Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
ADG126 Mono · 1 trial · 1 indication
| Arm | Type | Description |
|---|---|---|
| ADG126 mono dose escalation | EXPERIMENTAL | ADG126 monotherapy dose escalation will be traditional 3+3 cohort design. |
| ADG126 mono dose expansion | EXPERIMENTAL | Monotherapy dose expansion is designed to evaluate the preliminary antitumor activity of ADG126 at RP2D or the doses approved by the SRC. |
| ADG126-anti PD1 drug dose escalation | EXPERIMENTAL | Combination therapy will commence at a dose level lower than the cleared dose from the monotherapy dose escalation arms and approved by the SRC. |
| ADG126-anti PD1 drug dose expansion | EXPERIMENTAL | Combination therapy expansion will commence at RP2D or the dose approved by the SRC. |
| ADG126-ADG106 dose escalation | EXPERIMENTAL | Combination therapy will commence at a dose level lower than the cleared dose from the monotherapy dose escalation arms and approved by the SRC. |
| ADG126-ADG106 dose expansion | EXPERIMENTAL | Combination therapy expansion will commence at RP2D or the dose approved by the SRC. |
| Name | Type | Description |
|---|---|---|
| ADG126 Mono | BIOLOGICAL | ADG126 will be administered as an IV infusion over 30-60 minutes ± 15 minutes. |
| ADG126-anti PD1 | BIOLOGICAL | ADG126-toripalimab combination regimen will receive of toripalimab 15 to 30 minutes after the end of the ADG126 infusion |
| ADG126-ADG106 | BIOLOGICAL | ADG126-ADG106 combination regimen will be receive of ADG106 15 to 30 minutes after the end of the ADG126 infusion |
Inclusion criteria 1. Adults ≥18 years of age. 2. ECOG performance status 0 or 1. 3. Estimated life expectancy of more than 12 weeks . 4. Patients with advanced or metastatic solid tumors, confirmed by histologically or pathologically documented, who have progressed after all standard therapies, or...
| 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 |
ADG126 Mono is an investigational biologic developed by Adagene Inc. for advanced and metastatic solid tumors. It is an oncology candidate being studied in a Phase 1/2 clinical program. The Mono designation refers to ADG126 given as a single agent, distinct from regimens combining ADG126 with other antibodies.
ADG126 Mono is being developed for the treatment of advanced or metastatic solid tumors. The clinical program enrolls adults 18 years and older with these advanced cancers across sites in the United States, Australia, and Singapore. It is an investigational therapy and is not approved for commercial use.
ADG126 Mono is developed by Adagene Inc., a biotechnology company whose common stock trades under the ticker ADAG. Adagene is the sponsor of the clinical program evaluating ADG126 as a single agent and in combination regimens for advanced and metastatic solid tumors.
ADG126 Mono is in Phase 1/2 clinical development. Its single registered trial, NCT04645069, is a Phase 1/Phase 2 study that has been completed, with 58 participants enrolled. ADG126 Mono remains an investigational agent and has not been approved by the FDA.
ADG126 Mono was evaluated in trial NCT04645069, titled ADG126, ADG126 in Combination With Anti PD1 Antibody, and ADG126 in Combination With ADG106 in Advanced/Metastatic Solid Tumors. The Phase 1/Phase 2 study enrolled 58 adults across the United States, Australia, and Singapore and is listed as completed.
The NCT04645069 study of ADG126 Mono was a controlled trial that was not randomized and not double blinded. It enrolled 58 participants aged 18 years and older of all sexes, and it did not use biomarker-based selection for enrollment. The study covered advanced and metastatic solid tumors.