Skip to main content
OpenTrials
Completed

NCT Number: NCT05162469

A Study of SHR-A1909 in Subjects 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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Advanced Malignant Cancer

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Jilin Cancer Hospital

Changchun, Jilin, 130000, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

SHR-1909 injection

Drug

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)).

Primary outcomes

  1. MTD of SHR-1909

    Time frame: From Day 1 to 4 weeks

    Maximum tolerated dose (MTD) based on dose-limiting toxicities (DLTs)

  2. RP2D of SHR-1909

    Time frame: 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 outcomes

  1. Adverse Events

    Time frame: 90 days after the last dose

    Adverse Events documented by CTCAE 5.0

  2. Objective Response Rate (ORR)

    Time frame: Up to approximately 2 years

    Baseline to documented disease progression or study discontinuation

  3. Progression-Free Survival (PFS)

    Time frame: Up to approximately 2 years

    From Day 1 to Radiographic Progression or Death Due to Any Cause

Sponsors and collaborators

Lead sponsor

Shanghai Hengrui Pharmaceutical Co., Ltd.

Industry

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
Dec 17, 2021
Registry last updated
Jul 28, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.