selected from dose escalation (Part 1).

Drug: ASP1002

Monotherapy Dose Expansion (Part 2) in tumors highly expressing CLDN4 protein

EXPERIMENTAL

Participants with tumors highly expressing CLDN4 protein will receive ASP1002 with dose/regimen selected from dose escalation (Part 1).

Drug: ASP1002

Combination Therapy Dose Escalation Part 1: ASP1002 + bevacizumab + FOLFIRI- 2L MSS-mCRC

EXPERIMENTAL

Participants with MSS-mCRC will receive sequentially escalating doses of ASP1002 in combination with bevacizumab and FOLFIRI as a second line therapy.

Drug: ASP1002; Drug: Bevacizumab; Drug: Leucovorin; Drug: Fluorouracil; Drug: Irinotecan

Combination Therapy Dose Escalation Part 1: ASP1002 + bevacizumab + mFOLFOX6- 2L MSS-mCRC

EXPERIMENTAL

Participants with MSS-mCRC will receive sequentially escalating doses of ASP1002 in combination with bevacizumab and mFOLFOX6 as a second line therapy.

Drug: ASP1002; Drug: Bevacizumab; Drug: Oxaliplatin; Drug: Leucovorin; Drug: Fluorouracil

Combination Therapy Dose Escalation Part 1: ASP1002 + bevacizumab + TAS-102- 3L MSS-mCRC

EXPERIMENTAL

Participants with MSS-mCRC will receive sequentially escalating doses of ASP1002 in combination with bevacizumab and TAS-102 as a third line therapy.

Drug: ASP1002; Drug: Bevacizumab; Drug: Trifluridine-Tipiracil

Combination Therapy Dose Escalation Part 1: ASP1002 + bevacizumab- 4L MSS-mCRC

EXPERIMENTAL

Participants with MSS-mCRC will receive sequentially escalating doses of ASP1002 in combination with bevacizumab as fourth line therapy.

Drug: ASP1002

Combination Therapy Dose Escalation Part 1: ASP1002+pembrolizumab+pemetrexed+carboplatin-1L NSCLC

EXPERIMENTAL

Participants with non-small cell lung cancer (NSCLC) will receive sequentially escalating doses of ASP1002 in combination with pembrolizumab, pemetrexed and carboplatin as a first line therapy.

Drug: ASP1002; Drug: Pembrolizumab; Drug: Pemetrexed; Drug: Carboplatin

Combination Therapy Dose Escalation Part 1: ASP1002 + docetaxel + ramucirumab- 2L/3L NSCLC

EXPERIMENTAL

Participants with NSCLC will receive sequentially escalating doses of ASP1002 in combination with docetaxel and ramucirumab as second/ third line therapy.

Drug: ASP1002; Drug: Ramucirumab; Drug: Docetaxel

Combination Therapy Dose Escalation Part 1: ASP1002 + pembrolizumab- CLDN4-expressing solid tumors

EXPERIMENTAL

Participants with CLDN4-expressing solid tumors will receive sequentially escalating doses of ASP1002 in combination with pembrolizumab.

Drug: ASP1002; Drug: Pembrolizumab

Combination Therapy Dose Expansion Part 2: ASP1002 + bevacizumab + mFOLFOX6- 2L MSS-mCRC

EXPERIMENTAL

Participants with MSS-mCRC will receive ASP1002 in combination with bevacizumab and mFOLFOX6 with dose/regimen selected from dose escalation (Part 1) as a second line therapy.

Drug: ASP1002; Drug: Bevacizumab; Drug: Oxaliplatin; Drug: Leucovorin; Drug: Fluorouracil

Combination Therapy Dose Expansion Part 2: ASP1002 + bevacizumab + FOLFIRI- 2L MSS-mCRC

EXPERIMENTAL

Participants with MSS-mCRC will receive ASP1002 in combination with bevacizumab and FOLFIRI with dose/regimen selected from dose escalation (Part 1) as a second line therapy.

Drug: ASP1002; Drug: Bevacizumab; Drug: Leucovorin; Drug: Fluorouracil; Drug: Irinotecan

Combination Therapy Dose Expansion Part 2: ASP1002 + bevacizumab + TAS-102- 3L MSS-mCRC

EXPERIMENTAL

Participants with MSS-mCRC will receive ASP1002 in combination with bevacizumab and TAS-102 with dose/regimen selected from dose escalation (Part 1) as a third line therapy.

