Not yet recruiting NCT06586294
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
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Drug: AK129 Drug：oxaliplatin Drug：capecitabine, Drug: AK129 Drug：cadonilimab Drug：oxaliplatin Drug：capecitabine.
- Who it may be relevant to
- Registry conditions: Gastric Adenocarcinoma, Gastroesophageal Junction Adenocarcinoma. Basic parameters: 18 years — 75 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
A Phase Ib/II Open Label,Dose Escalation and Dose Extension Study Evaluating the Safety, Tolerability, and Initial Antitumor Efficacy of Anti-PD-1 and Lymphocyte Activation Gene 3(LAG-3) Bispecific Antibody AK129 Combined With Chemotherapy With or Without Cadonilimab in Patients With Human Epidermal Growth Factor Receptor 2 (HER2) Negative Unresectable Locally Advanced or Metastatic G/GEJ Adenocarcinoma
Overview
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
Interventions
- Drug 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. - 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.
Primary outcome measures
- Incidence and severity of adverse events(AE) [Time frame: Up to approximately 2 years]
- Incidence of serious adverse events(SAE) and suspected unexpected serious adverse reactions(SUSAR) [Time frame: Up to approximately 2 years]
- Incidence of dose-limiting toxicity(DLT) [Time frame: Up to approximately 2 years]
- Clinically significant changes in safety/laboratory evaluation parameters and AEs that led to treatment termination or suspension [Time frame: Up to approximately 2 years]
- Objective Solution Rate (ORR) based on RECIST v1.1 [Time frame: Up to approximately 2 years]
Secondary outcome measures (7)
- Disease control rate(DCR) [Time frame: Up to approximately 2 years]
- duration of response(DoR) [Time frame: Up to approximately 2 years]
- time to response(TTR) [Time frame: Up to approximately 2 years]
- progression-free survival(PFS) [Time frame: Up to approximately 2 years]
- overall survival(OS) [Time frame: Up to approximately 2 years]
- Serum AK129, cadonilimab concentration, blood concentration-time curve and derived PK argument [Time frame: Up to approximately 2 years]
- Number and percentage of subjects with anti-drug antibodies (ADA) for AK129 and cadonilimab [Time frame: Up to approximately 2 years]
Eligibility criteria
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.
- Active malignancy within the last 3 years.
- Active or untreated brain metastases, meningeal metastases, spinal cord compression, or pia meningeal disease are known to exist.
- The presence of clinical symptoms of pleural effusion, pericardial effusion, or abdominal effusion, or the need for frequent drainage.
- There was an active autoimmune disease that required systemic treatment within 2 years prior to the start of the study.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Non-randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
China · 1 center
- Zhejiang Cancer Hospital — Hanzhou
Identifiers
NCT: NCT06586294 · AK129-103