Skip to main content
OpenTrials
Not Yet Recruiting

NCT Number: NCT07756281

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

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.

Not Yet Recruiting

Trial opening soon.

Get Notified

Key information

Conditions

Pancreatic Cancer Digestive System Diseases Digestive System Neoplasms Endocrine Gland Neoplasms Endocrine System Diseases Neoplasms Neoplasms by Site Pancreatic Acinar Carcinoma Pancreatic Diseases Pancreatic Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Other names: PARP inhibitor

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.

Other names: RAS inhibitor

Primary outcomes

  1. 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

    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

Secondary outcomes

  1. Maximum plasma concentration (Cmax) of SNV1521

    Time frame: through study completion, an average of 1 year

    Cmax of SNV1521 following oral dosing in combination with daraxonrasib, based on concentration-time data collected at protocol-specified PK time points

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

    Time frame: through study completion, an average of 1 year

    AUC for SNV1521 following oral administration in combination with daraxonrasib, derived from concentration-time data at protocol-specified PK sampling time points

  3. Maximum plasma concentration (Cmax) of daraxonrasib

    Time frame: through study completion, an average of 1 year

    Cmax for daraxonrasib following oral administration in combination with SNV1521, derived from concentration-time data at protocol-specified PK sampling time points

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

    Time frame: through study completion, an average of 1 year

    AUC for daraxonrasib following oral administration in combination with SNV1521, derived from concentration-time data at protocol-specified PK sampling time points.

Study contacts

Contact information is provided by the study sponsor or research team.

Kevin O'Hayer

CONTACT

[email protected]

919-451-6590

Sponsors and collaborators

Lead sponsor

Synnovation Therapeutics, Inc.

Industry

Collaborators

  • Revolution Medicines, Inc.

Registry information

Official study title

A Phase 1, Open-Label, Dose-Escalation and Expansion Study of SNV1521 in Combination With RAS Inhibition in Participants With Locally Advanced Unresectable or Metastatic Pancreatic Cancer

Important dates

Study start
2026
Primary completion
2029
Study completion
2029
First posted
Aug 10, 2026
Registry last updated
Aug 10, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.