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)
Mechanism and Biochemical Profile
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>).