RECRUITING

Study of TJ033721 (givastomig) in Subjects with Advanced or Metastatic Solid Tumors

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Conditions

Solid TumorAdvanced CancerMetastatic CancerGastric CancerGastroesophageal Junction CarcinomaEsophageal Adenocarcinoma

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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

Official Title

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

Quick Facts

Study Start:2021-06-29
Study Completion:2026-12
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT04900818

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1 with adequate organ function
  2. * Have known PD-L1 status with prior testing by immunohistochemistry and a corresponding combined positive score (CPS)
  3. * Prior exposure to CLDN18.2 -targeted therapy
  4. * Prior exposure to 4-1BB agonists
  5. * Second malignancy within the last 3 years with the exception of cutaneous squamous cell carcinoma or cutaneous basal cell carcinoma or cervical carcinoma in situ
  6. * Known active or chronic Hepatitis B or Hepatitis C, other hepatitides
  7. * Unstable/active ulcer or digestive tract bleeding within 6 weeks
  8. * Active autoimmune disease requiring systemic treatment within the past 2 years
  9. * Active interstitial lung disease (ILD) or pneumonitis or a history of ILD or pneumonitis requiring treatment
  10. * Known active CNS metastases and/or carcinomatous meningitis. Subjects with previously treated brain metastases may participate provided they are clinically stable and without requirement of steroid treatment for at least 14 days prior to first dose of study treatment;
  11. * New York Heart Association (NYHA) Class 3 or 4 congestive heart failure, severe/unstable angina, myocardial infarction (MI), symptomatic congestive heart failure, cerebrovascular accident, transient ischemic attack (TIA), arterial embolism, percutaneous transluminal coronary angioplasty (PTCA), or coronary artery bypass grafting (CABG) in the previous 6 months
  12. * Diagnosis of immunodeficiency such as known active HIV
  13. * Any active infection requiring parenteral treatment
  1. Pregnancy or breastfeeding
  2. Severe psychiatric disorders
  3. Active substance abuse
  4. Unstable medical conditions
  5. Inability to comply with study requirements

Contacts and Locations

Study Contact

US Site Head
CONTACT
301-294-4408
us.info@i-mabbiopharma.com

Study Locations (Sites)

Stern Center for Cancer Clinical Trials and Research
Orange, California, 92868
United States
UCHealth Cancer Care - Anschutz Medical Campus
Aurora, Colorado, 80045
United States
Horizon Oncology Research, LLC.
Layfayette, Indiana, 47905
United States
Mass General Hospital
Boston, Massachusetts, 02114
United States
Rutgers Cancer Institute of New Jersey
New Brunswick, New Jersey, 08901
United States
NYU Langone
New York, New York, 10016
United States
Memorial Sloan Kettering Cancer Center
New York, New York, 10065
United States
Carolina BioOncology Institute
Huntersville, North Carolina, 28078
United States
Vanderbilt-Ingram Cancer Center
Nashville, Tennessee, 37232
United States
Mary Crowley Cancer Research
Dallas, Texas, 75230
United States
UW Carbone Cancer Center
Madison, Wisconsin, 53705
United States

Collaborators and Investigators

Sponsor: I-Mab Biopharma US Limited

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2021-06-29
Study Completion Date2026-12

Study Record Updates

Study Start Date2021-06-29
Study Completion Date2026-12

Terms related to this study

Additional Relevant MeSH Terms

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