Health Trials

Study of TJ033721 (Givastomig) in Subjects With Advanced or Metastatic Solid Tumors

ConditionsSolid TumorAdvanced CancerMetastatic CancerGastric CancerGastroesophageal Junction CarcinomaEsophageal AdenocarcinomaPDAC - Pancreatic Ductal AdenocarcinomaBiliary Tract Cancer (BTC)
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorI-Mab Biopharma US Limited

About this trial

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

Qualifiers

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)

Disqualifiers

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

Trial design

Treatments tested in this trial

  • TJ033721 (givastomig)
  • TJ033721 (givastomig) , nivolumab, chemotherapy
  • TJ033721 (givastomig), chemotherapy
  • TJ033721 (givastomig), durvalumab, chemotherapy

Treatment groups

330 Participants
are divided into 4 treatment groups

Sponsors and collaborators

I-Mab Biopharma US Limited

Lead sponsor

Bristol-Myers Squibb

Collaborator

Source ClinicalTrials.gov