A Study of ASP1002 in Adults for Treatment of Solid Tumors

NCT05719558 | Recruiting Phase 1 FDA Drug

• 1 other identifier: 1002-CL-0101
• Study Type: interventional
• Target: 210
• Locations: 1 country
• Sites: 15

Brief Summary

The main aims of this study are:

• To check the safety of ASP1002 in people with certain solid tumors.
• To check if the people can tolerate ASP1002.
• To find a suitable dose of ASP1002. This study will be in 2 parts. In Part 1, different small groups of people will receive lower to higher doses of ASP1002. 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 that worked the best in Part 1. People in this study will be adults with metastatic or locally advanced solid tumors with high levels of a protein called claudin 4. The people's cancer will have either spread to other parts of the body (metastatic) or spread to tissue close by (locally advanced). They will have been previously treated with available standard therapies or refused to receive those treatments. In both parts of the study, ASP1002 (the study treatment) will be given to people slowly through a tube into a vein. This is called an infusion. This will happen every week, every other week, or every 3 weeks, in treatment cycles. Treatment cycles may be 21 days or 28 days long. People in this study will continue treatment for up to 2 years until: they have medical problems that prevent them from continuing treatment; their cancer gets worse; they start other cancer treatment; they ask to stop treatment; they do not come back for treatment. 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 few weeks, the study doctors will check if each person's cancer has stayed the same or got worse. 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 treatment has finished. People will visit the clinic within 7 days after stopping treatment for a health check. Then, they may visit the clinic at 1 month and 3 months after stopping treatment for further health checks. People will have follow-up health checks for up to 1 year after their last dose of ASP1002.

Conditions

Advanced Solid Tumors

Keywords

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 (12)

• Pharmacokinetics (PK) of ASP1002 in serum: AUC0-7d

  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 (4)

ASP1002 Dose Escalation (Part 1)

EXPERIMENTAL

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

Drug: ASP1002

ASP1002 Dose Expansion (Part 2) non-small cell lung cancer (NSCLC)

EXPERIMENTAL

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

Drug: ASP1002

Experimental: AS1002 Dose Expansion (Part 2) urothelial carcinoma (UC)

EXPERIMENTAL

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

Drug: ASP1002

Experimental: ASP1002 Dose Expansion (Part 2) colorectal cancer (CRC)

EXPERIMENTAL

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

Drug: ASP1002

Interventions

ASP1002 DRUG

intravenous (IV) infusion

ASP1002 Dose Escalation (Part 1); ASP1002 Dose Expansion (Part 2) non-small cell lung cancer (NSCLC); Experimental: AS1002 Dose Expansion (Part 2) urothelial carcinoma (UC); Experimental: ASP1002 Dose Expansion (Part 2) colorectal cancer (CRC)

Eligibility Criteria

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

You may qualify if:

• Participant has locally-advanced (unresectable or metastatic solid tumor which is confirmed by available pathology records or current biopsy.
• I. NSCLC - adenocarcinoma, squamous cell carcinoma and adenosquamous are included; large cell carcinoma and sarcomatoid carcinoma are excluded.
• Note: NSCLC Not Otherwise Specified will require documented discussion with the medical monitor prior to study entry II. UC II. CRC IV. Prostate adenocarcinoma V. Epithelial ovarian cancer (including fallopian tube cancer) VI. 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 \[Hammond et al, 2010\].
• For dose expansion, the participant must have one of the following malignancies (for all tumor types, any component of neuroendocrine histology is not eligible):
• I. NSCLC - adenocarcinoma, squamous cell carcinoma and adenosquamous are included; large cell carcinoma and sarcomatoid carcinoma are excluded. Note: NSCLC Not Otherwise Specified will require documented discussion with the medical monitor prior to study entry.
• II. UC III. CRC IV. Tumor type for which a confirmed response was observed during dose escalation.
• Female participant is not pregnant, confirmed by pregnancy test (and medical evaluation by interview \[UNIQUE to Japan\]), 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 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) from either the primary tumor or a metastatic site, for which source and availability have been confirmed prior to study intervention; participants without available tissue should undergo a mandatory biopsy. If the participant is unable to undergo a biopsy due to safety concerns, enrollment into the study is at the discretion of the medical monitor. 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.
• Participant has an Eastern Cooperative Oncology Group (ECOG) Status of 0 or 1.
• Participants who have received radiotherapy must have completed this therapy (including stereotactic radiosurgery) at least 2 weeks prior to study intervention administration.

You may not qualify if:

• Participant weighs \< 40 kg.
• Participant has ongoing toxicity \>/= grade 2 per the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 considered clinically significant and attributable to prior antineoplastic therapies.
• Participant has 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 and 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.
• Participant has an active autoimmune 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.
• Participant has had a 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 or right bundle branch block with left anterior hemiblock (bifascicular block).
• Participant has a corrected 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 is known to have 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 are eligible. Note: No HIV testing is required at screening unless mandated per local requirements.
• Participant has any of the following per screening serology test:
• a. Hepatitis A virus antibodies immunoglobulin (IgM)
• b. Positive hepatitis B surface antigen (HBsAg) or detectable hepatitis B Deoxyribonucleic Acid (DNA). Participant with negative HBsAg, positive hepatitis B core antibody (anti-HBc) and negative hepatitis B surface antibody (anti-HBs) are eligible if hepatitis B DNA is undetectable
• c. 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.
• Participant has a history of drug-induced pneumonitis, interstitial lung disease (ILD), currently has pneumonitis, or a prior history of ILD or non-infectious pneumonitis requiring high-dose glucocorticoids.
• UNIQUE to Japan: Participant has a history of interstitial pneumonia.

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

Condition Hierarchy (Ancestors)

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

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, 2028
• Study Completion (Estimated): May 31, 2028
• Last Updated: March 18, 2026

Record last verified: 2026-03

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)