Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as RMC-9805
Zoldonrasib · 3 trials · 18 indications
PFS is defined as the time from randomization until disease progression or death from any cause, whichever occurs first. Progression is assessed per response evaluation criteria in solid tumors (RECIST) v1.1 by blinded independent central review (BICR).
OS is defined as the time from randomization until death from any cause.
Incidence and severity of treatment-emergent Adverse Events (AEs) and serious AEs and clinically significant changes in laboratory values, ECGs, and vital signs
Number of participants with Dose Limiting Toxicities (DLTs)
| Arm | Type | Description |
|---|---|---|
| Arm A: zoldonrasib + pembrolizumab + chemotherapy doublet | EXPERIMENTAL | study drug in combination with pembrolizumab and platinum-based chemotherapy doublet |
| Arm B: placebo + pembrolizumab + chemotherapy doublet | PLACEBO_COMPARATOR | placebo in combination with pembrolizumab and platinum-based chemotherapy doublet |
| Arm A: zoldonrasib + chemotherapy | EXPERIMENTAL | study drug in combination with Investigator choice chemotherapy (mFFX or GnP) |
| Arm B: placebo + chemotherapy | PLACEBO_COMPARATOR | placebo in combination with Investigator choice chemotherapy (mFFX or GnP) |
| RMC-9805 monotherapy arm | EXPERIMENTAL | Dose exploration and dose expansion |
| RMC-9805 plus RMC-6236 combination arm | EXPERIMENTAL | Dose exploration and dose expansion |
| Name | Type | Description |
|---|---|---|
| zoldonrasib | DRUG | oral tablets |
| Placebo | DRUG | oral tablets |
| pembrolizumab | DRUG | IV infusion or Subcutaneous injection |
| pemetrexed + cisplatin /carboplatin | DRUG | IV infusion of either pemetrexed + cisplatin or pemetrexed + carboplatin |
| 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 |
| RMC-9805 | DRUG | Oral Tablets |
| RMC-6236 | DRUG | Oral Tablets |
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, previously untreated metastatic non-squamous NSCLC. * Known PD-L1 status * Documented RAS G12D mutati...
Zoldonrasib is an investigational oral small molecule being studied for KRAS G12D-mutated cancers, including non-small cell lung cancer (NSCLC) and pancreatic cancer. It is being evaluated as a first-line treatment in metastatic non-squamous RAS G12D-mutated NSCLC and in metastatic KRAS G12D-mutated pancreatic adenocarcinoma, and in a Phase 1 study of KRAS G12D-mutant solid tumors.
Zoldonrasib targets RAS, specifically the KRAS G12D mutant protein. It is a small molecule designed to bind the RAS protein, and its clinical development is biomarker-selected, meaning patients are enrolled based on the presence of a KRAS G12D mutation in their tumor. RAS proteins are a family of signaling proteins involved in cell growth and division.
Zoldonrasib is being developed by Revolution Medicines, Inc., which trades on the Nasdaq under the ticker RVMD. The company is running the clinical program for the drug, including a Phase 3 study in non-small cell lung cancer and a Phase 3 study in pancreatic adenocarcinoma.
Zoldonrasib is in Phase 3 clinical development. It has received Breakthrough Therapy designation from the FDA. The program includes two Phase 3 trials, one in metastatic non-squamous RAS G12D-mutated NSCLC and one in metastatic KRAS G12D-mutated pancreatic adenocarcinoma, plus a Phase 1 study in KRAS G12D-mutant solid tumors.
Zoldonrasib is being studied in three recruiting trials. NCT07777822 is a Phase 3 trial of pembrolizumab plus pemetrexed plus platinum chemotherapy with or without Zoldonrasib in first-line metastatic non-squamous RAS G12D-mutated NSCLC, enrolling 430 patients. NCT07621718 (RASolute 305) is a Phase 3 trial in metastatic KRAS G12D-mutated pancreatic adenocarcinoma, enrolling 670 patients. NCT06040541 is a Phase 1 study in KRAS G12D-mutant solid tumors.
Yes, Zoldonrasib is also known as RMC-9805. RMC-9805 is the earlier code name used for the same investigational compound, and it appears under that name in the Phase 1 trial record NCT06040541. Both names refer to the same RAS-targeting small molecule being developed by Revolution Medicines.