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Protocol # 22-235

Status

Recruiting

Description

This trial is a first-in-human, open label, multi-center, dose escalation phase 1a study followed by a disease-specific dose expansion phase 1b study to evaluate the safety, efficacy, and pharmacokinetics (PK) of IMM2902, a HER2/SIRPα bispecific mAb-Trap antibody-receptor fusion protein, in patients with HER2-expressing advanced solid tumor.

Condition

  • Advanced Solid Tumor
  • Advanced Breast Cancer
  • Advanced Gastric Cancer

Interventions

  • IMM2902

Phase

Phase 1

Study Type

Interventional

Further Study Details

Primary Outcome:

  • Dose-Limiting Toxicity (DLT)
  • maximum tolerated dose (MTD) of IMM2902
  • dose for expansion (RDE) of IMM2902
  • Number of patients with Adverse Events（AEs）

Enrollment

135

Study Start Date

June 20, 2022

Eligibility

  • Gender:     All
  • Minimum age:     18 Years
  • Maximum age:     N/A
  • Healthy volunteers:     No

Sponsors

ImmuneOnco Biopharmaceuticals (Shanghai) Inc.

Source

ImmuneOnco Biopharmaceuticals (Shanghai) Inc.

Official title

A Phase 1, Open-Label, Multicenter, Dose Escalation Study Evaluating the Safety, Tolerability, and Preliminary Efficacy of IMM2902 in Patients With HER2-Expressing Advanced Solid Tumors

Clinicaltrials.gov Identifier

NCT05076591

     

Source: Clinicaltrials.gov. Through our founding membership in the Dana-Farber/Harvard Cancer Center, an NCI-designated Comprehensive Cancer Center, these clinical trials are conducted at the Massachusetts General Hospital Cancer Center and may be available at other partner institutions.