Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as Pembrolizumab (KEYTRUDA®)
ADG116 · 2 trials · 1 indication
Number of participants experiencing dose-limiting toxicities escalating dose levels in adults with advanced / metastatic solid tumor
Number of participants with adverse events as assessed by CTCAE v5.0
| Arm | Type | Description |
|---|---|---|
| Dose escalation | EXPERIMENTAL | ADG116 combination treatment with pembrolizumab (KEYTRUDA®), both drugs will be administered in each cohort. |
| Part A : Dose escalation of ADG116 monotherapy | EXPERIMENTAL | - |
| Part B : Dose escalation of ADG116 combined with anti PD1 drug | EXPERIMENTAL | - |
| Part C : Dose escalation of ADG116 combined with ADG106 | EXPERIMENTAL | - |
| Name | Type | Description |
|---|---|---|
| ADG116 | DRUG | IV infusion |
| ADG106 | DRUG | For the ADG116-ADG106 combination regimen, ADG116 and ADG106 will be administered until disease progression, intolerable toxicities, or withdrawal of consent, or up to 2 years. |
| anti PD1 drug | DRUG | For the ADG116-anti PD1 combination regimen, ADG116 and anti PD1 will be administered until disease progression, intolerable toxicities, or withdrawal of consent, or up to 2 years. |
Inclusion Criteria: * Patients must meet all of the following inclusion criteria to be eligible for participation in this study: 1. ≥ 18 years of age at the time of informed consent. 2. Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1 with no deterioration over the previous ...
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| Merck & Co., Inc. | MRK | 3 | PHASE2 | Pembrolizumab, Gardasil 9 |
| Incyte Corporation | INCY | 1 | PHASE2 | Retifanlimab |
| Novartis AG Sponsored ADR | NVS | 1 | PHASE1 | KFA115 |
| Iovance Biotherapeutics Inc | IOVA | 2 | PHASE2 | Aldesleukin |
| AstraZeneca PLC | AZN | 1 | - | Trastuzumab deruxtecan |
ADG116 is an investigational cancer therapy being studied in adults with advanced or metastatic solid tumors. It has been evaluated both as a single agent and in combination with other antibodies in Phase 1 and Phase 1b/2 clinical trials. It is not approved for any indication.
ADG116 targets CTLA-4, a protein receptor on T cells that acts as an immune checkpoint. By binding CTLA-4, the drug is designed to interfere with this checkpoint pathway in order to support anti-tumor immune activity. CTLA-4 is a well-characterized immuno-oncology target.
ADG116 is being developed by Adagene Inc., a biotechnology company that trades under the ticker ADAG. Adagene sponsored the clinical studies of ADG116 in patients with advanced or metastatic solid tumors.
ADG116 is in Phase 1 clinical development. It is investigational and has not been approved by the FDA for any indication. Two Phase 1 trials of ADG116 have been completed, one evaluating it with pembrolizumab and one evaluating it alone or in combination with anti-PD-1 or anti-CD137 antibodies.
ADG116 has been studied in two completed Phase 1 trials. NCT05277402 evaluated ADG116 in combination with pembrolizumab in patients with advanced or metastatic solid tumors in the United States. NCT04501276 evaluated ADG116 alone or combined with an anti-PD-1 or anti-CD137 antibody in the United States and Australia.
Across the two completed Phase 1 trials, 78 patients were enrolled in total. NCT04501276 enrolled 72 patients, and NCT05277402 enrolled 6 patients. Both studies enrolled adults aged 18 years and older with advanced or metastatic solid tumors.