Drug · Small Molecule
Setidegrasib
CI-DRUG-00000551Explore in graph →NCIt C206987 CHEMBL6068173 CIViC Phase 2
Regulatory
Approvals (0)
Each record names the authority, jurisdiction, indication text and status. A drug approved in one jurisdiction for one indication is not 'approved' in general.
Data not yet available
No regulatory approval recorded. Absence here is not evidence of absence: only ingested jurisdictions are covered.
What CancerIndex knows
Derived
Development pipeline
Most advanced stage across all cancers, then per top-level cancer reached through trial conditions or approval indications. Approval in any ingested jurisdiction outranks trial phase; counts are interventional studies.
| Scope | Stage | Max phase | Active | Recruiting | Phase 3 | Trials | Approvals | Jurisdictions | First approval | First trial |
|---|---|---|---|---|---|---|---|---|---|---|
| All cancers | Phase3 | Phase 3 | 3 | 3 | 2 | 3 | 0 | — | — | Jun 8, 2022 |
| Malignant Lung Neoplasm | Phase3 | Phase 3 | 1 | 1 | 1 | 1 | 0 | — | — | Apr 28, 2026 |
| Malignant Pancreatic Neoplasm | Phase3 | Phase 3 | 1 | 1 | 1 | 1 | 0 | — | — | Feb 17, 2026 |
ComputedclinicaltrialsProvenance
Curated evidence
Clinical evidence (2)
CIViC items in which this therapy appears, grouped by cancer context, then molecular profile. 50 items per page.
civicProvenance
- Source
- CIViC — Clinical Interpretation of Variants in Cancer
- Dataset
- CIViC evidence items
- Version
- civic-2026-09-08
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Evidence
- expert curation
- License
- CC0 1.0
- PMID
- 41879829
- Run
- ING-CIVIC-20260908-000001
| Therapy | Cancer | Type | Level | Direction · significance | Rating (1–5) | Status | Evidence | Source |
|---|---|---|---|---|---|---|---|---|
| KRAS G12D2 | ||||||||
| Setidegrasib | Lung Non-Small Cell Carcinoma | |||||||
Clinical trials
Trials with this intervention (3)
Most recently updated first, 50 per page.
clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Dataset
- ClinicalTrials.gov API v2 studies
- Retrieved
- Sep 26, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
| NCT | Title | Status | Phase | Enrollment (n) | Sponsor | Countries | Last update | Source |
|---|---|---|---|---|---|---|---|---|
| NCT07409272 | 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 | 614 | Astellas Pharma Global Development, Inc.INDUSTRY | 6 | Sep 22, 2026 | clinicaltrials |
| NCT07566052 | A Study to Compare Setidegrasib (ASP3082) With Docetaxel, in People With Non-small Cell Lung Cancer With a KRAS G12D Mutation |