Study of TJ033721 in Subjects With Advanced or Metastatic Solid Tumors

• ClinicalTrials.gov Identifier: NCT04900818
• Recruitment Status: Recruiting
• First Posted: May 25, 2021
• Last Update Posted: June 22, 2023
• Sponsor: I-Mab Biopharma US Limited
• Information provided by (Responsible Party): I-Mab Biopharma US Limited

Tracking Information

• First Submitted Date: May 20, 2021
• First Posted Date: May 25, 2021
• Last Update Posted Date: June 22, 2023
• Actual Study Start Date: June 29, 2021
• Estimated Primary Completion Date: September 2024 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: May 20, 2021)

• Dose-limiting toxicities (DLTs) [ Time Frame: 28 days ]
• Incidence and severity of AEs [ Time Frame: Up to 100 days post last dose ]
  The CTCAE criteria will be used to assess adverse events on this trial.
• Maximum tolerated or administered dose (MTD, MAD) [ Time Frame: 28 Days ]
  Based on DLT definitions

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: May 20, 2021)

• Pharmacokinetic (PK) Parameters: AUC∞ [ Time Frame: Up to 100 days post last dose ]
  Area under the curve from time zero extrapolated to infinity (AUC∞)
• Pharmacokinetic (PK) Parameters: AUCt [ Time Frame: up to 100 days post last dose ]
  AUC from time zero to the time of the last quantifiable concentration (AUC0-t)
• Pharmacokinetic (PK) Parameters: Cmax [ Time Frame: up to 100 days post last dose ]
  Maximum observed concentration
• Pharmacokinetic Parameters: Tmax [ Time Frame: up to 100 days post last dose ]
  Time of peak concentration (Tmax)
• Pharmacokinetic Parameters: T1/2 [ Time Frame: up to 100 days post last dose ]
  Investigational Product (IP) half-life (T1/2)

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Study of TJ033721 in Subjects With Advanced or Metastatic Solid Tumors
• Official Title: A Phase 1 Study of TJ033721 in Subjects With Advanced or Metastatic Solid Tumors
• Brief 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.
• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Phase 1
• Study Design: Allocation: N/A; Intervention Model: Sequential Assignment; Masking: None (Open Label); Primary Purpose: Treatment

Condition

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

Intervention

Drug: TJ033721

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

Study Arms

Experimental: Dose Escalation: TJ033721

Dose Escalation:: TJ033721 will be administered at up to 8 dose levels (0.1, 0.3, 1, 3, 5, 8, 12 and 15 mg/kg) bi-weekly (Q2W)

During dose expansion, TJ033721 will be administered Q2W, starting at the highest dose to have cleared the DLT period.

After the conclusion of dose expansion TJ033721 will be administered Q2W at the MAD or RP2D.

Intervention: Drug: TJ033721

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Recruiting
• Estimated Enrollment (submitted: June 20, 2023): 102
• Original Estimated Enrollment (submitted: May 20, 2021): 108
• Estimated Study Completion Date: December 2024
• Estimated Primary Completion Date: September 2024 (Final data collection date for primary outcome measure)

Eligibility Criteria

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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Contacts

Contact: US Site Head; 301-294-4408; us.info@i-mabbiopharma.com

• Listed Location Countries: China, United States

Administrative Information

• NCT Number: NCT04900818
• Other Study ID Numbers: TJ033721STM101
• Has Data Monitoring Committee: Yes

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

• Plan to Share IPD: No

• Current Responsible Party: I-Mab Biopharma US Limited
• Original Responsible Party: Same as current
• Current Study Sponsor: I-Mab Biopharma US Limited
• Original Study Sponsor: Same as current
• Collaborators: Not Provided
• Investigators: Not Provided
• PRS Account: I-Mab Biopharma US Limited
• Verification Date: June 2023