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

ParVation Therapeutics, Inc.

Status and phase: Enrolling; Phase 1

Conditions: Pancreatic Acinar Carcinoma; Pancreatic Cancer

Treatments: Drug: daraxonrasib; Drug: SNV1521

Study type: Interventional

Funder types: Industry

Identifiers

NCT07756281

SNV1521-102

Details and patient eligibility

About

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.

Enrollment: 40 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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40 participants in 1 patient group

Escalation

Experimental group

Description:

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.

Treatment:

Drug: SNV1521

Drug: daraxonrasib