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

Phase 1

• Conditions: Advanced Malignant Cancer
• Interventions: Drug: SHR-1909 injection

• Registration Number: NCT05162469
• Lead Sponsor: Shanghai Hengrui Pharmaceutical Co., Ltd.

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-12-05
• Study First Submitted QC: 2021-12-05
• Study First Posted: 2021-12-17
• Status Verified: 2022-02
• Study Start: 2022-02-23
• Last Update Submitted: 2022-02-28
• Last Update Posted: 2022-03-02
• Primary Completion: 2022-12-31
• Study Completion: 2023-03-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

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).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
SHR-1909 monotherapy	SHR-1909 injection	-

Primary Outcome Measures

Name	Time	Method
MTD of SHR-1909	From Day 1 to 4 weeks	Maximum tolerated dose (MTD) based on dose-limiting toxicities (DLTs)
RP2D of SHR-1909	From Day 1 to 90 days after last dose	Recommended Phase 2 Dose(RP2D) of SHR-1909 will be determined during the dose-escalation and dose-expansion parts of the study. RP2D will be determined using available safety, pharmacokinetics and pharmacodynamics data.

Secondary Outcome Measures

Name	Time	Method
Progression-Free Survival (PFS)	Up to approximately 2 years	From Day 1 to Radiographic Progression or Death Due to Any Cause
Objective Response Rate (ORR)	Up to approximately 2 years	Baseline to documented disease progression or study discontinuation
Adverse Events	90 days after the last dose	Adverse Events documented by CTCAE 5.0

Trial Locations

Locations (1)

Jilin Cancer Hospital; 🇨🇳 Changchun, Jilin, China