Clinical Trials

A Phase 1 clinical trial sponsored by GB006, Inc., a subsidiary of Gossamer Bio, Inc., evaluated ADH-503 (GB1275) as a monotherapy and in combination with an anti-PD-1 antibody. The study investigated patients across multiple advanced solid tumor indications, including pancreatic, gastric, esophageal, hepatocellular, and renal cell carcinomas, as well as triple-negative breast cancer and non-small cell lung cancer. Official records indicate that the recruitment status for this early-stage investigation is terminated.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT04060342 TERMINATED
Pancreatic Adenocarcinoma; Esophageal Adenocarcinoma; Esophageal Squamous Cell Carcinoma; Gastric Adenocarcinoma; Gastroesophageal Junction Adenocarcinoma; Triple Negative Breast Cancer; Castration-resistant Prostate Cancer; Microsatellite Stable Colorectal Cancer; Non-small Cell Lung Cancer; Small-cell Lung Cancer; Head and Neck Squamous Cell Carcinoma; Urothelial Carcinoma; Renal Cell Carcinoma; Hepatocellular Carcinoma
GB006, Inc., a wholly owned subsidiary of Gossamer Bio, Inc.
 2019-08-13 PHASE1

(data from https://clinicaltrials.gov, updated on 2022-08-18)

Check the ADH-503 (GB1275) product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

ADH-503 acts as a potent allosteric agonist of CD11b, binding to the integrin alpha M subunit to stabilize its active conformation and drive downstream intracellular signaling pathways in myeloid cells. This CD11b activation repolarizes immunosuppressive tumor-associated macrophages toward a pro-inflammatory phenotype, thereby alleviating immune suppression within the tumor microenvironment to inhibit malignant progression in conditions such as pancreatic adenocarcinoma and triple-negative breast cancer.

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.