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
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
Treatments tested in this trial
- ES502 Injection
Treatment groups
24 Participants
are divided into 1 treatment groupSponsors and collaborators
Ruijin Hospital
Lead sponsor
Shanghai Essight Bio Co.,Ltd
Collaborator
Source ClinicalTrials.gov