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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Part A dose escalation | Experimental | ES102 will be escalated in patients with advanced solid tumors. |
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| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ES102 | Drug | ES102 is administered via intravenous injection once every 21 days, every 21 days as a treatment cycle. |
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| Measure | Description | Time Frame |
|---|---|---|
| Maximum Tolerated Dose (MTD) and/or Recommended Phase 2 Dose (RP2D) of of ES102 | The MTD and/or RP2D of ES102 will be determined. | 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. | 2-3 years |
| Measure | Description | Time Frame |
|---|---|---|
| Area under the serum concentration time curve (AUC) of ES102 | Area under the serum concentration time curve (AUC) of ES102 will be determined. | 2-3 years |
| Maximum observed serum concentration (Cmax) of ES102 |
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Inclusion Criteria:
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 .
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.
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Jilin Cancer Hospital | Changchun | Jilin | China |
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| ID | Term |
|---|---|
| D009369 | Neoplasms |
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Maximum observed serum concentration (Cmax) of ES102 will be determined.
| 2-3 years |
| Trough observed serum concentration (Ctrough) of ES102 | Trough observed serum concentration (Ctrough) of ES102 will be determined. | 2-3years |
| Time to Cmax (Tmax) of ES102 | Time to Cmax (Tmax) of ES102 will be determined. | 2-3years |
| Immunogenicity of ES102 | Frequency of anti-drug antibodies (ADA) against ES102 will be determined. | 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). | 2-3years |