TNG462 Combination for Lung and Pancreatic Cancer

Recruiting at 11 trial locations

Overseen By Maxim Pimpkin, MD, PhD

Age: 18+

Sex: Any

Trial Phase: Phase 1 & 2

Sponsor: Tango Therapeutics, Inc.

Must not be taking: PRMT5 inhibitors, MAT2A inhibitors

Disqualifiers: Active infection, CNS metastases, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

183 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new oral treatment combination for lung and pancreatic cancer. Researchers aim to assess the safety and effectiveness of TNG462 when combined with either RMC-6236 or RMC-9805. The trial progresses through phases to determine the appropriate dose and identify early signs of efficacy against cancer. This study may suit individuals with advanced lung or pancreatic cancer who have tumors lacking a specific protein (MTAP) or a RAS gene mutation and who have tried standard treatments but not RAS-targeted ones. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive this new treatment.

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

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

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that TNG462, when combined with either RMC-6236 or RMC-9805, yields promising results in early studies. This treatment has effectively addressed various cancers, including non-small cell lung cancer and pancreatic cancer. Importantly, the safety of TNG462 is considered tolerable, allowing most patients to manage the side effects. For RMC-9805, the combination is generally safe at a specific dose, with few serious side effects reported.

As this trial is in its early stages, the researchers aim to learn more about the safety and tolerability of these combinations. Participants will receive close monitoring to address any side effects promptly. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Unlike standard treatments for lung and pancreatic cancer, which often involve chemotherapy or radiation, the investigational drugs TNG462, RMC-6236, and RMC-9805 are part of a targeted therapy approach. These treatments work differently by specifically targeting and interrupting cancer cell growth pathways. TNG462, in particular, is designed to be more selective in attacking cancer cells, potentially leading to fewer side effects compared to traditional chemotherapy. Researchers are excited because these drugs might offer a more effective and less toxic treatment option for patients with these challenging cancers.

What evidence suggests that this trial's treatments could be effective for lung and pancreatic cancer?

Research has shown that the combination of TNG462 and RMC-6236, which participants in this trial may receive, holds promise for treating certain cancers. Studies have found this combination effective in treating non-small cell lung cancer and pancreatic cancer. Early results suggest that TNG462 targets a common genetic change in these cancers. Another combination in this trial, TNG462 and RMC-9805, has also shown potential, with studies reporting significant tumor shrinkage when used with other treatments. These early findings suggest that both combinations could help control tumor growth in specific types of cancer. ^{1 2 4 6 7}

Who Is on the Research Team?

Maxim Pimpkin, MD, PhD

Principal Investigator

Tango Therapeutics, Inc.

Are You a Good Fit for This Trial?

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.

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

Group I: Experimental: Dose Expansion 2D Experimental Treatment 2 Interventions

Expansion arm at the RDE(s) of TNG462 in combination with gemcitabine/nab-paclitaxel

Group II: Experimental: Dose Expansion 2C Experimental Treatment 2 Interventions

Expansion arm at the RDE(s) of TNG462 in combination with mFOLFIRINOX

Group III: Experimental: Dose Escalation 1D Experimental Treatment 2 Interventions

Escalating doses of TNG462 in combination with gemcitabine/nab-paclitaxel

Group IV: Experimental: Dose Escalation 1C Experimental Treatment 2 Interventions

Escalating doses of TNG462 in combination with mFOLFIRINOX

Group V: Dose escalation 1B Experimental Treatment 2 Interventions

Escalating oral doses of TNG462 in combination with oral RMC-9805

Group VI: Dose Expansion 2B Experimental Treatment 2 Interventions

Expansion arm at the RDE(s) of oral TNG462 in combination with oralRMC-9805

Group VII: Dose Expansion 2A Experimental Treatment 2 Interventions

Expansion arm at the RDE(s) of oral TNG462 in combination with oral RMC-6236

Group VIII: Dose Escalation 1A Experimental Treatment 2 Interventions

Escalating oral doses of TNG462 in combination with oral RMC-6236

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+

Citations

1.

clinicaltrials.gov

clinicaltrials.gov/study/NCT06922591

NCT06922591 | Study to Evaluate the Safety, Tolerability & ...

TNG462-C102 is a Phase 1/2, open-label, multicenter study designed to determine the safety, tolerability, PK, PD, and preliminary antineoplastic activity of ...

2.

aacrjournals.org

aacrjournals.org/cancerres/article/85/8_Supplement_1/2996/757913/Abstract-2996-TNG462-an-MTA-cooperative-PRMT5

Abstract 2996: TNG462, an MTA-cooperative PRMT5 inhibitor ...

TNG462 is a clinical-stage, MTA-cooperative PRMT5 inhibitor currently being evaluated in an ongoing phase I/II clinical trial for solid tumors with MTAP loss.

3.

tangotx.gcs-web.com

tangotx.gcs-web.com/news-releases/news-release-details/tango-therapeutics-reports-positive-tng462-clinical-data-and

Tango Therapeutics Reports Positive TNG462 Clinical Data ...

TNG462 demonstrated durable clinical activity across multiple tumor types, including non-small cell lung cancer (NSCLC) and pancreatic cancer, in ongoing phase ...

4.

onclive.com

onclive.com/view/vopimetostat-demonstrates-early-evidence-of-efficacy-in-mtap-deleted-solid-tumors

Vopimetostat Demonstrates Early Evidence of Efficacy in ...

This trial is investigating vopimetostat plus the RAS(ON) multi-selective inhibitor daraxonrasib (RMC-6236) or the RAS(ON) G12D-selective ...

5.

ctv.veeva.com

ctv.veeva.com/study/study-to-evaluate-the-safety-tolerability-efficacy-of-tng462-in-combination-in-pdac-nsclc-patie

Study to Evaluate the Safety, Tolerability & Efficacy of TNG462 ...

TNG462-C102 is a Phase 1/2, open-label, multicenter study designed to determine the safety, tolerability, PK, PD, and preliminary antineoplastic ...

6.

trialx.com

trialx.com/clinical-trials/listings/313541/study-to-evaluate-the-safety-tolerability-efficacy-of-tng462-in-combination-in-pdac-nsclc-patients/?&radius=50

Study to Evaluate the Safety, Tolerability & ...

TNG462-C102 is a Phase 1/2, open-label, multicenter study designed to determine the safety, tolerability, PK, PD, and preliminary antineoplastic ...

7.

ir.tangotx.com

ir.tangotx.com/node/8666/pdf

Tango Therapeutics Reports Fourth Quarter and Full Year ...

In November 2024, the Company reported positive early data for TNG462, demonstrating durable clinical responses across multiple cancer types, ...