Study of Zoldonrasib + Chemo of Investigator's Choice vs Placebo + Chemo of Investigator's Choice as First-line Treatment in Metastatic KRAS G12D-mutated Pancreatic Adenocarcinoma ( RASolute 305 )

Summary

The purpose of this study is to evaluate the efficacy of an investigational RAS(ON) inhibitor administered in combination with chemotherapy compared to placebo in combination with chemotherapy.

Interventions

• Zoldonrasib · DRUG

  oral tablets

• Placebo · DRUG

  oral tablets

• Oxaliplatin · DRUG

  IV infusion

• Leucovorin (Calcium Folinate) · DRUG

  IV infusion

• 5-Fluorouracil · DRUG

  IV infusion

• Irinotecan · DRUG

  IV infusion

• Gemcitabine (GEM) · DRUG

  IV infusion

• Nab-paclitaxel · DRUG

  IV infusion

Published eligibility criteria

Verbatim from the registry. Only the site can decide how these apply to a specific patient.

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.
* Diagnosis of metastatic disease ≤ 6 weeks prior to screening.
* Documented KRAS G12D mutation status.
* Measurable disease per RECIST v1.1.
* Adequate organ function (bone marrow, liver, kidney, coagulation).
* Able to take oral medications.

Exclusion Criteria:

* Prior treatment with systemic anticancer therapy in unresectable locally advanced or metastatic setting.
* Prior systemic RAS-targeted therapy any time prior to randomization.
* Presence of other known driver mutations with approved targeted therapies
* Active or known history of untreated central nervous system metastatic 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.

Sites (6)

• The University of Arizona Cancer Center-North Campus, Tucson, Arizona · RECRUITING
• Moffitt Cancer Center, Tampa, Florida · RECRUITING
• Piedmont Healthcare, Atlanta, Georgia · RECRUITING
• University of Chicago Medical Center, Chicago, Illinois · RECRUITING
• Johns Hopkins University, Baltimore, Maryland · RECRUITING
• Astera Cancer Care, East Brunswick, New Jersey · RECRUITING