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

NCT07756281 | Not Yet Recruiting Phase 1 FDA Drug

• 1 other identifier: SNV1521-102
• Study Type: interventional
• Target: 40
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Pancreatic Cancer; Pancreatic Acinar Carcinoma

Keywords

daraxonrasib; PARP; pancreas; pancreatic cancer

Outcome Measures

Primary Outcomes (1)

• 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

  through study completion, an average of 1 year

Secondary Outcomes (4)

• Maximum plasma concentration (Cmax) of SNV1521

  through study completion, an average of 1 year

• Area under the plasma concentration-time curve (AUC) of SNV1521

  through study completion, an average of 1 year

• Maximum plasma concentration (Cmax) of daraxonrasib

  through study completion, an average of 1 year

• Area under the plasma concentration-time curve (AUC) of daraxonrasib

  through study completion, an average of 1 year

Study Arms (1)

Escalation

EXPERIMENTAL

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.

Drug: SNV1521; Drug: daraxonrasib

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.

Also known as: PARP inhibitor

Escalation

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.

Also known as: RAS inhibitor

Escalation

Eligibility Criteria

• Age: 18 Years+
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Synnovation Therapeutics, Inc.: lead
• Revolution Medicines, Inc.: collaborator

MeSH Terms

Conditions

Pancreatic Neoplasms

Interventions

Poly(ADP-ribose) Polymerase Inhibitors

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Enzyme Inhibitors; Molecular Mechanisms of Pharmacological Action; Pharmacologic Actions; Chemical Actions and Uses; Antineoplastic Agents; Therapeutic Uses

Central Study Contacts

Kevin O'Hayer

CONTACT

919-451-6590; kohayer@synnovationtx.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 9, 2026
• First Posted: August 10, 2026
• Study Start (Estimated): September 1, 2026
• Primary Completion (Estimated): June 1, 2029
• Study Completion (Estimated): June 1, 2029
• Last Updated: August 10, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will not share