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

NCT ID: NCT04982276

Last Updated: 2025-11-19

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 138 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-08-23
• Study Completion Date: 2027-01-31

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 .

Conditions

Gastric Adenocarcinoma and Gastroesophageal Junction Adenocarcinoma

Study Design

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

Study Groups

AK109 combined with chemotherapy

AK109 combined with paclitaxel, iv, every 3 weeks

Group Type: EXPERIMENTAL

AK109

Intervention Type: BIOLOGICAL

Subjects will receive AK109 by intravenous administration.

paclitaxel

Intervention Type: DRUG

Subjects will receive AK109 in combination with paclitaxel.

AK104 and AK109 combined with chemotherapy

AK104 combined with AK109 and paclitaxel, iv, every 3 weeks

Group Type: EXPERIMENTAL

AK109

Intervention Type: BIOLOGICAL

Subjects will receive AK109 by intravenous administration.

paclitaxel

Intervention Type: DRUG

Subjects will receive AK104 and AK109 in combination with paclitaxel.

AK104

Intervention Type: BIOLOGICAL

Subjects will receive AK104 by intravenous administration.

Interventions

AK109

Subjects will receive AK109 by intravenous administration.

Intervention Type: BIOLOGICAL

paclitaxel

Subjects will receive AK109 in combination with paclitaxel.

Intervention Type: DRUG

paclitaxel

Subjects will receive AK104 and AK109 in combination with paclitaxel.

Intervention Type: DRUG

AK104

Subjects will receive AK104 by intravenous administration.

Intervention Type: BIOLOGICAL

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 pathways.

3. In addition to PD1 or PD-L1,Prior exposure to anti-CTLA-4 antibody, or any other antibody or drug therapy for T cell co-stimulatory or checkpoint pathways, such as ICOS or agonists (e.g. CD40, CD137, GITR and OX40 etc).

4. Known history of primary immunodeficiency virus infection.

5. Known history of allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation.

6. Known history of interstitial lung disease.

7. Known history of active tuberculosis (TB).

8. Central nervous system (CNS) metastasis, meningeal metastasis, spinal cord compression, or leptomeningeal disease.

9. Patients with untreated chronic hepatitis B or HBV DNA exceeding 500IU/mL or active hepatitis C should be excluded. Patients with HCV antibody positive are eligible to participate in the study if the results of HCV RNA test show negative.

10. Known history of testing positive for human immunodeficiency virus (HIV).

11. Uncontrolled pleural effusion, pericardial effusion, or ascites requiring repeated drainage.

12. Subjects with active, known or suspected autoimmune disease, or a medical history of autoimmune disease, with the exceptions of the following: vitiligo, alopecia, Grave disease, psoriasis or eczema not requiring systemic treatment within the last 2 years, hypothyroidism (caused by autoimmune thyroiditis) only requiring steady doses of hormone replacement therapy and type I diabetes only requiring steady doses of insulin replacement therapy, or completely relieved childhood asthma that requires no intervention in adulthood, or primary diseases that will not relapse unless triggered by external factors.

13. Pregnant or lactating women.

• 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

Locations

Beijing Cancer Hospital

Beijing, , China

Site Status: RECRUITING

Countries

China

Central Contacts

Ting Liu, MD

Role: CONTACT

clinicaltrials@akesobio.com

+86 (0760) 8987 3999

Other Identifiers

AK109-201

Identifier Type: -

Identifier Source: org_study_id