This is a Phase 1b/2, open-label, dose escalation, dose expansion and dose optimization study to evaluate the safety, tolerability, PK, and immunogenicity of ADG126-pembrolizumab combination regimens in patients with advanced/metastatic solid tumors.
The study drug ADG126 is an anti-CTLA-4 fully human monoclonal antibody that specifically binds to human CTLA-4. Pembrolizumab is a PD-1 receptor-blocking antibody (a humanized IgG4 monoclonal antibody).
≥18 years of age at the time of informed consent.
Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1.
Wash out period from previous antitumor therapies
At least 1 measurable lesion at baseline according to the definition of RECIST v1.1.
Pregnant or breastfeeding females.
Childbearing potential who does not agree to the use of contraception during the treatment period.
Treatment with any investigational drug within washout period.
Prior treatment with a PD-1, PD-L1 targeting agent or a next-generation anti-CTLA-4 therapy with enhanced ADCC function.
Sequential
ADG126
DrugADG126 is an anti-CTLA-4 fully human monoclonal antibody that specifically binds to human CTLA-4.
Pembrolizumab (KEYTRUDA®)
DrugPembrolizumab (KEYTRUDA®) is a PD-1 receptor-blocking antibody (a humanized IgG4 monoclonal antibody).
Standard of Care (Trifluridine/Tipiracil-Bevacizumab)
DrugThe standard of care therapies will include Trifluridine/Tipiracil-Bevacizumab, approved for treating metastatic colorectal cancer (CRC)and various solid tumors.
Standard of care (Fruquintinib)
DrugThe standard of care therapy, Fruquintinib, is approved for treating metastatic colorectal cancer (CRC) and various solid tumors.
Maximum tolerated dose (MTD) and RP2D for ADG126 in combination with pembrolizumab.
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 tumors
Incidence rate of AEs as assessed by CTCAE v5.0
Access the preliminary antitumor activity of ADG126-pembrolizumab combination regimens
Number of Participants with preliminary antitumor activity
Maximum tolerated dose (MTD) and/or RP2D for ADG126 with Trifluridine/Tipiracil-Bevacizumab
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:
Pharmacokinetic (PK) profile/parameters
Area under the time concentration curve (AUC) from time zero to infinity (AUC0-inf)
Maximum (peak) plasma concentration (Cmax)
Maximum (peak) plasma concentration (Cmax)
Time to maximum (peak) concentration (Tmax)
Time to maximum (peak) concentration (Tmax)
Trough concentration (Ctrough)
Trough concentration (Ctrough)
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Adagene Inc
Lead sponsor
Merck Sharp & Dohme LLC
Collaborator
