Clinical Trials

Multiple clinical trials are currently evaluating Atamparib (RBN-2397) for the treatment of advanced solid tumors, advanced squamous non-small cell lung carcinoma, and non-small cell lung carcinoma adenocarcinoma. Sponsored by Ribon Therapeutics Inc. and Nerviano Medical Sciences (Shanghai) Ltd., these Phase I and Phase I/II studies encompass single-agent dose escalation protocols as well as combination therapies with pembrolizumab. Recruitment statuses across these trials range from recruiting to active, not recruiting.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT07374419 RECRUITING
NSCLC Adenocarcinoma; Solid Tumor
Nerviano Medical Sciences (Shanghai) Ltd.
 2026-03-18 PHASE1; PHASE2
NCT05127590 UNKNOWN
Advanced Squamous Non-Small Cell Lung Carcinoma
Ribon Therapeutics, Inc.
 2022-03-15 PHASE1; PHASE2
NCT04053673 UNKNOWN
Solid Tumor, Adult
Ribon Therapeutics, Inc.
 2019-08-01 PHASE1
NCT05127590 Active not recruiting
Advanced Squamous Non-Small Cell Lung Carcinoma
Ribon Therapeutics Inc.
 2022-03-15 Phase 1|Phase 2
NCT04053673 Recruiting
Solid Tumor Adult
Ribon Therapeutics Inc.
 2019-08-01 Phase 1

(data from https://clinicaltrials.gov, updated on 2026-07-29)

Check the Atamparib (RBN-2397) product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

Atamparib (RBN-2397) functions as a potent and selective NAD+-competitive inhibitor of poly(ADP-ribose) polymerase 7 (PARP7), directly binding to its catalytic domain and preventing PARP7-mediated mono-ADP-ribosylation of target proteins. This enzymatic blockade restores cellular type I interferon signaling and inhibits cancer cell proliferation, demonstrating strong anti-tumor therapeutic relevance in advanced solid tumors and non-small cell lung carcinoma.

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.