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New treatment option for Solid Tumor
Official title Givastomig Combined With Nivolumab and Chemotherapy in Adults With CLDN18.2 Positive Metastatic Gastric Cancer (GIVA-2)
ClinicalTrials.gov ID: NCT07432295
What this study is testing
What is Givastomig?
Givastomig is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for solid tumor.
Also referred to as TJ033721.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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.
You likely can't join if
- HER2-positive tumors.
- Second malignancy within 3 years, except certain skin or cervical cancers.
- Active or unstable gastrointestinal ulcer or bleeding within 6 weeks.
- Active autoimmune disease requiring systemic therapy within past 2 years or ongoing immunosuppressive therapy.
- Active pneumonitis or history requiring steroids/immunosuppressive therapy within 3 years.
- Participation in another therapeutic clinical trial.
See the full eligibility 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 ≥9 g/dL
- Hepatic: AST/ALT ≤3×ULN (≤5×ULN if liver metastases); bilirubin ≤1.5×ULN (≤3×ULN if Gilbert's)
- Renal: Creatinine ≤1.5×ULN or eGFR ≥50 mL/min/1.73 m²
- Life expectancy ≥90 days.
- Women of childbearing potential (WOCBP) and men must use effective contraception during the study and for a defined period after treatment.
- Willing and able to provide informed consent and comply with study procedures
- HER2-positive tumors.
- Second malignancy within 3 years, except certain skin or cervical cancers.
- Active or unstable gastrointestinal ulcer or bleeding within 6 weeks.
- Active autoimmune disease requiring systemic therapy within past 2 years or ongoing immunosuppressive therapy.
- Active pneumonitis or history requiring steroids/immunosuppressive therapy within 3 years.
- Participation in another therapeutic clinical trial.
- Major surgery or significant injury within 4 weeks prior to first dose, or planned major surgery within 6 months.
- Radiotherapy within protocol-specified timeframes without adequate recovery.
- Active CNS metastases or carcinomatous meningitis (previously treated brain metastases allowed if stable).
- Significant cardiovascular disease (NYHA Class 3-4 CHF, recent MI, unstable angina, TIA/stroke, or major cardiac procedures within 6 months).
- Active or uncontrolled HIV, hepatitis B, or hepatitis C infection, or immunodeficiency (controlled infection allowed).
- Receipt of live vaccine within 30 days or other vaccines within 7 days of first dose.
- Active infection requiring parenteral therapy.
- Known hypersensitivity to study drug components (e.g., DPD deficiency).
- Any other condition or laboratory abnormality that, in the investigator's judgment, increases risk or interferes with study participation.
The study team makes the final eligibility decision.
Where it's taking place
- Goodyear, Arizona, United States
- Duarte, California, United States
- Boston, Massachusetts, United States
- Beijing, China
- Kashiwa, Japan
- Tokyo, Japan
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Goodyear, Arizona, United States; Duarte, California, United States; Boston, Massachusetts, United States; Beijing, China; Kashiwa, Japan; Tokyo, Japan. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.