The Clinical Study of SHR-9839 for Injection in Patients With Advanced Solid Tumors

Hengrui Medicine

Status and phase: Enrolling; Phase 1

Conditions: Advanced Solid Tumor

Treatments: Drug: SHR-9839

Study type: Interventional

Funder types: Industry

Identifiers

NCT05836948

SHR-9839-I-101

Details and patient eligibility

About

This study is an open-label, phase I clinical trial of SHR-9839 in patients with advanced solid tumors. The whole study is divided into three stages: dose escalation, dose expansion and efficacy expansion.

Enrollment: 174 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Patients with histologically or cytologically confirmed unresectable locally advanced or metastatic solid tumors which is relapsed or refractory to standard treatment, or lack of standard treatment, or standard treatment is not applicable currently;
2. Have at least one measurable tumor lesion per RECIST v1.1;
3. ECOG performance status of 0-1;
4. Life expectancy ≥ 12 weeks;
5. Adequate bone marrow and organ function;
6. Subjects must voluntarily agree to participate in the trial and sign a written informed consent form.

Exclusion criteria

1. Patients with active central nervous system metastases or meningeal metastases;
2. Received anti-tumor treatment such as chemotherapy, biotherapy, targeted therapy, immunotherapy, radical radiotherapy, or other unlisted clinical research drugs or treatments within 4 weeks prior to the first use of the study drug;
3. History of serious cardiovascular and cerebrovascular diseases;
4. Subjects who received>30Gy of radiation therapy within 4 weeks before the first medication, and those who received ≤ 30Gy of palliative radiation therapy within 7 days before the first medication;
5. Adverse reactions of previous anti-tumor treatment have not recovered to Grade ≤ 1 per NCI-CTCAE v5.0.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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174 participants in 1 patient group

SHR-9839

Experimental group

Description:

three stages: dose escalation, dose expansion and efficacy expansion.

Treatment:

Drug: SHR-9839