KRAS G12D inhibitor (ON state) · small molecule

zoldonrasib

8 active trials across 2 of our biomarkers, targeting KRAS G12D. Not approved for any biomarker on marked.bio yet.

Also known as RMC-9805.

Counts only trials that select patients by one of the biomarkers on marked.bio, not every trial of this drug.

Biomarkers

BiomarkerActive trialsAll trialsFurthest active phase
KRAS G12D 8 8 Phase 3
KRAS G12C 4 4 Phase 1/2

Sponsors

Industry sponsors leading active biomarker-selected trials of zoldonrasib.

  1. Revolution Medicines 7
  2. Tango Therapeutics 1

Trials

Status

8 of 8 trials shown

  1. 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

    Recruiting Phase 3 Revolution Medicines Started 2026Primary completion 2029-03 NCT07805954

    daraxonrasibgemcitabinenab-paclitaxelzoldonrasib

    …ib (RMC-6236) Versus Gemcitabine and Nab-Paclitaxel as First-Line Treatment in Metastatic KRAS G12D-Mutated Pancreatic Adenocarcinoma

    KRAS G12DPancreatic Cancer, Pancreatic Cancer Metastatic, PDAC, PDAC - Pancreatic Ductal Adenocarcinoma

  2. Study of Pembrolizumab + Pemetrexed + Platinum Chemotherapy With or Without Zoldonrasib as First Line Treatment in Metastatic Non-squamous RAS G12D-Mutated NSCLC

    Recruiting Phase 3 Revolution Medicines Started 2026Primary completion 2029-10 NCT07777822

    zoldonrasibpembrolizumabpemetrexedcisplatincarboplatin

    …herapy With or Without Zoldonrasib as First Line Treatment in Metastatic Non-squamous RAS G12D-Mutated NSCLC

    KRAS G12DNSCLC, Non-small Cell Lung Cancer, Non-Small Cell Lung Cancer NSCLC, Non-Squamous Non Small Cell Lung Cancer

  3. 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 )

    Recruiting Phase 3 Revolution Medicines Started 2026Primary completion 2028-12 NCT07621718

    zoldonrasiboxaliplatinleucovorinfluorouracilirinotecangemcitabinenab-paclitaxel

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

    KRAS G12DPancreatic Cancer, Pancreatic Cancer Metastatic, PDAC, PDAC - Pancreatic Ductal Adenocarcinoma

  4. Study of RAS(ON) Inhibitors in Combination With Ivonescimab in Patients With Solid Tumors

    Recruiting Phase 1/2 Revolution Medicines Started 2026Primary completion 2029-05 NCT07397338

    daraxonrasibelironrasibzoldonrasibivonescimabcarboplatincisplatinpemetrexedcetuximab

    …ogically confirmed, locally advanced or metastatic solid tumor malignancy with documented RAS mutation in KRAS, HRAS, or NRAS.

    KRAS G12CKRAS G12DAdvanced Solid Tumors, Metastatic Solid Tumors, Non-small Cell Lung Cancer (NSCLC), NSCLC

  5. Study to Evaluate the Safety, Tolerability & Efficacy of TNG462 in Combination in PDAC & NSCLC Patients

    Recruiting Phase 1/2 Tango Therapeutics Started 2025Primary completion 2027-06 NCT06922591

    TNG462zoldonrasibdaraxonrasibmFOLFIRINOXgemcitabinenab-paclitaxel

    Arms A and B only: Has a tumor with a RAS mutation

    KRAS G12CKRAS G12DPDAC, PDAC - Pancreatic Ductal Adenocarcinoma, NSCLC, RAS Mutation

  6. Study of RAS(ON) Inhibitors in Patients With Advanced RAS-mutated NSCLC

    Recruiting Phase 1/2 Revolution Medicines Started 2024Primary completion 2027-06 NCT06162221

    elironrasibdaraxonrasibpembrolizumabcisplatincarboplatinpemetrexedzoldonrasib

    Must have pathologically documented, locally advanced or metastatic KRAS G12C-mutated solid tumor malignancy (not amenable to curative surgery) (Subprotocol A)

    KRAS G12CKRAS G12DNon-Small Cell Lung Cancer, NSCLC, KRAS, NRAS, HRAS-mutated NSCLC, KRAS G12C-mutated Solid Tumors, Lung Cancer, Lung Cancer Stage IV, Advanced Solid Tumor, Cancer

  7. Study of RAS(ON) Inhibitors in Patients With Gastrointestinal Solid Tumors

    Recruiting Phase 1/2 Revolution Medicines Started 2024Primary completion 2028-09 NCT06445062

    daraxonrasibmFOLFOX6bevacizumabmFOLFIRINOXcetuximabgemcitabinenab-paclitaxelzoldonrasibFOLFIRI

    …reatic carcinoma or poorly differentiated pancreatic carcinoma with metastatic disease or RAS-mutated, histologically or cytologically confirmed colorectal adenocarcinoma with documented unre…

    KRAS G12CKRAS G12DColorectal Cancer, CRC, Pancreatic Ductal Adenocarcinoma, PDAC

  8. Study of RMC-9805 in Participants With KRAS G12D-Mutant Solid Tumors

    Recruiting Phase 1 Revolution Medicines Started 2023Primary completion 2026-12 NCT06040541

    zoldonrasibdaraxonrasib

    Pathologically documented, locally advanced or metastatic solid tumor with a KRAS G12D-mutation

    KRAS G12DNon-small Cell Lung Cancer (NSCLC), Colorectal Cancer (CRC), Pancreatic Ductal Adenocarcinoma (PDAC), Advanced Solid Tumors