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Protocol # 21-385

Status

Recruiting

Description

This is an open label, multi-center, multiple dose Phase 1 study to evaluate the safety, tolerability, MTD PK, and PD of TJ033721 in subjects with advanced or metastatic solid tumors.

Condition

  • Solid Tumor
  • Advanced Cancer
  • Metastatic Cancer
  • Gastric Cancer
  • Gastroesophageal Junction Carcinoma
  • Esophageal Adenocarcinoma
  • Pancreatic Ductal Adenocarcinoma

Interventions

  • TJ033721

Phase

Phase 1

Study Type

Interventional

Further Study Details

Primary Outcome:

  • Dose-limiting toxicities (DLTs)
  • Incidence and severity of AEs
  • Maximum tolerated or administered dose (MTD, MAD)

Secondary Outcome:

  • Pharmacokinetic (PK) Parameters: AUC∞
  • Pharmacokinetic (PK) Parameters: AUCt
  • Pharmacokinetic (PK) Parameters: Cmax
  • Pharmacokinetic Parameters: Tmax
  • Pharmacokinetic Parameters: T1/2

Enrollment

132

Study Start Date

June 29, 2021

Eligibility

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

Sponsors

I-Mab Biopharma Co. Ltd.

Source

I-Mab Biopharma Co. Ltd.

Official title

A Phase 1 Study of TJ033721 in Subjects With Advanced or Metastatic Solid Tumors

Clinicaltrials.gov Identifier

NCT04900818

     

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.