Study of Zoldonrasib (RMC-9805) Plus Daraxonrasib (RMC-6236) Versus Gemcitabine and Nab-Paclitaxel as First-Line Treatment in Metastatic KRAS G12D-Mutated Pancreatic Adenocarcinoma

Summary

The purpose of this study is to evaluate the efficacy of combination therapy with two investigational RAS(ON) inhibitors (daraxonrasib and zoldonrasib) compared to chemotherapy.

Eligibility

Inclusion Criteria:

* At least 18 years old and has provided informed consent.
* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
* Histologically or cytologically confirmed pancreatic adenocarcinoma, including adenosquamous carcinoma, not previously treated in the locally advanced unresectable or metastatic setting.
* No prior treatment in the locally advanced unresectable or metastatic setting
* Diagnosis of metastatic disease ≤ 6 weeks prior to informed consent.
* Documented KRAS G12D mutation status.
* Measurable disease per RECIST v1.1.
* Adequate organ function (bone marrow, liver, kidney, coagulation).

Exclusion Criteria:

* Mutation status with known driver mutations for which there are approved targeted therapies.
* Acinar cell carcinoma, pancreatic neuroendocrine tumors, tumors involving islet cells or islet cell neoplasms, and other non-adenocarcinoma pancreatic malignancies.
* Tumors determined to originate from non-pancreatic primary sites.
* Prior treatment with MAPK-pathway targeted therapy or administration of RAS-targeted vaccine in the metastatic setting.
* Active or known history of untreated central nervous system metastatic or leptomeningeal disease.
* Any conditions that may affect the ability to take or absorb study drug.
* Major surgery within 28 days prior to randomization.
* Patient is unable or unwilling to comply with protocol-required study visits or procedures.
* Additional inclusion \& exclusion criteria may apply.

Conditions9

Interventions4

Locations1 site

Find trials near these locations

Related trials

• Study of Daraxonrasib (RMC-6236) in Patients With RAS Mutated NSCLC (RASolve 301) — Revolution Medicines, Inc.
• Study of Daraxonrasib (RMC-6236) in Patients With Resected Pancreatic Ductal Adenocarcinoma (PDAC) — Revolution Medicines, Inc.
• Study of Daraxonrasib and Daraxonrasib + GnP as First-line Treatment in Patients With Metastatic Pancreatic Adenocarcinoma — Revolution Medicines, Inc.
• Study of Elironrasib and Daraxonrasib as Monotherapies and Combination Therapy in Participants With Advanced KRAS G12C Mutant Solid Tumors — Revolution Medicines, Inc.
• Study of RAS(ON) Inhibitors in Combination With Ivonescimab in Patients With Solid Tumors — Revolution Medicines, Inc.
• A Study of BMS-986504 Monotherapy and in Combination With Other Agents in Participants With Advanced and/or Metastatic Solid Tumors With Homozygous MTAP Deletion (MountainTAP-5) — Bristol-Myers Squibb
• Study of RMC-5127 in Patients With Advanced KRAS G12V-Mutant Solid Tumors — Revolution Medicines, Inc.
• 9MW2821 in Combination With Toripalimab vs Standard Chemotherapy in Locally Advanced or Metastatic Urothelial Cancer — Mabwell (Shanghai) Bioscience Co., Ltd.

Browse More Trials