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

NCT05162469 | Completed Phase 1

• 1 other identifier: SHR-1909-I-101
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

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.

Conditions

Advanced Malignant Cancer

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (3)

• Adverse Events

  90 days after the last dose

• Objective Response Rate (ORR)

  Up to approximately 2 years

• Progression-Free Survival (PFS)

  Up to approximately 2 years

Study Arms (1)

SHR-1909 monotherapy

EXPERIMENTAL

Drug: SHR-1909 injection

Interventions

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)).

SHR-1909 monotherapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Shanghai Hengrui Pharmaceutical Co., Ltd.: lead

Study Sites (1)

Jilin Cancer Hospital

Changchun, Jilin, 130000, China

Location

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Dose escalation (non randomized， 6 arms); Dose-expansion and efficacy-expansion(non-randomized,1-3 arms)

Study Record Dates

• First Submitted: December 5, 2021
• First Posted: December 17, 2021
• Study Start: February 23, 2022
• Primary Completion: March 28, 2024
• Study Completion: June 13, 2024
• Last Updated: July 28, 2025

Record last verified: 2025-07

Locations

CN (1)