Combining ADG126 with Pembrolizumab for Advanced Solid Tumors

A Phase 1b/2, Open-Label, Dose Escalation and Expansion Study of ADG126 in Combination With Pembrolizumab (Anti PD-1 Antibody) in Patients With Advanced/Metastatic Solid Tumors

This study is testing a new combination of two cancer treatments, ADG126 and Pembrolizumab, to see if they can help people with advanced solid tumors who have run out of other treatment options.

Quick facts

• Phase: Phase1; Phase2
• Study type: Interventional
• Enrollment: 186 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Adagene Inc (Industry-sponsored)
• Drugs / interventions: prednisone, pembrolizumab, bevacizumab, fruquintinib
• Locations: 21 sites (Scottsdale, Arizona and 20 other locations)
• Trial ID: NCT05405595 on ClinicalTrials.gov

What this trial studies

This Phase 1b/2 clinical trial evaluates the safety, tolerability, pharmacokinetics, and immunogenicity of the combination of ADG126, an anti-CTLA-4 monoclonal antibody, with Pembrolizumab, a PD-1 receptor-blocking antibody, in patients with advanced or metastatic solid tumors. The study is designed as an open-label, multicenter, dose escalation and expansion trial, focusing on patients who have progressed after standard therapies or have no further treatment options available. Participants will undergo assessments to determine the effectiveness of this combination therapy in managing their condition.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older with advanced or metastatic solid tumors that have progressed after standard therapies.

Not a fit: Patients who have previously received immunotherapy may not benefit from this study.

Why it matters

Potential benefit: If successful, this combination therapy could provide a new treatment option for patients with advanced solid tumors who have limited alternatives.

How similar studies have performed: Other studies have shown promising results with similar immunotherapy combinations, suggesting potential for success in this approach.

Eligibility criteria

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 organ function.
6. An archival tumor biopsy is required and should be taken within 2 years of enrollment. If not available, a fresh tumor biopsy is acceptable.
7. 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.
8. Dose Expansion Phase Only: Tumor tissues (archived tissue) before treatment are required for all patients.

Exclusion Criteria:

1. Pregnant or breastfeeding females.
2. Childbearing potential who does not agree to the use of contraception during the treatment period.
3. Treatment with any investigational drug within washout period.
4. Prior treatment with a PD-1, PD-L1 targeting agent or a next-generation anti-CTLA-4 therapy with enhanced ADCC function.
5. History of significant irAEs or irAE.
6. Central nervous system (CNS) disease involvement.
7. History or risk of autoimmune disease.
8. Patients requiring systemic treatment with corticosteroids or other immunosuppressive medications (\>10 mg/day prednisone or equivalent).
9. Any uncontrolled active infections requiring systemic antimicrobial treatment (viral, bacterial, or other), or uncontrolled or poorly controlled, asthma, chronic obstructive pulmonary disease (COPD).
10. Major surgery within 4 weeks prior to the first dose of the study drug.
11. Has had an allogeneic tissue/solid organ transplant.
12. 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.
13. A positive COVID-19 test within 14 days of Cycle 1 Day 1.
14. History of Hypersensitivity or known to be allergic to protein drugs or recombinant protein.
15. Active hemoptysis or central airway invasion by metastatic tumor.

Where this trial is running

Scottsdale, Arizona and 20 other locations

• Honor Health Research Institute — Scottsdale, Arizona, United States (Recruiting)
• City of Hope National Medical Center — Duarte, California, United States (Recruiting)
• City of Hope Orange County — Irvine, California, United States (Recruiting)
• Florida cancer specialist/Sarah Cannon Research Institute — Sarasota, Florida, United States (Active_not_recruiting)
• The Cleveland Clinic — Cleveland, Ohio, United States (Recruiting)
• MD Anderson Cancer Center — Houston, Texas, United States (Recruiting)
• Fred Hutchinson Cancer Center — Seattle, Washington, United States (Recruiting)
• Fujian Cancer Hospital — Fuzhou, Fujian, China (Recruiting)
• SunYat-Sen University Cancer Center — Guangzhou, Guangdong, China (Recruiting)
• Hong Kong Humanity & Health Clinical Trial Center — Hong Kong, Hong Kong, China (Recruiting)
• Prince of Wales Hospital — Hong Kong, Hong Kong, China (Recruiting)
• Dong -A University Hospital — Seogu, Busan Gwangyeogsi, South Korea (Terminated)
• CHA Bundang Medical Center, CHA university — Seongnam, Gyeonggido, South Korea (Recruiting)
• The Catholic University of Korea Street. Vincent Hospital — Suwon, Gyeonggido, South Korea (Terminated)
• Chungbuk National University Hospital — Cheongju-si, North Chungcheong, South Korea (Recruiting)
• Samsung Medical Center — Seoul, Seoul Teugbyeolsi, South Korea (Recruiting)
• Keimyung University Dongsan Hospital — Daegu, South Korea (Terminated)
• Seoul National University Hospital — Seoul, South Korea (Recruiting)
• KangBuk Samsung Hospital — Seoul, South Korea (Terminated)
• Asan Medical Center — Seoul, South Korea (Recruiting)
• Severance Hospital Yonsei University Health System — Seoul, South Korea (Recruiting)

Study contacts

• Study coordinator: Xiaohong She, MS

Conditions Advanced/Metastatic Solid Tumors; ADG126-P001