Clinical Trials

A clinical trial sponsored by industry developer Boundless Bio, Inc. evaluated the therapeutic potential of BBI-355 as a single agent and in combination with select targeted therapies. This open-label, first-in-human Phase 1 study encompassed a broad range of advanced solid tumors, including triple-negative and ER+ breast cancer, high-grade serous ovarian carcinoma, high-grade endometrial carcinoma, head and neck squamous cell carcinoma, leiomyosarcoma, metastatic pancreatic cancer, and small cell lung cancer. According to trial registry records, recruitment for the study is currently terminated.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT05827614 TERMINATED
Triple Negative Breast Cancer (TNBC); High Grade Serous Ovarian Carcinoma; High Grade Endometrial Carcinoma; Anogenital Cancer; Head and Neck (HNSCC); Cutaneous Squamous Cell Carcinoma (CSCC); Cervical Squamous Cell Carcinoma; ER+ Breast Cancer; Leiomyosarcoma (LMS); Undifferentiated Pleomorphic Sarcoma (UPS); Pancreatic Cancer Metastatic; Small Cell Lung Cancer
Boundless Bio, Inc.
 2023-03-24 PHASE1

(data from https://clinicaltrials.gov, updated on 2026-08-19)

Check the CHK1-IN-12 product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

BBI-355 functions as a selective small-molecule inhibitor of checkpoint kinase 1 (CHK1) with an IC50 of 0.3 nM, binding to the kinase domain and preventing downstream phosphorylation of key DNA damage response transducers. This target inhibition abrogates intra-S and G2/M cell cycle checkpoints, inducing extensive DNA double-strand breaks and cell death, which drives single-agent and combination anti-tumor activity across clinical trial indications such as triple-negative breast cancer, high-grade serous ovarian carcinoma, 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.