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New treatment option for Advanced/Metastatic Solid Tumors
Official title ADG126 in Combination With Pembrolizumab in Patients With Advanced/Metastatic Solid Tumors
ClinicalTrials.gov ID: NCT05405595
What this study is testing
What is ADG126?
ADG126 is an investigational medicine, being studied as a potential treatment for advanced/metastatic solid tumors.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- ≥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.
You likely can't join if
- 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.
See the full eligibility criteria
- ≥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...
- Dose Expansion Phase Only: Tumor tissues (archived tissue) before treatment are required for all patients.
- 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...
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Scottsdale, Arizona, United States
- Duarte, California, United States
- Irvine, California, United States
- Sarasota, Florida, United States
- Cleveland, Ohio, United States
- Houston, Texas, United States
- Seattle, Washington, United States
- Fuzhou, Fujian, China
- Guangzhou, Guangdong, China
- Hong Kong, Hong Kong, China
- Seogu, Busan Gwangyeogsi, South Korea
- Seongnam, Gyeonggido, South Korea
- Suwon, Gyeonggido, South Korea
- Cheongju-si, North Chungcheong, South Korea
- Seoul, Seoul Teugbyeolsi, South Korea
- Daegu, South Korea
- Seoul, South Korea
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Scottsdale, Arizona, United States; Duarte, California, United States; Irvine, California, United States; Sarasota, Florida, United States; Cleveland, Ohio, United States; Houston, Texas, United States and 11 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.