ADG126 with Pembrolizumab for Advanced Solid Tumors
This study is testing a new combination of drugs, ADG126 and pembrolizumab (KEYTRUDA®), for people with advanced or metastatic (spread) solid tumors. ADG126 is a type of antibody that targets CTLA-4, and pembrolizumab targets PD-1, both involved in the immune system's fight against cancer. Researchers want to find the safest and most effective dose of this combination. They will also look at how well it works against the tumors. Some patients might also receive standard treatments like Trifluridine/Tipiracil-Bevacizumab or Fruquintinib. You could be eligible if you are at least 18 years old, have a good general health status (ECOG 0 or 1), and have measurable tumors.
- Study design
- This is an open-label (everyone knows what treatment is given) Phase 1b/2 study that will involve about 186 participants. It includes stages for increasing the drug dose, expanding the study to more people, and optimizing the dose.
- What's involved
- Not specified in the trial record.
- Compensation
- Not stated in the trial record.
- Follow-up
- The primary goals of the study, including safety and initial anti-tumor activity, will be measured at 9 months.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
ADG126 in Combination With Pembrolizumab in Patients With Advanced/Metastatic Solid Tumors
At a glance
Conditions
NCT05405595
Where you'd take part
This study runs at 21 sites. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.
Asan Medical Center
Seoul, South Koreano site contact published
Recruiting
CHA Bundang Medical Center, CHA university
Seongnam, Gyeonggido, South Koreano site contact published
Recruiting
Chungbuk National University Hospital
Cheongju-si, North Chungcheong, South Koreano site contact published
Recruiting
City of Hope National Medical Center
Duarte, Californiano site contact published
Recruiting
City of Hope Orange County
Irvine, Californiano site contact published
Recruiting
Fred Hutchinson Cancer Center
Seattle, Washingtonno site contact published
Recruiting
Fujian Cancer Hospital
Fuzhou, Fujian, Chinano site contact published
Recruiting
Hong Kong Humanity & Health Clinical Trial Center
Hong Kong, Hong Kong, Chinano site contact published
Recruiting
Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.
Study leadership
- Jiping Zha, MD, PhD · STUDY_DIRECTOR · Adagene Inc
Who to contact
Opens a ready-to-send draft in your own email app — review before sending.
What this trial measures
- Maximum tolerated dose (MTD) and RP2D for ADG126 in combination with pembrolizumab.9 months
To determine the maximum tolerated dose (MTD) and recommended phase 2 dose (RP2D) for ADG126+ pembrolizumab in dose escalation levels
- the safety and tolerability of ADG126 at escalating dose level in combination with pembrolizumab in adults with advanced metastatic solid tumors9 months
Incidence rate of AEs as assessed by CTCAE v5.0
- Access the preliminary antitumor activity of ADG126-pembrolizumab combination regimens9 months
Number of Participants with preliminary antitumor activity
- Maximum tolerated dose (MTD) and/or RP2D for ADG126 with Trifluridine/Tipiracil-Bevacizumab6 months
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:
- Access the preliminary antitumor activity of ADG126 with Pembrolizumab in combination standard of care6 months
To assess the preliminary antitumor activity of ADG126 + pembrolizumab in combination with the following SOC therapies in MSS CRC (Trifluridine/tipiracil-bevacizumab) SOC (Fruquintinib)
- Access and characterize the optimal dose based on safety and efficacy parameters9 months
To characterize the optimal dose based on safety and efficacy parameters