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

ConditionPancreatic Cancer

Trial statusRecruiting

Trial phaseEarly Phase 1

Trial typeInterventional

Biological sexAll

Age18+

SponsorRuijin Hospital

About this trial

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).

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age ≥18 years, regardless of gender;

Available fresh or archived tumor tissue samples (within the past 5 years) for testing at screening;

Individuals with histologically or cytologically confirmed advanced solid tumors for whom no standard therapy exists, who are refractory to standard therapy, or who are deemed unsuitable for standard therapy by the investigator. Tumor types include but are not limited to: pancreatic cancer, colorectal cancer, non-small cell lung cancer, intrahepatic cholangiocarcinoma, gallbladder cancer, ovarian cancer, endometrial cancer, and intestinal cancer;

RAS G12V mutation (KRAS/NRAS/HRAS) and positivity for HLA-DPB1*03:01, *14:01, *25:01, or *104:01;

Disqualifiers

Malignant tumors other than those under investigation in this study (except for cured thyroid cancer, skin basal cell carcinoma, or cervical carcinoma in situ) within the past 5 years;

Meningeal metastases;

Brain metastases, except for individuals who have received systematic and radical therapy (radiotherapy or surgery) for brain metastases, demonstrated radiologically stable disease for at least 4 weeks, discontinued systemic corticosteroids for more than 2 weeks, and remain asymptomatic.

Received prior targeted therapy targeting RAS-G12V within 4 weeks before the first dose, or within 5 half-lives of the therapeutic agent, whichever is longer;

Trial design

Design model

Single group

Treatments tested in this trial

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

Treatment groups

24 Participants

are divided into 1 treatment group

Group A: Dose escalation cohortExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

To evaluate the safety and tolerability of ES502 in subjects with advanced solid tumors

DLT, and incidence and severity of adverse effects.

Time frame

2 years

To determine the maximum tolerated dose (MTD)

Time frame

2 years

Secondary outcomes

Preliminary antitumor activity

Objective response rate (ORR),%

Time frame

2 years

Preliminary antitumor activity

Disease control rate (DCR),%

Time frame

2 years

Preliminary antitumor activity

Duration of response (DOR), in week, in month

Time frame

2 years

Preliminary antitumor activity

Progression-free survival (PFS) ,in month

Time frame

2 years

Other outcomes

Pharmacodynamic (PD)

Changes in peripheral blood T cells (CD3+ T cells, CD4+ T cells, and CD8+ T cells),cells/μL

Time frame

2 years

Pharmacodynamic (PD)

Changes in peripheral blood cytokines (IFN-γ, TNF-α, IL-2, IL-6, IL-10, CXCL9, CXCL10, CXCL11, and MCP-1),pg/mL

Time frame

2 years

Pharmacodynamic (PD)

RAS G12V mutation frequency，%

Time frame

2 years

Pharmacodynamic (PD)

Expression levels of HLA-DP, PD-L1, CD3, CD4 and CD8 ,MFI

Time frame

2 years

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Ruijin Hospital

Lead sponsor

Shanghai Essight Bio Co.,Ltd

Collaborator

Source ClinicalTrials.gov

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