A Phase 1b/2 Study of ADG116, ADG116 Combined With Anti-PD-1 Antibody or Anti-CD137 Antibody in Solid Tumors Patients

Phase 1

Active, not recruiting

• Conditions: Advanced/Metastatic Solid Tumors
• Interventions: Drug: ADG116; Drug: ADG106; Drug: anti PD1 drug

• Registration Number: NCT04501276
• Lead Sponsor: Adagene Inc

Brief Summary

This is a Phase 1, open-label, dose escalation study in patients with advanced/metastatic solid tumors. Study drug, ADG116, is an anti -CTLA-4 fully human monoclonal antibody that specifically binds to human CTLA-4. ADG106, a fully human ligand-blocking agonistic anti-CD137 IgG4 mAb, is expected to enhance the activity of activated T cells. The enhanced antitumor efficacy results observed from the preclinical studies of ADG116 in combination with ADG106 or anti-PD-1 provided further support to explore such combinations in clinical settings for better patient responses.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-07-29
• Study First Submitted QC: 2020-08-02
• Study First Posted: 2020-08-06
• Study Start: 2020-09-23
• Primary Completion: 2024-01-17
• Status Verified: 2024-08
• Last Update Submitted: 2024-08-13
• Last Update Posted: 2024-08-14
• Study Completion: 2025-02-01

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 72

Inclusion Criteria

Patients must meet all of the following inclusion criteria to be eligible for participation in this study:

1. ≥ 18 years of age at the time of informed consent.
2. Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1.
3. Patients with advanced or metastatic solid tumors, who have progressed after all standard therapies, or for whom no further standard therapy exists.
4. At least 1 measurable lesion at baseline according to the definition of RECIST v1.1.
5. Adequate organ function.

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Exclusion Criteria

• Patients who meet any of the following criteria cannot be enrolled:

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. Grade ≥ 3 immune-related AEs (irAEs) or irAE that lead to discontinuation of prior immunotherapy.
5. Central nervous system disease involvement
6. History or risk of autoimmune disease.
7. History of life-threatening hypersensitivity or known to be allergic to protein drugs or recombinant proteins or any ingredients contained in the ADG116 drug formulation.
8. Patients requiring systemic treatment with corticosteroids
9. Patients receiving granulocyte colony stimulating factor (G-CSF), within 14 days prior to the first dose of the study drug.
10. Any uncontrolled active infections requiring systemic antimicrobial treatment (viral, bacterial, or other), or uncontrolled or poorly controlled, asthma, chronic obstructive pulmonary disease (COPD).
11. Major surgery within 4 weeks prior to the first dose of the study drug.
12. Has had an allogeneic tissue/solid organ transplant.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
Part A : Dose escalation of ADG116 monotherapy	ADG116	-
Part B : Dose escalation of ADG116 combined with anti PD1 drug	ADG116	-
Part C : Dose escalation of ADG116 combined with ADG106	ADG106	-
Part C : Dose escalation of ADG116 combined with ADG106	ADG116	-
Part B : Dose escalation of ADG116 combined with anti PD1 drug	anti PD1 drug	-

Primary Outcome Measures

Name	Time	Method
Number of participants with adverse events as assessed by CTCAE v5.0	From first dose of ADG116 (Week 1 Day 1) to 28 days post last dose
Number of participants experiencing dose-limiting toxicities escalating dose levels in adults with advanced / metastatic solid tumors	From first dose of ADG116 (Week 1 Day 1) until 21 days

Secondary Outcome Measures

Name	Time	Method
Maximum (peak) plasma concentration (Cmax)	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)
Incidence of ADAs	From first dose (Cycle 1 Day 1,) until the last dose (up to 2 years)
Preliminary evidence of antitumor activity as characterized by objective response rate (ORR), disease control rate (DCR), duration of response (DOR), duration of stable disease, progression free survival (PFS), and overall survival (OS).	From first dose of ADG116 (Week 1 Day 1) to 28 days post last dose
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)
Time to maximum (peak) plasma concentration (Tmax)	From first dose (Cycle 1 Day 1,) until the last dose (up to 2 years)

Trial Locations

Locations (4)

Next Oncology; 🇺🇸 San Antonio, Texas, United States

Macquarie University; 🇦🇺 Sydney, Australia

Cabrini Hospital; 🇦🇺 Malvern, Australia

Ashford Cancer Centre Research; 🇦🇺 Kurralta Park, Australia