A Study of AK104/Placebo Plus AK109/Placebo And Paclitaxel in Gastric or Gastroesophageal Junction Adenocarcinoma

Launched by AKESO · Mar 26, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment combination for patients with advanced gastric cancer or gastroesophageal junction cancer who have not responded to previous treatments. Specifically, researchers are looking at the effects of two experimental drugs, AK104 and AK109, along with a standard chemotherapy drug called paclitaxel, compared to paclitaxel alone. The goal is to find out if the new combination is more effective and safe for patients who have already tried other therapies without success.

To be eligible for the trial, participants must be between 18 and 75 years old and have a confirmed diagnosis of advanced gastric or gastroesophageal junction adenocarcinoma. They should have already undergone treatment with specific immunotherapy and chemotherapy but did not see the desired results. Participants will need to be in relatively good health and have a life expectancy of at least three months. Throughout the trial, participants will receive regular check-ups and monitoring to assess their health and how well the treatment is working. It’s important for potential participants to discuss any concerns with their healthcare provider, as there are specific criteria that may exclude some individuals from joining the study.

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Eligibility criteria

• Inclusion Criteria:
• • 1. Signed informed consent
• • 2. Age ≥ 18 years and ≤ 75 years
• • 3. Histologically or cytologically documented advanced unresectable or metastatic gastric adenocarcinoma or gastroesophageal Junction (GEJ) adenocarcinoma.
• • 4. Failed first-line treatment with PD-(L)1 monoclonal antibody and standard chemotherapy
• • 5. At least one measurable disease based on RECIST v1.1
• • 6. ECOG status of 0 or 1
• • 7. Estimated survival ≥ 3 months
• • 8. Adequate organ function per protocol-defined criteria
• • 9. Women of childbearing potential and men with female partners of childbearing potential must agree to use effective contraception during treatment and for at least 120 days following the last dose of study treatment
• Exclusion Criteria:
• • 1. Mixed gastric or gastroesophageal Junction cancer containing other pathological components than adenocarcinoma
• • 2. HER2-positive
• • 3. Known other invasive malignancies within 3 years
• • 4. Subjects who are currently participating in other interventional study
• • 5. Received prior systemic anti-tumour therapy within 4 weeks before randomization
• • 6. Previous systemic treatment with taxane within 6 months before randomization
• • 7. Previous systemic treatment targeting VEGF or anti-VEGFR signaling pathways
• • 8. In addition to anti-PD-(L)1 monoclonal antibody, prior exposure to other immune checkpoint inhibitors, immune checkpoint agonists, immune cell therapy or other therapy that targets anti-tumor immune mechanisms
• • 9. History of immune-related adverse effects leading to recommendation against reintroduction of immunotherapy or any condition dependency on systemic therapy with glucocorticoids or immunosuppressive agents within 14 days prior to randomization
• • 10. History of severe infection within 4 weeks prior to randomization
• • 11. Presence of central nervous system metastases, leptomeningeal metastases, or spinal cord compression
• • 12. Uncontrolled pleural effusion, pericardial effusion or ascites requiring repeated drainage
• • 13. History or presence of a serious hemorrhage or known bleeding tendency within 2 months before randomization
• • 14. Major surgical procedure or serious trauma within 28 days prior to randomization
• • 15. History of interstitial lung disease or noninfectious pneumonitis
• • 16. Active infectious diseases, including tuberculosis, HIV infection, syphilis infection，or hepatitis B/C
• • 17. Known allergy to the antibody or any component of the study drug; Or the constitution of being allergic to multiple substances
• • 18. History of allogeneic organ transplantation or allogeneic haematopoietic stem cell transplantation
• • 19. Toxicities of prior anticancer therapy have not resolved to ≤ Grade 1 (NCI-CTCAE version 5.0)
• • 20. Use of live vaccines within 30 days prior to randomization
• • 21. Pregnant or lactating women.
• • 22. Any condition considered by the investigator to be inappropriate for enrollment