Clinical trial · Interventional
Dose-Esc/Exp RMC4630 & Cobi in Relapsed/Refractory Solid Tumors & RMC4630& Osi in EGFR+ Locally Adv/Meta NSCLC
Ph1b/2 Open-Label,Multicenter Dose-Esc & Dose-Exp Study of Combo RMC4630 & Cobimetinib in Participants w/Relapsed/Refractory Solid Tumors & Ph1b Study of RMC4630 w/Osimertinib in Participants w/EGFR Mutation+,Locally Adv or Meta NSCLC
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The purpose of this study is to evaluate the safety, tolerability, pharmacokinetic (PK), and pharmacodynamic (PD) profiles of RMC-4630 and cobimetinib in adult participants with relapsed/refractory solid tumors with specific genomic aberrations and to identify the recommended Phase 2 dose (RP2D); and to evaluate the safety, tolerability, pharmacokinetic (PK), and pharmacodynamic (PD) profiles of RMC-4630 and osimertinib in adult participants with EGFR mutation-positive locally advanced or metastatic NSCLC.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Solid Tumor | Solid Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Cobimetinib | Drug | Cobimetinib | ALIAS |
| Drug: Osimertinib | Drug | Osimertinib | ALIAS |
| RMC-4630 | Drug | Vociprotafib | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- RMC-4630 and Cobimetinib
- description
- RMC-4630 and Cobimetinib for oral administration
- interventionNames
- Drug: RMC-4630
- Drug: Cobimetinib
- type
- EXPERIMENTAL
- label
- RMC-4630 and Osimertinib
- description
- RMC-4630 and Osimertinib for oral administration
- interventionNames
- Drug: RMC-4630
- Drug: Drug: Osimertinib
Primary outcomes (2)
- measure
- Number of Participants With Adverse Events (AEs).
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Age ≥18 years * For RMC-4630 + Cobimetinib only - Participants who have advanced solid tumors that have failed, are intolerant to, or are considered ineligible for standard of care anti-cancer treatments including approved drugs for oncogenic drivers in their tumor type. * For RMC-4630 + Osimertinib only - Locally advanced or metastatic EGFR mutant NSCLC not amenable to curative surgery or radiotherapy * For RMC-4630 + Cobimetinib only - Participants must have one of the following genotypic aberrations: KRAS mutations and amplifications, BRAF Class 3 mutations, or NF1 LOF mutations * For RMC-4630 + Osimertinib only - Evidence of radiological documentation of progression with osimertinib monotherapy or an osimertinib containing regimen. Participants should not be considered a current candidate for 1st generation EGFR TKI's by the investigator. * Eastern Cooperative Oncology Group (ECOG) performance status of ≤1 * Adequate hematological, hepatic, and renal function * Capable of giving signed informed consent form (ICF). Willing and able to compile with study requirements and restrictions * Life expectancy \>12 weeks * Female of childbearing potential and males with partners of childbearing potential must comply with effective contraception criteria . Exclusion Criteria: * Primary central nervous system (CNS) tumors. * Known or suspected leptomeningeal or brain metastases or spinal cord compression. * For RMC-4630 + osimertinib arm only - Known or suspected Small cell, squamous, or pleomorphic lung transformations * Clinically significant cardiac disease * Active, clinically significant interstitial lung disease or pneumonitis * History or current evidence of retinal pigment epithelial detachment (RPED), central serous retinopathy, retinal vein occlusion (RVO), or predisposing factors to RPED or RVO * Known HIV infection or active/chronic hepatitis B or C infection. * Any other unstable or clinically significant concurrent medical condition that would, in the opinion of the investigator, jeopardize the safety of a participant, impact their expected survival through the end of the study participation, and/or impact their ability to comply with the protocol prior/concomitant therapy * Females who are pregnant or breastfeeding
References
Publications (0)
Data not yet available