🇮🇪Ireland
16°C Partly Cloudy · Dublin
Live Updates
--:--:-- IST
Writer Login
Latest
Clinical Trials in the USA / NCT04900818
Recruiting Phase 1

Study of TJ033721 (Givastomig) in Subjects With Advanced or Metastatic Solid Tumors

NCT04900818 · tracked via the Priya Life Science USA tracker
Sponsor
I-Mab Biopharma US Limited
Phase
Phase 1
Started
2021-06-29
Last updated
2026-03-05

Condition(s) studied

Solid TumorAdvanced CancerMetastatic CancerGastric CancerGastroesophageal Junction CarcinomaEsophageal AdenocarcinomaPDAC - Pancreatic Ductal AdenocarcinomaBiliary Tract Cancer (BTC)

Investigational drug(s) / intervention(s)

TJ033721 (givastomig)TJ033721 (givastomig) , nivolumab, chemotherapyTJ033721 (givastomig), chemotherapyTJ033721 (givastomig), durvalumab, chemotherapy

TJ033721 (givastomig): Tetravalent IgG(H)-scFv fusion-type of bi-specific antibody (BsAb)

TJ033721 (givastomig) , nivolumab, chemotherapy: Tetravalent IgG(H)-scFv fusion-type of bi-specific antibody (BsAb), nivolumab, chemotherapy

TJ033721 (givastomig), chemotherapy: Tetravalent IgG(H)-scFv fusion-type of bi-specific antibody (BsAb), chemotherapy

TJ033721 (givastomig), durvalumab, chemotherapy: Tetravalent IgG(H)-scFv fusion-type of bi-specific antibody (BsAb), durvalumab, chemotherapy

Study summary

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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
Healthy volunteers
No
Inclusion Criteria: Part 1 - Monotherapy Subjects with advanced or metastatic solid tumor in subjects whose disease has progressed despite standard therapy, or who has no further standard therapy, or who is unsuitable for available standard treatment options. Part 2 - Combination Therapy Subjects with treatment naïve locally advanced, unresectable or metastatic gastric, GEJ, esophageal adenocarcinoma; Part 3: Combination Therapy Subjects with unresectable, locally advanced or metastatic histologically confirmed pancreatic adenocarcinoma; Part 4: Combination Therapy Subjects with unresectable, locally advanced or metastatic histologically confirmed biliary tract cancer. * Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1 with adequate organ function * Have known PD-L1 status with prior testing by immunohistochemistry and a corresponding combined positive score (CPS) For dose expansion and Part 2, Part 3, Part 4 Combination subjects: • Must have CLDN18.2-positive tumor expression Exclusion Criteria * Prior exposure to CLDN18.2 -targeted therapy * Prior exposure to 4-1BB agonists * 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 * Known active or chronic Hepatitis B or Hepatitis C, other hepatitides * Unstable/active ulcer or digestive tract bleeding within 6 weeks * Active autoimmune disease requiring systemic treatment within the past 2 years * Active interstitial lung disease (ILD) or pneumonitis or a history of ILD or pneumonitis requiring treatment * 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; * 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 * Diagnosis of immunodeficiency such as known active HIV * Any active infection requiring parenteral treatment For Part 2, 3, 4 Combination subjects: • Prior treatment with anti-PD-1 or PD-L1 agent

Primary outcome measure(s)

Trial sites (21)

FacilityCityRegionStatus
Stern Center for Cancer Clinical Trials and Research Orange California Recruiting
UCHealth Cancer Care - Anschutz Medical Campus Aurora Colorado Recruiting
Horizon Oncology Research, LLC. Layfayette Indiana Completed
Mass General Hospital Boston Massachusetts Recruiting
Rutgers Cancer Institute of New Jersey New Brunswick New Jersey Completed
NYU Langone New York New York Recruiting
Memorial Sloan Kettering Cancer Center New York New York Recruiting
Carolina BioOncology Institute Huntersville North Carolina Completed
Vanderbilt-Ingram Cancer Center Nashville Tennessee Completed
Mary Crowley Cancer Research Dallas Texas Completed
UW Carbone Cancer Center Madison Wisconsin Recruiting
The Second Hospital of Anhui Medical University Hefei Anhui Withdrawn
Beijing Cancer Hospital Beijing Beijing Municipality Recruiting
Sixth Affiliated Hospital, Sun Yat-sen University Guangzhou Guangdong Active Not Recruiting
HARBIN Medical University Cancer Hospital Harbin Heilongjiang Completed
Henan Cancer Hospital Zhengzhou Henan Completed
Hubei Cancer Hospital Wuhan Hubei Completed
The First Hospital of China Medical University Shenyang Liaoning Completed
Zhongshan Hospital, Fudan University Shanghai Shanghai Municipality Completed
Tianjin Medical University Cancer Institute and Hospital Tianjin Tianjin Municipality Completed
Sir Run Run Shaw Hospital, Zhejiang University School of Medicine Hangzhou Zhejiang Completed
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT04900818 on ClinicalTrials.gov ↗ ← All trials in the USA