Clinical Trials

Multiple clinical trials evaluate the efficacy, safety, and pharmacokinetics of repotrectinib across Phase 1 through Phase 3 studies targeting advanced malignancies, including ROS1-positive non-small cell lung cancer and NTRK fusion-positive solid tumors. Encompassing active, completed, terminated, and withdrawn recruitment statuses, these investigations are supported by commercial sponsors such as Bristol-Myers Squibb and Turning Point Therapeutics alongside prominent academic research centers including Memorial Sloan Kettering Cancer Center.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT06552234 RECRUITING
NSCLC Stage IV; NSCLC, Stage III
Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer
 2024-10-01 PHASE2
NCT05004116 RECRUITING
Advanced Cancer; Metastatic Solid Tumor
Memorial Sloan Kettering Cancer Center
 2021-08-09 PHASE1; PHASE2
NCT03093116 RECRUITING
Locally Advanced Solid Tumors; Metastatic Solid Tumors
Turning Point Therapeutics, Inc.
 2017-03-07 PHASE1; PHASE2
NCT06315010 RECRUITING
NSCLC; Brain Metastases; ROS1 Gene Rearrangement
MedSIR
 2025-06-27 PHASE2
NCT04094610 RECRUITING
Locally Advanced Solid Tumors; Metastatic Solid Tumors; Lymphoma; Primary CNS Tumors
Turning Point Therapeutics, Inc.
 2020-03-12 PHASE1; PHASE2
NCT04772235 UNKNOWN
Nsclc
Instituto Oncológico Dr Rosell
 2022-02-11 PHASE1
NCT06140836 ACTIVE_NOT_RECRUITING
Carcinoma, Non-Small-Cell Lung
Bristol-Myers Squibb
 2023-12-21 PHASE3
NCT07223671 COMPLETED
Healthy Volunteers
Bristol-Myers Squibb
 2025-12-31 PHASE1
NCT06408168 TERMINATED
Hormone Receptor-positive Human Epidermal Growth Factor 2-negative; Metastatic Invasive LObular Carcinoma
M.D. Anderson Cancer Center
 2024-08-08 PHASE2
NCT06352528 COMPLETED
Hepatic Impairment; Healthy Volunteers
Bristol-Myers Squibb
 2024-04-29 PHASE1
NCT05828277 WITHDRAWN
Locally Advanced Solid Tumor; Metastatic Solid Tumor
Turning Point Therapeutics, Inc.
 2022-07-28 PHASE1
NCT05828303 WITHDRAWN
Advanced Solid Tumor; Metastatic Solid Tumor
Turning Point Therapeutics, Inc.
 2024-11-15 PHASE1
NCT06493409 COMPLETED
Healthy Volunteers
Bristol-Myers Squibb
 2024-08-26 PHASE1
NCT05071183 TERMINATED
KRAS Mutation-Related Tumors; Metastatic Solid Tumor; Advanced Solid Tumor
Turning Point Therapeutics, Inc.
 2021-09-23 PHASE1; PHASE2
NCT03093116 Recruiting
Locally Advanced Solid Tumors|Metastatic Solid Tumors
Turning Point Therapeutics Inc.|Zai Lab (Shanghai) Co. Ltd.
 2017-03-07 Phase 1|Phase 2

(data from https://clinicaltrials.gov, updated on 2026-07-07)

Check the Repotrectinib (TPX-0005) product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

Repotrectinib is a low-molecular-weight kinase inhibitor that selectively binds the ATP-binding domain of wild-type and mutant ALK, ROS1, TRK family receptors, and SRC, effectively suppressing downstream autophosphorylation and oncogenic intracellular signaling cascades. By inhibiting kinase-driven cell survival and proliferation pathways, repotrectinib induces apoptosis in malignant cells, underlying its observed therapeutic activity in clinical trial populations with ROS1-rearranged non-small cell lung cancer and NTRK fusion-positive solid tumors.

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>).

Jump to

Note: Technical data last updated: Sep 1, 2026.