Solid TumorsPhase 1NCT04730843
A Study of ES102 (OX40 Agonist) in Patients With Advanced Solid Tumors
A Phase 1 study testing ES102 in people with Solid Tumors 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) administered as a single agent 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 Tumors, Neoplasms, Malignant Tumor
- What is being tested?
- ES102
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteChina
- Study dates
- 1 Apr 2021to 1 Mar 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
- Ability to understand and the willingness to sign a written informed consent form.
- Males or females aged ≥18 years.
- Part A: 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.
- Part B: Subjects with NSCLC, ESCC, NPC, GI or Cervical cancers, with advanced disease, which has progressed despite all standard therapies or for whom no standard therapy exists, or who is unsuitable for available standard therapies.
- All subjects with NSCLC have documentation of absence of tumor activating EGFR mutation and absence of ALK and ROS1 gene rearrangements.
- PD-L1 by IHC result mandatory but any score allowed .
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- 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.
Who cannot join
- Prior exposure to OX40 agonists.
- Known allergies to CHO-produced antibodies, which in the opinion of the Investigator suggests an increased potential for an adverse hypersensitivity to ES102.
- 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.
- Patients with other malignancies within 2 years before screening shall be excluded in Part B. Some exceptions as defined per protocol apply.
- Hematologic malignancies (e.g., ALL, AML, MDS, CLL, CML, NHL, Hodgkin's lymphoma and multiple myeloma)
- Known or active primary central nervous system (CNS) tumors, leptomeningeal disease and CNS metastases. Exception: subjects with previously treated, asymptomatic, and clinically stable CNS metastases may be allowed study entry if certain criteria apply in Part B.
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- Grade ≥ 3 immune-related adverse events (irAEs) or irAE that lead to discontinuation of prior immunotherapy. 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.
- Treatment with systemic immunosuppressive medications within 4 weeks prior to the first dose of study drug. Certain exceptions as defined in protocol apply.
- History of hepatitis B, hepatitis C, or human immunodeficiency virus (HIV) infection for Part A. Exceptions as defined in protocol for Part B will apply.
- Active interstitial lung disease (ILD) or pneumonitis or a history of ILD or pneumonitis requiring treatment with steroids or other immunosuppressive medications.
- 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.
- Active, hemodynamically significant pulmonary embolism within 3 months prior to the first dose of study drug.
- Major surgery within 4 weeks prior to enrollment on this trial.
- Systemic anti-infectious drug treatments within 4 weeks prior to the first dose of study drug.
- Prior organ allograft transplantations or allogeneic peripheral blood stem cell (PBSC) or bone marrow (BM) transplantation.
- Pregnant or nursing females.
- Any known, documented, or suspected history of substance abuse that would preclude subject from participation, unless clinically justified (i.e., will not interfere with study participation and/or will not compromise trial objectives) per judgment of the Investigator and with approval of the Medical Monitor or Study Director.
- 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 Administered as a Single Agent 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) administered as a single agent in patients with advanced solid tumors.
- Conditions
- Solid Tumors, Neoplasms, Malignant Tumor
- Being tested
- ES102
- Keywords
- ES102, solid tumor, phase 1, OX40, 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
ES102 is administered via intravenous injection once every 21 days, every 21 days as a treatment cycle.
| Study group | Role | What they receive |
|---|---|---|
| Part A dose escalation | Experimental | ES102 will be escalated in patients with advanced solid tumors. Receives: Drug: ES102 |
| Part B expansion | Experimental | Subjects with advanced non-small cell lung cancer, advanced esophageal squamous cell carcinoma, other advanced solid tumors (such as nasopharyngeal carcinoma, cervical cancer, gastrointestinal tumors, other reproductive system tumors, etc.) will be treated with ES102 at the RP2D. Receives: Drug: ES102 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum Tolerated Dose (MTD) and/or Recommended Phase 2 Dose (RP2D) of of ES102
The MTD and/or RP2D of ES102 will be determined.
Measured: 2-3 years
Number of participants with adverse events and serious adverse events of ES102
The safety profile of ES102 will be assessed by the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), version 5.0.
Measured: 2-3 years
Secondary outcomes (6)
Area under the serum concentration time curve (AUC) of ES102
Area under the serum concentration time curve (AUC) of ES102 will be determined.
