Dose-Esc/Exp RMC4630 & Cobi in Relapsed/Refractory Solid Tumors & RMC4630& Osi in EGFR+ Locally A⦠(NCT03989115) | Clinical Trial Compass
CompletedPhase 1/2
Dose-Esc/Exp RMC4630 & Cobi in Relapsed/Refractory Solid Tumors & RMC4630& Osi in EGFR+ Locally Adv/Meta NSCLC
United States113 participantsStarted 2019-07-02
Plain-language summary
The purpose of this study is to evaluate the safety, tolerability, pharmacokinetic (PK), and pharmacodynamic (PD) proļ¬les 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) proļ¬les of RMC-4630 and osimertinib in adult participants with EGFR mutation-positive locally advanced or metastatic NSCLC.
Who can participate
Age range18 Years
SexALL
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Inclusion Criteria:
* Age ā„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 ā¤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 suspecā¦
What they're measuring
1
Number of Participants With Adverse Events (AEs).
Timeframe: AEs were collected from the start of intervention through 30 days post last day of study drug taken. Participants were monitored/assessed for adverse events for a maximum of 17 months which includes a maximum duration of 16 months on treatment.
2
Number of Participants With Dose Limiting Toxicities (DLTs)
Timeframe: Cycle 1: Study Day 1 - Study Day 28 (28 days)