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

ConditionsSolid Tumor Advanced Cancer Metastatic Cancer Gastric Cancer Gastroesophageal Junction Carcinoma Esophageal Adenocarcinoma PDAC - Pancreatic Ductal Adenocarcinoma Biliary 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

Locations

China

The Second Hospital of Anhui Medical University230601, HefeiAnhui, China

Beijing Cancer Hospital100142, BeijingBeijing Municipality, China

Sixth Affiliated Hospital, Sun Yat-sen University510655, GuangzhouGuangdong, China

HARBIN Medical University Cancer Hospital150086, HarbinHeilongjiang, China

Sponsors and collaborators

I-Mab Biopharma US Limited

Lead sponsor

Bristol-Myers Squibb

Collaborator

Source ClinicalTrials.gov