Study Stopped
Lack of clinical benefit
A Study of ASP1570 Taken by Itself, or ASP1570 Taken Together With Either Pembrolizumab, Standard Therapies, or Both, in Adults With Solid Tumors
A Phase 1/2 Study of ASP1570 as Monotherapy and in Combination With Pembrolizumab and/or Standard Therapies Including Chemotherapy and/or Immunotherapy in Participants With Locally Advanced or Metastatic Solid Tumors
6 other identifiers
interventional
226
6 countries
30
Brief Summary
Immune therapies work with the body's immune system to treat a number of cancers. They work with T-cells, a type of white blood cell, to target and attack specific tumors. However, some tumors can become resistant to attack by T-cells over time. They do this by sending "off" signals to T-cells. The researchers are finding ways to switch the T-cells back on. Before a treatment can be approved for use, clinical studies need to be done. This study will provide more information on ASP1570 in adults with advanced solid tumors. ASP1570 will either be given by itself, or given with another medicine called pembrolizumab, given with a standard cancer therapy, or given together with pembrolizumab and other medicines called pemetrexed and carboplatin. The main aims of this study are：
- To check the safety of ASP1570
- To check how well ASP1570 is tolerated
- To find a suitable dose of ASP1570 This study is for adults with advanced solid tumors. Their tumor has either grown outside of the area where it started (locally advanced and unresectable) or it has spread to other parts of the body (metastatic). Their cancer gets worse after standard therapy or they are unable to have standard therapy. The study doctors can give more advice about who can take part. This study will be in 2 parts. In Part 1, the most suitable dose of ASP1570 to give to people with advanced solid tumors will be worked out. Different small groups of people with advanced solid tumors will take lower to higher doses of ASP1570. People will either be given ASP1570 by itself, or ASP1570 with pembrolizumab, ASP1570 with a standard cancer therapy, or ASP1570 with pembrolizumab, pemetrexed and carboplatin. The study treatment given depends on the type of cancer people have. There are different doses of ASP1570, with each group staying on the same dose. There is just 1 standard dose of pembrolizumab. The dose of a standard cancer therapy depends on its label. After taking the lowest dose of ASP1570, the first group will be checked for medical problems. The next group can only take the higher dose of ASP1570 if the first group tolerates the lowest dose. This will continue in the same way for each group. Each group will take tablets of ASP1570 either once or twice every day in a 21-day cycle. People will continue with more treatment cycles on the same dose unless they can't tolerate the study treatment, their cancer gets worse or the study doctor decides that person should stop treatment. People who also receive treatment with pembrolizumab will be infused with pembrolizumab on the first day of every other cycle of ASP1570 (once every 6 weeks). People who are receiving a standard cancer therapy (with ASP1570) will be treated according to its label. In Part 2, different small groups of people with advanced solid tumors will take the most suitable dose of ASP1570 worked out from Part 1. The dose will not go above the highest dose that people could tolerate from Part 1. ASP1570 will be given either once a day or twice a day in a 21-day cycle. Pembrolizumab will be given once every 6 weeks. Other study treatments will be given in 14-day, 21-day or 28-day cycles. The cycle length and other study treatments given (pembrolizumab and the type of standard cancer therapy will depend on what type of tumor people have. The standard cancer therapies will be given according to their label. All groups will continue with more treatment cycles with ASP1570 (by itself with pembrolizumab, with a standard cancer therapy, or with pembrolizumab, pemetrexed and carboplatin) unless they can't tolerate the study treatment, their cancer gets worse or the study doctor decides that person should stop treatment.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started Oct 2021
Longer than P75 for phase_1
30 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 16, 2021
CompletedFirst Posted
Study publicly available on registry
October 19, 2021
CompletedStudy Start
First participant enrolled
October 19, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 11, 2026
CompletedStudy Completion
Last participant's last visit for all outcomes
May 11, 2026
CompletedJune 10, 2026
June 1, 2026
4.6 years
September 16, 2021
June 9, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (5)
Incidence of Dose Limiting Toxicities (DLTs) for ASP1570 Single Agent
A DLT is defined as any event meeting the DLT criteria occurring within 21 days of first dose on Cycle 1 Day 1 (C1D1), excluding toxicities clearly related to disease progression or intercurrent illness.
