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

NCT04991506 | Completed Phase 1

• 1 other identifier: ES102-1002
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Solid Tumor; Neoplasms; Malignant Tumor

Keywords

ES102; JS001; OX40; PD-1; Solid Tumors; Phase 1; INBRX-106

Outcome Measures

Primary Outcomes (3)

• MTD

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

  2-4 years

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

  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.

  2-4 years

• RP2D

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

  2-4 years

Secondary Outcomes (6)

• 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

• Trough observed serum concentration (Ctrough) of ES102 in combination with JS001

  2-4 years

• Time to Cmax (Tmax) of ES102 in combination with JS001

  2-4 years

• Immunogenicity of ES102 in combination with JS001

  2-4 years

Study Arms (2)

Part 1 ES102 Escalation in combination with JS001

EXPERIMENTAL

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

Drug: ES102; Drug: JS001

Part 2 ES102 Expansion in combination with JS001

EXPERIMENTAL

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

Drug: ES102; Drug: JS001

Interventions

ES102 DRUG

The active ingredient of ES102 is a recombinant, humanized, hexavalent IgG antibody that targets the human OX40 receptor (TNFRSF4)

Part 1 ES102 Escalation in combination with JS001; Part 2 ES102 Expansion in combination with JS001

JS001 DRUG

JS001 is administered via intravenous injection once every 21 days, every 21 days as a treatment cycle.

Also known as: Toripalimab

Part 1 ES102 Escalation in combination with JS001; Part 2 ES102 Expansion in combination with JS001

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Males or females aged ≥18 years.
• Ability to understand and the willingness to sign a written informed consent form.
• 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.
• 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%.
• 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 1.
• Estimated life expectancy, in the judgment of the investigator, of at least 12 weeks.
• 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.

You may not qualify if:

• Prior exposure to OX40 agonists.
• 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.
• 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.
• Known allergies to CHO-produced antibodies, which in the opinion of the Investigator suggests an increased potential for an adverse hypersensitivity to ES102.
• Subjects with allergic reactions to the active ingredients of JS001 or any of the excipients.
• Treatment with systemic immunosuppressive medications within 4 weeks prior to the first dose of study drug. Certain exceptions as defined in protocol apply.
• Receipt of live viral vaccine treatment within 4 weeks prior to the first dose of the study drug.
• Prior organ allograft transplantations or allogeneic peripheral blood stem cell (PBSC) or bone marrow (BM) transplantation.
• Subjects with primary or metastatic brain or meningeal tumors.
• Grade ≥ 3 immune-related adverse events (irAEs) or irAE that lead to discontinuation of prior immunotherapy. Some exceptions as defined per protocol apply.
• Subject has not recovered from all AEs of previous anticancer therapies to baseline or ≤ Grade 1 per CTCAE v5.0 before the first dose of study drug. Certain exceptions as defined in protocol apply.
• Hematologic malignancies.
• Receipt of treatment with G-CSF, GM-CSF, Thrombopoietic drugs or EPO within 14 days prior to the first dose of the study drug.
• Patients with other malignancies within 2 years before screening shall be excluded in Part B. 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.

Sponsors & Collaborators

• Elpiscience Biopharma, Ltd.: lead
• Shanghai Junshi Bioscience Co., Ltd.: collaborator

Study Sites (1)

Jilin Cancer Hospital

Changchun, Jilin, China

Location

MeSH Terms

Conditions

Neoplasms

Interventions

toripalimab

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 19, 2021
• First Posted: August 5, 2021
• Study Start: October 15, 2021
• Primary Completion: May 17, 2024
• Study Completion: May 17, 2024
• Last Updated: June 23, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)