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ES102

Phase 1

Solid Tumor | Small molecule | Oncology |Co-Diagnostics, Inc.|Last Updated: Jun 23, 2025

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
CONTROLLEDBiomarker
Total Trials1
Total Enrollment30
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT04991506A Study of ES102 (OX40 Agonist) in Combination With JS001 in Patients With Advanced Solid TumorsPHASE1 COMPLETED 30Oct 15, 2021May 17, 2024Jun 23, 20251 China
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Study Endpoints
Primary Endpoints
MTD
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
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
2-4 years

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

Secondary Endpoints
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
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Study Design & Arms
AllocationNON_RANDOMIZED
MaskingNONE
ModelSEQUENTIAL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Part 1 ES102 Escalation in combination with JS001EXPERIMENTALES102 will be escalated, in combination with JS001, in patients with advanced solid tumors.
Part 2 ES102 Expansion in combination with JS001EXPERIMENTALSubjects will be treated with ES102 at the RP2D in combination with JS001.
Interventions
NameTypeDescription
ES102DRUGThe active ingredient of ES102 is a recombinant, humanized, hexavalent IgG antibody that targets the human OX40 receptor (TNFRSF4)
JS001DRUGJS001 is administered via intravenous injection once every 21 days, every 21 days as a treatment cycle.
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites1

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 furth...

Countries:China
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