Dose Escalation of RMC-5552 Monotherapy in Relapsed/Refractory Solid Tumors
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ClinicalTrials.gov Identifier: NCT04774952 |
Recruitment Status :
Active, not recruiting
First Posted : March 1, 2021
Last Update Posted : February 20, 2024
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Solid Tumors | Drug: RMC-5552 | Phase 1 |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 108 participants |
Allocation: | N/A |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | A Phase 1/1b, Open-Label, Multicenter, Dose-Escalation Study of RMC 5552 Monotherapy in Adult Subjects With Relapsed/Refractory Solid Tumors |
Actual Study Start Date : | April 7, 2021 |
Estimated Primary Completion Date : | March 31, 2024 |
Estimated Study Completion Date : | March 31, 2024 |
Arm | Intervention/treatment |
---|---|
Experimental: RMC-5552
RMC-5552 for IV administration
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Drug: RMC-5552
RMC-5552 for IV administration |
- Number of participants with adverse events (AEs) [ Time Frame: up to 3 years ]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
- Number of participants with dose limiting toxicities (DLTs) [ Time Frame: 21 days ]Incidence and nature of DLTs with RMC-5552 monotherapy
- Cmax [ Time Frame: up to 3 years ]Peak plasma concentration of RMC-5552
- Tmax [ Time Frame: up to 3 years ]Time to achieve peak plasma concentration of RMC-5552
- Area Under the Curve (AUC) [ Time Frame: up to 3 years ]Area under the plasma concentration time curve of RMC-5552
- t1/2 [ Time Frame: up to 3 years ]Elimination half-life of RMC-5552
- Accumulation Ratio [ Time Frame: up to 3 years ]Ratio of accumulation of RMC-5552 from a single dose to steady state with repeated dosing
- Overall Response Rate (ORR) [ Time Frame: up to 3 years ]Overall response rate of RMC-5552 per RECIST v1.1
- Duration of Response (DOR) [ Time Frame: up to 3 years ]Duration of response of RMC-5552 per RECIST v1.1
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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04774952
United States, California | |
UC Irvine - Chao Family Comprehensive Cancer Center | |
Irvine, California, United States, 92868 | |
UC Davis Comprehensive Cancer Center | |
Sacramento, California, United States, 95817 | |
UC San Francisco - Helen Diller Family Comprehensive Cancer Center | |
San Francisco, California, United States, 94115 | |
United States, Florida | |
Moffitt Cancer Center | |
Tampa, Florida, United States, 33612 | |
United States, New York | |
Memorial Sloan Kettering Cancer Center | |
New York, New York, United States, 10021 | |
United States, Oklahoma | |
University of Oklahoma - Stephenson Cancer Center | |
Oklahoma City, Oklahoma, United States, 73104 | |
United States, Tennessee | |
Sarah Cannon Research Institute - Tennessee Oncology, PLLC | |
Nashville, Tennessee, United States, 37203 | |
United States, Texas | |
Dell Seton Medical Center at University of Texas | |
Austin, Texas, United States, 78712 |
Study Director: | Revolution Medicines, Inc | Revolution Medicines, Inc. |
Responsible Party: | Revolution Medicines, Inc. |
ClinicalTrials.gov Identifier: | NCT04774952 |
Other Study ID Numbers: |
RMC-5552-001 |
First Posted: | March 1, 2021 Key Record Dates |
Last Update Posted: | February 20, 2024 |
Last Verified: | February 2024 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Studies a U.S. FDA-regulated Drug Product: | Yes |
Studies a U.S. FDA-regulated Device Product: | No |
PIK3CA PTEN TSC1/2 STK11 MTOR MYC MAPK advanced solid tumor advanced solid malignancies melanoma skin cancer ovarian cancer endometrium/uterus cancer bladder cancer cervical cancer |
Carcinoma, Non-Small-Cell Lung Neoplasms, 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 Neoplasms, Glandular and Epithelial Gastrointestinal Neoplasms |
Neoplasms |