Multiple clinical trials evaluate the therapeutic efficacy, safety, pharmacokinetics, and drug interactions of telaglenastat across oncological indications, including non-small cell lung cancer, acute myeloid leukemia, IDH-mutant astrocytoma, and KEAP1- or NRF2-mutated solid tumors. Sponsored by industry leads like Calithera Biosciences alongside institutional partners such as the National Cancer Institute and M.D. Anderson Cancer Center, these early-phase studies range in status from active, recruiting, and completed to active not recruiting and terminated.
| NCT Number | Recruitment | Conditions | Sponsor/Collaborators | Start Date | Phases |
|---|---|---|---|---|---|
| NCT05521997 | NOT_YET_RECRUITING | Advanced Cervical Carcinoma; Cervical Cancer; Cervix Cancer; Cancer of the Cervix |
Washington University School of Medicine |
2026-12-31 | PHASE2 |
| NCT07223528 | NOT_YET_RECRUITING | Pulmonary Hypertension |
Chan, Stephen, MD, PhD |
2026-08 | PHASE1; PHASE2 |
| NCT03528642 | ACTIVE_NOT_RECRUITING | Astrocytoma, IDH-Mutant, Grade 2; Astrocytoma, IDH-Mutant, Grade 3 |
National Cancer Institute (NCI) |
2019-05-01 | PHASE1 |
| NCT04250545 | ACTIVE_NOT_RECRUITING | Leptomeningeal Neoplasm; Metastatic Lung Non-Small Cell Carcinoma; Metastatic Malignant Neoplasm in the Brain; Recurrent Lung Non-Small Cell Carcinoma; Stage IV Lung Cancer AJCC v8; Stage IVA Lung Cancer AJCC v8; Stage IVB Lung Cancer AJCC v8 |
National Cancer Institute (NCI) |
2020-10-26 | PHASE1 |
| NCT03831932 | ACTIVE_NOT_RECRUITING | Advanced Lung Non-Small Cell Carcinoma; Metastatic Lung Non-Small Cell Carcinoma; Stage IV Lung Cancer AJCC v8 |
National Cancer Institute (NCI) |
2020-03-16 | PHASE1; PHASE2 |
| NCT03798678 | ACTIVE_NOT_RECRUITING | Recurrent Multiple Myeloma; Refractory Multiple Myeloma |
National Cancer Institute (NCI) |
2019-07-08 | PHASE1 |
| NCT03872427 | ACTIVE_NOT_RECRUITING | Advanced Malignant Solid Neoplasm; Metastatic Malignant Solid Neoplasm; NF1 Mutation Positive Malignant Peripheral Nerve Sheath Tumor; Unresectable Malignant Solid Neoplasm |
National Cancer Institute (NCI) |
2019-12-14 | PHASE2 |
| NCT03263429 | COMPLETED | Colorectal Cancer; Metastatic Colorectal Cancer; RAS Wild Type Colorectal Cancer; Refractory Colorectal Cancer |
Vanderbilt-Ingram Cancer Center |
2017-08-23 | PHASE1; PHASE2 |
| NCT03047993 | COMPLETED | Acute Myeloid Leukemia With Multilineage Dysplasia; Blasts 20-30 Percent of Bone Marrow Nucleated Cells; Blasts 20-30 Percent of Peripheral Blood White Cells; Chronic Myelomonocytic Leukemia; High Risk Myelodysplastic Syndrome; IPSS Risk Category Intermediate-2; Myelodysplastic Syndrome |
M.D. Anderson Cancer Center |
2017-11-15 | PHASE1; PHASE2 |
| NCT02861300 | COMPLETED | Colorectal Cancer; Colon Cancer; Rectal Cancer; Solid Tumor |
David Bajor, MD |
2016-09-12 | PHASE1; PHASE2 |
| NCT03944902 | TERMINATED | Ovarian Cancer; Resistant BRCA Wild-Type Ovarian Cancer |
University of Alabama at Birmingham |
2021-09-01 | PHASE1 |
| NCT04824937 | UNKNOWN | Prostate Cancer Metastatic |
Massachusetts General Hospital |
2021-07 | PHASE2 |
| NCT04265534 | TERMINATED | Non-Small Cell Lung Cancer; Non-squamous Non-small-cell Lung Cancer; Non-Squamous Non-Small Cell Neoplasm of Lung; KEAP1 Gene Mutation; NRF2 Gene Mutation; NFE2L2 Gene Mutation |
Calithera Biosciences, Inc |
2020-07-24 | PHASE2 |
| NCT03965845 | COMPLETED | Solid Tumors; NSCLC; CRC; KRAS Gene Mutation |
Calithera Biosciences, Inc |
2019-06-25 | PHASE1; PHASE2 |
| NCT04607512 | COMPLETED | Cardiac Safety |
Calithera Biosciences, Inc |
2020-10-05 | PHASE1 |
| NCT04540965 | COMPLETED | Drug Interaction |
Calithera Biosciences, Inc |
2020-09-22 | PHASE1 |
| NCT04250545 | Recruiting | Leptomeningeal Neoplasm|Metastatic Lung Non-Small Cell Carcinoma|Metastatic Malignant Neoplasm in the Brain|Recurrent Lung Non-Small Cell Carcinoma|Stage IV Lung Cancer AJCC v8|Stage IVA Lung Cancer AJCC v8|Stage IVB Lung Cancer AJCC v8 |
National Cancer Institute (NCI) |
2020-10-26 | Phase 1 |
| NCT03428217 | COMPLETED | Advanced Renal Cell Carcinoma; Metastatic Renal Cell Carcinoma |
Calithera Biosciences, Inc |
2018-04-24 | PHASE2 |
| NCT03875313 | TERMINATED | Solid Tumor; Clear Cell Renal Cell Carcinoma; TNBC - Triple-Negative Breast Cancer; Colorectal Cancer; CRC; RCC; ccRCC |
