Dose Escalation of RMC-5552 Monotherapy in Relapsed/Refractory Solid Tumors

Revolution Medicines, Inc.58 enrolled

Overview

The purpose of this study is to evaluate the safety, tolerability, pharmacokinetic (PK), and pharmacodynamic (PD) profiles of escalating doses of RMC-5552 monotherapy in adult participants with relapsed/refractory solid tumors and to identify the recommended Phase 2 dose (RP2D).

This is an open-label, multicenter, Phase 1/1b study of RMC-5552 monotherapy in participants with advanced relapsed or refractory solid tumors. The study will include 2 components: 1) a Dose-Escalation Component for participants with relapsed or refractory solid tumors and 2) a Dose-Expansion Component for participants with relapsed or refractory solid tumors harboring certain specific mutations/rearrangements that result in hyperactivation of the mTOR pathway. Participants will be treated until disease progression per RECIST v1.1, unacceptable toxicity, or other criteria for withdrawal are met, whichever occurs first.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Solid Tumors

Interventions

RMC-5552DRUG

RMC-5552 for IV administration

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Participants (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 molecular aberrations in the mTOR pathway * Adequate hematologic, hepatic and renal function 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 * Subjects with abnormal fasting glucose, type 1 diabetes, or uncontrolled type 2 diabetes are excluded. * Subjects with stomatitis or mucositis of any grade

Locations (8)

UC Irvine - Chao Family Comprehensive Cancer Center

Irvine, California, United States

UC Davis Comprehensive Cancer Center

Sacramento, California, United States

UC San Francisco - Helen Diller Family Comprehensive Cancer Center

San Francisco, California, United States

Outcomes

Primary Outcomes

Number of participants with adverse events (AEs)

Incidence, nature, and severity of treatment-emergent AEs and serious AEs, including incidence and severity of findings in laboratory values or vital signs for RMC-5552 monotherapy

Time frame: up to 3 years

Number of participants with dose limiting toxicities (DLTs)

Incidence and nature of DLTs with RMC-5552 monotherapy

Time frame: 21 days

Secondary Outcomes

Cmax

Peak plasma concentration of RMC-5552

Time frame: up to 3 years

Tmax

Time to achieve peak plasma concentration of RMC-5552

Time frame: up to 3 years

Area Under the Curve (AUC)

Area under the plasma concentration time curve of RMC-5552

Time frame: up to 3 years

t1/2

Elimination half-life of RMC-5552

Time frame: up to 3 years

Accumulation Ratio

Ratio of accumulation of RMC-5552 from a single dose to steady state with repeated dosing

Time frame: up to 3 years

Overall Response Rate (ORR)

Overall response rate of RMC-5552 per RECIST v1.1

Time frame: up to 3 years

Duration of Response (DOR)

Data from ClinicalTrials.gov

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