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NCT05405595 | RECRUITING | Advanced/Metastatic Solid Tumors

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

Adagene Inc

Brief Summary:

This is a Phase 1b/2, open-label, dose escalation study to evaluate the safety, tolerability, PK, and immunogenicity of ADG126-pembrolizumab combination regimens in patients with advanced/metastatic solid tumors.

Condition or disease

Advanced/Metastatic Solid Tumors

Intervention/treatment

ADG126

Pembrolizumab (KEYTRUDA®)

Standard of Care (Trifluridine/Tipiracil-Bevacizumab)

Standard of care (Fruquintinib)

Phase

PHASE1

PHASE2

Detailed Description:

This is a Phase 1b/2, open-label, multicenter, dose escalation and dose expansion study to evaluate the safety, tolerability, PK, and preliminary efficacy of ADG126-Pembrolizumab alone or ADG126-Pembrolizumab in combination with trifluridine/tipiracil-bevacizumab or fruquintinib in patients with advanced/metastatic solid tumors, with a focus on MSS CRC. 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).

Study Type : INTERVENTIONAL
Estimated Enrollment : 152 participants
Masking : NONE
Primary Purpose : TREATMENT
Official Title : 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
Actual Study Start Date : 2022-06-15
Estimated Primary Completion Date : 2026-10-31
Estimated Study Completion Date : 2027-04-30

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
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 or fresh biopsy) 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 an anti-CTLA-4 therapy.
  • 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 severe Hypersensitivity (Grade ≥3)or known to be allergic to protein drugs or recombinant protein.
ADG126 in Combination With Pembrolizumab in Patients With Advanced/Metastatic Solid Tumors

Location Details

NCT05405595

Please Choose a site

How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations

RECRUITING

United States, Arizona

Honor Health Research Institute

Scottsdale, arizona, United States, 85251

RECRUITING

United States, California

City of Hope National Medical Center

Duarte, California, United States, 91010

RECRUITING

United States, Florida

Florida cancer specialist/Sarah Cannon Research Institute

Sarasota, florida, United States, 34232

RECRUITING

China, Fujian

Fujian Cancer Hospital

F U axis, Fujian, China,

RECRUITING

China, Guangdong

Sun Yat-Sen University Cancer Center

Guangzhou, Guangdong, China,

RECRUITING

China, Hong Kong

Hong Kong Humanity & Health Clinical Trial Center

Hong Kong, Hong Kong, China,

RECRUITING

China, Hong Kong

Prince of Wales Hospital

Hong Kong, Hong Kong, China,

RECRUITING

South Korea, bus an G netizen EO company

Dong -A University Hospital

Theo tools, bus an G netizen EO company, South Korea, 49201

RECRUITING

South Korea, Gyeonggi Do

CHA Bundang Medical Center, CHA university

Seongnam, Gyeonggi Do, South Korea, 13496

RECRUITING

South Korea, Gyeonggi Do

The Catholic University of Korea Street. Vincent Hospital

Suwon, Gyeonggi Do, South Korea, 16247

RECRUITING

South Korea, North Chungcheong

Chungbuk National University Hospital

Cheongju-si, North Chungcheong, South Korea, 28644

RECRUITING

South Korea, Seoul Teugbyeolsi

Samsung Medical Center

Seoul, Seoul Teugbyeolsi, South Korea, 06351

RECRUITING

South Korea,

Keimyung University Dongsan Hospital

Daegu, South Korea, 41931

RECRUITING

South Korea,

Seoul National University Hospital

Seoul, South Korea, 03080

RECRUITING

South Korea,

Hospital Priest

Seoul, South Korea, 03081

RECRUITING

South Korea,

Asan Medical Center

Seoul, South Korea, 05505

RECRUITING

South Korea,

Severance Hospital Yonsei University Health System

Seoul, South Korea, 3722