Clinical Trials

Several clinical trials evaluate TAS-116 (pimitespib) in advanced malignancies, focusing on refractory solid tumors, gastrointestinal stromal tumors, advanced breast cancer, non-small cell lung cancer, and gastrointestinal neoplasms. Spanning Phase 1, Phase 1a/1b, and Phase 2 development, these studies are supported by both industry sponsors, such as Taiho Pharmaceutical Co., Ltd. and GlaxoSmithKline, and academic institutions including Brown University. Recruitment statuses across these trials range from actively recruiting and completed to active non-recruiting and withdrawn.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT07689201 NOT_YET_RECRUITING
Gastrointestinal Neoplasms
GlaxoSmithKline
 2026-08-31 PHASE2
NCT04999761 RECRUITING
Advanced or Metastatic Solid Tumor; Pancreatic Ductal Adenocarcinoma; Colorectal Cancer; Non-small Cell Lung Cancer; Gastric Cancer; Alveolar Soft Part Sarcoma; Esophageal Cancer; Head and Neck Cancer; Biliary Tract Cancer
Taiho Pharmaceutical Co., Ltd.
 2021-06-01 PHASE1
NCT05245968 ACTIVE_NOT_RECRUITING
Gastrointestinal Stromal Tumors
Taiho Pharmaceutical Co., Ltd.
 2021-12-01 PHASE1
NCT05655598 WITHDRAWN
Advanced Breast Cancer; Treatment-Refractory Solid Tumors; Retinoblastoma Deficiency; SCLC; Soft Tissue Sarcoma; Endometrial Cancer; Bladder Cancer
Brown University
 2023-09-12 PHASE1
NCT05655598 Recruiting
Advanced Breast Cancer|Treatment-Refractory Solid Tumors|Retinoblastoma Deficiency|SCLC|Soft Tissue Sarcoma|Endometrial Cancer|Bladder Cancer
Brown University
 2023-09-12 Phase 1
NCT02965885 COMPLETED
Advanced Solid Tumors
Taiho Oncology, Inc.
 2017-07-10 PHASE1
NCT02965885 Completed
Advanced Solid Tumors
Taiho Oncology Inc.
 2017-07-10 Phase 1

(data from https://clinicaltrials.gov, updated on 2026-07-08)

Check the TAS-116 (Pimitespib) product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

Pimitespib (TAS-116) selectively binds to heat shock protein 90 (HSP90α and HSP90β), inhibiting geldanamycin-FITC binding to disrupt chaperone function and induce the destabilization of oncogenic client proteins. This molecular inhibition disrupts downstream pro-survival signaling cascades and suppresses tumor cell proliferation, providing therapeutic relevance in the clinical management of gastrointestinal stromal tumors 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.