Trial NCT07432295
Givastomig Combined With Nivolumab and Chemotherapy in Adults With CLDN18.2 Positive Metastatic Gastric Cancer (GIVA-2)
- Phase
- Phase 2
- Sponsor
- I-Mab Biopharma US Limited
- Conditions
- Solid Tumor; Advanced Cancer; Metastatic Cancer; Gastric Cancer; Gastroesophageal Junction Carcinoma; Esophageal Adenocarcinoma
- Ages
- 18+ years
Eligibility criteria
Highlighted: restrictions our model extracted, each a verbatim quote (pink = excludes outright, blue = only under conditions).
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.Performance status
* 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)Hepatic
* Renal: Creatinine ≤1.5×ULN or eGFR ≥50 mL/min/1.73 m²Renal
* 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
Exclusion Criteria:
* HER2-positive tumors.
* Second malignancy within 3 years, except certain skin or cervical cancers.Prior malignancy
* 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).Brain metastases
* Significant cardiovascular disease (NYHA Class 3-4 CHF, recent MI, unstable angina, TIA/stroke, or major cardiac procedures within 6 months).Cardiac
* Active or uncontrolled HIV, hepatitis B, or hepatitis C infection, or immunodeficiency (controlled infection allowed).HIV
* 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.
Restrictions found (7)
- Brain metastasesConditionalexclusionShow in the text
- CardiacOutrightexclusion
NYHA Class 3-4 CHF; recent MI; major cardiac procedures within 6 months
Show in the text - HepaticOutrightinclusion
AST/ALT ≤3×ULN (≤5×ULN if liver metastases); bilirubin ≤1.5×ULN (≤3×ULN if Gilbert's)
Show in the text - HIVConditionalexclusionShow in the text
- Performance statusOutrightinclusion
ECOG 0 or 1
Show in the text - Prior malignancyOutrightexclusion
within 3 years
Show in the text - RenalOutrightinclusion
Creatinine ≤1.5×ULN or eGFR ≥50 mL/min/1.73 m²
Show in the text
Recruiting in Massachusetts
- I-Mab Site 1002 · Boston, Suffolk County