Camonsertib (RP-3500) Clinical Trials

Size	Price	Qty
5mg	USD 570
25mg	USD 1,970

Clinical Trials

Multiple clinical trials evaluate camonsertib (RP-3500) alone or in combination with targeted therapies, such as PARP inhibitors, across indications including advanced solid tumors, metastatic cancer, breast cancer, non-small-cell lung carcinoma, and head and neck squamous cell carcinomas. Sponsored by pharmaceutical companies alongside academic and government institutions, these Phase 1 and Phase 2 studies encompass recruiting, active not recruiting, completed, and terminated statuses.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT04589845	ACTIVE_NOT_RECRUITING	Solid Tumors	Hoffmann-La Roche	2021-01-18	PHASE2
NCT07156227	RECRUITING	Clinical Stage III HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC v8; Recurrent Head and Neck Squamous Cell Carcinoma; Recurrent Hypopharyngeal Squamous Cell Carcinoma; Recurrent Laryngeal Squamous Cell Carcinoma; Recurrent Oral Cavity Squamous Cell Carcinoma; Recurrent Oropharyngeal Squamous Cell Carcinoma; Recurrent Paranasal Sinus Squamous Cell Carcinoma; Stage III Head and Neck Cutaneous Squamous Cell Carcinoma AJCC v8; Stage III Hypopharyngeal Carcinoma AJCC v8; Stage III Laryngeal Cancer AJCC v8; Stage III Lip and Oral Cavity Cancer AJCC v8; Stage III Oropharyngeal (p16-Negative) Carcinoma AJCC v8; Stage III Sinonasal Cancer AJCC v8; Stage IV Head and Neck Cutaneous Squamous Cell Carcinoma AJCC v8; Stage IVA Hypopharyngeal Carcinoma AJCC v8; Stage IVA Laryngeal Cancer AJCC v8; Stage IVA Lip and Oral Cavity Cancer AJCC v8; Stage IVA Oropharyngeal (p16-Negative) Carcinoma AJCC v8; Stage IVA Sinonasal Cancer AJCC v8; Stage IVB Hypopharyngeal Carcinoma AJCC v8; Stage IVB Laryngeal Cancer AJCC v8; Stage IVB Lip and Oral Cavity Cancer AJCC v8; Stage IVB Oropharyngeal (p16-Negative) Carcinoma AJCC v8; Stage IVB Sinonasal Cancer AJCC v8; Unresectable Head and Neck Squamous Cell Carcinoma; Unresectable Hypopharyngeal Squamous Cell Carcinoma; Unresectable Laryngeal Squamous Cell Carcinoma; Unresectable Oral Cavity Squamous Cell Carcinoma; Unresectable Oropharyngeal Squamous Cell Carcinoma; Unresectable Paranasal Sinus Squamous Cell Carcinoma	National Cancer Institute (NCI)	2027-02-13	PHASE1
NCT05601440	RECRUITING	Breast Cancer	Canadian Cancer Trials Group	2023-06-13	PHASE2
NCT04855656	RECRUITING	Advanced Solid Tumor	Debiopharm International SA	2021-04-30	PHASE1
NCT05566574	ACTIVE_NOT_RECRUITING	Solid Tumor; Metastatic Cancer	Memorial Sloan Kettering Cancer Center	2022-09-30	PHASE1; PHASE2
NCT05605509	COMPLETED	Advanced Cancer	Canadian Cancer Trials Group	2023-05-24	PHASE2
NCT03337698	TERMINATED	Carcinoma, Non-Small-Cell Lung	Hoffmann-La Roche	2017-12-27	PHASE1; PHASE2
NCT04497116	COMPLETED	Advanced Solid Tumor	Repare Therapeutics	2020-07-22	PHASE1; PHASE2
NCT04972110	TERMINATED	Advanced Solid Tumor, Adult	Repare Therapeutics	2021-07-21	PHASE1; PHASE2
NCT05405309	TERMINATED	Chronic Lymphocytic Leukemia	University of Utah	2022-09-23	PHASE1; PHASE2
NCT05566574	Recruiting	Solid Tumor\|Metastatic Cancer	Memorial Sloan Kettering Cancer Center\|Repare Therapeutics	2022-09-30	Phase 1\|Phase 2
NCT04972110	Recruiting	Advanced Solid Tumor Adult	Repare Therapeutics\|Roche Pharma AG	2021-07-21	Phase 1\|Phase 2
NCT04855656	Recruiting	Advanced Solid Tumor	Repare Therapeutics\|Debiopharm International SA	2021-04-30	Phase 1
NCT02723864	Completed	Neoplasms	National Cancer Institute (NCI)\|National Institutes of Health Clinical Center (CC)	2017-08-09	Phase 1

(data from https://clinicaltrials.gov, updated on 2026-09-04)

Check the Camonsertib (RP-3500) product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

Camonsertib (RP-3500) selectively binds to and inhibits ataxia telangiectasia and Rad3-related (ATR) kinase, suppressing its downstream phosphorylation cascades essential for DNA damage repair signaling and replication fork stabilization. This molecular disruption forces the accumulation of persistent double-strand DNA breaks and severe replication stress, ultimately leading to apoptotic cell death and tumor growth suppression in therapeutic settings such as advanced solid tumors, breast cancer, and head and neck carcinomas.

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>).