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

Gastric and Gastroesophageal Junction Adenocarcinoma Clinical Trial

Official title:

A Randomized, Double-blind, Phase 3 Study Of Cadonilimab (AK104) Plus Pulocimab (AK109) And Paclitaxel Versus Paclitaxel In Patients With Advanced Gastric Or Gastroesophageal Junction Adenocarcinoma Who Failed First-line Immunochemotherapy

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06341335
• Other study ID #: AK109-301
• Status: Not yet recruiting
• Phase: Phase 3
• Start date: May 2024
• Est. completion date: July 2027

Study information

• Verified date: March 2024
• Source: Akeso
• Contact: Ting Liu
• Phone: +86(0760)8987 3999
• Email: clinicaltrials[@]akesobio.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 506
• Est. completion date: July 2027
• Est. primary completion date: November 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Adenocarcinoma
• Esophageal Neoplasms
• Gastric and Gastroesophageal Junction Adenocarcinoma

Intervention

Drug:
• cadonilimab
iv, q3w
• pulocimab
iv, q3w
• paclitaxel
iv, q3w
• placebo
iv, q3w

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Akeso

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Progression-free survival (PFS) assessed by blinded independent central review (BICR)	PFS is defined as the time from randomization to the first documented progressive disease (PD) or death due to any cause, whichever occurs first (based on RECIST 1.1 criteria).	Up to 2 years
Primary	Overall survival (OS)	OS is defined as the time from randomization to death due to any cause.	Up to 2 years
Secondary	Progression-free survival (PFS) assessed by investigator	PFS is defined as the time from randomization to the first documented progressive disease (PD) or death due to any cause, whichever occurs first (based on RECIST 1.1 criteria).	Up to 2 years
Secondary	Objective Response Rate (ORR)	ORR is defined as proportion of subjects who have a complete or partial response relative to baseline according to RECIST 1.1 criteria	Up to 2 years
Secondary	Duration of Response (DoR)	DoR is defined as the duration from the first documentation of objective response to the first documented disease progression(based on RECIST v1.1 criteria) or death due to any cause, whichever occurs first.	Up to 2 years
Secondary	Disease control rate (DCR)	DCR is defined as the proportion of subjects with CR, PR, or SD (based on RECIST v1.1 criteria).	Up to 2 years