Study of RAS(ON) Inhibitors in Patients With Gastrointestinal Solid Tumors

NCT06445062
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Phase
Phase 1/Phase 2
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Recruitment status
Recruiting
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Participants
1,130
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Lead sponsor
Revolution Medicines, Inc.
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Start date
2024-05-24
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Number of sites
32
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Summary
The purpose of this platform study is to evaluate the safety, tolerability, pharmacokinetics (PK), and preliminary antitumor activity of novel RAS(ON) inhibitors combined with Standard(s) of Care (SOC) or with novel agents. The current subprotocols include the following: Subprotocol A: RMC-6236 + 5-fluorouracil-based regimens Subprotocol B: RMC-6236 + cetuximab with or without mFOLFOX6 Subprotocol C: RMC-6236 + gemcitabine + nab-paclitaxel Subprotocol D: RMC-9805 with or without RMC-6236 + 5-fluorouracil-based regimens Subprotocol E: RMC-9805 with or without RMC-6236 + cetuximab with or without mFOLFOX6 Subprotocol F: RMC-9805 with or without RMC-6236 + gemcitabine + nab-paclitaxel
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Short title
Study of RAS(ON) Inhibitors in Patients With Gastrointestinal Solid Tumors
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Official title
A Platform Study of RAS(ON) Inhibitors in Patients With Gastrointestinal Solid Tumors
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Control arm
Open label
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Registry reports results
No
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Listing at source
Listed
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Recruitment status
Recruiting
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Phase
Phase 1/Phase 2
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Study type
Interventional
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Completion date
2027-07-15
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First posted
2024-06-06
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Registry last updated
2026-07-29
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Primary completion date
2027-05-15
clinicaltrials.gov
Start date
2024-05-24
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Participants
1,130
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Participant count basis
Estimated
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Planned participants
1,130
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Protocol amendments
8
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Number of sites
32
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Data monitoring committee
Yes
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Registry sponsor category
Industry
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Lead sponsor
Revolution Medicines, Inc.
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Source registry
ClinicalTrials.gov
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Registry ID
NCT06445062
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ClinicalTrials.gov ID
NCT06445062
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Registry record
Open registry record
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Allocation
Not randomised
Model
Parallel groups
Purpose
Treatment
Masking
No masking
Sources for study design
clinicaltrials.gov

  1. Adverse events

    Timeframe: Up to 3 years

    Evaluate the safety and tolerability in the study population characterized by incidence, abnormal laboratory assessments, severity, and seriousness of adverse events in relation to the study treatment.

  2. Dose limiting toxicities

    Timeframe: 28 days

    Number of participants with dose limiting toxicities

  1. Pharmacokinetics of RMC-6236 and RMC-9805

    Timeframe: 21 weeks

    Blood concentration of RMC-6236 and RMC-9805 over time

  2. ORR

    Timeframe: Up to 3 years

    Overall Response Rate per RECIST v1.1

  3. DOR

    Timeframe: Up to 3 years

    Duration of Response per RECIST v1.1

  4. DCR

    Timeframe: Up to 3 years

    Incidence of Response per RECIST v1.1

  5. TTR

    Timeframe: Up to 3 years

    Time to Response per RECIST v1.1

  6. PFS

    Timeframe: Up to 3 years

    Progression Free Survival per RECIST v1.1

  7. OS

    Timeframe: Up to 3 years

    Overall Survival

Sources for outcomes
clinicaltrials.gov

Sex
All
Age groups
Adults, Older adults
Minimum age
18 Years
Healthy volunteers
No

All Patients (unless otherwise noted):

  • ≥ 18 years of age
  • ECOG PS is 0 to 1
  • Adequate organ function as outlined by the study
  • Pathologically or cytologically documented pancreatic carcinoma or poorly differentiated pancreatic carcinoma with metastatic disease or RAS-mutated, histologically or cytologically confirmed colorectal adenocarcinoma with documented unresectable or metastatic disease (Subprotocol A, B, and C)
  • Presence of RAS G12D mutation (Subprotocol D, E, F)

All Patients:

  • Primary central nervous system (CNS) tumors
  • Impaired gastrointestinal (GI) function that may significantly alter the absorption of RMC drugs
  • Major surgery within 28 days of first dose

Other inclusion/exclusion criteria may apply.

Sources for eligibility
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  • Ironwood Cancer and Research CentersChandler, United StatesRecruiting
  • Mayo Clinic HospitalPhoenix, United StatesRecruiting
  • HonorHealth Research InstituteScottsdale, United StatesRecruiting
  • UC San Diego Moores Cancer CenterLa Jolla, United StatesRecruiting
  • Cedars-Sinai Cancer at Cedars-Sinai Medical CenterLos Angeles, United StatesRecruiting
  • UCLA Hematology/Oncology- Santa MonicaLos Angeles, United StatesRecruiting
  • University of Colorado Hospital-Anschutz Cancer PavilionAurora, United StatesRecruiting
  • Yale-New Haven Hospital-Yale Cancer CenterNew Haven, United StatesRecruiting
  • Mayo Clinic Cancer CenterJacksonville, United StatesRecruiting
  • Moffitt Cancer CenterTampa, United StatesRecruiting
  • The University of Kansas Clinical Research CenterWestwood, United StatesRecruiting
  • The Sidney Kimmel Comprehensive Cancer Center at John HopkinsBaltimore, United StatesRecruiting
  • Massachusetts General HospitalBoston, United StatesRecruiting
  • Dana Farber Cancer InstituteBoston, United StatesRecruiting
  • Mayo ClinicRochester, United StatesRecruiting
  • Nebraska Cancer SpecialistsOmaha, United StatesRecruiting
  • University of Nebraska Medical CenterOmaha, United StatesRecruiting
  • Atlantic Health SystemMorristown, United StatesRecruiting
  • Northwell Health / RJ Zuckerberg Cancer CenterLake Success, United StatesRecruiting
  • Columbia University Medical CenterNew York, United StatesRecruiting
  • Memorial Sloan Kettering Cancer Center Main CampusNew York, United StatesRecruiting
  • Duke University Medical CenterDurham, United StatesRecruiting
  • University of Cincinnati Medical CenterCincinnati, United StatesRecruiting
  • Stephenson Cancer CenterOklahoma City, United StatesRecruiting
  • Hospital of the University of PennsylvaniaPhiladelphia, United StatesRecruiting

And 7 more, listed on the interactive page.

Sources for sites
clinicaltrials.gov

Sources for references
clinicaltrials.gov

Related records

Drugs (5)

Lead sponsors (1)

Conditions (6)

Targets (32)