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NCT05277402
ADG116 in Combination With Pembrolizumab in Patients With Advanced/Metastatic Solid Tumors
Phase 1 trial testing ADG116 in Advanced/Metastatic Solid Tumors in 6 participants. Completed in 1 December 2022.
1 August 2022
Quick facts
| Lead sponsor | Adagene Inc |
|---|---|
| Phase | Phase 1 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | sequential |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 6 |
| Start date | 9 February 2022 |
| Primary completion | 1 August 2022 |
| Estimated completion | 1 December 2022 |
| Sites | 2 locations across United States |
Drugs / interventions tested
- ADG116 — full drug profile →
Conditions studied
- Advanced/Metastatic Solid Tumors — all drugs for Advanced/Metastatic Solid Tumors →
Sponsor
Adagene Inc — full company profile →
Who can join
18 and older, any sex, with Advanced/Metastatic Solid Tumors. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
This is a Phase 1b, open-label, dose escalation study to evaluate the safety, tolerability, PK, and immunogenicity of an ADG116-pembrolizumab combination regimen in patients with advanced/metastatic solid tumors. Study drug ADG116, is an anti -CTLA-4 fully human monoclonal antibody that specifically binds to human CTLA-4. Pembrolizumab is a PD-1 receptor-blocking antibody (a humanized IgG4 monoclonal antibody) which is indicated for the treatment of patients across a number of indications. The treatment strategy of using anti-PD 1 therapy combined with anti-CTLA-4 therapy is to explore the potential of combination checkpoint inhibition regimens for the enhanced antitumor efficacy results.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
- PubMed search for NCT05277402
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of ADG116
Trials testing the same drug.
- NCT04501276 — A Phase 1b/2 Study of ADG116, ADG116 Combined With Anti-PD-1 Antibody or Anti-CD137 Antibody in Solid Tumors Patients · Phase 1 · completed
- NCT04111445 — Study of ADG116 in Patients With Advanced/Metastatic Solid Tumors · Phase 1 · terminated
Other recruiting trials for Advanced/Metastatic Solid Tumors
Currently open trials in the same condition.
- NCT07274813 — A Phase I Study to Evaluate the Safety, Tolerability, and PK of HLX37 in Advanced/Metastatic Solid Tumors · EARLY_PHASE1 · recruiting
- NCT07090499 — A Study to Learn About the Study Medicine Called PF-08046876 in People With Advanced Solid Tumors · Phase 1 · recruiting
- NCT07415863 — Phase 1/II Clinical Study of SYS6043 in the Treatment of Advanced/Metastatic Solid Tumors · Phase 1, PHASE2 · recruiting
- NCT05718895 — A Study of ATG-022 in Patients With Advanced/Metastatic Solid Tumors · Phase 1 · recruiting
- NCT05607498 — First in Human Study of EMB-07 in Locally Advanced/Metastatic Solid Tumors or Relapse/Refractory Lymphoma · Phase 1 · recruiting
Other Adagene Inc trials
Trials by the same sponsor.
- NCT05614258 — Study of ADG206 in Subjects With Advanced/Metastatic Solid Tumors · Phase 1 · active not recruiting
- NCT05405595 — ADG126 in Combination With Pembrolizumab in Patients With Advanced/Metastatic Solid Tumors · Phase 1, PHASE2 · recruiting
- NCT04645069 — ADG126, ADG126 in Combination With Anti PD1 Antibody, and ADG126 in Combination With ADG106 in Advanced/Metastatic Solid · Phase 1, PHASE2 · completed
- NCT04501276 — A Phase 1b/2 Study of ADG116, ADG116 Combined With Anti-PD-1 Antibody or Anti-CD137 Antibody in Solid Tumors Patients · Phase 1 · completed
- NCT04111445 — Study of ADG116 in Patients With Advanced/Metastatic Solid Tumors · Phase 1 · terminated
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT05277402 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Adagene Inc
- Last refreshed: 26 February 2024
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05277402.
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