21 days
Number of Participants with Adverse Events (AEs)
Adverse events (AEs) will be coded using medical dictionary for regulatory activities (MedDRA). An AE is any untoward medical occurrence in a participant temporally associated with the use of study IP, whether or not considered related to the study IP. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of study IP. This includes events related to the comparator and events related to the (study) procedures.
Up to 27 months
Change from baseline to 45 days after End of Treatment (EOT) in laboratory values
National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) grade changes from baseline to highest post-baseline grade will be assessed.
Baseline and 45 days after EOT
Number of participants with vital sign abnormalities and/or AEs
Number of participants with potentially clinically significant vital sign values.
Up to 27 months
Number of participants with electrocardiogram (ECG) abnormalities and/or AEs
Number of participants with potentially clinically significant ECG values.
Up to 24 months
Secondary Outcomes (10)
Objective Response Rate (ORR) of ASP1570 per Immune Response Evaluation Criteria in Solid Tumors (iRECIST)
Up to 27 months
ORR of ASP1570 per Response Evaluation Criteria In Solid Tumors 1.1 (RECIST 1.1)
Up to 27 months
Duration of Response (DOR) of ASP1570 per iRECIST
Up to 27 months
Duration of Response (DOR) of ASP1570 per RECIST 1.1
Up to 27 months
Disease Control Rate (DCR) of ASP1570 per iRECIST
Up to 27 months
- +5 more secondary outcomes
Study Arms (11)
ASP1570 Monotherapy Dose Escalation (Part 1)
EXPERIMENTALParticipants will receive daily dose of ASP1570 in a 21-day cycle.
ASP1570 + pembrolizumab Combination therapy Dose Escalation (Part 1)
EXPERIMENTALParticipants will receive daily dose of ASP1570 in a 21-day cycle. pembrolizumab will be administered every 6 weeks on day 1 of every other ASP1570 cycle.
ASP1570 + Docetaxel Combination therapy Dose Expansion - NSCLC 2L+ (Part 2)
EXPERIMENTALParticipants who have NSCLC will receive RP2D of ASP1570 daily in a 21-day cycle. Docetaxel will be administered every 6 weeks on day 1 of every other ASP1570 cycle.
ASP1570 Monotherapy Dose Expansion - Food Effect (Part 2)
EXPERIMENTALParticipants will receive RP2D of ASP1570 after the meal in a 21-day cycle. This cohort will be opened at the discretion of the sponsor.
ASP1570 Monotherapy Dose Expansion - Intermittent dosing (Part 2)
EXPERIMENTALParticipants will receive RP2D of ASP1570 with some periodical drug holiday in a 21-day cycle. This cohort will be opened at the discretion of the sponsor.
ASP1570 Monotherapy Dose Expansion - Stepwise dosing (Part 2)
EXPERIMENTALParticipants will receive ASP1570 administered by intra-subject dose escalation with gradual multiple dose steps (e.g., 3 steps) and increased dose up to RP2D in a 21-day cycle. This cohort will be opened at the discretion of the sponsor.
ASP1570 Monotherapy Dose Expansion Microsatellite stable - colorectal cancer (MSS-CRC) (Part 2)
EXPERIMENTALParticipants who have MSS-CRC will receive ASP1570 in a 21-day cycle.
ASP1570 + TAS-102 + Bevacizumab Combination therapy Dose Expansion - MSS-CRC 3L+ (Part 2)
EXPERIMENTALParticipants who have MSS-CRC will receive ASP1570 daily in a 28-day cycle. TAS-102 (Trifluridine + Tipiracil) will be administered on days 1 through 5 and days 8 through 12 of each 28-day cycle. Bevacizumab will be administered every 2 weeks.
ASP1570 Monotherapy Dose Expansion NSCLC (Part 2)
EXPERIMENTALParticipants who have NSCLC will receive ASP1570 in a 21-day cycle.
