Clinical Trials

Taletrectinib is currently evaluated across multiple clinical trials spanning Phase 1 through Phase 3, including observational studies and expanded access programs. These investigations target advanced solid tumors—primarily ROS1-positive non-small cell lung cancer and metastatic breast cancer—as well as pharmacokinetic profiles in healthy adult participants. Sponsored by academic investigators and biopharmaceutical companies such as Nuvation Bio, AnHeart Therapeutics, Innovent Biologics, and Daiichi Sankyo, these studies encompass recruitment statuses ranging from actively recruiting and completed to suspended and upcoming.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT07154706 RECRUITING
Non-small Cell Lung Cancer (NSCLC)
Nuvation Bio Inc.
 2025-08-21 PHASE3
NCT06214793 SUSPENDED
Breast Cancer; Metastatic Breast Cancer
Megan Kruse, MD
 2026-10 PHASE2
NCT06564324 RECRUITING
Non Small Cell Lung Cancer
Nuvation Bio Inc.
 2024-11-27 PHASE3
NCT07742384 NOT_YET_RECRUITING
Healthy Adult Participants
Nuvation Bio Inc.
 2026-08-01 PHASE1
NCT04919811 ACTIVE_NOT_RECRUITING
Non Small Cell Lung Cancer
Nuvation Bio Inc.
 2021-09-01 PHASE2
NCT02675491 COMPLETED
Advanced Solid Malignant Tumors
Daiichi Sankyo Co., Ltd.
 2016-02-10 PHASE1
NCT04919811 Recruiting
Non Small Cell Lung Cancer
AnHeart Therapeutics Inc.
 2021-09-01 Phase 2
NCT05357820 Completed
Solid Tumor
AnHeart Therapeutics Inc.
 2021-07-19 Phase 1
NCT02279433 COMPLETED
Solid Tumors
Nuvation Bio Inc.
 2014-09 PHASE1

(data from https://clinicaltrials.gov, updated on 2026-05-19)

Check the Taletrectinib (DS-6051b) product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

Taletrectinib acts as a potent, selective inhibitor of ROS1 and NTRK receptor tyrosine kinases, binding to their active kinase domains to block autophosphorylation and suppress downstream oncogenic signaling cascades. This pathway blockade inhibits cellular proliferation and triggers apoptosis in target-dependent malignant cells, underlying its antitumor activity observed in clinical trials for ROS1-positive non-small cell lung cancer and advanced 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>).

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