Dose-Escalation and Dose-Expansion of RMC-4630 and Cobimetinib in Relapsed/Refractory Solid Tumors

a study on Solid Tumor

Summary

for people ages 18 years and up (full criteria)
at Orange, California and other locations
study started
estimated completion
Sai-Hong Ignatius Ou, MD

Description

Summary

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).

Official 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

Details

This open-label, phase 1b/2 dose-escalation and dose-expansion study is designed to evaluate the safety and maximum tolerated dose (MTD) and recommended phase 2 dose (RP2D) of RMC-4630 in combination with cobimetinib in participants with relapsed/refractory solid tumors.

Keywords

Solid Tumor SHP2 PTPN11 NSCLC KRAS G12 BRAF Class 3 NF1 LOF KRAS amplification KRAS mutations advanced solid tumor advanced solid malignancies melanoma skin cancer ovarian cancer pancreatic cancer endometrium/uterus cancer bladder cancer cervical cancer carcinoma, non-small-cell lung neoplasm, squamous cell carcinoma, squamous cell esophageal neoplasms carcinoma, bronchogenic bronchial neoplasms lung neoplasms respiratory tract neoplasms thoracic neoplasms neoplasms by site neoplasms lung diseases respiratory tract diseases RMC-4630 Cobimetinib RMC-4630 and Cobimetinib

Eligibility

You can join if…

Open to people ages 18 years and up

  • Age ≥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 ≤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 >12 weeks
  • Female of childbearing potential and males with partners of childbearing potential must comply with effective contraception criteria .

You CAN'T join if...

  • Primary central nervous system (CNS) tumors.
  • Known or suspected leptomeningeal or brain metastases or spinal cord compression.
  • 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

Locations

  • UC Irvine - Chao Family Comprehensive Cancer Center accepting new patients
    Orange California 92868 United States
  • City of Hope accepting new patients
    Duarte California 91010 United States

Lead Scientist

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Revolution Medicines, Inc.
ID
NCT03989115
Phase
Phase 1/2
Study Type
Interventional
Last Updated