Trial NCT04900818
Study of TJ033721 (Givastomig) in Subjects With Advanced or Metastatic Solid Tumors
- Phase
- Phase 1
- Sponsor
- I-Mab Biopharma US Limited
- Conditions
- Solid Tumor; Advanced Cancer; Metastatic Cancer; Gastric Cancer; Gastroesophageal Junction Carcinoma; Esophageal Adenocarcinoma; PDAC - Pancreatic Ductal Adenocarcinoma; Biliary Tract Cancer (BTC)
- Ages
- 18+ years
Eligibility criteria
Highlighted: restrictions our model extracted, each a verbatim quote (pink = excludes outright, blue = only under conditions).
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 functionPerformance status
* 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 situPrior malignancy
* 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.Brain metastases 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 monthsCardiac
* Diagnosis of immunodeficiency such as known active HIVHIV
* Any active infection requiring parenteral treatment
For Part 2, 3, 4 Combination subjects:
• Prior treatment with anti-PD-1 or PD-L1 agent
Restrictions found (5)
- Brain metastasesOutrightexclusionShow in the text
- CardiacOutrightexclusion
NYHA Class 3 or 4; MI within previous 6 months
Show in the text - HIVOutrightexclusionShow in the text
- Performance statusOutrightinclusion
ECOG 0 or 1
Show in the text - Prior malignancyOutrightexclusion
within 3 years
Show in the text
Recruiting in Massachusetts
- Mass General Hospital · Boston, Suffolk County