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Study to Evaluate the Safety, Tolerability & Efficacy of TNG462 in Combination in PDAC & NSCLC Patients

ConditionsPDACPDAC - Pancreatic Ductal AdenocarcinomaNSCLCRAS MutationMTAP DeletionLung CancerPancreatic Cancer MetastaticThoracic Cancer
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorTango Therapeutics, Inc.

About this trial

TNG462-C102 is a Phase 1/2, open-label, multicenter study designed to determine the safety, tolerability, PK, PD, and preliminary antineoplastic activity of oral TNG462 in combination with RMC-6236, RMC-9805, mFOLFIRINOX or gemcitabine/nab-paclitaxel. The study comprises a dose escalation phase and a dose expansion phase.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Is ≥18 years of age at the time of signature of the main study ICF.

Has an ECOG PS of 0 or 1.

Has a tumor with loss of MTAP protein or bi-allelic deletion of the MTAP gene

Arms A and B only: Has a tumor with a RAS mutation

Disqualifiers

Has received prior treatment with a PRMT5 inhibitor, or MAT2A inhibitor

Arms A and B only: Prior enrollment in any phase 3 clinical trial of RMC-6236 or RMC-9805

Known allergy, hypersensitivity or intolerance to TNG462 (all arms), RMC-6236 Arm A), RMC-9805 (Arm B), mFOLFIRINOX (Arm C), gemcitabine/nab-paclitaxel (Arm D) or their excipients

Has uncontrolled intercurrent illness that will limit compliance with the study requirements.

Trial design

Design model

Sequential

Treatments tested in this trial

  • TNG462

    Drug

    MTA cooperative PRMT5 inhibitor

  • RMC-9805

    Drug

    RAS(ON) G12D selective covalent inhibitor

  • RMC-6236

    Drug

    RAS(ON) multi-selective inhibitor

  • mFOLFIRINOX

    Drug

    Chemotherapy

  • gemcitabine/nab-paclitaxel

    Drug

    Chemotherapy

Treatment groups

183 Participants
are divided into 8 treatment groups

8

Treatment groups

See each treatment group below.

Group A: Dose Escalation 1AExperimental treatment 2 interventions
Group B: Dose escalation 1BExperimental treatment 2 interventions
Group C: Dose Expansion 2AExperimental treatment 2 interventions
Group D: Dose Expansion 2BExperimental treatment 2 interventions
Group E: Experimental: Dose Escalation 1CExperimental treatment 2 interventions
Group F: Experimental: Dose Escalation 1DExperimental treatment 2 interventions
Group G: Experimental: Dose Expansion 2CExperimental treatment 2 interventions
Group H: Experimental: Dose Expansion 2DExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

Phase 1: Maximum Tolerated Dose

To determine the MTD and RD(s) of TNG462 in combination with RMC-6236 or RMC-9805

Time frame
21 days
2

Phase 1: Maximum Tolerated Dose

To determine the MTD and RD(s) of TNG462 in combination with mFOLFIRINOX or gemcitabine/nab-paclitaxel

Time frame
28 days
3

Phase 2: Combination Anti-neoplastic Activity

To assess preliminary evidence of antineoplastic activity of TNG462 in combination with RMC-6236, RMC-9805, mFOLFIRINOX or gemcitabine/nab-paclitaxel using RECIST 1.1

Time frame
12 weeks

Secondary outcomes

1

Phase 1: Combination Anti-neoplastic Activity

To assess preliminary evidence of antineoplastic activity of TNG462 in combination with RMC-6236, RMC-9805, mFOLFIRINOX, or gemcitabine/nab paclitaxel using RECIST 1.1

Time frame
12 weeks
2

Phase 1 and 2: Tmax of TNG462 and in Combination

To characterize the Tmax of TNG462 in combination with RMC-6236 or RMC-9805

Time frame
21 days
3

Phase 1 and 2: Tmax of TNG462 and in Combination

To characterize the Tmax of TNG462 in combination with mFOLFIRINOX, or gemcitabine/nab-paclitaxel

Time frame
28 days
4

Phase 1 and 2: Cmax of TNG462 and in Combination

To characterize the Cmax of TNG462 in combination with RMC-6236 or RMC-9805

Time frame
21 days

Other outcomes

Sponsors and contacts

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

Tango Therapeutics, Inc.

Lead sponsor

Revolution Medicines, Inc.

Collaborator

Source ClinicalTrials.gov
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