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

A Phase I Clinical Study Evaluating the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Efficacy of SHR-1909 Injection in Patients With Advanced Malignant Tumors

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.

Study Overview

• Status: Completed
• Conditions: Advanced Malignant Cancer
• Intervention / Treatment: Drug: SHR-1909 injection

• Study Type: Interventional
• Enrollment (Actual): 12
• Phase: Phase 1

Contacts and Locations

Study Locations

• China
  • Jilin
    • Changchun, Jilin, China, 130000
      • Jilin Cancer Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: SHR-1909 monotherapy	Drug: SHR-1909 injection; SHR-1909 for intravenous injection;Strength:6ml:0.3g/vial. Dose escalation (non randomized, 6 dose-levels); Dose-expansion and efficacy-expansion(non-randomized,1-3 dose-level(s)).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
MTD of SHR-1909	Maximum tolerated dose (MTD) based on dose-limiting toxicities (DLTs)	From Day 1 to 4 weeks
RP2D of SHR-1909	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.	From Day 1 to 90 days after last dose

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Shanghai Hengrui Pharmaceutical Co., Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): February 23, 2022
• Primary Completion (Actual): March 28, 2024
• Study Completion (Actual): June 13, 2024

Study Registration Dates

• First Submitted: December 5, 2021
• First Submitted That Met QC Criteria: December 5, 2021
• First Posted (Actual): December 17, 2021

Study Record Updates

• Last Update Posted (Actual): July 28, 2025
• Last Update Submitted That Met QC Criteria: July 24, 2025
• Last Verified: July 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms
• Other Study ID Numbers: SHR-1909-I-101

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No