Telaglenastat for Cancer

Not currently recruiting at 34 trial locations

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: National Cancer Institute (NCI)

Disqualifiers: Chemotherapy, Radiotherapy, Glioma, Hepatitis, others

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

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 1

Duration: 6 months

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment called telaglenastat hydrochloride for individuals with certain genetic mutations and tumors that have spread or cannot be surgically removed. The treatment blocks a substance cancer cells need to grow, potentially preventing tumor growth. Suitable candidates have tumors with specific genetic changes, such as NF1, KEAP1/NRF2, or STK11/LKB1 mutations, and lack other treatment options. As a Phase 2 trial, the research focuses on measuring the treatment's effectiveness in an initial, smaller group of participants.

Will I have to stop taking my current medications?

The trial does not specify if you must stop taking your current medications. However, you should be cautious if you are taking medications that interact with CYP2C9, as telaglenastat may affect them. It's important to discuss your current medications with the trial team to understand any potential interactions.

Is there any evidence suggesting that telaglenastat hydrochloride is likely to be safe for humans?

Research has shown that telaglenastat hydrochloride, the treatment under study, has generally been well-tolerated in past studies. When combined with other treatments, patients experienced manageable side effects, with no specific severe reactions commonly reported. This suggests that telaglenastat is relatively safe for use.

However, the treatment remains under investigation. While early results are promising for safety, more information is needed to fully understand its effects. Prospective trial participants might find reassurance in these early safety findings. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Telaglenastat hydrochloride is unique because it targets cancer cells by inhibiting glutaminase, an enzyme crucial for their energy production and growth. Unlike traditional cancer treatments like chemotherapy, which often target rapidly dividing cells indiscriminately, telaglenastat specifically disrupts the metabolism of cancer cells, potentially leading to fewer side effects. Researchers are excited about this treatment because it offers a more targeted approach to cancer therapy, which may improve efficacy and reduce harm to healthy cells.

What evidence suggests that telaglenastat hydrochloride might be an effective treatment for cancer?

Research has shown that telaglenastat hydrochloride might help stop cancer from growing by blocking an enzyme called glutaminase, which cancer cells need for growth. Early studies indicate that this drug can slow or halt the growth of solid tumors and certain nerve tumors. In some cases, combining telaglenastat with other treatments improved outcomes for patients with specific genetic changes. These findings suggest it could help manage cancer by targeting the growth mechanisms of cancer cells. ^{1 2 3 6 7}

Who Is on the Research Team?

Funda Meric-Bernstam

Principal Investigator

University of Texas MD Anderson Cancer Center LAO

Are You a Good Fit for This Trial?

Adults with advanced solid tumors or malignant peripheral nerve sheath tumors that can't be removed by surgery or have spread, and specific genetic mutations (NF1, KEAP1/NRF2, STK11/LKB1). Must meet certain health criteria, agree to contraception if applicable, and have no standard treatment options left. Cannot join if pregnant/breastfeeding, recently had cancer treatments, uncontrolled illnesses, allergic to similar compounds as the drug being tested.

Inclusion Criteria

My cancer has spread and cannot be removed with surgery.

I am older than 18 years.

I weigh at least 40 kg.

Exclusion Criteria

I have or had hepatitis B or C.

I am taking medications that affect my liver enzyme levels without being cautious.

Pregnant or breastfeeding women

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Treatment

Participants receive telaglenastat hydrochloride orally twice daily on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.

6 months

Monthly visits for imaging and blood sample collection

Follow-up

Participants are monitored for safety and effectiveness after treatment

Every 3 months

Quarterly visits (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Telaglenastat Hydrochloride

Trial Overview The trial is testing Telaglenastat Hydrochloride's effectiveness on patients with specific gene mutations in their tumors. This drug aims to block an enzyme needed for tumor cell growth which may halt the progression of cancer. The study includes imaging tests like CT and PET scans and biospecimen collection to monitor responses.

How Is the Trial Designed?

Group I: Treatment (telaglenastat hydrochloride) Experimental Treatment 6 Interventions

Patients receive telaglenastat hydrochloride PO BID on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients also undergo CT, MRI, or PET/CT during screening and on study, and collection of blood samples during screening and on study.

Who Is Running the Clinical Trial?

National Cancer Institute (NCI)

Lead Sponsor

Trials

14,080

Recruited

41,180,000+

Published Research Related to This Trial

A new standardized Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE) subset was developed specifically for monitoring adverse events in prostate cancer patients, based on input from 30 patients and 16 healthcare providers.

The final subset includes 12 key adverse events such as erectile dysfunction, urinary issues, and emotional distress, with 90% consensus among participants, highlighting the importance of capturing patient experiences for better care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Selecting a PRO-CTCAE-based subset for patient-reported symptom monitoring in prostate cancer patients: a modified Delphi procedure. Feldman, E., Pos, FJ., Smeenk, RJ., et al.[2023]

In a study involving 604 breast cancer patients undergoing chemotherapy, self-reported treatment-related side effects (TSEs) showed significantly longer durations compared to doctor-reported durations, highlighting the importance of patient perspectives in assessing side effects.

The findings suggest that doctors often underestimate the incidence and duration of TSEs, indicating that incorporating patient-reported outcomes into clinical practice could provide a more accurate understanding of the total burden of side effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Self-evaluation of duration of adjuvant chemotherapy side effects in breast cancer patients: A prospective study. Galizia, D., Milani, A., Geuna, E., et al.[2021]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT03872427

Study Details | NCT03872427 | Testing Whether Cancers ... This phase II trial studies how well glutaminase inhibitor telaglenastat hydrochloride (CB-839 HCl) works in treating patients with specific genetic mutations ...

2. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/40359708/

A phase I/II study of the safety and efficacy of telaglenastat (CB ... Telaglenastat in combination with nivolumab was generally well tolerated. The combination did not show a pattern of efficacy across ...

3. clinical-lung-cancer.com clinical-lung-cancer.com/article/S1525-7304(20)30308-9/fulltext

Phase 1 Trial of MLN0128 (Sapanisertib) and CB-839 HCl ... This phase 1 study will determine the recommended expansion dose and preliminary efficacy of MLN0128 and CB-839 in advanced non–small-cell lung ...

4. nature.com nature.com/articles/s41388-025-03495-w

Glutaminase as a metabolic target of choice to counter ... Together, these data demonstrate that colon cancer cells that survive to the long-term Palbociclib and Telaglenastat combined treatment ...

5. clinicaltrials.gov clinicaltrials.gov/study/NCT04250545

NCT04250545 | Testing of the Anti Cancer Drugs CB-839 ... To examine preliminary efficacy of CB-839 HCl (telaglenastat) and MLN0128 (sapanisertib) in squamous cell lung cancers (LSCC) and in select, molecularly ...

6. mycancergenome.org mycancergenome.org/content/clinical_trials/NCT03528642/

Clinical Trial: NCT03528642 The safety and tolerability of RT/TMZ/CB-839 HCl in patients is based on physician reported adverse event (AE) data. Measure: Progression-free ...

7. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1525730420303089

Phase 1 Trial of MLN0128 (Sapanisertib) and CB-839 HCl ... This phase 1 study will determine the recommended expansion dose and preliminary efficacy of MLN0128 and CB-839 in advanced non–small-cell lung cancer.