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Clinical Trial 19683

Cancer Type: Thoracic
Study Type: Treatment
NCT#: NCT03634982

Phase: Phase I
Principal Investigator: Haura, Eric

Call 813-745-6100
or 1-800-679-0775 Learn More

Overview

Study Title

A Phase 1, Open-Label, Multicenter, Dose-Escalation Study of RMC-4630 Monotherapy in Adult Participants with Relapsed/Refractory Solid Tumors

Summary

The purpose of this study is to evaluate the safety, tolerability, pharmacokinetic (PK), and pharmacodynamic (PD) profiles of escalating doses of RMC-4630 monotherapy in adult participants with relapsed/refractory solid tumors and to identify the recommended Phase 2 dose (RP2D).

Objective

Primary: * To characterize the safety and tolerability of RMC-4630 monotherapy in participants with relapsed/refractory solid tumors * To define the MTD, RP2D, and schedule for RMC-4630 monotherapy in participants with relapsed or refractory solid tumors Secondary: * To characterize the plasma PK of RMC-4630 after single- and repeat-dose administration * To characterize the relationship between plasma PK of RMC-4630 and PD * To assess PD markers of drug activity, including biochemical markers of SHP2 inhibition in blood or tumor tissue * To estimate the antitumor effects of RMC-4630 monotherapy at the RP2D in participants with relapsed/refractory solid tumors harboring specific genotypic aberrations in the RAS-MAPK pathway

Treatments

Therapies

Therapy (NOS)

Medications

RMC-4630 ()

Inclusion Criteria

Male or female, 18 years of age or older.

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 (below RP2DS) must have one of the following genotypic aberrations: KRAS amplification, KRASG12C (NSCLC), BRAF Class 3, or NF1 LOF (NSCLC and gynecologic cancers) mutations. For the Dose-Expansion Cohort at the RP2DS, only participants with relapsed or refractory ovarian or endometrial/uterine cancer (or carcinosarcomas) and an NF1 LOF mutation will be allowed. Participants in the QTc substudy may include any genotype and any histotype except pancreatic or colorectal cancer.

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 Participants previously treated for these conditions that have had stable central nervous system (CNS) disease, are asymptomatic and off corticosteroids, or are on stable dose of corticosteroids for at least 4 weeks, and have no evidence of clinical or radiographic disease progression over 4-weeks prior to study day 1 are eligible.

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

Other exclusions may apply

If you are interested in learning more about clinical trials, our clinical trial navigators can discuss your options and recommend opportunities that may be suitable for you. Call 813-745-6100 or 1-800-679-0775 (toll-free) or submit a clinical trials inquiry form.