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

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.

Interventions

• TJ033721 (givastomig) · DRUG

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

• TJ033721 (givastomig) , nivolumab, chemotherapy · DRUG

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

• TJ033721 (givastomig), chemotherapy · DRUG

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

• TJ033721 (givastomig), durvalumab, chemotherapy · DRUG

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

Published eligibility criteria

Verbatim from the registry. Only the site can decide how these apply to a specific patient.

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

Sites (21)

• 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, China · WITHDRAWN
• Beijing Cancer Hospital, Beijing, Beijing Municipality, China · RECRUITING
• Sixth Affiliated Hospital, Sun Yat-sen University, Guangzhou, Guangdong, China · ACTIVE_NOT_RECRUITING
• HARBIN Medical University Cancer Hospital, Harbin, Heilongjiang, China · COMPLETED
• Henan Cancer Hospital, Zhengzhou, Henan, China · COMPLETED
• Hubei Cancer Hospital, Wuhan, Hubei, China · COMPLETED
• The First Hospital of China Medical University, Shenyang, Liaoning, China · COMPLETED
• Zhongshan Hospital, Fudan University, Shanghai, Shanghai Municipality, China · COMPLETED
• Tianjin Medical University Cancer Institute and Hospital, Tianjin, Tianjin Municipality, China · COMPLETED
• Sir Run Run Shaw Hospital, Zhejiang University School of Medicine, Hangzhou, Zhejiang, China · COMPLETED