An Open-label, Multicenter, Dose-escalation and Cohort Expansion Phase 1 Clinical Study of ES102 Administered as a Single Agent in Patients With Advanced Solid Tumors

Elpiscience Biopharma, Ltd.1 site in 1 country18 target enrollmentApril 1, 2021

ConditionsSolid Tumors Neoplasms Malignant Tumor

InterventionsES102

DrugsES102

Overview

Phase: Phase 1
Intervention: ES102
Conditions: Solid Tumors
Sponsor: Elpiscience Biopharma, Ltd.
Enrollment: 18
Locations: 1
Primary Endpoint: Maximum Tolerated Dose (MTD) and/or Recommended Phase 2 Dose (RP2D) of of ES102
Status: Completed
Last Updated: 10 months ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

The purpose of this study is to evaluate the safety, tolerance, Dose-Limiting Toxicity (DLT), Maximum tolerated dose (MTD) and/or Recommended Phase 2 Dose (RP2D) of ES102 (OX40 Agonist) administered as a single agent in patients with advanced solid tumors.

Registry

clinicaltrials.gov

Start Date

April 1, 2021

End Date

March 1, 2024

Last Updated

10 months ago

Study Type

Interventional

Study Design

Sequential

Sex

All

Investigators

Sponsor

Elpiscience Biopharma, Ltd.

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Ability to understand and the willingness to sign a written informed consent form.
•Males or females aged ≥18 years.
•Part A: Subjects with pathological or cytological diagnosed advanced solid tumor, whose disease has progressed despite standard therapies, or for whom no further standard therapy exists, or who is unsuitable for available standard therapies.
•Part B: Subjects with NSCLC, ESCC, NPC, GI or Cervical cancers, with advanced disease, which has progressed despite all standard therapies or for whom no standard therapy exists, or who is unsuitable for available standard therapies.
•All subjects with NSCLC have documentation of absence of tumor activating EGFR mutation and absence of ALK and ROS1 gene rearrangements.
•PD-L1 by IHC result mandatory but any score allowed .
•At least one measurable lesion is required (RECIST v1.1)
•Adequate hematologic, coagulation, hepatic and renal function as defined per protocol.
•Eastern Cooperative Oncology Group performance status (ECOG PS) of 0 or
•Estimated life expectancy, in the judgment of the investigator, of at least 12 weeks.

Exclusion Criteria

•Prior exposure to OX40 agonists.
•Known allergies to CHO-produced antibodies, which in the opinion of the Investigator suggests an increased potential for an adverse hypersensitivity to ES
•Receipt of any anticancer investigational product or any approved anticancer drug(s) or biological product(s) within 4 weeks prior to the first dose of study drug with certain exceptions.
•Patients with other malignancies within 2 years before screening shall be excluded in Part B. Some exceptions as defined per protocol apply.
•Hematologic malignancies (e.g., ALL, AML, MDS, CLL, CML, NHL, Hodgkin's lymphoma and multiple myeloma)
•Known or active primary central nervous system (CNS) tumors, leptomeningeal disease and CNS metastases. Exception: subjects with previously treated, asymptomatic, and clinically stable CNS metastases may be allowed study entry if certain criteria apply in Part B.
•Grade ≥ 3 immune-related adverse events (irAEs) or irAE that lead to discontinuation of prior immunotherapy. Some exceptions as defined per protocol apply.
•Active autoimmune disease or documented history of autoimmune disease that required systemic steroids or other immunosuppressive medications. Certain exceptions as defined in protocol apply.
•Treatment with systemic immunosuppressive medications within 4 weeks prior to the first dose of study drug. Certain exceptions as defined in protocol apply.
•History of hepatitis B, hepatitis C, or human immunodeficiency virus (HIV) infection for Part A. Exceptions as defined in protocol for Part B will apply.

Arms & Interventions

Part A dose escalation

ES102 will be escalated in patients with advanced solid tumors.

Intervention: ES102

Part B expansion

Subjects with advanced non-small cell lung cancer, advanced esophageal squamous cell carcinoma, other advanced solid tumors (such as nasopharyngeal carcinoma, cervical cancer, gastrointestinal tumors, other reproductive system tumors, etc.) will be treated with ES102 at the RP2D.

Intervention: ES102

Outcomes

Primary Outcomes

Maximum Tolerated Dose (MTD) and/or Recommended Phase 2 Dose (RP2D) of of ES102

Time Frame: 2-3 years

The MTD and/or RP2D of ES102 will be determined.

Number of participants with adverse events and serious adverse events of ES102

Time Frame: 2-3 years

The safety profile of ES102 will be assessed by the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), version 5.0.