A Dose Escalation Study of Experimental RMC-4630 for Relapsed/Refractory Solid Tumors

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Age: 18 years or older
Gender:
Any
Healthy Volunteers: No
Keywords: Relapsed Solid Tumors, Refractory Solid Tumors, cancer, solid tumors
Type: Drug study, Phase 1
Target:
20 Participants
Investigator:
Description
The purpose of this study is to test a new drug called RMC-4630 (the study drug). RMC-4630 an experimental drug, which means that it is not approved by the US Food and Drug Administration (FDA) or any other health authorities. This is the first study in which RMC-4630 will be tested in humans. The safety of different doses of RMC-4630 and how your body processes RMC-4630 will be tested.
This study requires

The study team will make sure you qualify to take part in the study. Qualified participants will receive detailed information about the study. This may include a list of study-related tests and procedures.

Who can participate

Inclusion criteria:

  • Participant (male or female) ≥18 years of age
  • Participants who have advanced solid tumors that have failed, are intolerant to, or are considered ineligible for standard of care anticancer treatments including approved drugs for oncogenic drivers in their tumor type
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1
  • Participants in the Dose-Expansion Component must have one of the following genotypic aberrations: RTK mutations, amplifications or rearrangements, KRASG12, BRAF Class 3, or NF1 LOF mutations
  • Adequate hematologic, hepatic and renal function
  • Participant able to understand and voluntarily sign the informed consent form (ICF) and able to comply with the study visit schedule and other protocol requirements.
  • Participants willing to agree to not father a child/become pregnant and comply with effective contraception criteria

Exclusion criteria:

  • Known or suspected leptomeningeal or brain metastases or spinal cord compression
  • Primary central nervous system (CNS) tumors
  • 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
  • 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
Benefits and risks of participating
BENEFITS:

We cannot promise any benefits to you as a result of taking part in this research study.


RISKS:

The study doctor will discuss the risks associated with taking part in this research study.
Compensation
You will not be paid to take part in this research study.
Resources
Schedule
Study duration and period
Your total time in the study will depend on how your cancer responds to treatment and when you join the study. The total duration of the study is 3 years. Your participation could range from 1 Day (if you are not eligible) up to the entire duration of the study (3 years).
Recruitment period
From Dec. 11, 2018
Location
UC Davis Comprehensive Cancer Center
4501 X Street
Sacramento, CA 95817
Contact
Corinne Turrell
Research Topic
Conditions:
  • Solid Tumors