A Study of AK104/Placebo Plus AK109/Placebo And Paclitaxel in Gastric or Gastroesophageal Junction Adenocarcinoma
- Conditions
- Gastric and Gastroesophageal Junction Adenocarcinoma
- Interventions
- Registration Number
- NCT06341335
- Lead Sponsor
- Akeso
- Brief Summary
This randomized, multicenter, double-blind, phase 3 study will evaluate the efficacy and safety of the combination of cadonilimab (AK104) and pulocimab (AK109) and paclitaxel compared with paclitaxel in patients with advanced gastric or gastroesophageal junction adenocarcinoma who failed first-line immunochemotherapy.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 506
- Signed informed consent
- Age ≥ 18 years and ≤ 75 years
- Histologically or cytologically documented advanced unresectable or metastatic gastric adenocarcinoma or gastroesophageal Junction (GEJ) adenocarcinoma.
- Failed first-line treatment with PD-(L)1 monoclonal antibody and standard chemotherapy
- At least one measurable disease based on RECIST v1.1
- ECOG status of 0 or 1
- Estimated survival ≥ 3 months
- Adequate organ function per protocol-defined criteria
- Women of childbearing potential and men with female partners of childbearing potential must agree to use effective contraception during treatment and for at least 120 days following the last dose of study treatment
- Mixed gastric or gastroesophageal Junction cancer containing other pathological components than adenocarcinoma
- HER2-positive
- Known other invasive malignancies within 3 years
- Subjects who are currently participating in other interventional study
- Received prior systemic anti-tumour therapy within 4 weeks before randomization
- Previous systemic treatment with taxane within 6 months before randomization
- Previous systemic treatment targeting VEGF or anti-VEGFR signaling pathways
- In addition to anti-PD-(L)1 monoclonal antibody, prior exposure to other immune checkpoint inhibitors, immune checkpoint agonists, immune cell therapy or other therapy that targets anti-tumor immune mechanisms
- History of immune-related adverse effects leading to recommendation against reintroduction of immunotherapy or any condition dependency on systemic therapy with glucocorticoids or immunosuppressive agents within 14 days prior to randomization
- History of severe infection within 4 weeks prior to randomization
- Presence of central nervous system metastases, leptomeningeal metastases, or spinal cord compression
- Uncontrolled pleural effusion, pericardial effusion or ascites requiring repeated drainage
- History or presence of a serious hemorrhage or known bleeding tendency within 2 months before randomization
- Major surgical procedure or serious trauma within 28 days prior to randomization
- History of interstitial lung disease or noninfectious pneumonitis
- Active infectious diseases, including tuberculosis, HIV infection, syphilis infection，or hepatitis B/C
- Known allergy to the antibody or any component of the study drug; Or the constitution of being allergic to multiple substances
- History of allogeneic organ transplantation or allogeneic haematopoietic stem cell transplantation
- Toxicities of prior anticancer therapy have not resolved to ≤ Grade 1 (NCI-CTCAE version 5.0)
- Use of live vaccines within 30 days prior to randomization
- Pregnant or lactating women.
- Any condition considered by the investigator to be inappropriate for enrollment
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Cadonilimab in combination with pulocimab and paclitaxel cadonilimab Cadonilimab (AK104) in combination with pulocimab (AK109) and paclitaxel, iv, every 3 weeks Cadonilimab in combination with pulocimab and paclitaxel paclitaxel Cadonilimab (AK104) in combination with pulocimab (AK109) and paclitaxel, iv, every 3 weeks Placebo in combination with paclitaxel paclitaxel Placebo in combination with Paclitaxel, iv, every 3 weeks Placebo in combination with paclitaxel placebo Placebo in combination with Paclitaxel, iv, every 3 weeks Cadonilimab in combination with pulocimab and paclitaxel pulocimab Cadonilimab (AK104) in combination with pulocimab (AK109) and paclitaxel, iv, every 3 weeks
- Primary Outcome Measures
Name Time Method Progression-free survival (PFS) assessed by blinded independent central review (BICR) Up to 2 years PFS is defined as the time from randomization to the first documented progressive disease (PD) or death due to any cause, whichever occurs first (based on RECIST 1.1 criteria).
Overall survival (OS) Up to 2 years OS is defined as the time from randomization to death due to any cause.
- Secondary Outcome Measures
Name Time Method Progression-free survival (PFS) assessed by investigator Up to 2 years PFS is defined as the time from randomization to the first documented progressive disease (PD) or death due to any cause, whichever occurs first (based on RECIST 1.1 criteria).
Objective Response Rate (ORR) Up to 2 years ORR is defined as proportion of subjects who have a complete or partial response relative to baseline according to RECIST 1.1 criteria
Duration of Response (DoR) Up to 2 years DoR is defined as the duration from the first documentation of objective response to the first documented disease progression(based on RECIST v1.1 criteria) or death due to any cause, whichever occurs first.
Disease control rate (DCR) Up to 2 years DCR is defined as the proportion of subjects with CR, PR, or SD (based on RECIST v1.1 criteria).
Trial Locations
- Locations (1)
Peking University Cancer Hospital & Institute
🇨🇳Beijing, China