Clinical Trials

Several completed Phase 1 clinical trials sponsored by Curis Inc. have evaluated the oral checkpoint antagonist CA-170 in patients with advanced solid tumors or lymphomas. Conducted as open-label, dose-escalation and dose-expansion studies, these evaluations assessed the agent's safety, pharmacokinetics, pharmacodynamics, and preliminary efficacy to determine its clinical feasibility. Ultimately, these efforts established the initial pharmacological profile and therapeutic safety of oral CA-170 in advanced oncological settings.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT02812875 COMPLETED
Advanced Solid Tumors or Lymphomas
Curis, Inc.
2016-05 PHASE1
NCT02812875 Completed
Advanced Solid Tumors or Lymphomas
Curis Inc.
2016-05 Phase 1

(data from https://clinicaltrials.gov, updated on 2020-06-26)

Check the CA-170 (AUPM-170) product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

CA-170 acts as a potent, orally available small-molecule inhibitor that target-binds to programmed cell death ligand-1 (PD-L1) and V-domain immunoglobulin suppressor of T-cell activation (VISTA), thereby blocking checkpoint-mediated immunosuppressive signaling pathways. This target inhibition prevents T-cell inactivation and restores anti-tumor lymphocyte proliferation, driving effective immune-mediated tumor regression in advanced solid tumors or lymphomas.

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>).

Note: Technical data last updated: Sep 1, 2026.