A Study of Anti-PD-1 and LAG-3 Bispecific Antibody(AK129) Combined With Chemotherapy With or Without Cadonilimab in the First-line Treatment of Unresectable Locally Advanced or Metastatic G/ GEJ Adenocarcinoma

NCT ID: NCT06586294

Last Updated: 2024-09-19

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 294 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-09-10
• Study Completion Date: 2026-07-31

Brief Summary

Phase Ib/II clinical study of AK129 combined with chemotherapy with or without cadonilimab in first-line treatment of advanced HER2 negative gastric cancer or gastroesophageal junction adenocarcinoma

Conditions

Gastric Adenocarcinoma; Gastroesophageal Junction Adenocarcinoma

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

The dose escalation and expansion stage of AK129 combined with chemotherapy;

Part 1: The dose escalation stage： 3 dose groups of AK129 were set up, combination with chemotherapy of XELOX,followed by AK129 and capecitabine maintenance; Part 2：The dose expansion stage： Two to three dosing regimens were set for expansion of AK129 in combination with XELOX.

Group Type: EXPERIMENTAL

Drug: AK129 Drug：oxaliplatin Drug：capecitabine

Intervention Type: DRUG

AK129 is administered intravenously according to the frequency every three weeks(Q3W) and different dosage of administration at different stages.Oxaliplatin is administered intravenously according to the frequency and dosage 130 mg/m2 on day 1 Q3W.Capecitabine is administered intravenously according to the frequency and dosage 1000 mg/m2 oral twice daily on day 1 to 14 Q3W.

The dose escalation and expansion stage of AK129 combined with chemotherapy with cadonilimab

Part 1:The dose escalation stage： 3 dose groups of AK129 were set up, combination with cadonilimab and chemotherapy of XELOX,followed by AK129 and cadonilimab maintenance; Part 2:The dose expansion stage： Two to three dosing regimens were set for expansion of AK129 in combination with cadonilimab and chemotherapy of XELOX.

Group Type: EXPERIMENTAL

Drug: AK129 Drug：cadonilimab Drug：oxaliplatin Drug：capecitabine

Intervention Type: DRUG

AK129 is administered intravenously according to the frequency Q3W and different dosage of administration at different stages. Cadonilimab is administered intravenously according to the frequency and dosage 10mg/kg Q3W.Oxaliplatin is administered intravenously according to the frequency and dosage 130 mg/m2 on day 1 Q3W.Capecitabine is administered intravenously according to the frequency and dosage 1000 mg/m2 oral twice daily on day 1 to 14 Q3W.

Interventions

Drug: AK129 Drug：oxaliplatin Drug：capecitabine

AK129 is administered intravenously according to the frequency every three weeks(Q3W) and different dosage of administration at different stages.Oxaliplatin is administered intravenously according to the frequency and dosage 130 mg/m2 on day 1 Q3W.Capecitabine is administered intravenously according to the frequency and dosage 1000 mg/m2 oral twice daily on day 1 to 14 Q3W.

Intervention Type: DRUG

Drug: AK129 Drug：cadonilimab Drug：oxaliplatin Drug：capecitabine

AK129 is administered intravenously according to the frequency Q3W and different dosage of administration at different stages. Cadonilimab is administered intravenously according to the frequency and dosage 10mg/kg Q3W.Oxaliplatin is administered intravenously according to the frequency and dosage 130 mg/m2 on day 1 Q3W.Capecitabine is administered intravenously according to the frequency and dosage 1000 mg/m2 oral twice daily on day 1 to 14 Q3W.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

1. The subject must sign the written informed consent form(ICF) voluntarily.

2. Aged ≥ 18 to ≤ 75 years,male and female at the time of signing the ICF.

3. Histologically confirmed adenocarcinoma of the gastric or gastroesophageal junction (GEJ).

4. Inoperable locally advanced or metastatic gastric or gastroesophageal junction adenocarcinoma.

5. Participants had not previously received systemic therapy for locally advanced or metastatic gastric or gastroesophageal junction adenocarcinoma.

6. According to RECIST v1.1 criteria, subjects had at least one measurable tumor target.

Exclusion Criteria

1. Subjects with known HER2 positive gastric or gastroesophageal junction adenocarcinoma.

2. Histopathological examination confirmed other pathological types.

3. Had received palliative local therapy for non-target lesions within 2 weeks before the first administration.

4. Past treatment with immune checkpoint inhibitors,immune checkpoint agonists,immune cell therapy and any treatment targeting the immune mechanism of tumor action.

5. History of gastrointestinal perforation and fistula within 6 months before the first dose.

6. Active or previously documented inflammatory bowel disease,inability to swallow, malabsorption syndrome.

7. Active malignancy within the last 3 years.

8. Active or untreated brain metastases, meningeal metastases, spinal cord compression, or pia meningeal disease are known to exist.

9. The presence of clinical symptoms of pleural effusion, pericardial effusion, or abdominal effusion, or the need for frequent drainage.

10. There was an active autoimmune disease that required systemic treatment within 2 years prior to the start of the study.

• 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

Xiangdong Cheng, MD

Role: PRINCIPAL_INVESTIGATOR

Zhejiang Cancer Hospital

Locations

Zhejiang Cancer Hospital

Hanzhou, Zhejiang, China

Countries

China

Central Contacts

Xiao Xu, MD, PhD

Role: CONTACT

clinicaltrials@akesobio.com

+86 (0760) 8987 3999

Facility Contacts

Xiangdong Cheng, Doctor

Role: primary

Chengxd516@126.com

0571 - 88122222

Other Identifiers

AK129-103

Identifier Type: -

Identifier Source: org_study_id