Study of ASP7517 Alone and With Pembrolizumab in Participants With Advanced Solid Tumors Expressing WT1 Antigen
- Conditions
- Advanced MalignanciesAdvanced Cancer
- Registration Number
- NCT04837196
- Lead Sponsor
- Astellas Pharma Global Development, Inc.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 24
Inclusion Criteria:<br><br> - Participant has locally-advanced (unresectable) or metastatic solid tumor malignancy<br> that is confirmed by available pathology records or current biopsy. Participant must<br> also have received all standard therapies (unless the therapy is contraindicated or<br> intolerable) appropriate to provide clinical benefit for his/her specific tumor<br> type. However, participants with metastatic melanoma who have not received<br> checkpoint inhibitors [CPIs] (i.e., CPIs naive) may enroll in the Phase 2<br> Combination Therapy Arm Dose Expansion Cohort to receive CPI: Pembrolizumab.<br><br> - Participant must be diagnosed with solid tumor known to express WT1 antigen such as,<br> but not limited to melanoma, ovarian cancer or Colorectal Cancer (CRC).<br><br> - Participant consents to provide an archival tumor specimen in a tissue block or<br> unstained serial slides, if available, prior to study treatment.<br><br> - Participant has an Eastern Cooperative Oncology Group (ECOG) Performance Status of =<br> 2.<br><br> - Participant's last dose of prior antineoplastic therapy, including any<br> immunotherapy, was 21 days or 5 half-lives, whichever is shorter, prior to<br> initiation of IP administration. A participant with BRAF gene, epidermal growth<br> factor receptor (EGFR) or anaplastic lymphoma kinase (ALK) mutation positive<br> non-small cell lung carcinoma is allowed to remain on epidermal growth factor<br> receptor (EGFR) tyrosine kinase inhibitor (TKI) or anaplastic lymphoma kinase (ALK)<br> or BRAF inhibitor therapy until 4 days prior to the start of Investigational Product<br> (IP) administration.<br><br> - Participant has completed any radiotherapy (including stereotactic radiosurgery) at<br> least 2 weeks prior to IP administration.<br><br> - Participant's Adverse Events (AEs) (excluding alopecia) from prior therapy have<br> improved to grade 1 or baseline within 14 days prior to start of IP.<br><br> - Participant has adequate organ function prior to start of IP. If a participant has<br> received a recent blood transfusion, the laboratory tests must be obtained = 4 weeks<br> after any blood transfusion.<br><br> - A female participant is eligible to participate if she is not pregnant and at least<br> 1 of the following conditions applies:<br><br> - Not a woman of childbearing potential (WOCBP) OR<br><br> - WOCBP who agrees to follow the contraceptive guidance from the time of informed<br> consent through at least 6 months after the final IP administration.<br><br> - Female participant must agree not to breastfeed starting at screening and throughout<br> the IP and for 180 days after the final IP administration.<br><br> - Female participant must not donate ova starting at screening and throughout the IP<br> and for 180 days after the final IP administration.<br><br> - A male participant with female partner(s) of childbearing potential (including<br> breastfeeding partner) must agree to use contraception throughout the treatment<br> period and for at least 180 days after the final IP administration.<br><br> - Male participant must not donate sperm during the treatment period and for 180 days<br> after the final IP administration.<br><br> - Male participant with pregnant partner(s) must agree to remain abstinent or use a<br> condom for the duration of the pregnancy throughout the study period and for 180<br> days after the final IP administration.<br><br> - Participant agrees not to participate in another interventional study while<br> receiving IP.<br><br>Additional Inclusion Criteria for Participants in the Expansion Cohorts:<br><br> - Participant meets one of the following:<br><br> - Participant has the tumor type for which a confirmed response was observed in a<br> monotherapy dose escalation cohort (monotherapy arm only) cohort; OR<br><br> - For tumor specific expansion cohorts of ASP7517 or ASP7517 with pembrolizumab,<br> participant has the applicable tumor type; CPI refractory metastatic melanoma<br> (monotherapy and combination arms), CPI naïve melanoma (combination arm only),<br> ovarian cancer, colorectal cancer (CRC).<br><br> - Participant has at least 1 measurable lesion per response evaluation criteria in<br> solid tumors (RECIST) v1.1. Lesions situated in a previously irradiated area are<br> considered measurable if progression has been demonstrated in such lesions.