A Study of Anti-PD-1 and LAG-3 Bispecific Antibody(AK129) Combined With Chemotherapy With or With… (NCT06586294) | Clinical Trial Compass
Not Yet RecruitingPhase 1/2
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
China294 participantsStarted 2024-09-10
Plain-language 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
Who can participate
Age range18 Years – 75 Years
SexALL
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Inclusion criteria
✓. The subject must sign the written informed consent form(ICF) voluntarily.
✓. Aged ≥ 18 to ≤ 75 years,male and female at the time of signing the ICF.
✓. Histologically confirmed adenocarcinoma of the gastric or gastroesophageal junction (GEJ).
✓. Inoperable locally advanced or metastatic gastric or gastroesophageal junction adenocarcinoma.
✓. Participants had not previously received systemic therapy for locally advanced or metastatic gastric or gastroesophageal junction adenocarcinoma.
✓. According to RECIST v1.1 criteria, subjects had at least one measurable tumor target.
Exclusion criteria
✕. Subjects with known HER2 positive gastric or gastroesophageal junction adenocarcinoma.
✕. Histopathological examination confirmed other pathological types.
✕. Had received palliative local therapy for non-target lesions within 2 weeks before the first administration.
✕. Past treatment with immune checkpoint inhibitors,immune checkpoint agonists,immune cell therapy and any treatment targeting the immune mechanism of tumor action.
✕. History of gastrointestinal perforation and fistula within 6 months before the first dose.
✕. Active or previously documented inflammatory bowel disease,inability to swallow, malabsorption syndrome.
What they're measuring
1
Incidence and severity of adverse events(AE)
Timeframe: Up to approximately 2 years
2
Incidence of serious adverse events(SAE) and suspected unexpected serious adverse reactions(SUSAR)
Timeframe: Up to approximately 2 years
3
Incidence of dose-limiting toxicity(DLT)
Timeframe: Up to approximately 2 years
4
Clinically significant changes in safety/laboratory evaluation parameters and AEs that led to treatment termination or suspension
Timeframe: Up to approximately 2 years
5
Objective Solution Rate (ORR) based on RECIST v1.1