A Study of SHR-A1909 in Subjects With Advanced Malignant Tumors

Hengrui Medicine

Status and phase: Completed; Phase 1

Conditions: Advanced Malignant Cancer

Treatments: Drug: SHR-1909 injection

Study type: Interventional

Funder types: Industry

Identifiers

NCT05162469

SHR-1909-I-101

Details and patient eligibility

About

This is an, open-label, multi-center, three-part phase I trial to evaluate the safety, pharmacokinetics and immunogenicity of SHR-1909 and preliminary anti-tumor efficacy of SHR-1909 in advanced malignant cancer.

Enrollment: 12 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1;
• Patients must have cytologically or histologically confirmed advanced malignant tumor, and must have failed standard treatment;
• Toxicities caused by prior anti-tumor treatments must have resolved to CTCAE Grade ≤ 1 prior to the first dose (except for alopecia or hypothyroidism treated with hormone replacement therapy or diabetes controlled with insulin);
• Adequate organ function.

Exclusion criteria

• With CNS infiltration, or ascites requiring paracentesis or symptomatic pleural effusion;
• Received prior CAR T-cell therapy;
• Received allogeneic hematopoietic stem cell transplantation within 3 months prior to the start of study treatment, or with acute/chronic graft versus host disease;
• With active infection or fever of unknown origin (> 38.5 °C).

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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12 participants in 1 patient group

SHR-1909 monotherapy

Experimental group

Treatment:

Drug: SHR-1909 injection