Study of TJ033721 in Subjects With Advanced or Metastatic Solid Tumors

Gastric Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04900818
• Other study ID #: TJ033721STM101
• Status: Recruiting
• Phase: Phase 1
• Start date: June 29, 2021
• Est. completion date: December 2024

Study information

• Verified date: June 2023
• Source: I-Mab Biopharma Co. Ltd.
• Contact: US Site Head
• Phone: 301-294-4408
• Email: us.info[@]i-mabbiopharma.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 102
• Est. completion date: December 2024
• Est. primary completion date: September 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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.

• 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 study only:

• Advanced or metastatic gastric cancer, gastroesophageal junction carcinoma, and esophageal adenocarcinoma without further standard therapy or unsuitable for available standard treatment options.

• Must have CLDN18.2-positive tumor expression as determined by the CLDN18.2 IHC assay

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, pulmonary embolism, percutaneous transluminal coronary angioplasty (PTCA), deep vein thrombosis, 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

Related Conditions & MeSH terms

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

Intervention

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

Locations

Country	Name	City	State
China	Beijing Cancer Hospital	Beijing	Beijing
China	Sixth Affiliated Hospital, Sun Yat-sen University	Guangzhou	Guangdong
China	Sir Run Run Shaw Hospital, Zhejiang University School of Medicine	Hongzhou	Zhejiang
China	Zhongshan Hospital, Fudan University	Shanghai	Shanghai
China	The First Hospital of China Medical University	Shenyang	Liaoning
China	Tianjin Medical University Cancer Institute and Hospital	Tianjin	Tianjin
China	Hubei Cancer Hospital	Wuhan	Hubei
China	Henan Cancer Hospital	Zhengzhou	Henan
United States	UCHealth Cancer Care - Anschutz Medical Campus	Aurora	Colorado
United States	Mass General Hospital	Boston	Massachusetts
United States	Mary Crowley Cancer Research	Dallas	Texas
United States	Carolina BioOncology Institute	Huntersville	North Carolina
United States	Horizon Oncology Research, LLC.	Lafayette	Indiana
United States	UW Carbone Cancer Center	Madison	Wisconsin
United States	Vanderbilt-Ingram Cancer Center	Nashville	Tennessee
United States	Rutgers Cancer Institute of New Jersey	New Brunswick	New Jersey
United States	Memorial Sloan Kettering Cancer Center	New York	New York
United States	NYU Langone	New York	New York
United States	Stern Center for Cancer Clinical Trials and Research	Orange	California

Sponsors (1)

Lead Sponsor	Collaborator
I-Mab Biopharma Co. Ltd.

Countries where clinical trial is conducted

United States,  China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Dose-limiting toxicities (DLTs)		28 days
Primary	Incidence and severity of AEs	The CTCAE criteria will be used to assess adverse events on this trial.	Up to 100 days post last dose
Primary	Maximum tolerated or administered dose (MTD, MAD)	Based on DLT definitions	28 Days
Secondary	Pharmacokinetic (PK) Parameters: AUC8	Area under the curve from time zero extrapolated to infinity (AUC8)	Up to 100 days post last dose
Secondary	Pharmacokinetic (PK) Parameters: AUCt	AUC from time zero to the time of the last quantifiable concentration (AUC0-t)	up to 100 days post last dose
Secondary	Pharmacokinetic (PK) Parameters: Cmax	Maximum observed concentration	up to 100 days post last dose
Secondary	Pharmacokinetic Parameters: Tmax	Time of peak concentration (Tmax)	up to 100 days post last dose
Secondary	Pharmacokinetic Parameters: T1/2	Investigational Product (IP) half-life (T1/2)	up to 100 days post last dose