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

Phase 1Not Yet RecruitingNCT07756281

Synnovation Therapeutics, Inc.40 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Pancreatic Cancer Pancreatic Acinar Carcinoma

Interventions

daraxonrasibDRUG

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.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Adults (18 years and older). * Diagnosis of pancreatic cancer that cannot be removed by surgery or has spread to other parts of the body. * Cancer confirmed by tissue or cell examination (histology or cytology). * At least one measurable tumor on scans. * Good enough general health and organ function to receive study treatment, as judged by the study doctor. * Able to swallow oral medicines. * Willing to follow study visit schedule and contraception requirements. Exclusion Criteria: * Serious heart, lung, liver, or other medical problems that would make study treatment unsafe. * Active, uncontrolled infections. * Other active cancers that could interfere with study assessments (except certain early-stage cancers that have been treated). * Prior treatments or medicines that are not allowed by the protocol (for example, some strong drug interactions). * Known brain or nervous system involvement from the cancer that is not stable or controlled. * Pregnant or breastfeeding, or unwilling to use required birth control during and after the study.

Outcomes

Primary Outcomes

Safety and tolerability of SNV1521 plus daraxonrasib: treatment-emergent adverse events, serious adverse events, and dose-limiting toxicities

Number, type, and severity of treatment-emergent adverse events, serious adverse events, and dose-limiting toxicities in participants receiving SNV1521 plus daraxonrasib, used to identify doses suitable for further study, classified and graded according to CTCAE v6.0 and protocol-defined DLT criteria