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NCT05178888
Adagrasib in Combination With Palbociclib in Patients With Advanced Solid Tumors (KRYSTAL-16)
Completed
Phase 1
Last updated 11 February 2025
What this trial tests
Phase 1 trial testing MRTX849 in Advanced Solid Tumor in 11 participants. Completed in 30 December 2024.
Timeline
20 January 2022
Primary endpoint
15 June 2023
15 June 2023
30 December 2024
Quick facts
| Lead sponsor | Mirati Therapeutics Inc. |
|---|---|
| Phase | Phase 1 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | non randomized |
| Design | sequential |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 11 |
| Start date | 20 January 2022 |
| Primary completion | 15 June 2023 |
| Estimated completion | 30 December 2024 |
| Sites | 4 locations across United States |
Drugs / interventions tested
- MRTX849 — full drug profile →
- Palbociclib (Palbociclib) — full drug profile →
Conditions studied
- Advanced Solid Tumor — all drugs for Advanced Solid Tumor →
Sponsor
Mirati Therapeutics Inc. — full company profile →
Who can join
18 and older, any sex, with Advanced Solid Tumor. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
This study will evaluate the safety and clinical activity of MRTX849 (adagrasib) in combination with palbociclib in patients with advanced solid tumor malignancies with KRAS G12C mutation.
Publications & conference data
8 peer-reviewed publications reference this trial (live from Europe PMC):
-
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 -
Targeting KRAS in cancer.
Singhal A, Li BT, O'Reilly EM. · · 2024 · cited 209× · PMID 38637634 · DOI 10.1038/s41591-024-02903-0 -
Cyclin-dependent protein kinases and cell cycle regulation in biology and disease.
Pellarin I, Dall'Acqua A, Favero A, Segatto I, et al · · 2025 · cited 132× · PMID 39800748 · DOI 10.1038/s41392-024-02080-z -
Targeting small GTPases: emerging grasps on previously untamable targets, pioneered by KRAS.
Yin G, Huang J, Petela J, Jiang H, et al · · 2023 · cited 50× · PMID 37221195 · DOI 10.1038/s41392-023-01441-4 -
Cancer cell cycle dystopia: heterogeneity, plasticity, and therapy.
Witkiewicz AK, Kumarasamy V, Sanidas I, Knudsen ES. · · 2022 · cited 47× · PMID 35599231 · DOI 10.1016/j.trecan.2022.04.006 -
MYC and KRAS cooperation: from historical challenges to therapeutic opportunities in cancer.
Casacuberta-Serra S, González-Larreategui Í, Capitán-Leo D, Soucek L. · · 2024 · cited 43× · PMID 39164274 · DOI 10.1038/s41392-024-01907-z -
Targeted therapies for KRAS-mutant non-small cell lung cancer: from preclinical studies to clinical development-a narrative review.
Santarpia M, Ciappina G, Spagnolo CC, Squeri A, et al · · 2023 · cited 41× · PMID 36895930 · DOI 10.21037/tlcr-22-639 -
KRAS G12C inhibitor combination therapies: current evidence and challenge.
Miyashita H, Kato S, Hong DS. · · 2024 · cited 39× · PMID 38756650 · DOI 10.3389/fonc.2024.1380584
Verify or expand the search:
- PubMed search for NCT05178888
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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
- NCT04975256 — Adagrasib in Combination With BI 1701963 in Patients With Cancer (KRYSTAL 14) · Phase 1 · terminated
Other recruiting trials for Advanced Solid Tumor
Currently open trials in the same condition.
- NCT07300943 — Study in Advanced Solid Tumor Patients · Phase 1, PHASE2 · recruiting
- NCT07304128 — A Study of PLB-002 in Advanced Solid Tumors · Phase 1 · recruiting
- NCT07213830 — A Study to Assess the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, Immunogenicity and Anti-tumour Activity · Phase 1, PHASE2 · recruiting
- NCT07226349 — A Study of BG-75098 Alone and in Combination With Other Agents in Adults With Advanced Solid Tumors · Phase 1 · recruiting
- NCT07222267 — An Investigational Study of BG-75202 Alone and in Combination With Other Therapeutic Agents in Adults With Advanced Soli · Phase 1 · recruiting
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 NCT05178888 (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: 11 February 2025
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/NCT05178888.
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