Status:
RECRUITING
ADG126 in Combination With Pembrolizumab in Patients With Advanced/Metastatic Solid Tumors
Lead Sponsor:
Adagene Inc
Collaborating Sponsors:
Merck Sharp & Dohme LLC
Conditions:
Advanced/Metastatic Solid Tumors
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
Brief Summary
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 ...
Detailed Description
This is a Phase 1b/2, open-label, multicenter, dose escalation, dose expansion and dose optimization study to evaluate the safety, tolerability, PK, and preliminary efficacy of ADG126-Pembrolizumab or...
Eligibility Criteria
Inclusion
- ≥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.
- Adequate organ function.
- An archival tumor biopsy is required and should be taken within 2 years of enrollment. If not available, a fresh tumor biopsy is acceptable.
- For Dose Escalation Phase Only: Patients with histologically or cytologically confirmed, locally advanced or metastatic solid tumors, who have progressed after all standard therapies, or for whom no further standard therapy exists.
- Dose Expansion Phase Only: Tumor tissues (archived tissue) before treatment are required for all patients.
Exclusion
- 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.
- History of significant irAEs or irAE.
- Central nervous system (CNS) disease involvement.
- History or risk of autoimmune disease.
- Patients requiring systemic treatment with corticosteroids or other immunosuppressive medications (\>10 mg/day prednisone or equivalent).
- Any uncontrolled active infections requiring systemic antimicrobial treatment (viral, bacterial, or other), or uncontrolled or poorly controlled, asthma, chronic obstructive pulmonary disease (COPD).
- Major surgery within 4 weeks prior to the first dose of the study drug.
- Has had an allogeneic tissue/solid organ transplant.
- Has received a COVID-19 vaccine within 7 days prior to the first dose of study treatment. Has received a live or live-attenuated vaccine within 30 days prior to the first dose of study treatment. Note: Administration of killed vaccines are allowed.
- A positive COVID-19 test within 14 days of Cycle 1 Day 1.
- History of Hypersensitivity or known to be allergic to protein drugs or recombinant protein.
- Active hemoptysis or central airway invasion by metastatic tumor.
Key Trial Info
Start Date :
June 15 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 30 2027
Estimated Enrollment :
186 Patients enrolled
Trial Details
Trial ID
NCT05405595
Start Date
June 15 2022
End Date
April 30 2027
Last Update
January 7 2026
Active Locations (21)
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1
Honor Health Research Institute
Scottsdale, Arizona, United States, 85251
2
City of Hope National Medical Center
Duarte, California, United States, 91010
3
City of Hope Orange County
Irvine, California, United States, 92618
4
Florida cancer specialist/Sarah Cannon Research Institute
Sarasota, Florida, United States, 34232