Phase 2
Completed N=22
Study of ASP7517 Alone and With Pembrolizumab in Participants With Advanced Solid Tumors Expressing WT1 Antigen
Advanced Malignancies · Cancer
Source: ClinicalTrials.gov NCT04837196 ↗
Enrolled (actual)
22
Serious AEs
20.8%
Results posted
Aug 2025
Primary outcomePrimary: Number of Participants With Treatment Emergent Adverse Events and Serious Adverse Events: Monotherapy — 3; 7; 2; 0 Participants
Summary
The purpose of this study was to evaluate the safety, tolerability, and clinical response of ASP7517, and determine the Recommended Phase 2 Dose (RP2D) and/or the Maximum Tolerated Dose (MTD) of ASP7517 when administered as a single agent and in combination with pembrolizumab.
This study also evaluated other measures of anticancer activity of ASP7517 when administered as a single agent and in combination with pembrolizumab based on central and local assessment.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Treatment Emergent Adverse Events and Serious Adverse Events: Monotherapy |
3; 7; 2; 0; 2; 0 | — |
| PRIMARY Number of Participants With Treatment Emergent Adverse Events and Serious Adverse Events: Combination Therapy |
3; 8; 1; 2 | — |
| PRIMARY Number of Participants With ECOG Performance Status at Cycle (C) 1 Day (D) 1 |
1; 4; 2; 1; 3; 2 | — |
| PRIMARY Number of Participants With ECOG Performance Status at C1D2 |
1; 3; 1; 3; 2; 5 | — |
| PRIMARY Number of Participants With ECOG Performance Status at C1D4 |
1; 4; 1; 1; 3; 2 | — |
| PRIMARY Number of Participants With ECOG Performance Status at C1D8 |
1; 3; 1; 1; 3; 2 | — |
| PRIMARY Number of Participants With ECOG Performance Status at C1D15 |
1; 3; 1; 1; 2; 2 | — |
| PRIMARY Number of Participants With ECOG Performance Status at C2D1 |
0; 3; 1; 2; 2; 2 | — |
| PRIMARY Number of Participants With ECOG Performance Status at C2D4 |
0; 3; 1; 2; 1; 2 | — |
| PRIMARY Number of Participants With ECOG Performance Status at C2D8 |
0; 2; 1; 2; 1; 2 | — |
| PRIMARY Number of Participants With ECOG Performance Status at C2D15 |
0; 1; 0; 2; 1; 2 | — |
| PRIMARY Number of Participants With ECOG Performance Status at C3D1 |
0; 1; 1; 1; 1; 2 | — |
| PRIMARY Number of Participants With ECOG Performance Status at C3D8 |
0; 1; 1; 1; 1; 2 | — |
| PRIMARY Number of Participants With ECOG Performance Status at C3D15 |
0; 0; 1; 1; 1; 2 | — |
| PRIMARY Number of Participants With ECOG Performance Status at C4D1 |
0; 0; 1; 1; 1; 2 | — |
| PRIMARY Number of Participants With ECOG Performance Status at C4D8 |
0; 0; 1; 1; 1; 0 | — |
| PRIMARY Number of Participants With ECOG Performance Status at C4D15 |
0; 1; 0; 1; 0; 3 | — |
| PRIMARY Number of Participants With ECOG Performance Status at C5D1 |
0; 3; 0; 0; 0; 0 | — |
| PRIMARY Number of Participants With ECOG Performance Status at C5D8 |
0; 3; 0; 0; 0; 0 | — |
| PRIMARY Number of Participants With ECOG Performance Status at C5D15 |
0; 3; 0; 0; 0; 0 | — |
| PRIMARY Number of Participants With ECOG Performance Status at C6D1 |
0; 3; 0; 0; 0; 0 | — |
| PRIMARY Number of Participants With ECOG Performance Status at C6D8 |
0; 2; 0; 0; 0; 0 | — |
| PRIMARY Number of Participants With ECOG Performance Status at C6D15 |
0; 1; 0; 0; 0; 0 | — |
| PRIMARY Number of Participants With ECOG Performance Status at End of Treatment (EOT): Monotherapy |
1; 2; 0; 1; 1; 2 | — |
| PRIMARY Number of Participants With ECOG Performance Status at End of Treatment (EOT): Combination Therapy. |
0; 1; 1; 4; 0; 0 | — |
| PRIMARY Number of Participants With ECOG Performance Status at 30 Day Follow Up: Monotherapy |
0; 0; 1; 0; 0; 0 | — |
| PRIMARY Number of Participants With ECOG Performance Status at 30 Day Follow Up: Combination Therapy |
1; 1; 0; 2; 0; 0 | — |
| PRIMARY Number of Participants With ECOG Performance Status at 60 Day Follow Up: Monotherapy |
0; 1; 0; 1; 0; 1 | — |
| PRIMARY Number of Participants With ECOG Performance Status at 60 Day Follow Up: Combination Therapy |
0; 1; 0; 0; 0; 0 | — |
| PRIMARY Number of Participants With ECOG Performance Status at 90 Day Follow Up: Monotherapy |
1; 0; 0; 0; 0; 0 | — |
| PRIMARY Number of Participants With ECOG Performance Status at 90 Day Follow Up: Combination Therapy |
0; 1; 0; 0; 0; 0 | — |
| PRIMARY Number of Participants With Dose Limiting Toxicities (DLTs) |
0; 0; 0; 0 | — |
| PRIMARY Objective Response Rate (iORR) Per Immune Response Evaluation Criteria in Solid Tumors (iRECIST) by Investigator Assessment |
0; 0; 0; 0; 0; 0 | — |
| SECONDARY Objective Response Rate (ORR) Per RECIST v1.1 by Investigator Assessment |
