A Phase II Study of HR070803 in the Treatment of Advanced Esophageal Cancer

Hengrui Medicine

Status and phase: Enrolling; Phase 2

Conditions: Advanced Esophageal Cancer

Treatments: Drug: HR070803

Study type: Interventional

Funder types: Industry

Identifiers

NCT05425472

HR070803-201

Details and patient eligibility

About

To evaluate the efficacy, safety and pharmacokinetic characteristics of HR070803 in the treatment of advanced esophageal cancer.

Enrollment: 30 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. ECOG performance status 0 or 1
2. Histologically confirmed advanced esophageal carcinoma
3. At least one measurable lesion is present according to the efficacy evaluation criteria for solid tumors (RECIST 1.1)
4. Able and willing to provide a written informed consent

Exclusion criteria

1. The tumor obviously invades adjacent organs of esophageal lesions
2. BMI≤18.5 kg/m2 or weight loss ≥10% within 2 months prior to screening
3. Subjects with unresolved adverse effects of prior therapy at the time of enrolment
4. Subjects who had received anti-tumor treatments such as surgery, chemotherapy, radiotherapy recently

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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30 participants in 1 patient group

HR070803

Experimental group

Description:

HR070803 monotherapy will be administered by intravenous infusion

Treatment:

Drug: HR070803