A study of ASP1570 taken by itself or with pembrolizumab in adults with solid tumors

Phase 1

Conditions: Advanced Solid Tumors
MedDRA version: 21.0Level: LLTClassification code: 10049280Term: Solid tumour Class: 10029104
Therapeutic area: Diseases [C] - Neoplasms [C04]

Registration Number: CTIS2023-505084-37-00

Lead Sponsor: Astellas Pharma Global Development Inc.

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 330

Inclusion Criteria

1. Institutional Review Board (IRB)/Independent Ethics Committee (IEC) approved written informed consent and privacy language (not applicable to China sites) as per national regulations (e.g., Health Insurance Portability and Accountability Act authorization for US study sites) must be obtained from the participant prior to any study-related procedures (including withdrawal of prohibited medication, if applicable)., 10. Participant has adequate organ function prior to start of study treatment (within 7 days prior to study drug 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); serum potassium >= 3.4 mEq/L; serum magnesium >= 1.7 mg/dL; serum ionized calcium >= 4.7 mg/dL. 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., 11. Participant has activated partial thromboplastin time and international normalized ratio (INR) = 1.5 × ULN and is not receiving anticoagulation., 12. Female participant is not pregnant and at least one of the following conditions apply: a. Not a woman of childbearing potential (WOCBP) b. 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 pembrolizumab administration, whichever occurs later., 13. 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 pembrolizumab administration, whichever occurs later., 14. Female participant must not donate ova starting at first dose of IP and throughout the study period and for at least 45 days after final ASP1570 administration or at least 120 days after pembrolizumab administration, whichever occurs later., 15. 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 pembrolizumab administration, whichever occurs later., 16. 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 pembrolizumab administration, whichever occurs later., 17. 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 administr

Exclusion Criteria

1. Participant has received investigational therapy within 21 days or 5 half-lives, whichever is shorter, (UNIQUE to China: and/or anti-tumor Chinese traditional medicine within 28 days) prior to the first dose of ASP1570 or 4 weeks prior to the first dose of pembrolizumab. Participants may continue the following therapies until 4 days prior to the start of study intervention administration: a.An EGFR TKI in a participant with EGFR-activating mutations (not applicable to NSCLC participants), b.ALK inhibitor in a participant with an ALK mutation (not applicable to NSCLC participants) or, c.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)., 19. 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., 20. Participant has had a major surgical procedure and has not completely recovered within 28 days prior to the first dose of IP., 11. Participant has a history of immune related pneumonitis (interstitial lung disease), currently has pneumonitis requiring high-dose glucocorticoids., 21. Participant has a history of bleeding diathesis., 22. Participant requires use of any anticoagulation therapy., 23. Participant has any condition, which, in the investigator’s opinion, makes the participant unsuitable for study participation., 24. Participant has a known or suspected hypersensitivity to ASP1570 or pembrolizumab (for combination therapy participants only), or any components of the formulation used., 25. 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 treatment., 26. For combination therapies, HIV-infected participants with a history of Kaposi sarcoma and/or Multicentric Castleman Disease., 12. Participant has an infection requiring systemic therapy within 14 days prior to the first dose of IP., 3. 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 30 mg per day of hydrocortisone and up to 10 mg prednisone) are allowed., 13. 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., 14. Participant has received a prior allogeneic hematopoietic stem cell transplant or solid organ transplant., 15. Participant is expected to require another form of antineoplastic therapy while on study treatment., 16. 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/so

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To determine the safety and tolerability of ASP1570 as monotherapy and in combination with pembrolizumab<br><br>To determine the RP2D and/or MTD, final recommended regimen of ASP1570 as monotherapy and in combination with pembrolizumab;Secondary Objective: To evaluate the anti-tumor effects of ASP1570 as monotherapy and in combination with pembrolizumab, To evaluate pharmacokinetics of ASP1570 as monotherapy and in combination with pembrolizumab, To evaluate the effect of ASP1570 as monotherapy and in combination with pembrolizumab on level and proliferative index of TILs in tumor microenvironment;Primary end point(s): Safety variables (e.g., incidence of DLTs and AEs; change from baseline in laboratory tests, vital signs and ECG)

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s):ORR, DOR, and DCR of ASP1570 as monotherapy and in combination with pembrolizumab per iRECIST and RECIST 1.1;Secondary end point(s):Selected pharmacokinetic parameters of ASP1570 as monotherapy and in combination with pembrolizumab in plasma: Cmax, tmax, AUCtau and Ctrough;Secondary end point(s):Changes in tumor infiltration with CD4/CD8 cells and level of their proliferation (CD4/CD8, Ki67+)

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