Solid TumorPhase 1NCT04991506
A Study of ES102 (OX40 Agonist) in Combination With JS001 in Patients With Advanced Solid Tumors
A Phase 1 study testing ES102 and JS001 in people with Solid Tumor and Neoplasms, run by Elpiscience Biopharma, Ltd. at 1 site in China.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Solid Tumor, Neoplasms, Malignant Tumor
- What is being tested?
- ES102 and JS001
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteChina
- Study dates
- 15 Oct 2021to 17 May 2024
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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
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
- Being tested
- ES102, JS001
- Keywords
- ES102, JS001, OX40, PD-1, Solid Tumors, Phase 1, INBRX-106
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ES102Drug
The active ingredient of ES102 is a recombinant, humanized, hexavalent IgG antibody that targets the human OX40 receptor (TNFRSF4)
JS001Drug
Also called Toripalimab
JS001 is administered via intravenous injection once every 21 days, every 21 days as a treatment cycle.
| Study group | Role | What they receive |
|---|---|---|
| Part 1 ES102 Escalation in combination with JS001 | Experimental | ES102 will be escalated, in combination with JS001, in patients with advanced solid tumors. Receives: 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. Receives: Drug: ES102; Drug: JS001 |
What is being measured
The primary outcome is the main question the study is designed to answer.
MTD
Maximum Tolerated Dose (MTD) of ES102 in combination with JS001
Measured: 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.
Measured: 2-4 years
RP2D
Recommended Phase 2 Dose (RP2D) of ES102 in combination with JS001
Measured: 2-4 years
Secondary outcomes (6)
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.
Measured: 2-4 years
Maximum observed serum concentration of ES102 in combination with JS001
Maximum observed serum concentration of ES102 in combination with JS001 will be determined.
Measured: 2-4 years
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.
Measured: 2-4 years
Time to Cmax (Tmax) of ES102 in combination with JS001
Time to Cmax (Tmax) of ES102 in combination with JS001 will be determined.
Measured: 2-4 years
Immunogenicity of ES102 in combination with JS001
Frequency of anti-drug antibodies (ADA) against ES102 in combination with JS001 will be determined.
Measured: 2-4 years
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).
Measured: 2-4 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Aug 2021
- Study start15 Oct 2021
- Primary completion17 May 2024
- Study completion17 May 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Solid TumorStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Elpiscience Biopharma, Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Shanghai Junshi Bioscience Co., Ltd.
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04991506
- Sponsor's protocol ID
- ES102-1002
- Status last verified
- Jun 2025
- First submitted
- 19 Jul 2021
- Last updated
- 23 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT04991506
- Acronym / sponsor ID
- ES102-1002
- Conditions
- Solid Tumor, Neoplasms, Malignant Tumor
- Keywords
- ES102, JS001, OX40, PD-1, Solid Tumors, Phase 1, INBRX-106
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Elpiscience Biopharma, Ltd.Industry (pharma, biotech, devices)
- Collaborators
- Shanghai Junshi Bioscience Co., Ltd.
- Study start
- 15 Oct 2021 (actual)
- Primary completion
- 17 May 2024 (actual)
- Study completion
- 17 May 2024 (actual)
- First posted
- 5 Aug 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Part 1 ES102 Escalation in combination with JS001 | Experimental | Drug: ES102, Drug: JS001ES102 will be escalated, in combination with JS001, in patients with advanced solid tumors. |
| Part 2 ES102 Expansion in combination with JS001 | Experimental | Drug: ES102, Drug: JS001Subjects will be treated with ES102 at the RP2D in combination with JS001. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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)
Key exclusion criteria (24 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ES102The active ingredient of ES102 is a recombinant, humanized, hexavalent IgG antibody that targets the human OX40 receptor (TNFRSF4) | Drug | Part 1 ES102 Escalation in combination with JS001, Part 2 ES102 Expansion in combination with JS001 |
| JS001Also: ToripalimabJS001 is administered via intravenous injection once every 21 days, every 21 days as a treatment cycle. | Drug | Part 1 ES102 Escalation in combination with JS001, Part 2 ES102 Expansion in combination with JS001 |
Primary outcome
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
6 secondary outcomes
Area under the serum concentration time curve (AUC) of ES102 in combination with JS001
Time frame: 2-4 years
Maximum observed serum concentration of ES102 in combination with JS001
Time frame: 2-4 years
Trough observed serum concentration (Ctrough) of ES102 in combination with JS001
Time frame: 2-4 years
Time to Cmax (Tmax) of ES102 in combination with JS001
Time frame: 2-4 years
Immunogenicity of ES102 in combination with JS001
Time frame: 2-4 years
Anti-tumor activity of ES102 in combination with JS001
Time frame: 2-4 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jun 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing ES102 and JS001 in people with Solid Tumor and Neoplasms, run by Elpiscience Biopharma, Ltd. at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 24 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
MTD (time frame: 2-4 years). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jun 2025.