A Randomized, Multicenter, Open-Label, Phase 2 Study of Givastomig (TJ033721) in Combination With Nivolumab and Chemotherapy Versus Nivolumab and Chemotherapy in Participants With Previously Untreated CLDN18.2 Positive and PD-1L Positive Locally Advanced or Metastatic Gastric, Esophageal, or Gastroesophageal Junction Adenocarcinoma
I-Mab Biopharma US Limited
Summary
The goal of this clinical trial is to learn if givastomig in combination with standard therapy works to treat adults with cancer in the stomach and/or esophagus (GEA adenocarcinoma). It will also help the researchers to learn more about the safety of givastomig. The main questions it aims to answer are: * Does the addition of givastomig to standard therapy increase the amount of time that participants survive without progression of their cancer? * What toxicities do participants experience when taking givastomig? Participants may be able to take part in the study if they have unresectable or metastatic GEA and if their cancer cells express certain proteins called Claudin 18.2 (CLDN18.2) and PD-L1. Participants whose cancer cells express a protein called HER2 cannot take part. Up to 180 participants will be randomly assigned to received givastomig at one of two doses in combination with an immunotherapy medicine called nivolumab and chemotherapy OR to receive nivolumab and chemotherapy alone. These therapies will be given primarily via intravenous (into a vein) infusion every 2 or 3 weeks. Participants will: * Visit the study treatment center for infusions and/or check-ups and tests every 1-3 weeks * Report any changes in their symptoms to their study doctors * Have scans to check for any changes in their cancer every 8-12 weeks
Description
This is a randomized, global, open-label, multicenter Phase 2 study evaluating the efficacy and safety of givastomig (TJ033721) in combination with nivolumab and chemotherapy compared with nivolumab and chemotherapy alone in participants with previously untreated, HER2-negative, CLDN18.2-positive, and PD-L1-positive locally advanced, unresectable, or metastatic gastroesophageal adenocarcinoma (GEA). Approximately 180 participants will be randomized in a 1:1:1 ratio to one of three treatment arms. Two investigational arms will receive givastomig in combination with nivolumab and chemotherapy,…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * Histologically confirmed unresectable, locally advanced, or metastatic gastric, gastroesophageal junction (GEJ), or esophageal adenocarcinoma (EAC). * Treatment-naïve for advanced/metastatic disease (prior adjuvant/neoadjuvant therapy allowed if ≥6 months since last dose). * CLDN18.2 positive (membrane intensity score ≥1+ on ≥1% of tumor cells). * PD-L1 positive (CPS ≥1). * At least 1 measurable lesion per RECIST v1.1. * ECOG performance status 0 or 1. * Adequate organ function, including: * Hematologic: WBC ≥2,000/μL; ANC ≥1,500/μL; platelets ≥100,000/μL; hemoglobin…
Interventions
- DrugGivastomig
Givastomig 8mg/kg Q2W IV or 12mg/kg Q3W IV
- DrugNivolumab
Q2 or Q3W IV
- Drug5Fluorouracil
Q2W IV
- DrugLeucovorin
Q2W IV
- DrugOxaliplatin
Q2W or Q3W IV
- DrugCapecitabine
Twice daily x 14 days every 3 weeks PO
Locations (3)
- I-Mab Site 1016Goodyear, Arizona
- I-MAB Site 1005Duarte, California
- I-Mab Site 1013Sugarland, Texas