Clinical Trials Logo

Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT05008783
Other study ID # AK104-302
Secondary ID
Status Active, not recruiting
Phase Phase 3
First received
Last updated
Start date September 17, 2021
Est. completion date April 14, 2025

Study information

Verified date April 2024
Source Akeso
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

A randomized, Double-blind, Multicenter, phase III Clinical Study of Comparing the Efficacy and Safety of AK104 Plus Oxaliplatin and Capecitabine (XELOX) Versus Placebo Plus XELOX as First-line Treatment for locally advanced Unresectable or Metastatic Gastric Adenocarcinoma or Gastroesophageal Junction Adenocarcinoma.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 610
Est. completion date April 14, 2025
Est. primary completion date August 18, 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years to 75 Years
Eligibility Inclusion Criteria: - Subjects must meet all of the following inclusion criteria to be enrolled in the study: 1. Ability to understand and voluntarily sign a written informed consent form (ICF), which must be signed before the specified study procedures required for the study are performed. 2. Males or females aged = 18 to = 75 years at the time of signing informed consent. 3. Histopathologically confirmed gastric adenocarcinoma or gastroesophageal junction (GEJ) adenocarcinoma. 4. Unresectable locally advanced or metastatic gastric adenocarcinoma or GEJ adenocarcinoma. 5. Subjects have not received prior systemic therapy for locally advanced or metastatic gastric adenocarcinoma or adenocarcinoma of the gastroesophageal junction. For subjects who have received prior neoadjuvant/adjuvant chemotherapy or chemoradiotherapy for curative intent, the time between disease progression and last treatment should be at least 6 months. 6. Subjects have at least one measurable tumor lesion per RECIST v1.1; lesions that received radiotherapy are not selected as target lesions, unless the lesion is the only measurable lesion and has unequivocal progression as judged by imaging, it can be considered as a target lesion. Exclusion Criteria: - Subjects who meet any of the following criteria are not eligible to participate in this study: 1. Subjects with known HER2-positive gastric or GEJ adenocarcinoma. 2. Histopathology or cytology confirmed other pathological types, such as squamous cell carcinoma, sarcoma, or undifferentiated carcinoma. 3. Subjects who received palliative local therapy for non-target lesions within 2 weeks prior to the first dose; systemic nonspecific immunomodulatory therapy (e.g., interleukin, interferon, thymosin, etc.) within 2 weeks prior to the first dose; and Chinese herbal medicine or traditional Chinese medicinal products with anti-tumor indications within 2 weeks prior to the first dose. 4. Subjects who received any prior treatments targeting the mechanism of tumor immunity. 5. Medical history of gastrointestinal perforation or gastrointestinal fistula within 6 months prior to the first dose. If the perforation or fistula has been treated with resection or repair and the disease has recovered or resolved as judged by the Investigator, enrollment may be allowed. 6. Active or previously documented inflammatory bowel disease (e.g., Crohn's disease or ulcerative colitis). 7. Active malignancies within the past 3 years, with the exception of tumors in this study and cured local tumors, such as basal cell carcinoma of skin, squamous cell carcinoma of skin, superficial bladder cancer, carcinoma in situ of cervix, carcinoma in situ of breast, localized prostate cancer, etc. 8. Known active or untreated brain metastases, meningeal metastases, spinal cord compression, or leptomeningeal disease. 9. Presence of clinically symptomatic pleural effusion, pericardial effusion, or ascites requiring frequent drainage (= 1/month). 10. Active autoimmune disease requiring systemic treatment within 2 years prior to the start of study treatment, or autoimmune diseases that may relapse or require scheduled treatment as judged by the Investigator.

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
AK104
AK104 (administered on Day 1 of each cycle, Q3W)+Oxaliplatin (130 mg/m2 intravenous infusion for 2-6 hours on Day 1, Q3W,up to 6 cycles)+ Capecitabine(1000 mg/m2, p.o., Bid, Q3W,up to 6 cycles) . Afterward, AK104 will be used for maintenance treatment (administered on Day 1 of each cycle, Q3W)
Placebo
Placebo (administered on Day 1 of each cycle, Q3W)+Oxaliplatin (130 mg/m2 intravenous infusion for 2-6 hours on Day 1, Q3W,up to 6 cycles)+ Capecitabine(1000 mg/m2, p.o., Bid, Q3W,up to 6 cycles) . Afterward,Placebo will be used for maintenance treatment (administered on Day 1 of each cycle, Q3W)

Locations

Country Name City State
China Peking University Cancer Hospital Beijing Beijing
China West China Hospital of Sichuan University Chengdu Sichuan
China Fujian Provincial Cancer Hospital Fuzhou Fujian
China The First Affiliated Hospital of Zhejiang University Medical College Hangzhou Zhejiang
China Yunnan Cancer Hospital Kunming Yunnan
China Fudan University Cancer Hospital Shanghai Shanghai
China Zhongshan Hospital, Fudan University Shanghai Shanghai

Sponsors (1)

