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

Adagene

Status and phase: Completed; Phase 1

Conditions: Advanced/Metastatic Solid Tumors

Treatments: Drug: anti PD1 drug; Drug: ADG106; Drug: ADG116

Study type: Interventional

Funder types: Industry

Identifiers

NCT04501276

ADG116-1003

Details and patient eligibility

About

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.

Enrollment: 72 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

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72 participants in 3 patient groups

Part A : Dose escalation of ADG116 monotherapy

Experimental group

Treatment:

Drug: ADG116

Part B : Dose escalation of ADG116 combined with anti PD1 drug

Experimental group

Treatment:

Drug: ADG116

Drug: anti PD1 drug

Part C : Dose escalation of ADG116 combined with ADG106

Experimental group

Treatment:

Drug: ADG116

Drug: ADG106