Sapanisertib + Telaglenastat for Lung Cancer

Recruiting in Palo Alto (17 mi)

+7 other locations

Jonathan Wesley Riess, M.D., M.S. for ...

Overseen byJonathan W. Riess

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1

Waitlist Available

Sponsor: National Cancer Institute (NCI)

No Placebo Group

Trial Summary

What is the purpose of this trial?This phase I/Ib trial studies the side effects and best dose of CB-839 HCl when given together with sapanisertib in treating patients with non-small cell lung cancer that has spread to other places in the body (advanced). CB-839 HCl and sapanisertib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.

Eligibility Criteria

This trial is for adults with advanced non-small cell lung cancer (NSCLC) that worsened after platinum-based chemotherapy or PD-(L)1 inhibitors. Participants must have specific mutations if they've had targeted therapies, manageable brain metastases, and meet certain health criteria like stable blood sugar and organ function. Pregnant women, those unable to swallow pills, or with severe illnesses are excluded.

Inclusion Criteria

ECOG-ACRIN performance status 0-2

Patients must have stage IV or recurrent/metastatic NSCLC and have progressed on or after platinum-based chemotherapy and/or PD-(L)1 immune checkpoint inhibitor

Dose escalation: patients with NSCLC known to harbor EGFR, ALK, ROS1, BRAF V600E/K activating mutations must have also progressed on appropriate FDA-approved targeted therapies

+21 more

Exclusion Criteria

HIV-infected patients

You are currently taking part in another study with a new or experimental treatment.

Patients who have had chemotherapy within 3 weeks or radiotherapy within 2 weeks (6 weeks for nitrosoureas or mitomycin C) prior to entering the study

+8 more

Participant Groups

The trial tests the safety and optimal doses of two anti-cancer drugs: CB-839 HCl (Telaglenastat) and MLN0128 (Sapanisertib), when used together in patients with NSCLC. These drugs aim to block enzymes essential for tumor cell growth.

1Treatment groups

Experimental Treatment

Group I: Treatment (CB-839 HCl, sapanisertib)Experimental Treatment2 Interventions

Patients receive glutaminase inhibitor CB-839 hydrochloride PO BID and sapanisertib PO QD on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.