A First-in-Human (FIH), Open-Label, Phase 1/2 Dose Escalation and Expansion Study of ADG126, ADG126 in Combination With Anti PD1 Antibody, and ADG126 in Combination With ADG106 in Patients With Advanced/Metastatic Solid Tumors
Overview
- Phase
- Phase 1
- Status
- Completed
- Sponsor
- Adagene Inc
- Enrollment
- 58
- Locations
- 9
- Primary Endpoint
- Number of participants with adverse events as assessed by CTCAE v5.0 ADG126-ADG106 combination regimens
Overview
Brief Summary
ADG126, ADG126 in Combination with anti-PD1 antibody, and ADG126 in Combination with ADG106 in Patients with Advanced/Metastatic Solid Tumors .
Detailed Description
ADG126 is a novel anti-CTLA-4 fully human IgG1 antibody prodrug that is modified with Adagene Safebody technology to control the activation of anti-CTLA4 activity.ADG106 is a fully human ligand-blocking, agonistic anti-CD137 IgG4 mAb which is expected to enhance the activity of activated T cells. The enhanced antitumor efficacy results observed from the preclinical studies of ADG126 in combination with ADG106 or anti-PD-1 provided further support to explore such combinations in clinical settings for better patient responses.
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Sequential
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- Not provided
Exclusion Criteria
- •Treatment with any investigational drug within washout period.
- •Major trauma or major surgery within 4 weeks prior to first dose of study drug(s)
- •History of significant immune-mediated AE.
- •Central nervous system (CNS) disease involvement.
- •Prior organ allograft transplantations or allogeneic peripheral blood stem cell (PBSC)/bone marrow (BM) transplantation
- •Clinically significant cardiac disease.
- •Evidence of active uncontrolled viral, bacterial, or systemic fungal infection.
- •Patients who received:
- •A COVID-19 vaccine within 7 days of Cycle 1 Day
- •Live vaccines or live-attenuated vaccines within 28 days prior to Cycle 1 Day
Outcomes
Primary Outcomes
Number of participants with adverse events as assessed by CTCAE v5.0 ADG126-ADG106 combination regimens
Time Frame: From first dose of ADG126 (Week 1 Day 1) to 90 days post last dose
Number of participants experiencing dose-limiting toxicities escalating dose levels in adults with advanced / metastatic solid tumors
Time Frame: From first dose of ADG126 (Week 1 Day 1) until 21 days
Secondary Outcomes
- Time to maximum (peak) plasma concentration (Tmax)(From first dose (Cycle 1 Day 1, ) until the last dose (up to 2 years))
- Trough plasma concentration (Ctrough)(From first dose (Cycle 1 Day 1, ) until the last dose (up to 2 years))
- Area under the time concentration curve (AUC) from time zero to infinity (AUC0-inf)(From first dose (Cycle 1 Day 1, ) until the last dose (up to 2 years))
- Antidrug antibodies (ADAs)(From first dose (Cycle 1 Day 1, ) until the last dose (up to 2 years))
- Maximum (peak) plasma concentration (Cmax)(From first dose (Cycle 1 Day 1, ) until the last dose (up to 2 years))