Drug: ASP1002; Drug: Bevacizumab; Drug: Trifluridine-Tipiracil

Combination Therapy Dose Expansion Part 2: ASP1002 + bevacizumab- 4L MSS-mCRC

EXPERIMENTAL

Participants with MSS-mCRC will receive ASP1002 in combination with bevacizumab with dose/regimen selected from dose escalation (Part 1) as fourth line therapy.

Drug: ASP1002; Drug: Bevacizumab

Combination Therapy Dose Expansion Part 2: ASP1002+pembrolizumab+pemetrexed +carboplatin-1L NSCLC

EXPERIMENTAL

Participants with non-small cell lung cancer (NSCLC) will receive ASP1002 in combination with pembrolizumab, pemetrexed and carboplatin with dose/regimen selected from dose escalation (Part 1) as a first line therapy.

Drug: ASP1002; Drug: Pembrolizumab; Drug: Pemetrexed; Drug: Carboplatin

Combination Therapy Dose Expansion Part 2: ASP1002+ ramucirumab + docetaxel- 2L/3L NSCLC

EXPERIMENTAL

Participants with NSCLC will receive ASP1002 in combination with Ramucirumab and Docetaxel with dose/regimen selected from dose escalation (Part 1) as a second/third line therapy.

Drug: ASP1002; Drug: Ramucirumab; Drug: Docetaxel

Combination Therapy Dose Expansion Part 2: ASP1002 + pembrolizumab- CLDN4-expressing solid tumors

EXPERIMENTAL

Participants with CLDN4-expressing solid tumors will receive ASP1002 in combination with pembrolizumab with dose/regimen selected from dose escalation (Part 1).

Drug: ASP1002; Drug: Pembrolizumab

Interventions

ASP1002 DRUG

Intravenous (IV) infusion. Dose interruptions, reductions, and treatment discontinuations will be implemented according to protocol-defined toxicity management criteria.

Combination Therapy Dose Escalation Part 1: ASP1002 + bevacizumab + FOLFIRI- 2L MSS-mCRC; Combination Therapy Dose Escalation Part 1: ASP1002 + bevacizumab + TAS-102- 3L MSS-mCRC; Combination Therapy Dose Escalation Part 1: ASP1002 + bevacizumab + mFOLFOX6- 2L MSS-mCRC; Combination Therapy Dose Escalation Part 1: ASP1002 + bevacizumab- 4L MSS-mCRC; Combination Therapy Dose Escalation Part 1: ASP1002 + docetaxel + ramucirumab- 2L/3L NSCLC; Combination Therapy Dose Escalation Part 1: ASP1002 + pembrolizumab- CLDN4-expressing solid tumors; Combination Therapy Dose Escalation Part 1: ASP1002+pembrolizumab+pemetrexed+carboplatin-1L NSCLC; Combination Therapy Dose Expansion Part 2: ASP1002 + bevacizumab + FOLFIRI- 2L MSS-mCRC; Combination Therapy Dose Expansion Part 2: ASP1002 + bevacizumab + TAS-102- 3L MSS-mCRC; Combination Therapy Dose Expansion Part 2: ASP1002 + bevacizumab + mFOLFOX6- 2L MSS-mCRC; Combination Therapy Dose Expansion Part 2: ASP1002 + bevacizumab- 4L MSS-mCRC; Combination Therapy Dose Expansion Part 2: ASP1002 + pembrolizumab- CLDN4-expressing solid tumors; Combination Therapy Dose Expansion Part 2: ASP1002+ ramucirumab + docetaxel- 2L/3L NSCLC; Combination Therapy Dose Expansion Part 2: ASP1002+pembrolizumab+pemetrexed +carboplatin-1L NSCLC; Monotherapy Dose Escalation (Part 1); Monotherapy Dose Expansion (Part 2) in microsatellite stable metastatic colorectal cancer(MSS-mCRC); Monotherapy Dose Expansion (Part 2) in microsatellite stable prostate cancer(MSS-Pca); Monotherapy Dose Expansion (Part 2) in tumors highly expressing CLDN4 protein

Bevacizumab DRUG

IV infusion

Combination Therapy Dose Escalation Part 1: ASP1002 + bevacizumab + FOLFIRI- 2L MSS-mCRC; Combination Therapy Dose Escalation Part 1: ASP1002 + bevacizumab + TAS-102- 3L MSS-mCRC; Combination Therapy Dose Escalation Part 1: ASP1002 + bevacizumab + mFOLFOX6- 2L MSS-mCRC; Combination Therapy Dose Expansion Part 2: ASP1002 + bevacizumab + FOLFIRI- 2L MSS-mCRC; Combination Therapy Dose Expansion Part 2: ASP1002 + bevacizumab + TAS-102- 3L MSS-mCRC; Combination Therapy Dose Expansion Part 2: ASP1002 + bevacizumab + mFOLFOX6- 2L MSS-mCRC; Combination Therapy Dose Expansion Part 2: ASP1002 + bevacizumab- 4L MSS-mCRC

