A Study of Dose Escalation of ES502 in Patients With Advanced Pancreatic Cancer

Sponsor
Ruijin Hospital
Study ID
NCT07649928
Phase
EARLY_PHASE1
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • ES502 Injection — DRUG
    Bispecific soluble HLA-DP restricted RASG12V specific T-cell receptor fused to anti-CD3 with Fc

Study Details

ESSIGHT-HJG-ES502-01 is a dose-escalation study of ES502 in patients with advanced pancreatic cancer. The study will enroll patients with advanced, RAS G12V positive pancreatic cancer who have no effective treatment options available (HLA genotyping required).

Key Dates

First listed
Jun 16, 2026
Start date
May 18, 2026
Status verified
Jun 2026
Primary completion
Dec 31, 2028
Completion
Jun 30, 2029

Study Design

Enrollment
24 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Dose escalation cohort
    A dose-escalation study will be conducted following the standard 3+3 design, with doses of 20, 60, 180, and 540 μg. A total of 10-24 subjects are planned to be enrolled. Depending on the subject's conditions (including but not limited to safety results, pharmacokinetic and pharmacodynamic data, etc.), and under the premise of ensuring subject safety, the investigator and/or ethics committee may decide to increase the dose or add new dose groups.

Primary Outcome Measure

To evaluate the safety and tolerability of ES502 in subjects with advanced solid tumors [ Time Frame: 2 years ]

Central Contacts

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