Lead Sponsor Collaborator
Akeso

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary Overall Survival (os) OS in the ITT population. Up to 2 years
Secondary ORR ORR is the proportion of subjects with CR or PR based on RECIST v1.1 Up to 2 years
Secondary DCR DCR is defined as the proportion of subjects with CR, PR, or SD, based on RECIST v1.1 Up to 2 years
Secondary DoR DoR is defined as the duration from the first documentation of objective response to the first documented disease progression or death due to any cause, whichever occurs first. Up to 2 years
Secondary TTR TTR is defined as the time to response base on RECIST v1.1 Up to 2 years
Secondary PFS PFS is defined as the time from randomization to the first documented progressive disease (PD) or death due to any cause, whichever occurs first assessed by investigator Per RECIST 1.1 Up to 2 years
Secondary AE Incidence and severity of adverse events (AEs) and serious adverse events (SAEs), and clinically significant abnormal laboratory results. From the subject signs the ICF to 30 days (AE) and 90 days (SAE) after the last dose of study treatment or initiation of other anti-tumor therapy, whichever occurs first
Secondary Observed concentrations of AK104 The endpoints for assessment of PK of AK104 include serum concentrations of AK104 at different timepoints after AK104 administration From first dose of AK104 through the last dose of AK104, about average of 9 months.
Secondary Number of subjects who develop detectable anti-drug antibodies (ADAs) The immunogenicity of AK104 will be assessed by summarizing the number of subjects who develop detectable antidrug antibodies (ADAs). From first dose of AK104 through 30 days after last dose of AK104
See also
  Status Clinical Trial Phase
Recruiting NCT05977998 - A Phase II Study of Perioperative Paclitaxel in Patients With Gastric Adenocarcinoma and Carcinomatosis or Positive Cytology Phase 2
Recruiting NCT05059444 - ORACLE: Observation of ResiduAl Cancer With Liquid Biopsy Evaluation
Not yet recruiting NCT04931420 - Study Comparing Standard of Care Chemotherapy With/ Without Sequential Cytoreductive Surgery for Patients With Metastatic Foregut Cancer and Undetectable Circulating Tumor-Deoxyribose Nucleic Acid Levels Phase 2
Recruiting NCT03257163 - Pembrolizumab, Capecitabine, and Radiation Therapy in Treating Patients With Mismatch-Repair Deficient and Epstein-Barr Virus Positive Gastric Cancer Phase 2
Completed NCT02128243 - Trial of S-1 Maintenance Therapy in Metastatic Esophagogastric Cancer Phase 2
Completed NCT01178944 - Pralatrexate and Oxaliplatin in Treating Patients With Unresectable or Metastatic Esophageal, Stomach, or Gastroesophageal Junction Cancer Phase 2
Terminated NCT00209079 - Phase II Trial of Gleevec and Taxotere as a Combined Regimen for Advanced Gastric Adenocarcinoma Phase 2
Terminated NCT02862535 - Study to Evaluate the Safety and Tolerability of Andecaliximab as Monotherapy and in Combination With Anti-Cancer Agents in Japanese Participants With Gastric or Gastroesophageal Junction Adenocarcinoma Phase 1
Recruiting NCT04430738 - Tucatinib Plus Trastuzumab and Oxaliplatin-based Chemotherapy or Pembrolizumab-containing Combinations for HER2+ Gastrointestinal Cancers Phase 1/Phase 2
Recruiting NCT04114136 - Anti-PD-1 mAb Plus Metabolic Modulator in Solid Tumor Malignancies Phase 2
Completed NCT03196232 - Epacadostat and Pembrolizumab in Treating Patients With Metastatic or Unresectable Gastroesophageal Junction or Gastric Cancer Phase 2
Recruiting NCT04047953 - Paclitaxel (Albumin-bound) Combined With Oxaliplatin and S-1 Conversion Therapy for Gastric Adenocarcinoma N/A
Completed NCT02864381 - Study to Evaluate the Efficacy and Safety of Andecaliximab Combined With Nivolumab Versus Nivolumab Alone in Adults With Unresectable or Recurrent Gastric or Gastroesophageal Junction Adenocarcinoma Phase 2
Completed NCT02891447 - Heated Mitomycin and Cisplatin During Surgery in Treating Patients With Stomach or Gastroesophageal Cancer Phase 2
Terminated NCT04032704 - A Study of Ladiratuzumab Vedotin in Advanced Solid Tumors Phase 2
Terminated NCT04604132 - Derazantinib Alone or in Combination With Paclitaxel, Ramucirumab or Atezolizumab in Gastric Adenocarcinoma Phase 1/Phase 2
Completed NCT02830594 - Pembrolizumab and Palliative Radiation Therapy in Treating Patients With Metastatic Esophagus, Stomach, or Gastroesophageal Junction Cancer Phase 2
Recruiting NCT06038578 - A Study of TRK-950 When Used in Combination With Ramucirumab and Paclitaxel in Patients With Gastric Cancer Phase 2
Terminated NCT04099277 - A Study of LY3435151 in Participants With Solid Tumors Phase 1
Recruiting NCT04581473 - Study to Evaluate the Efficacy, Safety and Pharmacokinetics of CT041 Autologous CAR T-cell Injection Phase 1/Phase 2