marked.bio

KRAS G12D degrader · degrader

setidegrasib

4 active trials, targeting KRAS G12D. Not approved for any biomarker on marked.bio yet.

Also known as ASP3082.

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 4 4 Phase 3

Sponsors

Industry sponsors leading active biomarker-selected trials of setidegrasib.

  1. Astellas 3

Trials

4 of 4 trials shown

  1. A Study to Evaluate the Effectiveness and Safety of Setidegrasib, Given With Either mFOLFIRINOX or NALIRIFOX Chemotherapies, in People With Pancreatic Cancer

    Recruiting Phase 3 Astellas Started 2026Primary completion 2029-08 NCT07409272

    setidegrasiboxaliplatinleucovorinirinotecanfluorouracilliposomal irinotecan

    …G12D mutation based on local or central testing (confirmation of a participant's positive KRAS G12D mutation result must be available prior to randomization).

    KRAS G12DPancreatic Cancer, Metastatic Pancreatic Cancer, Metastatic Pancreatic Adenocarcinoma

  2. A Study to Compare Setidegrasib (ASP3082) With Docetaxel, in People With Non-small Cell Lung Cancer With a KRAS G12D Mutation

    Recruiting Phase 3 Astellas Started 2026Primary completion 2030-06 NCT07566052

    setidegrasibdocetaxel

    The participant's positive KRAS G12D mutation result (either in tumor tissue or plasma ctDNA) must be available prior to rando…

    KRAS G12DNon-small Cell Lung Cancer (NSCLC)

  3. Study Investigating ASP3082 in Patients With Metastatic/Locally Advanced Non-small-cell Lung Cancer (NSCLC) and Pancreatic Ductal Adenocarcinoma (PDAC), With Biomarker Analysis to Characterize Response/Resistance

    Recruiting Phase 2 Gustave Roussy, Cancer Campus, Grand Paris Started 2026Primary completion 2027-09 NCT07483983

    setidegrasib

    … advanced (unresectable) or metastatic NSCLC (cohort 1) or PDAC (cohort 2) and documented KRAS G12D mutation on the most recent tumor biopsy or circulating tumor DNA (ctDNA) analysis

    KRAS G12DMetastatic/Locally Advanced Non-Small-Cell Lung Cancer, Metastatic/Locally Pancreatic Ductal Adenocarcinoma

  4. A Study of ASP3082 in Adults With Advanced Solid Tumors

    Recruiting Phase 1 Astellas Started 2022Primary completion 2028-12 NCT05382559

    setidegrasibcetuximableucovorinoxaliplatinfluorouracilirinotecannab-paclitaxelgemcitabinedocetaxelpembrolizumabcisplatincarboplatin

    … lung cancer (NSCLC) (Note: for Cohort H only, the tumor must be non-squamous NSCLC) with KRAS G12D mutation and

    KRAS G12DSolid Tumor