<br><br> - Participant consents to provide a tumor specimen in a tissue block or unstained<br> serial slides obtained within 56 days prior to first dose of IP. If a recent tissue<br> sample cannot be provided due to medical or safety concerns, enrollment into the<br> study must be discussed with the medical monitor.<br><br> - Participant consents to undergoing a tumor biopsy (core tissue biopsy or excision)<br> during the treatment period as indicated in the schedule of assessments if predose<br> biopsy is available and if medically feasible.<br><br>Exclusion Criteria:<br><br> - Participant weighs < 45 kg at screening.<br><br> - Participant has received investigational therapy (other than an investigational EGFR<br> TKI in a participant with EGFR activating mutations or ALK or BRAF inhibitor in a<br> participant with an ALK mutation) within 21 days or 5 half-lives, whichever is<br> shorter, prior to start of IP.<br><br> - Participant requires or has received systemic steroid therapy or any other<br> immunosuppressive therapy within 14 days prior to Cycle 1 Day 1. Participants using<br> a physiologic replacement dose of hydrocortisone or its equivalent (defined as up to<br> 30 mg per day of hydrocortisone up to 10 mg per day of prednisone) are allowed.<br><br> - Participant has symptomatic central nervous system (CNS) metastases or participant<br> has evidence of unstable CNS metastases even if asymptomatic (e.g., progression on<br> scans). Participants with previously treated CNS metastases are eligible, if they<br> are clinically stable and have no evidence of CNS progression by imaging for at<br> least 4 weeks prior to start of IP and are not requiring immunosuppressive doses of<br> systemic steroids (> 30 mg per day of hydrocortisone or > 10 mg per day of<br> prednisone or equivalent) for longer than 2 weeks.<br><br> - Participant has an active autoimmune disease. Participants with type 1 diabetes<br> mellitus, endocrinopathies stably maintained on appropriate replacement therapy or<br> skin disorders (e.g., vitiligo, psoriasis or alopecia) not requiring systemic<br> treatment are allowed.<br><br> - Participant was discontinued from prior immunomodulatory therapy due to a grade = 3<br> toxicity that was mechanistically related (e.g., immune related) to the agent.<br><br> - Participant has known history of serious hypersensitivity reaction to a known<br> ingredient of ASP7517 or pembrolizumab or severe hypersensitivity reaction to<br> treatment with another monoclonal antibody.<br><br> - Participant has a known history of human immunodeficiency virus.<br><br> - Participant with known history of positive hepatitis B surface antigen or isolated<br> hepatitis B core antibody (including acute HBV or chronic HBV) or hepatitis C ([HCV]<br> ribonucleic acid [RNA] detected by qualitative assay). Hepatitis C RNA testing is<br> not required in participants with negative hepatitis C antibody testing.<br><br> - Participant has received a live vaccine against infectious diseases within 28 days<br> prior to initiation of IP.<br><br> - Participant has a history of dru
Not provided
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Incidence of Dose Limiting Toxicities (DLTs);Number of participants with adverse events (AEs);Number of participants with serious adverse events (SAEs);Number of participants with laboratory value abnormalities and/or AEs;Number of participants with 12-lead electrocardiogram (ECG) abnormalities and/or AEs;Number of participants with vital sign abnormalities and/or AEs;Number of participants with physical exam abnormalities and/or AEs;Number of participants at each grade of the Eastern Cooperative Oncology Group (ECOG) performance status;Objective Response Rate per modified Response Evaluation Criteria in Solid Tumors (iRECIST) (iORR)
- Secondary Outcome Measures
Name Time Method Objective Response Rate (ORR) per Response Evaluation Criteria for Solid Tumors (RECIST) v1.1;Disease Control Rate per iRECIST (iDCR);Disease Control Rate (DCR) per RECIST v1.1;Progression-Free Survival per iRECIST (iPFS) using Independent Central Review;Progression-Free Survival per iRECIST (iPFS) using Investigator Assessment;Progression-Free Survival (PFS) per RECIST v1.1 using Independent Central Review;Progression Free Survival (PFS) per RECIST v1.1 using Investigator Assessment;Duration of Overall Survival (OS);Duration of Response per iRECIST (iDOR) using Independent Central Review;Duration of Response per iRECIST (iDOR) using Investigator Assessment;Duration of Response (DOR) per RECIST v1.1 using Independent Central Review;Duration of Response (DOR) per RECIST v1.1 using Investigator Assessment