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

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ClinicalTrials.gov Identifier: NCT04774952
Recruitment Status : Recruiting
First Posted : March 1, 2021
Last Update Posted : May 14, 2021
Sponsor:
Information provided by (Responsible Party):
Revolution Medicines, Inc.

Brief Summary:
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).

Condition or disease Intervention/treatment Phase
Solid Tumors Drug: RMC-5552 Phase 1

Detailed Description:
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.

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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
Drug: RMC-5552
RMC-5552 for IV administration




Primary Outcome Measures :
  1. 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

  2. Number of participants with dose limiting toxicities (DLTs) [ Time Frame: 21 days ]
    Incidence and nature of DLTs with RMC-5552 monotherapy


Secondary Outcome Measures :
  1. Cmax [ Time Frame: up to 3 years ]
    Peak plasma concentration of RMC-5552

  2. Tmax [ Time Frame: up to 3 years ]
    Time to achieve peak plasma concentration of RMC-5552

  3. Area Under the Curve (AUC) [ Time Frame: up to 3 years ]
    Area under the plasma concentration time curve of RMC-5552

  4. t1/2 [ Time Frame: up to 3 years ]
    Elimination half-life of RMC-5552

  5. Accumulation Ratio [ Time Frame: up to 3 years ]
    Ratio of accumulation of RMC-5552 from a single dose to steady state with repeated dosing

  6. Overall Response Rate (ORR) [ Time Frame: up to 3 years ]
    Overall response rate of RMC-5552 per RECIST v1.1

  7. 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
Criteria

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

Information from the National Library of Medicine

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


Contacts
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Contact: Revolution Medicines, Inc. (650) 779-2300 CT-Inquiries@RevMed.com

Locations
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United States, California
UC Irvine - Chao Family Comprehensive Cancer Center Not yet recruiting
Irvine, California, United States, 92868
Contact: Oliver Quines, MD    714-456-6244    ucstudy@uci.edu   
Contact: Kim Inocencio    (714) 456-8549    ucstudy@uci.edu   
Principal Investigator: Sai-Hong Ignatius Ou, MD         
UC Davis Comprehensive Cancer Center Not yet recruiting
Sacramento, California, United States, 95817
Contact: Anthony Martinez    916-734-6447    axmartinez@ucdavis.edu   
Principal Investigator: Jonathan Riess, MD         
UC San Francisco - Helen Diller Family Comprehensive Cancer Center Not yet recruiting
San Francisco, California, United States, 94115
Contact: Erika Zigman    415-885-3728    Erika.zigman@ucsf.edu   
Contact: Swati Sudarsan    (415) 885-3728    Swati.Sudarsan@ucsf.edu   
Principal Investigator: Pamela Munster, MD         
United States, Florida
Moffitt Cancer Center Recruiting
Tampa, Florida, United States, 33612
Contact: Nevena Ugrenovic    813-745-2025    nevena.ugrenovic@moffitt.org   
Principal Investigator: Eric Haura, MD         
United States, New York
Memorial Sloan Kettering Cancer Center Not yet recruiting
New York, New York, United States, 10021
Contact: Erin Frederickson    646-888-4888    frederie@mskcc.org   
Principal Investigator: Alison Schram, MD         
United States, Oklahoma
University of Oklahoma - Stephenson Cancer Center Recruiting
Oklahoma City, Oklahoma, United States, 73104
Contact       Phase1-Referrals@ouhsc.edu   
Principal Investigator: Susanna Ulahannan, MD         
United States, Tennessee
Sarah Cannon Research Institute - Tennessee Oncology, PLLC Recruiting
Nashville, Tennessee, United States, 37203
Contact    615-339-4214    asksarah@sarahcannon.com   
Principal Investigator: Howard Burris, MD         
United States, Texas
Dell Seton Medical Center at University of Texas Not yet recruiting
Austin, Texas, United States, 78712
Contact: Lindsey Simon    512-495-5419    lmsimon@ascension.org   
Principal Investigator: Anna Capasso, MD         
Sponsors and Collaborators
Revolution Medicines, Inc.
Investigators
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Study Director: Revolution Medicines, Inc Revolution Medicines, Inc.
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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: May 14, 2021
Last Verified: April 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Revolution Medicines, Inc.:
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
Additional relevant MeSH terms:
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Neoplasms