RASolute 303: A Phase 3 Global, Multicenter, Open-label, Randomized, 3-Arm Study of Daraxonrasib Monotherapy or Daraxonrasib Plus Gemcitabine and Nab-paclitaxel versus Gemcitabine and Nab-paclitaxel as a First-Line Treatment for Patients with Metastatic Pancreatic Adenocarcinoma

The purpose of this study is to evaluate the safety and efficacy of an investigational
RAS(ON) inhibitor administered as monotherapy or in combination with chemotherapy,
compared with standard of care (SOC) chemotherapy alone.

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 informed consent.

- Documented RAS mutation status, either mutant or wild-type.

- 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 metastatic setting or prior
RAS-targeted therapy in any treatment setting.

- 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.