0; 0; 0; 0; 0; 0 | — |
| SECONDARY Disease Control Rate Per iRECIST (iDCR) by Investigator Assessment |
33.3; 42.9; 0; 33.3; 57.1; 33.3 | — |
| SECONDARY Disease Control Rate (DCR) Per RECIST v1.1 by Investigator Assessment |
33.3; 42.9; 0; 33.3; 57.1; 33.3 | — |
| SECONDARY Progression-Free Survival Per iRECIST (iPFS) Using Investigator Assessment |
398.0; 57.0; 77.0; 106.0; 106.0 | — |
| SECONDARY Progression-Free Survival Per RECIST (PFS) Using Investigator Assessment |
57.0; 57.0; 77.0; 57.0; 57.0 | — |
| SECONDARY Overall Survival (OS) |
404.0; 169.0; NA; NA; NA | — |
| SECONDARY Duration of Response Per iRECIST (iDOR) |
— | — |
| SECONDARY Duration of Response (DOR) Per RECIST v1.1 |
— | — |
Eligibility Criteria
Inclusion Criteria
- Participant has locally-advanced (unresectable) or metastatic solid tumor malignancy that is confirmed by available pathology records or current biopsy. Participant must also have received all standard therapies (unless the therapy is contraindicated or intolerable) appropriate to provide clinical benefit for his/her specific tumor type. However, participants with metastatic melanoma who have not received checkpoint inhibitors [CPIs] (i.e., CPIs naive) may enroll in the Phase 2 Combination Therapy Arm Dose Expansion Cohort to receive CPI: Pembrolizumab.
- Participant must be diagnosed with solid tumor known to express WT1 antigen such as, but not limited to melanoma, ovarian cancer or Colorectal Cancer (CRC).
- Participant consents to provide an archival tumor specimen in a tissue block or unstained serial slides, if available, prior to study treatment.
- Participant has an Eastern Cooperative Oncology Group (ECOG) Performance Status of ≤ 2.
- Participant's last dose of prior antineoplastic therapy, including any immunotherapy, was 21 days or 5 half-lives, whichever is shorter, prior to initiation of IP administration. A participant with BRAF gene, epidermal growth factor receptor (EGFR) or anaplastic lymphoma kinase (ALK) mutation positive non-small cell lung carcinoma is allowed to remain on epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor (TKI) or anaplastic lymphoma kinase (ALK) or BRAF inhibitor therapy until 4 days prior to the start of Investigational Product (IP) administration.
- Participant has completed any radiotherapy (including stereotactic radiosurgery) at least 2 weeks prior to IP administration.
- Participant's Adverse Events (AEs) (excluding alopecia) from prior therapy have improved to grade 1 or baseline within 14 days prior to start of IP.
- Participant has adequate organ function prior to start of IP. If a participant has received a recent blood transfusion, the laboratory tests must be obtained ≥ 4 weeks after any blood transfusion.
- A female participant is eligible to participate if she is not pregnant and at least 1 of the following conditions applies:
- Not a woman of childbearing potential (WOCBP) OR
- WOCBP who agrees to follow the contraceptive guidance from the time of informed consent through at least 6 months after the final IP administration.
- Female participant must agree not to breastfeed starting at screening and throughout the IP and for 180 days after the final IP administration.
- Female participant must not donate ova starting at screening and throughout the IP and for 180 days after the final IP administration.
- A 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 180 days after the final IP administration.
- Male participant must not donate sperm during the treatment period and for 180 days after the final IP administration.
- 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 180 days after the final IP administration.
- Participant agrees not to participate in another interventional study while receiving IP.
Additional Inclusion Criteria for Participants in the Expansion Cohorts:
- Participant meets one of the following:
- Participant has the tumor type for which a confirmed response was observed in a monotherapy dose escalation cohort (monotherapy arm only) cohort; OR
- For tumor specific expansion cohorts of ASP7517 or ASP7517 with pembrolizumab, participant has the applicable tumor type; CPI refractory metastatic melanoma (monotherapy and combination arms), CPI naïve melanoma (combination arm only), ovarian cancer, colorectal cancer (CRC).
- 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
Data sourced from ClinicalTrials.gov (NCT04837196). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.