ADG126 in Combination With Pembrolizumab in Patients With Advanced/Metastatic Solid Tumors

Part of paid clinical trials in Scottsdale, Arizona.

Sponsor
Adagene Inc
Study ID
NCT05405595
Phase
PHASE1/PHASE2
Status
Recruiting
Apply to this trial

Conditions

  • Advanced/Metastatic Solid Tumors

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • 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.

Study Details

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).

Key Dates

Start date
Jun 15, 2022
Status verified
Jan 2026
Primary completion
Oct 31, 2026
Completion
Apr 30, 2027

Study Design

Enrollment
186 participants (estimated)
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: ADG126 in combination with Pembrolizumab (Trade name KEYTRUDA®)
    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.
  • Experimental: ADG126 and pembrolizumab (KEYTRUDA®) in combination with Trifluridine/Tipiracil-Bevacizumab
    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.
  • Experimental: ADG126 and pembrolizumab (KEYTRUDA®) in combination with fruquintinib
    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.
  • Experimental: Dose Optimization
    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.

Primary Outcome Measure

Maximum tolerated dose (MTD) and RP2D for ADG126 in combination with pembrolizumab. [ Time Frame: 9 months ]

Central Contacts

Locations (7)

FacilityCityStateZIPSite coordinators
Honor Health Research InstituteScottsdaleArizona85251
Sharma Sunil, MD
City of Hope National Medical CenterDuarteCalifornia91010
Daneng Li, MD
Marwan Fakih, MD
City of Hope Orange CountyIrvineCalifornia92618
Pashtoon Kasi, MD
Florida cancer specialist/Sarah Cannon Research InstituteSarasotaFlorida34232-
The Cleveland ClinicClevelandOhio44195-0001
Smitha Krishnamurthi, MD
MD Anderson Cancer CenterHoustonTexas77030
David Hong, MD
Mary Trahan
Fred Hutchinson Cancer CenterSeattleWashington98109
Rachael Safyan, MD

Find similar trials in Scottsdale, AZ

By research site
Honor Health Research Institute· Scottsdale, AZCity of Hope National Medical Center· Duarte, CACity of Hope Orange County· Irvine, CAFlorida cancer specialist/Sarah Cannon Research Institute· Sarasota, FLThe Cleveland Clinic· Cleveland, OHMD Anderson Cancer Center· Houston, TX

Related Studies