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Testing ASP1570 alone or with other therapies for advanced solid tumors

A Phase 1/2 Study of ASP1570 as Monotherapy and in Combination With Pembrolizumab or Standard Therapies Including Chemotherapy and/or Immunotherapy in Participants With Locally Advanced or Metastatic Solid Tumors

Phase1; Phase2 Interventional Astellas Pharma Inc · NCT05083481

This study is testing a new immune therapy called ASP1570, either by itself or with other treatments, to see if it can help adults with advanced solid tumors that haven't responded to standard therapies.

Quick facts

PhasePhase1; Phase2
Study typeInterventional
Enrollment310 (estimated)
Ages18 Years and up
SexAll
SponsorAstellas Pharma Inc Industry-sponsored
Drugs / interventionsbevacizumab, pembrolizumab, chemotherapy, immunotherapy, radiation, prednisone
Locations26 sites (Fullerton, California and 25 other locations)
Trial IDNCT05083481 on ClinicalTrials.gov

What this trial studies

This study evaluates the safety and tolerability of ASP1570, an immune therapy, in adults with advanced solid tumors. Participants will receive ASP1570 either alone, in combination with pembrolizumab, or alongside standard cancer treatments. The study aims to determine the appropriate dosage of ASP1570 and assess its effectiveness in reactivating T-cells to combat tumors that have become resistant to treatment. The research will involve patients with locally advanced or metastatic solid tumors who have progressed on standard therapies.

Who should consider this trial

Good fit: Ideal candidates include adults with locally advanced or metastatic solid tumors who have progressed on standard therapies.

Not a fit: Patients with early-stage tumors that are resectable or those who have not yet undergone standard therapies may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide a new treatment option for patients with advanced solid tumors that are resistant to current therapies.

How similar studies have performed: Other studies have shown promise with similar immune therapy approaches, indicating potential for success in this novel combination.

Eligibility criteria

Show full inclusion / exclusion criteria 
Inclusion Criteria:

* 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 and Combination 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: Tumor types will be determined at the sponsor's discretion.)
* Monotherapy Expansion Cohorts and China-specific Safety Lead-in Cohort:

  a) Participant has histologically confirmed diagnosis of locally advanced or metastatic MSS-CRC and has progressed was intolerant to at least 2 prior cancer therapy regimens administered for metastatic disease.
* Monotherapy Dose Optimization Cohorts:

  a) Participant has histologically confirmed diagnosis of locally advanced or metastatic MSS-CRC and has progressed or was intolerant to at least 2 prior cancer therapy regimens administered for metastatic disease.
* Combination Therapy Cohorts:

  a) For NSCLC Combination Therapy Cohort only:
* Participant has histologically confirmed or cytologically confirmed diagnosis of Stage IV NSCLC and has progressed on or after platinum-based chemotherapy and/or checkpoint inhibitors.
* Participant is eligible to receive docetaxel. b) For MSS CRC Combination Therapy Cohort only:
* Participant has histologically confirmed diagnosis of locally advanced or metastatic MSS-CRC.
* Participant must have progressed or was intolerant to at least 2 prior cancer therapy regimens administered for metastatic disease.
* Participant is eligible to receive TAS-102 and bevacizumab.

Monotherapy and Combination Therapy Additional Backfill Participants:

* Participant has histologically confirmed diagnosis of Stage IV NSCLC and has progressed on or after receiving platinum based chemotherapy and/or checkpoint inhibitors in the first line of therapy.
* Participant has an Eastern Cooperative Oncology Group (ECOG) Status of 0 or 1.
* Monotherapy cohorts and combination dose escalation cohorts only:
* Participant's last dose of prior antineoplastic therapy, including any immunotherapy, was at least 21 days prior to the first dose of study intervention administration. A participant with solid tumors that have a NTRK gene fusion without a known acquired resistance mutation or EGFR or anaplastic lymphomas kinase (ALK) mutation-positive NSCLC is allowed to remain on EGFR tyrosine kinase inhibitor (TKI), ALK inhibitor therapy or NTRK inhibitor therapy until 4 days prior to the first dose of study intervention. Note: This is not applicable to participants with NSCLC in the combination dose expansion cohort.
* Participants who have received radiotherapy must have completed this therapy (including stereotactic radiosurgery) at least 2 weeks prior to the first dose of study intervention.
* Participant's adverse events (excluding alopecia) from prior therapy have resolved or improved to grade 1 at least 14 days prior to the first dose of study intervention. Note: Participants 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 adequate organ function prior to start of study treatment (within 7 days prior to study intervention treatment initiation) as indicated by the following laboratory values. If a participant has received a recent blood transfusion, the laboratory tests must be obtained \>= 2 weeks after any blood transfusion: Absolute Neutrophil Count (ANC) \>= 1500/µL; Platelets \>= 100,000/µL; Hemoglobin \>= 9 g/dL (Criterion must be met without packed red blood cell transfusion within the 2 weeks prior. Participants can be on stable dose of erythropoietin (approximately ≥ 3 months); Creatinine clearance \>= 60 mL/min (calculated by Cockcroft-Gault equation); Total Bilirubin either (a) \<= 1.5 x ULN or (b) Direct bilirubin \<= ULN and total bilirubin \< 3 x ULN (for participants with Gilbert's syndrome); aspartate aminotransferase (AST) \[serum glutamic oxaloacetic transaminase (SGOT)\] and alanine aminotransferase (ALT) \[serum glutamic pyruvic transaminase (SGPT)\] \<= 2.5 x ULN without liver metastases (or \<= 5 x ULN if liver metastases are present); Thyroid stimulating hormone (TSH) within normal limits. Note: if TSH is not within normal limits at baseline, participant may still be eligible if T3 and/or FT4 are within the normal limits.
* Participant has activated partial thromboplastin time and international normalized ratio (INR) \<= 1.5 x ULN and is not receiving anticoagulation.
* Female participant is not pregnant and at least one 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 45 days after final ASP1570 administration or at least 120 days after administration of pembrolizumab or standard therapies, whichever occurs later.
* Female participant must agree not to breastfeed starting at screening and throughout the study period and for at least 45 days after final ASP1570 administration or at least 120 days after administration of pembrolizumab or standard therapies, whichever occurs later.
* Female participant must not donate ova starting at first dose of study intervention and throughout the study period and for at least 45 days after final ASP1570 administration or at least 120 days after administration of pembrolizumab or standard therapies, whichever occurs later.
* Male participant with female partner(s) of childbearing potential (including breastfeeding partner) must agree to use contraception throughout the treatment period and for at least 45 days after final ASP1570 administration or at least 120 days after administration of pembrolizumab or standard therapies, whichever occurs later.
* Male participant must not donate sperm during the treatment period and for at least 45 days after final ASP1570 administration or at least 120 days after administration of pembrolizumab or standard therapies, whichever occurs later.
* Male participant with pregnant partner(s) must agree to remain abstinent or use a condom for the duration of the pregnancy throughout the study period and for at least 45 days after final ASP1570 administration or at least 120 days after administration of pembrolizumab or standard therapies, whichever occurs later.
* Participant agrees not to participate in another interventional study while receiving study treatment in the present study.

Exclusion Criteria:

* Participant has received investigational therapy within 21 days or 5 half-lives, whichever is shorter, (UNIQUE to China: and/or antitumor Chinese traditional medicine within 28 days) prior to the first dose of ASP1570 or 4 weeks prior to the first dose of pembrolizumab or standard therapies.
* Participants may continue the following therapies until 4 days prior to the start of study intervention administration:

  1. An EGFR TKI in a participant with EGFR-activating mutations (not applicable to NSCLC participants),
  2. ALK inhibitor in a participant with an ALK mutation (not applicable to NSCLC participants) or,
  3. NTRK inhibitor in a participant with solid tumors that have a NTRK gene fusion without a known acquired resistance mutation (not applicable to NSCLC participants).
* 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 not requiring immunosuppressive doses of systemic steroids (\> 10 mg per day of prednisone or equivalent) for no longer than 2 weeks.
* Participant has an autoimmune disease. Participants 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 was discontinued from prior immunomodulatory therapy due to a Grade \>= 3 toxicity 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) or detectable hepatitis B DNA. Participants 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
  * 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 immune related pneumonitis (interstitial lung disease \[ILD\]), currently has pneumonitis requiring high-dose glucocorticoids.
* 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. 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 \>150 and/or diastolic blood pressure \> 100 mmHg on 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 that makes the participant unsuitable for study participation.
* Participant has any condition that makes the participant unsuitable for study participation.
* Participant has a known or suspected hypersensitivity to ASP1570. For participants entering combination therapy, they have a known or suspected hypersensitivity to the respective standard therapy study intervention (pembrolizumab, docetaxel, TAS 102 and/or bevacizumab), or any components of the formulation used.
* For the combination therapies, participant has received radiation therapy to the lung that is \> 30 Gy within 6 months of the first dose of study intervention.
* All Solid Tumors Combination Therapy Cohort only: HIV-infected participants with a history of Kaposi sarcoma and/or multicentric Castleman disease.
* Dose expansion combination therapy, China safety lead in and backfill participants: NSCLC participants with known actionable driver mutation (e.g., EGFR, ALK, NTRK.

Where this trial is running

Fullerton, California and 25 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Advanced Solid TumorsASP1570Pembrolizumab
Last reviewed 2026-06-15 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.