Oxaliplatin DRUG

IV infusion

Combination Therapy Dose Escalation Part 1: ASP1002 + bevacizumab + mFOLFOX6- 2L MSS-mCRC; Combination Therapy Dose Expansion Part 2: ASP1002 + bevacizumab + mFOLFOX6- 2L MSS-mCRC

Leucovorin DRUG

IV infusion

Combination Therapy Dose Escalation Part 1: ASP1002 + bevacizumab + FOLFIRI- 2L MSS-mCRC; Combination Therapy Dose Escalation Part 1: ASP1002 + bevacizumab + mFOLFOX6- 2L MSS-mCRC; Combination Therapy Dose Expansion Part 2: ASP1002 + bevacizumab + FOLFIRI- 2L MSS-mCRC; Combination Therapy Dose Expansion Part 2: ASP1002 + bevacizumab + mFOLFOX6- 2L MSS-mCRC

Fluorouracil DRUG

IV infusion

Combination Therapy Dose Escalation Part 1: ASP1002 + bevacizumab + FOLFIRI- 2L MSS-mCRC; Combination Therapy Dose Escalation Part 1: ASP1002 + bevacizumab + mFOLFOX6- 2L MSS-mCRC; Combination Therapy Dose Expansion Part 2: ASP1002 + bevacizumab + FOLFIRI- 2L MSS-mCRC; Combination Therapy Dose Expansion Part 2: ASP1002 + bevacizumab + mFOLFOX6- 2L MSS-mCRC

Irinotecan DRUG

IV infusion

Combination Therapy Dose Escalation Part 1: ASP1002 + bevacizumab + FOLFIRI- 2L MSS-mCRC; Combination Therapy Dose Expansion Part 2: ASP1002 + bevacizumab + FOLFIRI- 2L MSS-mCRC

Trifluridine-Tipiracil DRUG

Film-coated tablet

Combination Therapy Dose Escalation Part 1: ASP1002 + bevacizumab + TAS-102- 3L MSS-mCRC; Combination Therapy Dose Expansion Part 2: ASP1002 + bevacizumab + TAS-102- 3L MSS-mCRC

Pembrolizumab DRUG

IV infusion

Combination Therapy Dose Escalation Part 1: ASP1002 + pembrolizumab- CLDN4-expressing solid tumors; Combination Therapy Dose Escalation Part 1: ASP1002+pembrolizumab+pemetrexed+carboplatin-1L NSCLC; Combination Therapy Dose Expansion Part 2: ASP1002 + pembrolizumab- CLDN4-expressing solid tumors; Combination Therapy Dose Expansion Part 2: ASP1002+pembrolizumab+pemetrexed +carboplatin-1L NSCLC

Pemetrexed DRUG

IV infusion

Combination Therapy Dose Escalation Part 1: ASP1002+pembrolizumab+pemetrexed+carboplatin-1L NSCLC; Combination Therapy Dose Expansion Part 2: ASP1002+pembrolizumab+pemetrexed +carboplatin-1L NSCLC

Carboplatin DRUG

IV infusion

Combination Therapy Dose Escalation Part 1: ASP1002+pembrolizumab+pemetrexed+carboplatin-1L NSCLC; Combination Therapy Dose Expansion Part 2: ASP1002+pembrolizumab+pemetrexed +carboplatin-1L NSCLC

Ramucirumab DRUG

IV infusion

Combination Therapy Dose Escalation Part 1: ASP1002 + docetaxel + ramucirumab- 2L/3L NSCLC; Combination Therapy Dose Expansion Part 2: ASP1002+ ramucirumab + docetaxel- 2L/3L NSCLC

Docetaxel DRUG

IV infusion

Combination Therapy Dose Escalation Part 1: ASP1002 + docetaxel + ramucirumab- 2L/3L NSCLC; Combination Therapy Dose Expansion Part 2: ASP1002+ ramucirumab + docetaxel- 2L/3L NSCLC

