Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
ADG126 · 1 trial · 1 indication
To determine the maximum tolerated dose (MTD) and recommended phase 2 dose (RP2D) for ADG126+ pembrolizumab in dose escalation levels
Incidence rate of AEs as assessed by CTCAE v5.0
Number of Participants with preliminary antitumor activity
To assess the safety and tolerability of ADG126 + pembrolizumab in combination with the following SOC therapies (Trifluridine/tipiracil-bevacizumab) in MSS CRC To determine the MTD and/or RP2D for ADG126 + pembrolizumab in combination with the following SOC therapies in MSS CRC:
To assess the preliminary antitumor activity of ADG126 + pembrolizumab in combination with the following SOC therapies in MSS CRC (Trifluridine/tipiracil-bevacizumab) SOC (Fruquintinib)
To characterize the optimal dose based on safety and efficacy parameters
| Arm | Type | Description |
|---|---|---|
| ADG126 in combination with Pembrolizumab (Trade name KEYTRUDA®) | EXPERIMENTAL | An IV infusion of ADG126 over 60-90 minutes will be administered 30-60 minutes after administration of pembrolizumab (KEYTRUDA®) infusion. A treatment cycle will consist of 21 days. ADG126 and Pembrolizumab (KEYTRUDA®) combination treatment both will be dosed until progressive disease (PD), intolerable toxicities, withdrawals of consent, or up to 35 cycles. |
| ADG126 and pembrolizumab (KEYTRUDA®) in combination with Trifluridine/Tipiracil-Bevacizumab | EXPERIMENTAL | To evaluate the preliminary antitumor efficacy of ADG126 and Pembrolizumab (KEYTRUDA®) in combination with SOC (Trifluridine/Tipiracil-Bevacizumab) while assessing safety and tolerability. Standard of care treatment will be administered according to the specifications outlined in the Investigational Brochure. Will be dosed until progressive disease (PD), intolerable toxicities, withdrawals of consent, or up to 35 cycles. |
| ADG126 and pembrolizumab (KEYTRUDA®) in combination with fruquintinib | EXPERIMENTAL | To evaluate the preliminary antitumor efficacy of ADG126 and Pembrolizumab (KEYTRUDA®) in combination with SOC (Fruquintinib) while assessing safety and tolerability. The dose strength for treatment will be based on the IB and protocol. Fruquintinib (Fruzaqla) is orally given once daily for the first 21 days of each 28-day cycle. Each treatment cycle consists of 14 days. Will be dosed until progressive disease (PD), intolerable toxicities, withdrawals of consent, or up to 35 cycles. |
| Dose Optimization | EXPERIMENTAL | The randomized phase 2 Dose Optimization arm is intended to test two dosing regimens of ADG126 in combination with pembrolizumab (KEYTRUDA®), which allows the selection of an optimal regimen. The study treatments may continue for up to 35 treatments for pembrolizumab (KEYTRUDA®) if given every 21 days and 18 treatments for pembrolizumab (KEYTRUDA®) if given every 42 days until PD, intolerable toxicities or withdrawal of consent. |
| Name | Type | Description |
|---|---|---|
| ADG126 | DRUG | ADG126 is an anti-CTLA-4 fully human monoclonal antibody that specifically binds to human CTLA-4. |
| Pembrolizumab (KEYTRUDA®) | DRUG | Pembrolizumab (KEYTRUDA®) is a PD-1 receptor-blocking antibody (a humanized IgG4 monoclonal antibody). |
| Standard of Care (Trifluridine/Tipiracil-Bevacizumab) | DRUG | The standard of care therapies will include Trifluridine/Tipiracil-Bevacizumab, approved for treating metastatic colorectal cancer (CRC)and various solid tumors. |
| Standard of care (Fruquintinib) | DRUG | The standard of care therapy, Fruquintinib, is approved for treating metastatic colorectal cancer (CRC) and various solid tumors. |
Inclusion Criteria: 1. ≥18 years of age at the time of informed consent. 2. Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1. 3. Wash out period from previous antitumor therapies 4. At least 1 measurable lesion at baseline according to the definition of RECIST v1.1. 5. Adequate o...
| 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 |
ADG126 is an investigational small molecule being studied for the treatment of advanced or metastatic solid tumors. It is currently in Phase 1 clinical development, meaning it has not been approved by regulatory authorities and is still being evaluated for safety and efficacy in patients.
ADG126 targets CTLA-4, a protein involved in regulating immune responses. By targeting CTLA-4, ADG126 is designed to modulate the immune system's ability to fight cancer cells. This mechanism is being explored in the context of advanced or metastatic solid tumors.
ADG126 is being developed by Adagene Inc., a biopharmaceutical company listed on the stock exchange under the ticker symbol ADAG. The company is conducting clinical trials to evaluate the drug's safety and efficacy in patients with advanced or metastatic solid tumors.
ADG126 is currently in Phase 1 clinical development. It is an investigational drug, meaning it has not been approved by regulatory authorities. The Phase 1 trial is actively recruiting participants to assess the drug's safety, tolerability, and preliminary efficacy in combination with another therapy.
ADG126 is being studied in a Phase 1 clinical trial with the identifier NCT05405595. This trial is evaluating ADG126 in combination with pembrolizumab in patients with advanced or metastatic solid tumors. The study is recruiting participants in the United States, China, and South Korea, with an enrollment target of 186 patients.
ADG126 is a distinct investigational drug developed by Adagene Inc. It is not known to be the same as any other approved or investigational medication. Its unique mechanism of targeting CTLA-4 differentiates it from other therapies, and it is being studied specifically for advanced or metastatic solid tumors.