NCT04250545

Testing of the Anti Cancer Drugs CB-839 HCl (Telaglenastat) and MLN0128 (Sapanisertib) in Advanced Stage Non-small Cell Lung Cancer

Active, enrolled Phase 1 Last updated 25 November 2025

What this trial tests

Phase 1 trial testing Sapanisertib in Leptomeningeal Neoplasm in 22 participants. Participants enrolled and being followed up; not accepting new ones.

Timeline

26 October 2020

Primary endpoint
21 November 2025

21 November 2026

Quick facts

Lead sponsor	National Cancer Institute (NCI)
Phase	Phase 1
Status	Active, enrolled
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	22
Start date	26 October 2020
Primary completion	21 November 2025
Estimated completion	21 November 2026
Sites	7 locations across United States

Drugs / interventions tested

• Sapanisertib — full drug profile →
• Telaglenastat Hydrochloride — full drug profile →

Conditions studied

• Leptomeningeal Neoplasm — all drugs for Leptomeningeal Neoplasm →
• Metastatic Lung Non-Small Cell Carcinoma — all drugs for Metastatic Lung Non-Small Cell Carcinoma →
• Metastatic Malignant Neoplasm in the Brain — all drugs for Metastatic Malignant Neoplasm in the Brain →
• Recurrent Lung Non-Small Cell Carcinoma — all drugs for Recurrent Lung Non-Small Cell Carcinoma →

Sponsor

National Cancer Institute (NCI)

Who can join

18 and older, any sex, with Leptomeningeal Neoplasm or Metastatic Lung Non-Small Cell Carcinoma. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. Targeting cancer metabolism in the era of precision oncology.
   Stine ZE, Schug ZT, Salvino JM, Dang CV. · · 2022 · cited 839× · PMID 34862480 · DOI 10.1038/s41573-021-00339-6
2. Altered metabolism in cancer: insights into energy pathways and therapeutic targets.
   Tufail M, Jiang CH, Li N. · · 2024 · cited 265× · PMID 39294640 · DOI 10.1186/s12943-024-02119-3
3. Enhancing the Efficacy of Glutamine Metabolism Inhibitors in Cancer Therapy.
   Yang WH, Qiu Y, Stamatatos O, Janowitz T, et al · · 2021 · cited 222× · PMID 34020912 · DOI 10.1016/j.trecan.2021.04.003
4. Tumor microenvironment signaling and therapeutics in cancer progression.
   Goenka A, Khan F, Verma B, Sinha P, et al · · 2023 · cited 203× · PMID 37005490 · DOI 10.1002/cac2.12416
5. A glutamine tug-of-war between cancer and immune cells: recent advances in unraveling the ongoing battle.
   Wang B, Pei J, Xu S, Liu J, et al · · 2024 · cited 81× · PMID 38459595 · DOI 10.1186/s13046-024-02994-0
6. Treatment Strategies for KRAS-Mutated Non-Small-Cell Lung Cancer.
   O'Sullivan É, Keogh A, Henderson B, Finn SP, et al · · 2023 · cited 52× · PMID 36980522 · DOI 10.3390/cancers15061635
7. The role of bone marrow microenvironment (BMM) cells in acute myeloid leukemia (AML) progression: immune checkpoints, metabolic checkpoints, and signaling pathways.
   Bakhtiyari M, Liaghat M, Aziziyan F, Shapourian H, et al · · 2023 · cited 51× · PMID 37735675 · DOI 10.1186/s12964-023-01282-2
8. Role of glutamine and its metabolite ammonia in crosstalk of cancer-associated fibroblasts and cancer cells.
   Li X, Zhu H, Sun W, Yang X, et al · · 2021 · cited 48× · PMID 34503536 · DOI 10.1186/s12935-021-02121-5