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

NCT ID: NCT06341335

Last Updated: 2024-06-24

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE3
• Total Enrollment: 506 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-06-19
• Study Completion Date: 2027-07-31

Brief 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.

Conditions

Gastric and Gastroesophageal Junction Adenocarcinoma

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Cadonilimab in combination with pulocimab and paclitaxel

Cadonilimab (AK104) in combination with pulocimab (AK109) and paclitaxel, iv, every 3 weeks

Group Type: EXPERIMENTAL

cadonilimab

Intervention Type: DRUG

iv, q3w

pulocimab

Intervention Type: DRUG

iv, q3w

paclitaxel

Intervention Type: DRUG

iv, q3w

Placebo in combination with paclitaxel

Placebo in combination with Paclitaxel, iv, every 3 weeks

Group Type: ACTIVE_COMPARATOR

paclitaxel

Intervention Type: DRUG

iv, q3w

placebo

Intervention Type: DRUG

iv, q3w

Interventions

cadonilimab

iv, q3w

Intervention Type: DRUG

pulocimab

iv, q3w

Intervention Type: DRUG

paclitaxel

iv, q3w

Intervention Type: DRUG

placebo

iv, q3w

Intervention Type: DRUG

Other Intervention Names

AK104; AK109

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Akeso

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Lin Shen, MD

Role: PRINCIPAL_INVESTIGATOR

Peking University Cancer Hospital & Institute

Xiaotian Zhang, MD

Role: PRINCIPAL_INVESTIGATOR

Peking University Cancer Hospital & Institute

Locations

Peking University Cancer Hospital & Institute

Beijing, , China

Site Status: RECRUITING

Countries

China

Central Contacts

Ting Liu

Role: CONTACT

clinicaltrials@akesobio.com

+86(0760)8987 3999

Facility Contacts

Lin Shen, MD

Role: primary

Other Identifiers

AK109-301

Identifier Type: -

Identifier Source: org_study_id