No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
18 and older
Sex
Any
Trial phase
Phase 1
Study type
Interventional
Purpose
Treatment
Participants needed
330 (estimated)
Sponsor
I-Mab Biopharma US Limited · Industry
Who this trial is looking for
This trial is looking for people with advanced or metastatic solid tumors who have not responded to standard treatments or do not have other options available. Participants will receive the drug Givastomig to evaluate its safety and effectiveness.
Are You a Good Fit for This Trial?
Rules you outActive autoimmune diseaseActive interstitial lung diseaseKnown active CNS metastasesImmunodeficiency
You may be able to join if
I have advanced or metastatic solid tumor cancer.
My cancer has progressed despite standard therapy.
I have no further standard therapy options.
I am treatment naïve for my specific type of cancer.
I have a CLDN18.2-positive tumor.
I have been tested for PD-L1 status.
You may not be able to join if
I have had prior exposure to CLDN18.2-targeted therapy.
I have had prior exposure to 4-1BB agonists.
I have had another cancer in the last 3 years, except for certain skin cancers.
I have known active Hepatitis B or C.
I have had digestive tract bleeding or ulcers recently.
I have an active autoimmune disease that needs treatment.
I have known active brain metastases.
I have had severe heart problems in the last 6 months.
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer three quick questions written from this study's own rules to see if you may qualify. No account needed to find out.
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.
Trial Locations
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Status
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 …
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
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