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A Study of ES102 (OX40 Agonist) in Combination With JS001 in Patients With Advanced Solid Tumors | Clinical Trials | Clareo Health

COMPLETEDPHASE1

A Study of ES102 (OX40 Agonist) in Combination With JS001 in Patients With Advanced Solid Tumors

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

NCT04991506•Elpiscience Biopharma, Ltd.

View on ClinicalTrials.gov

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.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

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 1.
•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 ES102.
•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.
+14 more criteria

Locations (1)

Jilin Cancer Hospital

Changchun, Jilin, China

Key Dates

Start Date

October 15, 2021

Primary Completion Date

May 17, 2024

Completion Date

May 17, 2024

Last Updated

June 23, 2025

Enrollment

ACTUAL participants

Conditions

Solid TumorNeoplasmsMalignant Tumor

Interventions

ES102

DRUG

JS001

DRUG

Collection of Serum and Tissue Samples From Patients With Biopsy-Proved or Suspected Malignant Disease

NCT00026884

Malignant NeoplasmsHereditary Neoplastic Syndromes+3 more

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RECRUITINGPHASE1

A Study of PYX-201 in Advanced Solid Tumors

NCT05720117

Solid TumorAdvanced Solid Tumor

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: June 23, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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A Study of ES102 (OX40 Agonist) in Combination With JS001 in Patients With Advanced Solid Tumors

Inclusion Criteria

Exclusion Criteria

Collection of Serum and Tissue Samples From Patients With Biopsy-Proved or Suspected Malignant Disease

A Study of PYX-201 in Advanced Solid Tumors

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