A Phase 1b, Open-Label, Dose Escalation Study of ADG116 in Combination With Pembrolizumab (Anti-PD-1 Antibody) in Patients With Advanced/Metastatic Solid Tumors

Adagene Inc2 sites in 1 country6 target enrollmentFebruary 9, 2022

ConditionsAdvanced/Metastatic Solid Tumors

InterventionsADG116

DrugsADG116

Overview

Phase: Phase 1
Intervention: ADG116
Conditions: Advanced/Metastatic Solid Tumors
Sponsor: Adagene Inc
Enrollment: 6
Locations: 2
Primary Endpoint: Dose-limiting toxicity (DLT) and RP2D of ADG116 in combination with pembrolizumab.
Status: Completed
Last Updated: 2 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

This is a Phase 1b, open-label, dose escalation study to evaluate the safety, tolerability, PK, and immunogenicity of an ADG116-pembrolizumab combination regimen 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. Pembrolizumab is a PD-1 receptor-blocking antibody (a humanized IgG4 monoclonal antibody) which is indicated for the treatment of patients across a number of indications. The treatment strategy of using anti-PD 1 therapy combined with anti-CTLA-4 therapy is to explore the potential of combination checkpoint inhibition regimens for the enhanced antitumor efficacy results.

Registry

clinicaltrials.gov

Start Date

February 9, 2022

End Date

December 1, 2022

Last Updated

2 years ago

Study Type

Interventional

Study Design

Sequential

Sex

All

Investigators

Sponsor

Adagene Inc

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Patients must meet all of the following inclusion criteria to be eligible for participation in this study:
•≥ 18 years of age at the time of informed consent.
•Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1 with no deterioration over the previous 2 weeks.
•Patients with advanced or metastatic solid tumors, histologically or pathologically confirmed, who have progressed after all standard therapies, or for whom no further standard therapy exists. Patients who have declined standard therapy or have no access to standard therapy may be enrolled and the reasons for lack of access need to be documented.
•Patients should have at least 1 measurable lesion at baseline according to the definition of RECIST v1.
•Lesions situated in a previously irradiated area are considered measurable if progression has been demonstrated in such lesions.
•Patients previously treated with anti-CTLA 4 checkpoint inhibitors or anti programmed cell death 1 (PD-1)/L1 will also be recruited if they meet all eligibility criteria. For anti-PD-1/L1 patients, patients must have progressed on treatment with an anti PD 1/L1 monoclonal antibody (mAb) administered either as monotherapy, or in combination with other checkpoint inhibitors or other therapies. Anti PD-1/L1 treatment progression is defined by meeting all of the following criteria:
•Has received at least 2 doses of an approved anti-PD-1/L1 mAb.
•Has demonstrated disease progression (PD) after PD-1/L1 as defined by RECIST v1.
•The initial evidence of PD is to be confirmed by a second assessment no less than 4 weeks from the date of the first documented PD, in the absence of rapid clinical progression.

Exclusion Criteria

•Patients who meet any of the following criteria cannot be enrolled:
•Pregnant or breastfeeding females.
•Females of childbearing potential and males whose partners are of childbearing potential who do not agree to the use of 2 forms of highly effective contraception during the treatment period and for 6 months after the last dose of study drug.
•Treatment with any investigational drug within 4 weeks prior to the first dose of study drug.
•Grade ≥ 3 immune-related AEs (irAEs) or irAE that lead to discontinuation of prior immunotherapy.
•Has known active CNS metastases and/or carcinomatous meningitis. Participants with previously treated brain metastases may participate provided they are radiologically stable, i.e., without evidence of progression for at least 4 weeks by repeat imaging (note that the repeat imaging should be performed during study screening), clinically stable and without requirement of steroid treatment for at least 14 days prior to first dose of study treatment.
•History of severe hypersensitivity (Grade ≥ 3) or known to be allergic to protein drugs or recombinant proteins or any ingredients contained in the ADG116 or pembrolizumab drug formulation.
•Has an active autoimmune disease that has required systemic treatment in past 2 years (i.e., with use of disease modifying agents, corticosteroids or immunosuppressive drugs). Replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency) is not considered a form of systemic treatment and is allowed.
•Patients requiring systemic treatment with corticosteroids (\>10 mg/day prednisone or equivalent) or other immunosuppressive medications within 21 days before the planned first dose of study drug. Ophthalmologic, nasal, inhaled and intra-articular injections of steroids are allowed.
•Patients receiving granulocyte colony stimulating factor (G-CSF), granulocyte macrophage colony stimulating factor (GM-CSF), erythropoietin, or blood (red blood cell \[RBC\] or platelet) transfusion within 14 days prior to the first dose of the study drug.