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• For Monotherapy:
• Participant has locally-advanced (unresectable or metastatic solid tumor) confirmed by available pathology records or current biopsy.
• a. For monotherapy dose escalation, participant must have one of the following malignancies:NSCLC-adenocarcinoma, squamous cell carcinoma and adenosquamous are included; large cell carcinoma and sarcomatoid carcinoma are excluded, UC, CRC, prostate adenocarcinoma, epithelial ovarian cancer (including fallopian tube cancer) and triple-negative breast cancer (TNBC).
• TNBC defined as unequivocal TNBC histology (ER 1 negative/progesterone receptor-negative/HER2-negative). This is defined by \< 1% expression of ER and progesterone receptor by IHC and that are, for HER2, either 0 to 1+ by IHC, or IHC 2+ and FISH negative (not amplified) as per current ASCO/CAP guidelines \[Hammond et al, 2010\].
• b. For tumor-specific monotherapy dose expansion, participant must have one of the following malignancies mCRC, mAPMR-PCa and tumor type for which a confirmed response was observed during dose escalation.
• Monotherapy expansion mCRC/mAPMR-PCa cohort: Participants with MSS/MSI-L mCRC/mAPMR-PCa, are eligible.
• Monotherapy expansion select CLDN4-expressing tumors cohort: Participants with metastatic solid tumors known to highly express CLDN4 are eligible.
• Participant has progressed, is intolerant, has refused, or there are no approved therapies that impart significant clinical benefit (no limit to the number of prior treatment regimens).
• Female participant is not pregnant, confirmed by pregnancy test (and medical evaluation by interview and at least 1 of the following conditions apply:
• Not a woman of childbearing potential (WOCBP)
• WOCBP who agrees to follow the contraceptive guidance from the time of informed consent through at least 90 days after final ASP1002 study intervention administration.
• Participant has progressed, is intolerant, has refused, or there are no standard approved therapies that impart significant clinical benefit (no limit to the number of prior treatment regimens).
• Participant has accessible archival tumor tissue (\< 6 months old at the date of consent) from either the primary tumor or a metastatic site, with source and availability confirmed prior to Cycle 1 Day 1 (C1D1); participants without available tissue should undergo a mandatory biopsy. Participant should undergo a tumor biopsy during the treatment period as indicated in the schedule of assessments. Note: Tumor tissue collection (at screening/baseline and on-treatment) is optional for participants enrolled initially in dose levels 1 to 3 in dose escalation; however, protocol de-escalation and expansion of dose levels similar to dose levels 1 to 3 may require collection and processing of screening/baseline and on-treatment tumor samples.
• Participant has at least 1 measurable lesion per RECIST v1.1. Lesions situated in a previously irradiated area are considered measurable if progression has been demonstrated in such lesions.
• Eastern Cooperative Oncology Group (ECOG) Status of 0 or 1 within 7 days before the first dose of study drug.

You may not qualify if:

• Participant weighs \< 40 kg.
• Ongoing toxicity that has not resolved to ≤ grade 1 per CTCAE version 5.0 and is considered clinically significant and in the opinion of the investigator, attributable to prior antineoplastic therapy.
• Symptomatic CNS metastases or evidence of uncontrolled CNS disease even if asymptomatic (e.g. progression on scans). Participants with previously treated CNS metastases are eligible, if they are clinically stable/have no evidence of CNS progression by imaging for at least 4 weeks prior to start of study intervention and are not requiring immunosuppressive doses of systemic steroids (equivalent to \> 10 mg per day of prednisone) for longer than 2 weeks.
• Active autoimmune disease, a history of inflammatory bowel disease (IBD)or other immune-related GI disorders (e.g., ulcerative colitis, Crohn's disease). Participant with type 1 diabetes mellitus, endocrinopathies stably maintained on appropriate replacement therapy, or skin disorders (e.g., vitiligo, psoriasis or alopecia) not requiring systemic treatment are allowed.
• Myocardial infarction or unstable angina within 6 months prior to the start of study intervention or currently has an uncontrolled illness including, but not limited to, symptomatic congestive heart failure, clinically significant cardiac disease, unstable angina pectoris, cardiac arrhythmia, complete left bundle branch block, obligate use of a cardiac pacemaker, long QT syndrome, right bundle branch block with left anterior hemiblock (bifascicular block) or severe hypertension not controlled with medical management.
• Corrected QT interval (QTcF) interval (single electrocardiogram (ECG)) \> 470 ms within 7 days prior to the first study intervention administration on day 1.
• Participant has left ventricular ejection fraction (LVEF) \< 45% noted in screening echocardiogram (ECHO). Any clinically significant findings from this ECHO should be discussed with the medical monitor.
• Participant with human immunodeficiency virus (HIV) infection. However, participants with HIV infection with CD4+ T cell counts \>/=350 cells/μL and no history of acquired immunodeficiency syndrome (AIDS)-defining opportunistic infections within the past 6 months or controlled disease on stable HAART without evidence of uncontrolled infection or clinically-relevant drug interactions with ASP1002 are eligible.
• Any of the following per screening serology test:
• Hepatitis A virus antibodies immunoglobulin (IgM)
• Positive HBsAg or detectable hepatitis B DNA. Participant with negative HBsAg, positive anti-HBc, must have HBV DNA testing performed.Participant is eligible if hepatitis B DNA is undetectable.
• hepatitis C virus (HCV) antibodies unless HCV Ribonucleic acid (RNA) is undetectable d HCV antibodies, and antigens (UNIQUE to Japan), unless HCV RNA is undetectable.
• History of drug or radiation induced pneumonitis, interstitial lung disease (ILD), currently has pneumonitis, or prior history of ILD/non-infectious pneumonitis requiring high-dose glucocorticoids.
• Unique to Japan: History of interstitial pneumonia.
• Uncontrolled intercurrent illness including, ongoing or active infection, symptomatic congestive heart failure, substance abuse or psychiatric illness/social situations that would limit compliance with study visits or requirements or a condition that could invalidate communication with the investigator.

