Clinical Trials Logo

Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04991506
Other study ID # ES102-1002
Secondary ID
Status Recruiting
Phase Phase 1
First received
Last updated
Start date October 15, 2021
Est. completion date June 30, 2025

Study information

Verified date April 2023
Source Elpiscience Biopharma, Ltd.
Contact Ning Chen
Phone 86 15021415086
Email clinical-operation@elpiscience.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 82
Est. completion date June 30, 2025
Est. primary completion date May 31, 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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. - 11.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. - 12.Hematologic malignancies. - 13.Receipt of treatment with G-CSF, GM-CSF, Thrombopoietic drugs or EPO within 14 days prior to the first dose of the study drug. - 14.Patients with other malignancies within 2 years before screening shall be excluded in Part B. Some exceptions as defined per protocol apply. - 15.Active autoimmune disease or documented history of autoimmune disease that required systemic steroids or other immunosuppressive medications. Certain exceptions as defined in protocol apply. - 16.Active interstitial lung disease (ILD) or pneumonitis or a history of ILD or pneumonitis requiring treatment with steroids or other immunosuppressive medications. - 17.Clinically significant cardiac condition, including myocardial infarction, uncontrolled angina, cerebrovascular accident, or other acute uncontrolled heart disease < 6 months; left ventricular ejection fraction (LVEF) < 50%; New York Heart Association (NYHA) Class III or IV congestive heart failure; or uncontrolled hypertension. - 18.History of pulmonary embolism within 12 weeks prior to the first dose of study drug administration. - 19.Major surgery within 4 weeks prior to enrollment on this trial. - 20.History of hepatitis B, hepatitis C, or human immunodeficiency virus (HIV) infection for Part 1. Exceptions as defined in protocol for Part 2 will apply. - 21.Receiving the systemic anti-infectious drug treatments within 4 weeks prior to the first dose of study drug. - 22.Pregnant or nursing females. - 23.Any known, documented, or suspected history of substance abuse that would preclude subject from participation, certain exceptions as defined in protocol apply. - 24.The subject is inappropriate to participate in this study for other reasons in the judgment of the Investigator.

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
ES102
The active ingredient of ES102 is a recombinant, humanized, hexavalent IgG antibody that targets the human OX40 receptor (TNFRSF4)
JS001
JS001 is administered via intravenous injection once every 21 days, every 21 days as a treatment cycle.

Locations

Country Name City State
China Jilin Cancer Hospital Changchun Jilin

Sponsors (2)

Lead Sponsor Collaborator
Elpiscience Biopharma, Ltd. Shanghai Junshi Bioscience Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary MTD Maximum Tolerated Dose (MTD) of ES102 in combination with JS001 2-4 years
Primary 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
Primary RP2D Recommended Phase 2 Dose (RP2D) of ES102 in combination with JS001 2-4 years
Secondary Area under the serum concentration time curve (AUC) of ES102 in combination with JS001 Area under the serum concentration time curve (AUC) of ES102 in combination with JS001 will be determined. 2-4 years
Secondary Maximum observed serum concentration of ES102 in combination with JS001 Maximum observed serum concentration of ES102 in combination with JS001 will be determined. 2-4 years
Secondary Trough observed serum concentration (Ctrough) of ES102 in combination with JS001 Trough observed serum concentration (Ctrough) of ES102 in combination with JS001 will be determined. 2-4 years
Secondary Time to Cmax (Tmax) of ES102 in combination with JS001 Time to Cmax (Tmax) of ES102 in combination with JS001 will be determined. 2-4 years
Secondary Immunogenicity of ES102 in combination with JS001 Frequency of anti-drug antibodies (ADA) against ES102 in combination with JS001 will be determined. 2-4 years
Secondary Anti-tumor activity of ES102 in combination with JS001 Tumor response will be determined by the revised Response Evaluation Criteria in Solid Tumors version 1.1 (RECISTv1.1). 2-4 years
See also
  Status Clinical Trial Phase
Completed NCT03826043 - THrombo-Embolic Event in Onco-hematology N/A
Terminated NCT03166631 - A Trial to Find the Safe Dose for BI 891065 Alone and in Combination With BI 754091 in Patients With Incurable Tumours or Tumours That Have Spread Phase 1
Completed NCT01938846 - BI 860585 Dose Escalation Single Agent and in Combination With Exemestane or With Paclitaxel in Patients With Various Advanced and/or Metastatic Solid Tumors Phase 1
Recruiting NCT06058312 - Individual Food Preferences for the Mediterranean Diet in Cancer Patients N/A
Completed NCT03308942 - Effects of Single Agent Niraparib and Niraparib Plus Programmed Cell Death-1 (PD-1) Inhibitors in Non-Small Cell Lung Cancer Participants Phase 2
Recruiting NCT06018311 - Exercising Together for Hispanic Prostate Cancer Survivor-Caregiver Dyads N/A
Withdrawn NCT05431439 - Omics of Cancer: OncoGenomics
Completed NCT01343043 - A Pilot Study of Genetically Engineered NY-ESO-1 Specific NY-ESO-1ᶜ²⁵⁹T in HLA-A2+ Patients With Synovial Sarcoma Phase 1
Completed NCT01938638 - Open Label Phase I Dose Escalation Study With BAY1143572 in Patients With Advanced Cancer Phase 1
Recruiting NCT05514444 - Study of MK-4464 as Monotherapy and in Combination With Pembrolizumab in Participants With Advanced/Metastatic Solid Tumors (MK-4464-001) Phase 1
Recruiting NCT02292641 - Beyond TME Origins N/A
Terminated NCT00954512 - Study of Robatumumab (SCH 717454, MK-7454) in Combination With Different Treatment Regimens in Participants With Advanced Solid Tumors (P04722, MK-7454-004) Phase 1/Phase 2
Recruiting NCT04958239 - A Study to Test Different Doses of BI 765179 Alone and in Combination With Ezabenlimab in Patients With Advanced Cancer (Solid Tumors) Phase 1
Recruiting NCT04627376 - Multimodal Program for Cancer Related Cachexia Prevention N/A
Completed NCT01222728 - Using Positron Emission Tomography to Predict Intracranial Tumor Growth in Neurofibromatosis Type II Patients
Recruiting NCT06004440 - Real World Registry for Use of the Ion Endoluminal System
Active, not recruiting NCT05636696 - COMPANION: A Couple Intervention Targeting Cancer-related Fatigue N/A
Not yet recruiting NCT06035549 - Resilience in East Asian Immigrants for Advance Care Planning Discussions N/A
Recruiting NCT06004466 - Noninvasive Internal Jugular Venous Oximetry
Not yet recruiting NCT02806557 - Profiling Neutrophil Counts in Patients on Chemotherapy N/A