Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
ADG126 · 2 trials · 2 indications
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
ORR, defined as the proportion of participants with a complete response or partial response on two consecutive occasions \>=4 weeks apart during Stage 1, as determined by the investigator according to RECIST v1.1.
| 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. |
| Stage 1: Atezolizumab + Bevacizumab | ACTIVE_COMPARATOR | Participants will receive atezolizumab plus bevacizumab until unacceptable toxicity or loss of clinical benefit, as determined by the investigator after an integrated assessment of radiographic and biochemical data, local biopsy results (if available), and clinical status. |
| Stage 1: Atezolizumab + Bevacizumab + Tiragolumab | EXPERIMENTAL | Participants will receive atezolizumab plus bevacizumab plus tiragolumab until unacceptable toxicity or loss of clinical benefit, as determined by the investigator after an integrated assessment of radiographic and biochemical data, local biopsy results (if available), and clinical status. |
| Stage 1: Atezolizumab + Bevacizumab + Tocilizumab | EXPERIMENTAL | Participants will receive atezolizumab plus bevacizumab plus tocilizumab until unacceptable toxicity or loss of clinical benefit, as determined by the investigator after an integrated assessment of radiographic and biochemical data, local biopsy results (if available), and clinical status. |
| Stage 1: Atezolizumab + Bevacizumab + TPST-1120 | EXPERIMENTAL | Participants will receive atezolizumab plus bevacizumab plus TPST-1120 until unacceptable toxicity or loss of clinical benefit, as determined by the investigator after an integrated assessment of radiographic and biochemical data, local biopsy results (if available), and clinical status. |
| Stage 1: Tobemstomig 2100 mg Q2W + Bevacizumab | EXPERIMENTAL | Participants will receive Tobemstomig plus bevacizumab until unacceptable toxicity or loss of clinical benefit, as determined by the investigator after an integrated assessment of radiographic and biochemical data, local biopsy results (if available), and clinical status. |
| Stage 1: Tobemstomig 600 mg Q3W + Bevacizumab | EXPERIMENTAL | Participants will receive Tobemstomig plus bevacizumab until unacceptable toxicity or loss of clinical benefit, as determined by the investigator after an integrated assessment of radiographic and biochemical data, local biopsy results (if available), and clinical status. |
| Stage 1: Tobemstomig 1200 mg Q3W + Bevacizumab | EXPERIMENTAL | Participants will receive Tobemstomig plus bevacizumab until unacceptable toxicity or loss of clinical benefit, as determined by the investigator after an integrated assessment of radiographic and biochemical data, local biopsy results (if available), and clinical status. |
| Stage 1: Atezolizumab + Bevacizumab + ADG126 | EXPERIMENTAL | Participants will receive atezolizumab plus bevacizumab plus ADG126 until unacceptable toxicity or loss of clinical benefit as determined by the investigator after an integrated assessment of radiographic and biochemical data, local biopsy results (if available), and clinical status. |
| Stage 1: Atezolizumab + Bevacizumab + IO-108 1200 mg Q3W | EXPERIMENTAL | Participants will receive atezolizumab plus bevacizumab plus IO-108 until unacceptable toxicity or loss of clinical benefit, as determined by the investigator after an integrated assessment of radiographic and biochemical data, local biopsy results (if available), and clinical status. |
| Stage 1: Atezolizumab + Bevacizumab + NKT2152 | EXPERIMENTAL | Participants will receive atezolizumab plus bevacizumab plus NKT2152 until unacceptable toxicity or loss of clinical benefit, as determined by the investigator after an integrated assessment of radiographic and biochemical data, local biopsy results (if available), and clinical status. |
| Stage 1: Atezolizumab + Bevacizumab+ IO-108 1800 mg Q3W | EXPERIMENTAL | Participants will receive atezolizumab plus bevacizumab plus IO-108 until unacceptable toxicity or loss of clinical benefit, as determined by the investigator after an integrated assessment of radiographic andbiochemical data, local biopsy results (if available), and clinical status |
| 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. |
| Atezolizumab | DRUG | Atezolizumab will be administered at a dose of 1200 mg by IV on Day 1 of each 21 day cycle. |
| Bevacizumab 15 mg/kg | DRUG | Bevacizumab will be administered at a dose of 15 mg/kg by IV infusion on Day 1 of each 21 day cycle. |
| Tiragolumab | DRUG | Tiragolumab will be administered at a dose of 600 mg by IV infusion on Day 1 of each 21 day cycle. |
| Tocilizumab | DRUG | Tocilizumab will be administered at a dose of 8 mg/kg by IV infusion on Day 1 of each 21 day cycle. |
| TPST-1120 | DRUG | TPST-1120 will be administered at a dose of 1200 mg by mouth on Days 1-21 of each 21 day cycle. |
| Tobemstomig 2100 mg | DRUG | Tobemstomig will be administered at a dose of 2100 mg by IV infusion on Days 1 and 15 of each 28 day cycle. |
| Bevacizumab 10 mg/kg | DRUG | Bevacizumab will be administered at a dose of 10 mg/kg by IV infusion on Days 1 and 15 of each 28 day cycle. |
| Tobemstomig 600 mg | DRUG | Tobemstomig will be administered at a dose of 600 mg by IV infusion on Day 1 of each 21 day cycle. |
| Tobemstomig 1200 mg | DRUG | Tobemstomig will be administered at a dose of 1200 mg every 3 weeks. |
| IO-108 1800 mg | DRUG | IO-108 will be administered at a dose 1800 mg by IV infusion on Day 1 of each 21 day cycle. |
| NKT2152 | DRUG | NKT2152 will be administered by mouth. |
| IO-108 1200 mg | DRUG | IO-108 will be administered at a dose 1200 mg by IV infusion on Day 1 of each 21 day cycle. |
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 | 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 is an investigational small molecule developed by Adagene Inc. (ticker ADAG) that targets CTLA-4. It is being studied in oncology for advanced liver cancers and advanced or metastatic solid tumors. It is currently in Phase 1 clinical development and has not been approved by the FDA.
ADG126 is being evaluated for the treatment of advanced liver cancers and advanced or metastatic solid tumors. It is an investigational therapy in Phase 1 testing and is not approved for any indication. Clinical studies are enrolling adults 18 years and older.
ADG126 targets CTLA-4, a protein target in the immune checkpoint pathway. By binding CTLA-4, the drug is designed to act on a mechanism relevant to oncology. It is being studied both as a single agent and in combination with pembrolizumab in advanced solid tumors.
ADG126 is being developed by Adagene Inc., which trades under the ticker ADAG. The company is running Phase 1 clinical trials of the drug in advanced liver cancers and advanced or metastatic solid tumors across multiple countries, including the United States, China, and South Korea.
ADG126 is in Phase 1 clinical development. It is an investigational drug and has not been approved by the FDA. Two Phase 1 studies are listed: one recruiting and one active but not recruiting, with a combined enrollment of 518 patients across both trials.
ADG126 is being studied in two Phase 1 trials. NCT05405595 evaluates ADG126 in combination with pembrolizumab in advanced or metastatic solid tumors and is recruiting. NCT04524871, the Morpheus-Liver study, evaluates immunotherapy-based combinations in advanced liver cancers and is active but not recruiting.