Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
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 | 2 | PHASE2 | pembrolizumab |
| Incyte Corporation | INCY | 1 | PHASE2 | Chemotherapy, Retifanlimab |
| Iovance Biotherapeutics Inc | IOVA | 2 | PHASE2 | E7 TCR-T cells, Aldesleukin |
| Novartis AG Sponsored ADR | NVS | 1 | PHASE1 | KFA115, pembrolizumab |
| AstraZeneca PLC | AZN | 1 | - | Trastuzumab deruxtecan |
ADG116 is an investigational small molecule being studied for the treatment of advanced or metastatic solid tumors. It is in Phase 1 clinical development and has been evaluated in two completed trials, both of which enrolled adult patients with advanced or metastatic solid tumors.
ADG116 is being developed by Adagene Inc., a biopharmaceutical company listed on the NASDAQ under the ticker symbol ADAG. The company is conducting clinical trials of ADG116 in patients with advanced or metastatic solid tumors.
ADG116 is in Phase 1 clinical development. It has completed two Phase 1 trials, one of which was a Phase 1b/2 study, but it is not yet approved by the FDA and remains an investigational drug.
ADG116 has been studied in two completed clinical trials: NCT04501276, a Phase 1b/2 study of ADG116 alone or combined with anti-PD-1 or anti-CD137 antibodies in solid tumor patients, and NCT05277402, a Phase 1 study of ADG116 in combination with pembrolizumab in patients with advanced or metastatic solid tumors.
ADG116 is a small molecule, but its specific molecular target has not been disclosed in the available information. It is being studied in combination with immunotherapies such as anti-PD-1 antibodies and pembrolizumab, suggesting it may modulate immune responses in the tumor microenvironment.