ASP1570 + Pembrolizumab + Pemetrexed + Carboplatin CTDE - NSCLC 1L (Part 2)
EXPERIMENTALParticipants who have NSCLC will receive ASP1570 daily in a 21-day cycle. Pembrolizumab will be administered every 6 weeks on day 1 of every other ASP1570 cycle. Pemetrexed and carboplatin will be administered on day 1 of each 21-day cycle. Combination therapy Dose Expansion (CTDE)
ASP1570 + Bevacizumab + mFOLFOX6 or FOLFIRI Combination therapy Dose Expansion - MSS-CRC 2L (Part 2)
EXPERIMENTALParticipants who have MSS-CRC will receive ASP1570 in a 14-day cycle. Bevacizumab, will be administered every 2 weeks. mFOLFOX6 (oxaliplatin, Leucovorin, 5-fluorouracil) or FOLFIRI (Leucovorin, 5-Fluorouracil, Irinotecan) will administered every 2 weeks.
Interventions
Intravenous Infusion
Intravenous Infusion
Intravenous Infusion
Intravenous Infusion
Oral tablet
Intravenous Infusion
Intravenous Infusion
Intravenous Infusion
Intravenous Infusion
Intravenous Infusion
Oral Administration
Eligibility Criteria
You may qualify if:
- Participant has locally-advanced (unresectable) or metastatic solid tumor malignancy which is confirmed by available pathology records or current biopsy.
- Participant has at least 1 measurable lesion per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1. Lesions situated in a previously irradiated area are considered measurable if progression has been demonstrated in such lesions.
- Monotherapy Escalation Cohorts and China-specific Safety Lead-in Cohort:
- a) Participant has progressed on standard therapies, is no longer eligible for standard therapies or has refused standard approved therapies (no limit to the number of prior treatment regimens). (UNIQUE to China: Certain tumor types with specific criteria may be prioritized at the sponsor's discretion).
- Monotherapy Expansion Cohorts:
- a) Participant has MSS-CRC or NSCLC and has progressed was intolerant to at least 2 prior anti-cancer therapy regimens administered for metastatic disease.
- Monotherapy Dose Optimization Cohorts:
- a) Participant has MSS-CRC or NSCLC and has progressed or was intolerant to at least 2 prior anti-cancer therapy regimens administered for metastatic disease.
- Combination Therapy Escalation and/or Expansion Cohorts:
- a) For NSCLC (2L+) Combination Therapy Cohort only:
- Participant has Stage IV NSCLC and has progressed on or after checkpoint inhibitors with or without platinum-based chemotherapy.
- Participant is eligible to receive docetaxel. b) For MSS-CRC (3L+) Combination Therapy Cohorts only:
- Participant must have progressed or was intolerant to at least 2 prior anti-cancer therapy regimens administered for metastatic disease.
- Participant is eligible to receive TAS-102 and bevacizumab.
- All Comers Combination with Pembrolizumab Cohorts only:
- +63 more criteria
You may not qualify if:
- Participant has received antineoplastic therapy, including investigational therapy within 28 days or 5 half-lives (whichever is shorter) (antitumor traditional Chinese medicine within 14 days) prior to the start of study intervention administration.
- Participant requires or has received systemic steroid therapy or any other immunosuppressive therapy within 14 days prior to the first dose of IP. Participants using a physiologic replacement dose of hydrocortisone or its equivalent (defined as up to 10 mg prednisone) are allowed.
- Participant requires strong or moderate CYP2D6 inhibitors (e.g., bupropion, fluoxetine, paroxetine, duloxetine, abiraterone) during the study.
- Participant has symptomatic central nervous system (CNS) metastases or participant has evidence of unstable CNS metastases 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 treatment and are on a stable dose of ≤ 10 mg/day of prednisone or equivalent for at least 2 weeks (if requiring steroid treatment). Participant does not have leptomeningeal disease.
- Participant has an autoimmune disease. Participants with type 1 diabetes mellitus, endocrinopathies stably maintained on appropriate replacement therapy are allowed.
- Participant was discontinued from prior immunomodulatory therapy due to a toxicity that requires permanent discontinuation per toxicity management guidelines that was mechanistically related (e.g., immune related) to the agent.
- Participant has a known history of human immunodeficiency virus (HIV) infection. However, participants with HIV with cluster of differentiation 4 (CD4)+ T-cell counts ≥ 350 cells/µL and no history of AIDS-defining opportunistic infections within the past 6 months are eligible. NOTE: Screening for HIV infection should be conducted per local requirements.
- Participant has any of the following per screening serology test:
- Hepatitis A virus (HAV) antibodies (immunoglobulin M \[IgM\])
- Positive hepatitis B surface antigen (HBsAg). For participants with negative HBsAg, but positive HBcAB, an HBV DNA test will be performed and if positive the participants will be excluded.
- Hepatitis C virus (HCV) antibodies unless HCV RNA is undetectable
- Participant has received a live or live attenuated vaccine against infectious diseases within 28 days prior to the first dose of study intervention.
- Participant has a history of noninfectious pneumonitis/interstitial lung disease \[ILD\], that required steroids, or currently has pneumonitis/interstitial lung disease.
- Participant has received prior radiotherapy within 2 weeks of start of study treatment or have had a history of radiation pneumonitis.
- Note: Participants must have recovered from all radiation-related toxicities and not require corticosteroids \> 10 mg per day of prednisone or equivalent. A 1-week washout is permitted for palliative radiation (≤ 2 weeks of radiotherapy) to non-CNS disease.
- +18 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Merck Sharp & Dohme LLCcollaborator
- Astellas Pharma Global Development, Inc.lead
Study Sites (30)
Providence Medical Foundation
Fullerton, California, 92835, United States
California Research Institute
Los Angeles, California, 90027, United States
USC/Norris Comprehensive Cancer Center
Los Angeles, California, 90033, United States
Florida Cancer Specialist & Research Institute Sarasota
Sarasota, Florida, 34232, United States
University of Chicago
Chicago, Illinois, 60637, United States
University of Kentucky Medical Center MCC-CRO
Lexington, Kentucky, 40536, United States
Nebraska Methodist Hospital
Omaha, Nebraska, 68130, United States
University Hospitals Cleveland Medical Center
Cleveland, Ohio, 44106, United States
UPMC Hillman Cancer Center
Pittsburgh, Pennsylvania, 15232, United States
SCRI Oncology Partners
Nashville, Tennessee, 37203, United States
Mary Crowley Research Center
Dallas, Texas, 75230, United States
University of Wisconsin Clinical Science Center
Madison, Wisconsin, 53792, United States
Sun Yat-Sen University Cancer Center
Guangzhou, Guangdong, China
Second Affiliated Hospital Zhejiang University School of Medicine (SAHZU)
Hangzhou, Zhejiang, China
Beijing Cancer Hospital
Beijing, China
Shanghai East Hospital
Shanghai, China
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, China
FR33007
Besançon, France
Site FR33002
Bordeaux, France
FR33008
Paris, France
FR33005
Saint-Herblain, France
FR33009
Toulouse, France
National Cancer Center Hospital
Chuo-ku, Tokyo, Japan
Cancer Institute Hospital Of JFCR
Koto-ku, Tokyo, Japan
Puerto Rico Medical Center
Río Piedras, Puerto Rico
Site ES34005
A Coruña, Barcelona, Spain
Site ES34002
Madrid, Spain
ES34008
Málaga, Spain
Site ES34007
Málaga, Spain
Site ES34006
Pozuelo de Alarcón, Spain
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Medical Director
Astellas Pharma Global Development, Inc.
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
September 16, 2021
First Posted
October 19, 2021
Study Start
October 19, 2021
Primary Completion
May 11, 2026
Study Completion
May 11, 2026
Last Updated
June 10, 2026
Record last verified: 2026-06
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.
Access to anonymized individual participant level data collected during the study, in addition to study-related supporting documentation, is planned for studies conducted with approved product indications and formulations, as well as products terminated during development. Studies conducted with product indications or formulations that remain active in development are assessed after study completion to determine if Individual Participant Data can be shared. Further details on Astellas' data sharing policy can be found at https://www.clinicaltrials.astellas.com/transparency/.