NCT04501276

A Phase 1b/2 Study of ADG116, ADG116 Combined With Anti-PD-1 Antibody or Anti-CD137 Antibody in Solid Tumors Patients

Completed Phase 1 Last updated 8 January 2026

What this trial tests

Phase 1 trial testing ADG116 in Advanced/Metastatic Solid Tumors in 72 participants. Completed in 30 November 2025.

Timeline

23 September 2020

Primary endpoint
17 January 2024

30 November 2025

Quick facts

Lead sponsor	Adagene Inc
Phase	Phase 1
Status	Completed
Study type	INTERVENTIONAL
Allocation	non randomized
Design	sequential
Masking	none
Primary purpose	treatment
Enrollment	72
Start date	23 September 2020
Primary completion	17 January 2024
Estimated completion	30 November 2025
Sites	4 locations across United States, Australia

Drugs / interventions tested

• ADG116 — full drug profile →
• ADG106 — full drug profile →
• anti PD1 drug — 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 1, open-label, dose escalation study 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. ADG106, a fully human ligand-blocking agonistic anti-CD137 IgG4 mAb, is expected to enhance the activity of activated T cells. The enhanced antitumor efficacy results observed from the preclinical studies of ADG116 in combination with ADG106 or anti-PD-1 provided further support to explore such combinations in clinical settings for better patient responses.

Publications & conference data

7 peer-reviewed publications reference this trial (live from Europe PMC):

1. The emerging landscape of novel 4-1BB (CD137) agonistic drugs for cancer immunotherapy.
   Claus C, Ferrara-Koller C, Klein C. · · 2023 · cited 65× · PMID 36727218 · DOI 10.1080/19420862.2023.2167189
2. Development of pharmacological immunoregulatory anti-cancer therapeutics: current mechanistic studies and clinical opportunities.
   Yin N, Li X, Zhang X, Xue S, et al · · 2024 · cited 48× · PMID 38773064 · DOI 10.1038/s41392-024-01826-z
3. 4-1BB: A promising target for cancer immunotherapy.
   Kim AMJ, Nemeth MR, Lim SO. · · 2022 · cited 38× · PMID 36185242 · DOI 10.3389/fonc.2022.968360
4. Macrophage and monocyte subsets as new therapeutic targets in cancer immunotherapy.
   Fendl B, Berghoff AS, Preusser M, Maier B. · · 2023 · cited 34× · PMID 36731326 · DOI 10.1016/j.esmoop.2022.100776
5. Recent research and clinical progress of CTLA-4-based immunotherapy for breast cancer.
   Zhang H, Mi J, Xin Q, Cao W, et al · · 2023 · cited 12× · PMID 37860188 · DOI 10.3389/fonc.2023.1256360
6. Targeting 4-1BB for tumor immunotherapy from bench to bedside.
   Wang YT, Ji WD, Jiao HM, Lu A, et al · · 2022 · cited 6× · PMID 36189243 · DOI 10.3389/fimmu.2022.975926
7. Expanding the immunotherapy universe in extensive-stage small cell lung cancer: from chemoimmunotherapy backbone to next-wave combinations.
   Chi X, Dong Y, Zhu L, Su D, et al · · 2025 · PMID 41415276 · DOI 10.3389/fimmu.2025.1693401