A Study of ASP1570 Taken by Itself, or ASP1570 Taken Together With Either Pembrolizumab, Standard Therapies, or Both, in Adults With Solid Tumors

Stopped early · Phase 1/Phase 2

Conditions studied: Advanced Solid Tumors

In brief

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.

Key facts

Study ID

NCT05083481

Run by

Astellas Pharma Global Development, Inc.

People needed

226

Starts

2021-10-19

Expected to finish

2026-05-11

Last updated by the study team

2026-06-10

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

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:
• Participant who has progressed on standard therapies, are no longer eligible for standard therapies or has refused standard approved therapies.
• Participant is eligible to receive pembrolizumab
• For NSCLC (1L) Combination Therapy Cohorts only:
• Participant has PD-L1 low (TPS = 1% to 49%) or negative (TPS < 1%) and AGA negative Stage IV adenocarcinoma (mixed histology is not allowed).
• Participant has not received prior systemic treatment for their advanced/metastatic NSCLC.
• Participant who remains disease free for 12 months following the completion of neoadjuvant/adjuvant treatment is eligible.
• Participant is eligible to receive pembrolizumab + pemetrexed + carboplatin.
• For MSS-CRC (2L) Combination Therapy Cohorts only:
• Participant is AGA negative and HER2 negative.
• mFOLFOX6 + Bevacizumab:

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.
• Participant has an infection requiring systemic therapy within 14 days prior to the first dose of study intervention.
• Participant has received a prior allogenic hematopoietic stem cell transplant or solid organ transplant.
• Participant is expected to require another form of antineoplastic therapy while on study treatment.
• Participant has had a myocardial infarction or unstable angina within 6 months prior to the start of study treatment or currently has an uncontrolled illness including, but not limited to symptomatic congestive heart failure, clinically significant cardiac disease, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
• Participant has inadequately controlled hypertension (defined as systolic blood pressure >= 140 and/or diastolic blood pressure >= 90 mmHg on antihypertensive medications, or systolic blood pressure > 130 and/or diastolic blood pressure > 80 mmHg without antihypertensive medications).
• Participant has a corrected QT interval using Fridericia's formula (QTcF) > 450 msec (for male and female participants) during screening. ECGs will be performed in triplicate during screening. (The average of the triplicate readings will be used in the calculation for corrected QT interval [QTc]).
• Participant has a prior malignancy, other than the current malignancy for which the participant is seeking treatment, active (i.e., requiring treatment or intervention) within the previous 2 years except for locally curable malignancies that have been apparently cured, such as basal or squamous cell skin cancer, superficial bladder cancer or carcinoma in situ of the cervix or breast.
• Participant has had a major surgical procedure and has not completely recovered within 28 days prior to the first dose of study intervention.
• Participant has a history of bleeding diathesis that makes the participant unsuitable for study participation.
• Participant requires use of any anticoagulation therapy.

Where it is running

• Providence Medical Foundation — Fullerton, California, United States
• California Research Institute — Los Angeles, California, United States
• USC/Norris Comprehensive Cancer Center — Los Angeles, California, United States
• Florida Cancer Specialist & Research Institute Sarasota — Sarasota, Florida, United States
• University of Chicago — Chicago, Illinois, United States
• University of Kentucky Medical Center MCC-CRO — Lexington, Kentucky, United States
• Nebraska Methodist Hospital — Omaha, Nebraska, United States
• University Hospitals Cleveland Medical Center — Cleveland, Ohio, United States
• UPMC Hillman Cancer Center — Pittsburgh, Pennsylvania, United States
• SCRI Oncology Partners — Nashville, Tennessee, United States
• Mary Crowley Research Center — Dallas, Texas, United States
• University of Wisconsin Clinical Science Center — Madison, Wisconsin, 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

Full record on ClinicalTrials.gov

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