This is a phase 2 multicenter study that will evaluate the safety and efficacy of sacituzumab tirumotecan (Sac-TMT) plus fruquintinib for the treatment of participants with locally advanced or metastatic gastric (G) or gastroesophageal junction (GEJ) adenocarcinoma who have failed 1 prior line of therapy.
Histologically and/or cytologically confirmed metastatic or locally advanced adenocarcinoma of the gastric or gastroesophageal junction, unresectable;
Subjects who have failed first-line standard systemic therapy, or experienced disease progression or recurrence within 6 months after completion of adjuvant systemic therapy (HER2-positive subjects must have received prior anti-HER2 therapy);
Have at least one measurable lesion per RECIST v1.1, subjects with only cutaneous or bone lesions are not eligible for enrollment;
Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1 within 7 days prior to study drug administration;
Participants unable to receive oral administration due to dysphagia, intractable vomiting, or known drug malabsorption;
Participants with active gastric/duodenal ulcer, ulcerative colitis, intestinal obstruction, or other gastrointestinal disorders/conditions judged by the Investigator to carry a risk of gastrointestinal hemorrhage or perforation; or with a history of intestinal perforation or fistula within the preceding 6 months; or with unresolved intestinal perforation/fistula following prior surgical repair;
Participants with known meningeal metastasis, brainstem metastasis, spinal cord metastasis and/or spinal cord compression, or active/untreated central nervous system (CNS) metastases. Participants with previously locally treated brain metastases may be enrolled if clinically stable for at least 4 weeks prior to dosing and not requiring corticosteroids or anticonvulsants for a minimum of 14 days before the first dose;
Participants diagnosed with another malignant tumor within 3 years prior to dosing, except malignancies cured by local therapy such as basal cell carcinoma of the skin, cutaneous squamous cell carcinoma, carcinoma in situ of the cervix, etc.;
Single group
Sacituzumab Tirumotecan + Fruquintinib
DrugSac TMT: 4mg/kg Q2W, IV Infusion Fruquinitinib: 3mg QD PO, d1-21, Q4W
Percentage of Participants who Experience Dose Limiting Toxicities (DLTs) During the Safety Lead-In Phase
DLTs are defined as any drug-related adverse event (AE) according to the National Cancer Institute Common Terminology for Adverse Events (NCI CTCAE) Version 5.0, observed during the DLT evaluation period that results in a change to a given dose or a delay in initiating the next cycle. The percentage of participants who experience at least one DLT will be presented.
Objective Response Rate (ORR)
ORR is defined as the percentage of participants with Complete Response (CR: disappearance of all target lesions) or Partial Response (PR: at least a 30% decrease in the sum of diameters of target lesions) per Response Evaluation Criteria In Solid Tumors Version 1.1 (RECIST 1.1). The percentage of participants who experience CR or PR as assessed by investigators will be presented.
Progression Free Survival (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 as assessed by RECIST 1.1. PD is defined as ≥20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of ≥5 mm. The appearance of one or more new lesions is also considered PD. PFS as assessed by investigators will be presented.
Duration of Response (DOR)
For participants who demonstrate a confirmed Complete Response (CR: disappearance of all target lesions) or Partial Response (PR: at least a 30% decrease in the sum of diameters of target lesions) per RECIST 1.1, DOR is defined as the time from first documented evidence of CR or PR until progressive disease (PD) or death. Per RECIST 1.1, PD is defined as at least a 20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. The appearance of one or more new lesions is also considered PD. DOR as assessed by investigators will be presented.
Disease Control Rate (DCR)
DCR is defined as the percentage of participants with Complete Response (CR: disappearance of all target lesions), Partial Response (PR: at least a 30% decrease in the sum of diameters of target lesions) or Stable Disease (SD: less than a 30% decrease and less than a 20% increase in the sum of diameters of target lesions, with no new lesions identified) per Response Evaluation Criteria In Solid Tumors Version 1.1 (RECIST 1.1).
Overall Survival (OS)
OS is defined as the time from the date of enrollment to the date of death from any cause. OS will be presented.
Exploration of Efficacy predictors
Tumor tissue and plasma specimens will be collected from patients at baseline, upon disease response and at disease progression for exploratory analyses of efficacy-related biomarkers.
Click on the lead sponsor to view all of their trials.
Tianjin Medical University Cancer Institute and Hospital
Lead sponsor
Peking Union Medical College Hospital
Collaborator
This trial is not recruiting at the moment. You can still explore other options:
