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

NCT07756281 — Phase 1, Not yet recruiting, 40 participants, ParVation Therapeutics, Inc.

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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

Registry	NCT07756281
Status	Not yet recruiting
Phase	Phase 1
Study type	Interventional; na, single group, masking: none, treatment
Enrollment	40 (Estimated)
Sponsor	ParVation Therapeutics, Inc. (Industry); collaborators: Revolution Medicines, Inc.
Conditions	Pancreatic Cancer, Pancreatic Acinar Carcinoma
Interventions	SNV1521, daraxonrasib (Drug)
Dates	start 2026-09-01 (estimated), primary completion 2029-06-01 (estimated), completion 2029-06-01 (estimated), first posted 2026-08-10, last updated 2026-08-10

-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.

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+Arms and interventions

Arm	Type	Interventions	Description
Escalation	Experimental	Drug: SNV1521; Drug: daraxonrasib	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.

SNV1521 (Drug), also known as PARP inhibitor: 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), also known as RAS inhibitor: 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.

+Outcome measures

Primary outcomes

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

Maximum plasma concentration (Cmax) of SNV1521 [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
Area under the plasma concentration-time curve (AUC) of SNV1521 [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
Maximum plasma concentration (Cmax) of daraxonrasib [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
Area under the plasma concentration-time curve (AUC) of daraxonrasib [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.

+Eligibility

Sex: All, ages: 18 Years to any

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.