Measured: 2-3 years
Maximum observed serum concentration (Cmax) of ES102
Maximum observed serum concentration (Cmax) of ES102 will be determined.
Measured: 2-3 years
Trough observed serum concentration (Ctrough) of ES102
Trough observed serum concentration (Ctrough) of ES102 will be determined.
Measured: 2-3years
Time to Cmax (Tmax) of ES102
Time to Cmax (Tmax) of ES102 will be determined.
Measured: 2-3years
Immunogenicity of ES102
Frequency of anti-drug antibodies (ADA) against ES102 will be determined.
Measured: 2-3years
Anti-tumor activity of ES102
Tumor response will be determined by the revised Response Evaluation Criteria in Solid Tumors version 1.1 (RECISTv1.1).
Measured: 2-3years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jan 2021
- Study start1 Apr 2021
- Primary completion1 Mar 2024
- Study completion1 Mar 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Solid TumorsStudies 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
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Elpiscience Biopharma, Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04730843
- Sponsor's protocol ID
- ES102-1001
- Status last verified
- Jun 2025
- First submitted
- 26 Jan 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 Administered as a Single Agent in Patients With Advanced Solid Tumors
- ClinicalTrials.gov ID
- NCT04730843
- Acronym / sponsor ID
- ES102-1001
- Conditions
- Solid Tumors, Neoplasms, Malignant Tumor
- Keywords
- ES102, solid tumor, phase 1, OX40, INBRX-106
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Elpiscience Biopharma, Ltd.Industry (pharma, biotech, devices)
- Study start
- 1 Apr 2021 (actual)
- Primary completion
- 1 Mar 2024 (actual)
- Study completion
- 1 Mar 2024 (actual)
- First posted
- 29 Jan 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) administered as a single agent 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 A dose escalation | Experimental | Drug: ES102ES102 will be escalated in patients with advanced solid tumors. |
| Part B expansion | Experimental | Drug: ES102Subjects with advanced non-small cell lung cancer, advanced esophageal squamous cell carcinoma, other advanced solid tumors (such as nasopharyngeal carcinoma, cervical cancer, gastrointestinal tumors, other reproductive system tumors, etc.) will be treated with ES102 at the RP2D. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Ability to understand and the willingness to sign a written informed consent form.
- Males or females aged ≥18 years.
- Part A: 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.
- Part B: Subjects with NSCLC, ESCC, NPC, GI or Cervical cancers, with advanced disease, which has progressed despite all standard therapies or for whom no standard therapy exists, or who is unsuitable for available standard therapies.
- All subjects with NSCLC have documentation of absence of tumor activating EGFR mutation and absence of ALK and ROS1 gene rearrangements.
Key exclusion criteria (19 listed)
- Prior exposure to OX40 agonists.
- Known allergies to CHO-produced antibodies, which in the opinion of the Investigator suggests an increased potential for an adverse hypersensitivity to ES102.
- 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.
- Patients with other malignancies within 2 years before screening shall be excluded in Part B. Some exceptions as defined per protocol apply.
- Hematologic malignancies (e.g., ALL, AML, MDS, CLL, CML, NHL, Hodgkin's lymphoma and multiple myeloma)
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 |
|---|---|---|
| ES102ES102 is administered via intravenous injection once every 21 days, every 21 days as a treatment cycle. | Drug | Part A dose escalation, Part B expansion |
Primary outcome
Maximum Tolerated Dose (MTD) and/or Recommended Phase 2 Dose (RP2D) of of ES102
Time frame: 2-3 years
The MTD and/or RP2D of ES102 will be determined.
Number of participants with adverse events and serious adverse events of ES102
Time frame: 2-3 years
The safety profile of ES102 will be assessed by the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), version 5.0.
6 secondary outcomes
Area under the serum concentration time curve (AUC) of ES102
Time frame: 2-3 years
Maximum observed serum concentration (Cmax) of ES102
Time frame: 2-3 years
Trough observed serum concentration (Ctrough) of ES102
Time frame: 2-3years
Time to Cmax (Tmax) of ES102
Time frame: 2-3years
Immunogenicity of ES102
Time frame: 2-3years
Anti-tumor activity of ES102
Time frame: 2-3years
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 in people with Solid Tumors 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 11 inclusion and 19 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?
Maximum Tolerated Dose (MTD) and/or Recommended Phase 2 Dose (RP2D) of of ES102 (time frame: 2-3 years). The study lists 2 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.