A Study of E7386 in Combination With Pembrolizumab in Previously Treated Participants With Select… (NCT05091346) | Clinical Trial Compass
CompletedPhase 1/2
A Study of E7386 in Combination With Pembrolizumab in Previously Treated Participants With Selected Solid Tumors
United States89 participantsStarted 2021-10-27
Plain-language summary
The Phase 1b part of this study is conducted to assess the safety and tolerability of E7386 in combination with pembrolizumab in participants with previously treated selected solid tumors, and to determine the recommended Phase 2 dose (RP2D) of E7386 in combination with pembrolizumab.
The Phase 2 part of this study is conducted to assess the objective response rate (ORR) of E7386 in combination with pembrolizumab (melanoma, colorectal cancer \[CRC\], hepatocellular carcinoma \[HCC\]) or of E7386 in combination with pembrolizumab plus lenvatinib (HCC) according to Response Evaluation Criteria in Solid Tumors (RECIST) 1.1.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Male or female, age \>=18 years at the time of informed consent
✓. Have a histologically or cytologically-documented, advanced (metastatic and/or unresectable) selected solid tumor for which prior standard systemic therapy has failed. Selected tumor types: melanoma (excluding uveal melanoma), CRC, HCC
✓. Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
✓. Must have disease progression on current or since the last anticancer treatment
✓. At least one measurable lesion by computer tomography (CT) or magnetic imaging resonance (MRI) based on RECIST 1.1
✓. Adequate organ function and serum mineral level per blood work as confirmed by the investigator
✓. Calcium (albumin-corrected) within normal range
✓. Potassium within normal reference range
Exclusion criteria
✕. Have present or progressive accumulation of pleural, ascitic, or pericardial fluid requiring drainage or diuretic drugs within 2 weeks prior to study drug administration. The participant can receive diuretic drugs as needed per the treating physician. Consult with the sponsor if the participant has more than trivial/trace fluid accumulation.
What they're measuring
1
Phase 1b Part: Number of Participants With Dose-limiting Toxicities (DLTs)
Timeframe: Cycle 1 (Cycle length=21 days)
2
Phase 1b Part: Number of Participants With Treatment Emergent Adverse Events (TEAEs)
Timeframe: Up to 30 days after last dose of study drug (up to 12.73 months)
3
Phase 1b Part: Number of Participants With Serious TEAEs
Timeframe: Up to 90 days after last dose of study drug (up to 14.73 months)
✕. Prior treatment with E7386 or prior therapy with anti-PD-1, anti-PD-L1, or anti PD-L2 agent or with an agent directed to another stimulatory or co-inhibitory T-cell receptor (example, CTLA-4, OX 40, CD137) that was discontinued due to a Grade 3 or higher immune-related (ir)AE
✕. Participants with central nervous system (CNS) metastases are not eligible unless they are previously treated are radiologically stable, that is, without evidence of progression for at least 4 weeks by repeat imaging (note that the repeat imaging should be performed during study screening), and are clinically stable and without requirement of steroid treatment for at least 14 days prior to first dose of study treatment
✕. Any active infection requiring systemic treatment
✕. Have severe hypersensitivity to study drugs and/or any of its excipients
✕. Have a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to the first dose of study drug.
✕. Have an active autoimmune disease that has required systemic treatment in the past 2 years
✕. Have a history of (non-infectious) pneumonitis that required steroids or has current pneumonitis