Sponsors & Collaborators

• Astellas Pharma Global Development, Inc.: lead

Study Sites (15)

Yale University Cancer Center

New Haven, Connecticut, 06520, United States

RECRUITING

Hartford HealthCare Cancer Institute at The Hospital of Central Connecticut

Plainville, Connecticut, 06062, United States

RECRUITING

University of Florida

Gainesville, Florida, 32610, United States

RECRUITING

University of Iowa Hospitals

Iowa City, Iowa, 52242, United States

RECRUITING

Norton Cancer Institute

Louisville, Kentucky, 40202, United States

RECRUITING

Henry Ford Hospital

Detroit, Michigan, 48202, United States

RECRUITING

HealthPartners Cancer Research Center

Saint Paul, Minnesota, 55101, United States

RECRUITING

Icahn School of Medicine at Mount Sinai

New York, New York, 10029, United States

RECRUITING

University Hospitals of Cleveland

Cleveland, Ohio, 44106, United States

RECRUITING

Prisma Health-Upstate Cancer Institute

Greenville, South Carolina, 29605, United States

COMPLETED

SCRI Oncology Partners

Nashville, Tennessee, 37203, United States

COMPLETED

University of Texas Southwestern

Dallas, Texas, 75235, United States

COMPLETED

Mary Crowley Cancer Research Center

Dallas, Texas, 75251, United States

RECRUITING

NEXT Oncology Virginia

Fairfax, Virginia, 22031, United States

RECRUITING

Swedish Cancer Institute

Edmonds, Washington, 21632, United States

RECRUITING

MeSH Terms

Conditions

Neoplasms; Neoplasm Metastasis

Interventions

Bevacizumab; Oxaliplatin; Leucovorin; Fluorouracil; Irinotecan; trifluridine tipiracil drug combination; pembrolizumab; Pemetrexed; Carboplatin; Ramucirumab; Docetaxel

Condition Hierarchy (Ancestors)

Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Coordination Complexes; Organic Chemicals; Formyltetrahydrofolates; Tetrahydrofolates; Folic Acid; Pterins; Pteridines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Coenzymes; Enzymes and Coenzymes; Uracil; Pyrimidinones; Pyrimidines; Heterocyclic Compounds, 1-Ring; Camptothecin; Alkaloids; Guanine; Hypoxanthines; Purinones; Purines; Glutamates; Amino Acids, Acidic; Amino Acids; Amino Acids, Dicarboxylic; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Diterpenes; Terpenes

Study Officials

• Medical Director

  Astellas Pharma Global Development, Inc.

  STUDY DIRECTOR

Central Study Contacts

Astellas Pharma Global Development, Inc.

CONTACT

800-888-7704; Astellas.registration@astellas.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 31, 2023
• First Posted: February 9, 2023
• Study Start: March 13, 2023
• Primary Completion (Estimated): April 30, 2030
• Study Completion (Estimated): May 31, 2030
• Last Updated: July 23, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• Time Frame: Access to participant level data is offered to researchers after publication of the primary manuscript (if applicable) and is available as long as Astellas has legal authority to provide the data.
• Access Criteria: Researchers must submit a proposal to conduct a scientifically relevant analysis of the study data. The research proposal is reviewed by an Independent Research Panel. If the proposal is approved, access to the study data is provided in a secure data sharing environment after receipt of a signed Data Sharing Agreement.

Locations

US (15)