Calithera Biosciences, Inc |
2019-05-20 | PHASE1; PHASE2 |
| NCT02771626 | TERMINATED | Clear Cell Renal Cell Carcinoma (ccRCC); Melanoma; Non-small Cell Lung Cancer (NSCLC) |
Calithera Biosciences, Inc |
2016-08-01 | PHASE1; PHASE2 |
| NCT03057600 | COMPLETED | Triple Negative Breast Cancer; TNBC - Triple-Negative Breast Cancer |
Calithera Biosciences, Inc |
2017-05-01 | PHASE2 |
| NCT03163667 | COMPLETED | Clear Cell Renal Cell Carcinoma |
Calithera Biosciences, Inc |
2017-09-06 | PHASE2 |
| NCT02071862 | COMPLETED | Solid Tumors; Triple-Negative Breast Cancer; Non Small Cell Lung Cancer; Renal Cell Carcinoma; Mesothelioma; Fumarate Hydratase (FH)-Deficient Tumors; Succinate Dehydrogenase (SDH)-Deficient Gastrointestinal Stromal Tumors (GIST); Succinate Dehydrogenase (SDH)-Deficient Non-gastrointestinal Stromal Tumors; Tumors Harboring Isocitrate Dehydrogenase-1 (IDH1) and IDH2 Mutations; Tumors Harboring Amplifications in the cMyc Gene |
Calithera Biosciences, Inc |
2014-02 | PHASE1 |
| NCT02944435 | COMPLETED | Healthy Volunteers |
Calithera Biosciences, Inc |
2016-10 | PHASE1 |
| NCT02944435 | Completed | Healthy Volunteers |
Calithera Biosciences Inc |
2016-10 | Phase 1 |
| NCT02071927 | COMPLETED | Acute Myeloid Leukemia (AML); Acute Lymphocytic Leukemia (ALL) |
Calithera Biosciences, Inc |
2014-03 | PHASE1 |
| NCT02071888 | COMPLETED | Non-Hodgkin's Lymphoma (NHL); Multiple Myeloma; Waldenstrom's Macroglobulinemia (WM); Other B-cell NHL Subtypes, Including WM; T-cell NHL |
Calithera Biosciences, Inc |
2014-02 | PHASE1 |
| NCT02071927 | Completed | Acute Myeloid Leukemia (AML)|Acute Lymphocytic Leukemia (ALL) |
Calithera Biosciences Inc |
2014-03 | Phase 1 |
(data from https://clinicaltrials.gov, updated on 2026-09-03)
Check the
Telaglenastat (CB-839)
product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.
Mechanism and Biochemical Profile
Appendix RUO and cGMP Quality Standards
| Quality Dimension | RUO (Research Use Only) | cGMP (Current Good Manufacturing Practice) |
|---|---|---|
| Clinical Applicability | Prohibited in human clinical trials or medical diagnostics. | Mandatory for human clinical trials (Phase I–III) and therapies. |
| Regulatory Status | Non-regulated grade; exempt from drug manufacturing laws. | Legally enforced by health authorities (e.g., FDA, EMA, NMPA). |
| Facility Environment | Unclassified analytical or research laboratories. | Validated Cleanrooms (ISO Class 5–8) with continuous monitoring. |
| Quality Control | Basic purity and activity testing. | Rigorous safety release testing (Sterility, Endotoxin, Mycoplasma). |
| Process Validation | Basic equipment calibration; no process validation required. | Full qualification (IQ/OQ/PQ) and complete batch records. |
| Quality Assurance | Vendor self-declared without required formal QMS. | Mandatory QA/QC unit, Change Control, CAPA, and vendor audits. |
| Regulatory Impact | High risk of IND rejection if used as a critical raw material. | Required for IND/NDA filings, supported by Drug Master Files (DMF). |
Footnotes
Regulatory Note: Governed by FDA (21 CFR Parts 210/211/312), EMA (EudraLex Vol 4), ICH Guidelines (E6/Q7/Q9/Q10), and compendial standards (USP <71>/<85>/<1043>).
- Telaglenastat (CB-839) Mechanism of Action: Glutaminase Inhibition in Tumor Cell Research
- Telaglenastat (CB-839) Working Concentration | Cell Culture | Treatment
- Telaglenastat (CB-839) Solubility in DMSO
- Telaglenastat (CB-839) Stock Solution
- Telaglenastat (CB-839) Storage
- Telaglenastat (CB-839) Stability
- Telaglenastat (CB-839) Combination Database
- Telaglenastat (CB-839) Molecular Weight
- Telaglenastat (CB-839) SMILES
- Telaglenastat (CB-839) CAS Number
- Telaglenastat (CB-839) Chemical Structure (2D and 3D)
- Telaglenastat (CB-839) IC50 for Cell-based and Cell-free Assays
- Telaglenastat (CB-839) Sigma (5.33717)? Try a better option.
- Telaglenastat (CB-839) MedChemExpress (HY-12248)? Try a better option.
- Telaglenastat (CB-839) Cayman (22038)? Try a better option.
- Telaglenastat (CB-839) Abmole (M3003)? Try a better option.
- Telaglenastat (CB-839) Tocris (7591)? Try a better option.
- Telaglenastat (CB-839) SDS｜MSDS
Note: Technical data last updated: Sep 1, 2026.