This is a randomized, controlled, open-label, multicenter Phase III study to evaluate the efficacy and safety of ATG-022 compared with Investigator's Choice in participants with CLDN18.2-positive advanced gastric or gastroesophageal junction adenocarcinoma.
This study is based on the positive data for ATG-022 monotherapy in CLDN18.2-positive advanced gastric/GEJ adenocarcinoma obtained from the CLINCH study. Through PopPK and exposure-response (E-R) analysis of ATG-022, this study will use ATG-022 monotherapy at 1.8 mg/kg compared to Investigator's Choice to evaluate the efficacy and safety of the two treatment regimens in participants with advanced gastric/GEJ adenocarcinoma who have received prior second-line systemic therapy. The Investigator's Choice regimen includes two optional drugs: Docetaxel or Irinotecan. Both docetaxel and irinotecan are commonly used single-agent chemotherapy drugs in third-line treatment for gastric cancer.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
380
1.8 mg/kg,D1, Q3W,every 21 days as one cycle
Docetaxel: 75-100 mg/m², D1, Q3W, every 21 days as one cycle Irinotecan: 125 mg/m², D1, D8, Q3W, every 21 days as one cycle
Progression-Free Survival(PFS )
PFS is defined as the duration from randomization to the first objective documentation of PD or death from any cause
Time frame: From randomization to first PD or death. Tumour assessments at baseline, q6w (±1w) during treatment, q12w (±1w) after 12m, q24w (±1w) after 24m, until PD/death/study end (~228 OS events, ~1yr after LPI).
Overall Survival(OS)
Duration from randomization to death from any cause
Time frame: From randomization to death. Survival follow-up q3m (±14d) until death/study termination (~228 OS events).
Objective response rate (ORR)
ORR is Defined as the percentage of participants achieving a CR or PR
Time frame: Proportion with confirmed CR/PR. Based on tumour assessments per schedule (as above). Data cutoff at study completion.
Disease control rate (DCR)
DCR is Defined as the percentage of participants achieving CR, PR, or SD ≥ 3 months
Time frame: Proportion with CR/PR/SD ≥3 months (confirmed by ≥2 assessments). Assessment schedule as above. Data cutoff at study completion.
Duration of response (DOR)
DOR is defined as the duration from the first meeting of the criteria for CR or PR to the first documented PD or death from any cause
Time frame: From first documented CR/PR to first PD or death. Assessment schedule same as PFS. Data cutoff at study completion.
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
The First Affiliated Hospital of Bengbu Medical University
Bengbu, Anhui, China
The First Affiliated Hospital of Anhui Medical University
Hefei, Anhui, China
The First Affiliated Hospital of University of Science and Technology of China (Anhui Provincial Hospital)
Hefei, Anhui, China
The Second Affiliated Hospital of Anhui Medical University
Hefei, Anhui, China
Beijing Cancer Hospital
Beijing, Beijing Municipality, China
Beijing Friendship Hospital, Capital Medical University
Beijing, Beijing Municipality, China
Beijing GoBroad Hospital
Beijing, Beijing Municipality, China
Peking Union Medical College Hospital
Beijing, Beijing Municipality, China
The First Affiliated Hospital of Chongqing Medical University
Chongqi, Chongqing Municipality, China
Fujian Cancer Hospital
Fuzhou, Fujian, China
...and 104 more locations