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Trial Title:
A Study of AK104/Placebo Plus AK109/Placebo And Paclitaxel in Gastric or Gastroesophageal Junction Adenocarcinoma
NCT ID:
NCT06341335
Condition:
Gastric and Gastroesophageal Junction Adenocarcinoma
Conditions: Official terms:
Adenocarcinoma
Esophageal Neoplasms
Paclitaxel
Study type:
Interventional
Study phase:
Phase 3
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Intervention:
Intervention type:
Drug
Intervention name:
cadonilimab
Description:
iv, q3w
Arm group label:
Cadonilimab in combination with pulocimab and paclitaxel
Other name:
AK104
Intervention type:
Drug
Intervention name:
pulocimab
Description:
iv, q3w
Arm group label:
Cadonilimab in combination with pulocimab and paclitaxel
Other name:
AK109
Intervention type:
Drug
Intervention name:
paclitaxel
Description:
iv, q3w
Arm group label:
Cadonilimab in combination with pulocimab and paclitaxel
Arm group label:
Placebo in combination with paclitaxel
Intervention type:
Drug
Intervention name:
placebo
Description:
iv, q3w
Arm group label:
Placebo in combination with paclitaxel
Summary:
This randomized, multicenter, double-blind, phase 3 study will evaluate the efficacy and
safety of the combination of cadonilimab (AK104) and pulocimab (AK109) and paclitaxel
compared with paclitaxel in patients with advanced gastric or gastroesophageal junction
adenocarcinoma who failed first-line immunochemotherapy.
Criteria for 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
Gender:
All
Minimum age:
18 Years
Maximum age:
75 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Peking University Cancer Hospital & Institute
Address:
City:
Beijing
Country:
China
Status:
Recruiting
Contact:
Last name:
Lin Shen, MD
Start date:
June 19, 2024
Completion date:
July 2027
Lead sponsor:
Agency:
Akeso
Agency class:
Industry
Source:
Akeso
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06341335
