Clinical Trials/NCT04991506

NCT04991506

Completed

Phase 1

An Open-label, Multicenter, Dose-escalation and Cohort Expansion Phase 1 Clinical Study of ES102 in Combination With JS001 in Patients With Advanced Solid Tumors

Elpiscience Biopharma, Ltd.1 site in 1 country30 target enrollmentOctober 15, 2021

ConditionsSolid Tumor Neoplasms Malignant Tumor

InterventionsES102 JS001

DrugsES102 JS001

Overview

Phase: Phase 1
Intervention: ES102
Conditions: Solid Tumor
Sponsor: Elpiscience Biopharma, Ltd.
Enrollment: 30
Locations: 1
Primary Endpoint: MTD
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) in combination with JS001 (anti-PD-1 checkpoint inhibitor) in patients with advanced solid tumors.

Registry

clinicaltrials.gov

Start Date

October 15, 2021

End Date

May 17, 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

•1.Males or females aged ≥18 years.
•2.Ability to understand and the willingness to sign a written informed consent form.
•3.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 and at least has progressed after receiving first line therapy.
•4.PD-L1 by IHC: Parts 1 and Part 2 D2-D3: IHC result mandatory but any score allowed. Part 2 D1: Tumor Proportion Score (TPS) ≥ 1%.
•5.At least one measurable lesion is required (RECIST v1.1)
•6.Adequate hematologic, coagulation, hepatic and renal function as defined per protocol.
•7.Eastern Cooperative Oncology Group performance status (ECOG PS) of 0 or
•8.Estimated life expectancy, in the judgment of the investigator, of at least 12 weeks.
•9.Male and female subjects of childbearing potential and their spouses must be willing to use feasible contraceptive methods considered effective by the investigator, from the time of signing informed consent and for the duration of study participation through 3 months, following the last dose of study drug. Postmenopausal women are considered to have no fertility potential only if menostasis lasts for at least 12 months.

Exclusion Criteria

•1.Prior exposure to OX40 agonists.
•2.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.
•3.Receipt of non-CNS adjuvant radiation therapy within 1 week prior to the first dose, receipt of radiation therapy within 2 weeks or with radiation pneumonia, have not recovered from radiation-related toxicity or still require hormonal treatment for radiation-related toxicity.
•4.Known allergies to CHO-produced antibodies, which in the opinion of the Investigator suggests an increased potential for an adverse hypersensitivity to ES
•5.Subjects with allergic reactions to the active ingredients of JS001 or any of the excipients.
•6.Treatment with systemic immunosuppressive medications within 4 weeks prior to the first dose of study drug. Certain exceptions as defined in protocol apply.
•7.Receipt of live viral vaccine treatment within 4 weeks prior to the first dose of the study drug.
•8.Prior organ allograft transplantations or allogeneic peripheral blood stem cell (PBSC) or bone marrow (BM) transplantation.
•9.Subjects with primary or metastatic brain or meningeal tumors.
•10.Grade ≥ 3 immune-related adverse events (irAEs) or irAE that lead to discontinuation of prior immunotherapy. Some exceptions as defined per protocol apply.

Arms & Interventions

Part 1 ES102 Escalation in combination with JS001

ES102 will be escalated, in combination with JS001, in patients with advanced solid tumors.

Intervention: ES102

Part 1 ES102 Escalation in combination with JS001

ES102 will be escalated, in combination with JS001, in patients with advanced solid tumors.

Intervention: JS001

Part 2 ES102 Expansion in combination with JS001

Subjects will be treated with ES102 at the RP2D in combination with JS001.

Intervention: ES102

Part 2 ES102 Expansion in combination with JS001

Subjects will be treated with ES102 at the RP2D in combination with JS001.

Intervention: JS001

Outcomes

Primary Outcomes

MTD

Time Frame: 2-4 years

Maximum Tolerated Dose (MTD) of ES102 in combination with JS001

Frequency and severity of adverse events of ES102 in combination with JS001

Time Frame: 2-4 years

The safety profile of ES102 in combination with JS001 will be assessed by the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), version 5.0.

RP2D

Time Frame: 2-4 years

Recommended Phase 2 Dose (RP2D) of ES102 in combination with JS001

Secondary Outcomes

Area under the serum concentration time curve (AUC) of ES102 in combination with JS001(2-4 years)
Maximum observed serum concentration of ES102 in combination with JS001(2-4 years)
Time to Cmax (Tmax) of ES102 in combination with JS001(2-4 years)
Trough observed serum concentration (Ctrough) of ES102 in combination with JS001(2-4 years)
Immunogenicity of ES102 in combination with JS001(2-4 years)
Anti-tumor activity of ES102 in combination with JS001(2-4 years)