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Title:
A Phase 1b/2, Open-Label, Multicenter Dose-Escalation and Dose-Expansion Study of the Combination of RMC-4630 and Cobimetinib in Adult Participants with Relapsed/Refractory Solid Tumors with Specific Genomic Aberrations (RMC-4630-02)
Protocol Number:
J19100
Phase:
Phase I/II
Physician:
Julie Brahmer
Sites:
Johns Hopkins Kimmel Cancer Center in Baltimore
Purpose:
The purpose of this study is to evaluate the safety, tolerability, pharmacokinetic (PK), and pharmacodynamic (PD) pro?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).
Eligibility:
Inclusion Criteria:•Age equal to 18 years•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.•Eastern Cooperative Oncology Group (ECOG) performance status of equal to 1•Participants must have one of the following genotypic aberrations: KRAS mutations and amplifications, BRAF Class 3 mutations, or NF1 LOF mutations•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 greater than 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.•Clinically significant cardiac disease•Active, clinically signi?cant 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 signi?cant 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
Treatment:
Treatment will be administered on an outpatient basis. RMC-4630 will be taken orally two times weekly (D1 and D4)for 28 days of a 28 day cycle. Cobimetinib will be taken orally daily for 21 days of a 28 day cycle.
Population:
Adult
Last Update
02/19/2020 05:03 AM