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

ConditionsColorectal CancerCRCPancreatic Ductal AdenocarcinomaPDACGastrointestinal CancerMetastatic Pancreatic Ductal Adenocarcinoma
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorRevolution Medicines, Inc.

About this trial

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

Subprotocol G: RMC-9805 + cetuximab + FOLFIRI

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

≥ 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, C and G)

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • RMC-6236

    Drug

    Oral tablet

  • mFOLFOX6 regimen

    Drug

    IV infusion

  • bevacizumab

    Drug

    IV infusion

  • mFOLFIRINOX regimen

    Drug

    IV infusion

  • cetuximab

    Drug

    IV infusion

  • gemcitabine

    Drug

    IV infusion

  • nab-paclitaxel

    Drug

    IV infusion

  • RMC-9805

    Drug

    Oral Tablet

  • FOLFIRI regimen

    Drug

    IV infusion

Treatment groups

1,130 Participants
are divided into 7 treatment groups

7

Treatment groups

See each treatment group below.

Group A: Subprotocol A: RAS-mutated unresectable or metastatic CRC or metastatic PDACExperimental treatment 4 interventions
Group B: Subprotocol B: RAS-mutated unresectable or metastatic CRC or metastatic PDACExperimental treatment 3 interventions
Group C: Subprotocol C: metastatic PDACExperimental treatment 3 interventions
Group D: Subprotocol D: RAS G12D-mutated unresectable or metastatic CRC or metastatic PDACExperimental treatment 5 interventions
Group E: Subprotocol E: RAS G12D-mutated unresectable or metastatic CRC or metastatic PDACExperimental treatment 4 interventions
Group F: Subprotocol F: RAS G12D-mutated metastatic PDACExperimental treatment 4 interventions
Group G: Subprotocol G: RAS G12D-mutated metastatic CRCExperimental treatment 3 interventions

Trial outcomes

Primary outcomes

1

Adverse events (Subprotocols A-F)

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.

Time frame
Up to 3 years
2

Dose limiting toxicities (Subprotocols A-F)

Number of participants with dose limiting toxicities

Time frame
28 days
3

Objective Response Rate (ORR) Per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1) as assessed by Blinded Independent Central Review (BICR)(Subprotocol G)

Time frame
Up to 3 years

Secondary outcomes

1

Pharmacokinetics of RMC-6236 (Subprotocols A-F)

Blood concentration of RMC-6236 over time

Time frame
21 weeks
2

Pharmacokinetics of RMC-9805 (Subprotocols D-G)

Blood concentration of RMC-9805 over time

Time frame
21 weeks
3

ORR assessed by Investigator (Subprotocols A-G)

Overall Response Rate per RECIST v1.1

Time frame
Up to 3 years
4

DOR (Subprotocols A-G)

Duration of Response per RECIST v1.1

Time frame
Up to 3 years

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Revolution Medicines, Inc.

Lead sponsor

Source ClinicalTrials.gov
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