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NCT03634982
Dose Escalation of RMC-4630 Monotherapy in Relapsed/Refractory Solid Tumors
Phase 1 trial testing RMC-4630 in Solid Tumors in 133 participants. Status unknown.
31 March 2023
Quick facts
| Lead sponsor | Revolution Medicines, Inc. |
|---|---|
| Phase | Phase 1 |
| Status | Status unknown |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 133 |
| Start date | 28 September 2018 |
| Primary completion | 31 March 2023 |
| Estimated completion | 31 May 2023 |
| Sites | 12 locations across United States |
Drugs / interventions tested
- RMC-4630 — full drug profile →
Conditions studied
- Solid Tumors — all drugs for Solid Tumors →
Sponsor
Revolution Medicines, Inc. — full company profile →
Who can join
18 and older, any sex, with Solid Tumors. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
The purpose of this study is to evaluate the safety, tolerability, pharmacokinetic (PK), and pharmacodynamic (PD) profiles of escalating doses of RMC-4630 monotherapy in adult participants with relapsed/refractory solid tumors and to identify the recommended Phase 2 dose (RP2D).
Publications & conference data
8 peer-reviewed publications reference this trial (live from Europe PMC):
-
RAS-targeted therapies: is the undruggable drugged?
Moore AR, Rosenberg SC, McCormick F, Malek S. · · 2020 · cited 832× · PMID 32528145 · DOI 10.1038/s41573-020-0068-6 -
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 -
Tumor biomarkers for diagnosis, prognosis and targeted therapy.
Zhou Y, Tao L, Qiu J, Xu J, et al · · 2024 · cited 379× · PMID 38763973 · DOI 10.1038/s41392-024-01823-2 -
Role of oncogenic KRAS in the prognosis, diagnosis and treatment of colorectal cancer.
Zhu G, Pei L, Xia H, Tang Q, et al · · 2021 · cited 342× · PMID 34742312 · DOI 10.1186/s12943-021-01441-4 -
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 -
Emerging strategies to target RAS signaling in human cancer therapy.
Chen K, Zhang Y, Qian L, Wang P. · · 2021 · cited 164× · PMID 34301278 · DOI 10.1186/s13045-021-01127-w -
Progress on Ras/MAPK Signaling Research and Targeting in Blood and Solid Cancers.
Dillon M, Lopez A, Lin E, Sales D, et al · · 2021 · cited 99× · PMID 34680208 · DOI 10.3390/cancers13205059
Verify or expand the search:
- PubMed search for NCT03634982
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of RMC-4630
Trials testing the same drug.
- NCT04916236 — Combination Therapy of RMC-4630 and LY3214996 in Metastatic KRAS Mutant Cancers · Phase 1 · terminated
- NCT05054725 — Combination Study of RMC-4630 and Sotorasib for NSCLC Subjects With KRASG12C Mutation After Failure of Prior Standard Th · Phase 2 · completed
- NCT04185883 — Sotorasib Activity in Subjects With Advanced Solid Tumors With KRAS p.G12C Mutation (CodeBreak 101) · Phase 1 · active not recruiting
- NCT03989115 — Dose-Esc/Exp RMC4630 & Cobi in Relapsed/Refractory Solid Tumors & RMC4630& Osi in EGFR+ Locally Adv/Meta NSCLC · Phase 1, PHASE2 · completed
Other recruiting trials for Solid Tumors
Currently open trials in the same condition.
- NCT07529002 — Clinical Application of 89Zr-s-C1 PET/CT Imaging in Solid Tumors · recruiting
- NCT07416123 — A Study of GEN1106 in Participants With Solid Tumors · Phase 1 · recruiting
- NCT07522073 — A Study to Evaluate Chemotherapy With or Without INCB161734 in Previously Untreated, KRAS G12D-Mutated Metastatic Pancre · Phase 3 · recruiting
- NCT07395258 — A Study to Test Different Doses of BI 3923948 Alone and in Combination With an Anti-PD-1 Antibody in People With Differe · Phase 1 · recruiting
- NCT07505069 — Exploring the Clinical Value of RT01-89Zr PET Imaging in Solid Tumors · EARLY_PHASE1 · recruiting
Other Revolution Medicines, Inc. trials
Trials by the same sponsor.
- NCT07252232 — Study of Daraxonrasib (RMC-6236) in Patients With Resected Pancreatic Ductal Adenocarcinoma (PDAC) · Phase 3 · recruiting
- NCT06881784 — Study of Daraxonrasib (RMC-6236) in Patients With RAS Mutated NSCLC (RASolve 301) · Phase 3 · recruiting
- NCT06445062 — Study of RAS(ON) Inhibitors in Patients With Gastrointestinal Solid Tumors · Phase 1, PHASE2 · recruiting
- NCT06040541 — Study of RMC-9805 in Participants With KRAS G12D-Mutant Solid Tumors · Phase 1 · recruiting
- NCT05462717 — Dose Escalation and Dose Expansion Study of RMC-6291 Monotherapy in Subjects With Advanced KRASG12C Mutant Solid Tumors · Phase 1 · active not recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT03634982 (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 Revolution Medicines, Inc.
- Last refreshed: 1 September 2022
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/NCT03634982.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing