Clinical trial NCT04900818: Study 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
Conditions: Solid Tumor
Advanced Cancer
Metastatic Cancer
Gastric Cancer
Gastroesophageal Junction Carcinoma
Esophageal Adenocarcinoma
Lead sponsor: I-Mab Biopharma US Limited
Sponsor class: INDUSTRY
Collaborators: name: Bristol-Myers Squibb
First posted: 2021-05-25
Enrollment: 168
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

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 (givastomig) in subjects with advanced or metastatic solid tumors.


Eligibility criteria: 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;

* 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 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 Combination subjects:

• Prior treatment with anti-PD-1 or PD-L1

Primary outcomes:
measure: Dose-limiting toxicities (DLTs)
timeFrame: 28 days
measure: Incidence and severity of AEs
timeFrame: Up to 100 days post last dose
measure: Maximum tolerated or administered dose (MTD, MAD)
timeFrame: 28 Days
Secondary outcomes:
measure: Pharmacokinetic (PK) Parameters: AUC∞
timeFrame: Up to 100 days post last dose
measure: Pharmacokinetic (PK) Parameters: AUCt
timeFrame: up to 100 days post last dose
measure: Pharmacokinetic (PK) Parameters: Cmax
timeFrame: up to 100 days post last dose
measure: Pharmacokinetic Parameters: Tmax
timeFrame: up to 100 days post last dose
measure: Pharmacokinetic Parameters: T1/2
timeFrame: up to 100 days post last dose
Other outcomes:
Locations:
city: Orange
country: United States
facility: Stern Center for Cancer Clinical Trials and Research
state: California
city: Aurora
country: United States
facility: UCHealth Cancer Care - Anschutz Medical Campus
state: Colorado
city: Layfayette
country: United States
facility: Horizon Oncology Research, LLC.
state: Indiana
city: Boston
country: United States
facility: Mass General Hospital
state: Massachusetts
city: New Brunswick
country: United States
facility: Rutgers Cancer Institute of New Jersey
state: New Jersey
city: New York
country: United States
facility: NYU Langone
state: New York
city: New York
country: United States
facility: Memorial Sloan Kettering Cancer Center
state: New York
city: Huntersville
country: United States
facility: Carolina BioOncology Institute
state: North Carolina
city: Nashville
country: United States
facility: Vanderbilt-Ingram Cancer Center
state: Tennessee
city: Dallas
country: United States
facility: Mary Crowley Cancer Research
state: Texas
city: Madison
country: United States
facility: UW Carbone Cancer Center
state: Wisconsin
city: Hefei
country: China
facility: The Second Hospital of Anhui Medical University
state: Anhui
city: Beijing
country: China
facility: Beijing Cancer Hospital
state: Beijing
city: Guangzhou
country: China
facility: Sixth Affiliated Hospital, Sun Yat-sen University
state: Guangdong
city: Harbin,
country: China
facility: HARBIN Medical University Cancer Hospital
state: Heilongjiang
city: Zhengzhou
country: China
facility: Henan Cancer Hospital
state: Henan
city: Wuhan
country: China
facility: Hubei Cancer Hospital
state: Hubei
city: Shenyang
country: China
facility: The First Hospital of China Medical University
state: Liaoning
city: Shanghai
country: China
facility: Zhongshan Hospital, Fudan University
state: Shanghai
city: Tianjin
country: China
facility: Tianjin Medical University Cancer Institute and Hospital
state: Tianjin
city: Hongzhou
country: China
facility: Sir Run Run Shaw Hospital, Zhejiang University School of Medicine
state: Zhejiang
Study officials:
References: