First in Human Study of SNV1521 With a RAS Inhibitor for People With Advanced Pancreatic Cancer

Sponsor
Synnovation Therapeutics, Inc.
Study ID
NCT07756281
Phase
PHASE1
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • SNV1521 — DRUG
    SNV1521 is an oral investigational anticancer drug. In this study, SNV1521 is administered at different dose levels together with the RAS inhibitor daraxonrasib in adults with locally advanced unresectable or metastatic pancreatic cancer.
  • daraxonrasib — DRUG
    Daraxonrasib is an oral targeted cancer medicine used in this study together with SNV1521. It is given once daily to help evaluate the safety and tolerability of the drug combination in people with advanced pancreatic cancer.

Study Details

This study is a Phase 1 clinical trial testing an oral investigational drug called SNV1521 together with a RAS-targeted cancer medicine in people with pancreatic cancer that cannot be removed by surgery or has spread. The main goals are to find doses of the drug combination that are safe and tolerable and to look for early signs that the treatment may help control the cancer. Participants will receive the study medicines in repeating cycles and will have regular blood tests, scans, and other exams to monitor side effects and how their cancer responds.

Key Dates

First listed
Aug 10, 2026
Start date
Sep 30, 2026
Status verified
Aug 2026
Primary completion
Jun 1, 2029
Completion
Jun 1, 2029

Study Design

Enrollment
40 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Escalation
    Participants in this arm will take SNV1521 by mouth together with a RAS-targeted cancer medicine. The dose of SNV1521 will be increased in small steps to find a safe and tolerable dose of the combination in people with advanced pancreatic cancer.

Primary Outcome Measure

Safety and tolerability of SNV1521 plus daraxonrasib: treatment-emergent adverse events, serious adverse events, and dose-limiting toxicities [ Time Frame: through study completion, an average of 1 year ]

Central Contacts

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