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

Akeso

Status and phase: Not yet enrolling; Phase 2; Phase 1

Conditions: Gastroesophageal Junction Adenocarcinoma; Gastric Adenocarcinoma

Treatments: Drug: Drug: AK129 Drug：cadonilimab Drug：oxaliplatin Drug：capecitabine; Drug: Drug: AK129 Drug：oxaliplatin Drug：capecitabine

Study type: Interventional

Funder types: Industry

Identifiers

NCT06586294

AK129-103

Details and patient eligibility

About

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

Enrollment: 294 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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294 participants in 2 patient groups

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

Experimental group

Description:

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.

Treatment:

Drug: Drug: AK129 Drug：oxaliplatin Drug：capecitabine

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

Experimental group

Description:

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.

Treatment:

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