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Recruiting Phase 1, Phase 2 NCT04982276

A Study of AK109 and AK104 in Advanced Gastric Adenocarcinoma or Gastroesophageal Junction Adenocarcinoma

Trial Parameters

Condition Gastric Adenocarcinoma and Gastroesophageal Junction Adenocarcinoma
Sponsor Akeso
Study Type INTERVENTIONAL
Phase Phase 1, Phase 2
Enrollment 138
Sex ALL
Min Age 18 Years
Max Age 75 Years
Start Date 2021-08-23
Completion 2025-12-30
Interventions
AK109paclitaxelpaclitaxel

Brief Summary

This is a multicentre, Phase Ib/II Clinical Study of AK109 and AK104 With or Without Chemotherapy in Second-line Treatment of Advanced Gastric Adenocarcinoma or Gastroesophageal Junction Adenocarcinoma .

Eligibility Criteria

Inclusion Criteria: 1. Written and signed informed consent 2. Age ≥ 18 years but ≤ 75 years 3. ECOG of 0 or 1. 4. Estimated life expectancy of ≥3 months. 5. Histologically or cytologically documented advanced unresectable or metastatic gastric adenocarcinoma or gastroesophageal Junction (GEJ) adenocarcinoma. 6. At least one measurable lesion per RECIST v1.1. 7. Gastric adenocarcinoma or gastroesophageal junction (GEJ) adenocarcinoma with failure of first-line treatment with anti-PD-1/L1 and chemotherapy 8. Adequate organ function. 9. Have agreed to take effective contraception from the date of signing the informed consent form until 120 days after the last administration. Exclusion Criteria: 1. Other invasive malignancies within 3 years, except for locally treatable (manifested as cured) malignancies, such as basal or skin squamous cell carcinoma, superficial bladder cancer, cervical or breast carcinoma in situ. 2. Any previous systemic therapy targeting VEGF or anti-VEGFR signaling pa

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