TNG462 for Solid Cancers

Recruiting in Palo Alto (17 mi)

+22 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1 & 2

Recruiting

Sponsor: Tango Therapeutics, Inc.

Must not be taking: Antiretrovirals

Disqualifiers: Active infection, Liver disease, HIV, others

No Placebo Group

Breakthrough Therapy

Trial Summary

What is the purpose of this trial?

This trial is testing a new oral drug called TNG462 in patients with advanced or metastatic solid tumors that have an MTAP deletion. The drug works by blocking a protein that helps these cancer cells grow. The goal is to see if TNG462 can stop the cancer from growing and spreading.

Do I need to stop my current medications for the trial?

The trial information does not specify if you need to stop taking your current medications. It's best to discuss this with the trial team or your doctor.

Research Team

Maeve Waldron-Lynch, MD

Principal Investigator

Tango Therapeutics, Inc.

Eligibility Criteria

This trial is for adults with advanced solid tumors that have an MTAP deletion. They should have tried standard treatments, be in fairly good health (ECOG score of 0-1), and have no major organ issues. Pregnant or breastfeeding women, those with allergies to TNG462, uncontrolled illnesses, other cancer treatments ongoing or planned, significant GI absorption issues, active serious infections or liver disease are excluded.

Inclusion Criteria

I am 18 years old or older.

My tumor lacks the MTAP gene or protein.

Negative serum pregnancy test result at screening

Exclusion Criteria

Patient has a prior or ongoing clinically significant illness, medical condition, surgical history, physical finding, or laboratory abnormality that, in the investigator's opinion, may affect the safety of the patient or impair the assessment of study results

I have heart problems that affect my daily life.

I have another active cancer besides the one being studied.

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Dose Escalation

Participants receive escalating doses of TNG462 as a single agent and in combination with pembrolizumab to estimate the maximum tolerated dose

4 weeks

Multiple visits (in-person)

Dose Expansion

Participants receive TNG462 at the identified recommended phase 2 dose (RP2D) in specific MTAP-deleted tumor types

16-18 weeks

Regular visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• TNG462 (PRMT5 Inhibitor)

Trial Overview The study tests TNG462's safety and how well patients tolerate it. It's a first-in-human study with two parts: dose escalation to find the safe amount to give people and then dose expansion focusing on specific tumor types. Up to 159 participants will take this oral PRMT5 inhibitor.

Participant Groups

Group I: Dose Expansion in Solid Tumors Experimental Treatment 1 Intervention

Participants with other MTAP-deleted solid tumors will receive TNG462 at the identified RP2D(s)

Group II: Dose Expansion in Sarcoma Experimental Treatment 1 Intervention

Participants with MTAP-deleted sarcoma (soft tissue or bone) will receive TNG462 at the identified RP2D(s)

Group III: Dose Expansion in Pancreatic Ductal Adenocarcinoma Experimental Treatment 1 Intervention

Participants with MTAP-deleted pancreatic ductal adenocarcinoma will receive TNG462 at the identified RP2D(s)

Group IV: Dose Expansion in NSCLC in Combination with Pembrolizumab Experimental Treatment 2 Interventions

Participants NSCLC (squamous and non squamous) MTAP-deleted solid tumors will receive TNG462 at the identified RP2D(s)

Group V: Dose Expansion in NSCLC Experimental Treatment 1 Intervention

Participants with MTAP-deleted NSCLC (squamous and non squamous) will receive TNG462 at the identified RP2D(s)

Group VI: Dose Expansion in Mesothelioma Experimental Treatment 1 Intervention

Participants with MTAP-deleted mesothelioma will receive TNG462 at the identified RP2D(s)

Group VII: Dose Escalation Experimental Treatment 2 Interventions

Participants with MTAP-deleted solid tumors (excluding primary CNS) will receive escalating doses of TNG462 single agent and in combination with pembrolizumab to estimate the MTD

Who Is Running the Clinical Trial?

Tango Therapeutics, Inc.

Lead Sponsor

Trials

5

Recruited

740+