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NCT04975256
Adagrasib in Combination With BI 1701963 in Patients With Cancer (KRYSTAL 14)
Terminated
Phase 1
Last updated 16 December 2024
What this trial tests
Phase 1 trial testing MRTX849 in Advanced Cancer in 7 participants. Terminated before completion.
Timeline
28 July 2021
Primary endpoint
2 November 2022
2 November 2022
15 November 2022
Quick facts
| Lead sponsor | Mirati Therapeutics Inc. |
|---|---|
| Phase | Phase 1 |
| Status | Terminated |
| Study type | INTERVENTIONAL |
| Allocation | non randomized |
| Design | sequential |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 7 |
| Start date | 28 July 2021 |
| Primary completion | 2 November 2022 |
| Estimated completion | 15 November 2022 |
| Sites | 4 locations across United States |
Drugs / interventions tested
- MRTX849 — full drug profile →
- BI 1701963 — full drug profile →
Conditions studied
- Advanced Cancer — all drugs for Advanced Cancer →
- Metastatic Cancer — all drugs for Metastatic Cancer →
- Malignant Neoplasm of Colon — all drugs for Malignant Neoplasm of Colon →
- Malignant Neoplasm of Lung — all drugs for Malignant Neoplasm of Lung →
Sponsor
Mirati Therapeutics Inc. — full company profile →
Who can join
18 and older, any sex, with Advanced Cancer or Metastatic Cancer. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
This study will evaluate safety, tolerability, drug levels, molecular effects and clinical activity of MRTX849 (adagrasib) in combination with BI 1701963 in patients with advanced solid tumors that have a KRAS G12C mutation.
Publications & conference data
8 peer-reviewed publications reference this trial (live from Europe PMC):
-
Targeting the RAS/RAF/MAPK pathway for cancer therapy: from mechanism to clinical studies.
Bahar ME, Kim HJ, Kim DR. · · 2023 · cited 519× · PMID 38105263 · DOI 10.1038/s41392-023-01705-z -
The current state of the art and future trends in RAS-targeted cancer therapies.
Punekar SR, Velcheti V, Neel BG, Wong KK. · · 2022 · cited 382× · PMID 36028717 · DOI 10.1038/s41571-022-00671-9 -
Expanding the Reach of Precision Oncology by Drugging All KRAS Mutants.
Hofmann MH, Gerlach D, Misale S, Petronczki M, et al · · 2022 · cited 247× · PMID 35046095 · DOI 10.1158/2159-8290.cd-21-1331 -
Recent advances in targeting the "undruggable" proteins: from drug discovery to clinical trials.
Xie X, Yu T, Li X, Zhang N, et al · · 2023 · cited 246× · PMID 37669923 · DOI 10.1038/s41392-023-01589-z -
First-in-Human Phase I/IB Dose-Finding Study of Adagrasib (MRTX849) in Patients With Advanced <i>KRAS</i><sup><i>G12C</i></sup> Solid Tumors (KRYSTAL-1).
Ou SI, Jänne PA, Leal TA, Rybkin II, et al · · 2022 · cited 240× · PMID 35167329 · DOI 10.1200/jco.21.02752 -
Targeting KRAS in cancer.
Singhal A, Li BT, O'Reilly EM. · · 2024 · cited 209× · PMID 38637634 · DOI 10.1038/s41591-024-02903-0 -
The path to the clinic: a comprehensive review on direct KRAS<sup>G12C</sup> inhibitors.
Kwan AK, Piazza GA, Keeton AB, Leite CA. · · 2022 · cited 142× · PMID 35045886 · DOI 10.1186/s13046-021-02225-w -
Drugging KRAS: current perspectives and state-of-art review.
Parikh K, Banna G, Liu SV, Friedlaender A, et al · · 2022 · cited 103× · PMID 36284306 · DOI 10.1186/s13045-022-01375-4
Verify or expand the search:
- PubMed search for NCT04975256
- Europe PMC full search
- ASCO Meeting Library
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Related trials
Other trials of MRTX849
Trials testing the same drug.
- NCT05722327 — Phase I Trial of Adagrasib (MRTX849) in Combination With Cetuximab and Irinotecan in Patients With Colorectal Cancer · Phase 1 · active not recruiting
- NCT05634525 — Phase Ib Trial of the KRASG12C Inhibitor Adagrasib (MRTX849) in KRAS G12C Mutant Metastatic Pancreatic Cancer Patients · Phase 1 · withdrawn
- NCT05578092 — A Phase 1 Study of MRTX0902 in Solid Tumors With Mutations in the KRAS MAPK Pathway · Phase 1 · terminated
- NCT05263986 — The Clinical Trial to Evaluate the Pharmacokinetics and Safety of MRTX849 in Patients With Advanced Solid Tumors · Phase 1 · unknown
- NCT05178888 — Adagrasib in Combination With Palbociclib in Patients With Advanced Solid Tumors (KRYSTAL-16) · Phase 1 · completed
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Other Mirati Therapeutics Inc. trials
Trials by the same sponsor.
- NCT07415031 — A Solid Tumor Study for Long Term Treatment of Cancer Patients Who Participated in Adagrasib Studies · Phase 2 · not yet recruiting
- NCT06875310 — A Study of Adagrasib Plus Pembrolizumab Plus Chemotherapy vs. Placebo Plus Pembrolizumab Plus Chemotherapy in Participan · Phase 3 · recruiting
- NCT06801418 — Bioequivalence Study Between Adagrasib Reference Tablets and High Drug Load Tablets · Phase 1 · completed
- NCT05853575 — Trial of Two Adagrasib Dosing Regimens in NSCLC With KRAS G12C Mutation (KRYSTAL 21) · Phase 2 · active not recruiting
- NCT05840510 — Adagrasib in Combination With Nab-Sirolimus in Patients With Advanced Solid Tumors and Non-Small Cell Lung Cancer With a · Phase 1 · terminated
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
Data sources for this page
- Trial protocol + status: ClinicalTrials.gov NCT04975256 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Mirati Therapeutics Inc.
- Last refreshed: 16 December 2024
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04975256.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing