133 Participants Needed

TNG462 Combination for Lung and Pancreatic Cancer

Recruiting at 1 trial location
MW
Overseen ByMaeve Waldron-Lynch, MD
Age: 18+
Sex: Any
Trial Phase: Phase 1 & 2
Sponsor: Tango Therapeutics, Inc.
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

Trial Summary

What is the purpose of 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 or RMC-9805. The study comprises a dose escalation phase and a dose expansion phase.

Research Team

MW

Maeve Waldron-Lynch, MD

Principal Investigator

Tango Therapeutics, Inc.

Eligibility Criteria

This trial is for adults with advanced lung or pancreatic cancer who have tried standard treatments but haven't had RAS-targeted therapy. They should be relatively healthy (ECOG PS of 0 or 1), have specific genetic changes in their tumors, and measurable disease. Participants must also be able to swallow pills.

Inclusion Criteria

8. Has evidence of measurable disease based on RECIST v1.1.
10. Must be able to swallow tablets.
I have never been treated with RAS-targeted therapy.
See 6 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Dose Escalation

Escalating oral doses of TNG462 in combination with RMC-6236 or RMC-9805 to determine the maximum tolerated dose

3 weeks
Multiple visits (in-person)

Dose Expansion

Expansion arm at the recommended dose of oral TNG462 in combination with RMC-6236 or RMC-9805 to assess antineoplastic activity

9 weeks
Regular visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

  • RMC-6236
  • RMC-9805
  • TNG462
Trial Overview The study tests TNG462 combined with either RMC-6236 or RMC-9805 in patients with certain types of lung and pancreatic cancers. It's an early-phase trial to find out the right dose, how safe it is, and if it might work against these cancers.
Participant Groups
4Treatment groups
Experimental Treatment
Group I: Dose escalation 1BExperimental Treatment2 Interventions
Escalating oral doses of TNG462 in combination with oral RMC-9805
Group II: Dose Expansion 2BExperimental Treatment2 Interventions
Expansion arm at the RDE(s) of oral TNG462 in combination with oralRMC-9805
Group III: Dose Expansion 2AExperimental Treatment2 Interventions
Expansion arm at the RDE(s) of oral TNG462 in combination with oral RMC-6236
Group IV: Dose Escalation 1AExperimental Treatment2 Interventions
Escalating oral doses of TNG462 in combination with oral RMC-6236

Find a Clinic Near You

Who Is Running the Clinical Trial?

Tango Therapeutics, Inc.

Lead Sponsor

Trials
5
Recruited
740+

Revolution Medicines, Inc.

Industry Sponsor

Trials
14
Recruited
4,500+
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