2025-02-05
minor
Study Status, Study Description, Study Design, Arms and Interventions, Outcome Measures, Eligibility v1
Enrollment target220→260
Study arms4→5
InterventionsDose Escalation (Drug), Dose Expansion1 (Drug), Dose Expansion2 (Drug), phase II (Drug)→Dose Escalation (Drug), Dose Expansion1 (Drug), Dose Expansion2 (Drug), Dose Expansion3 (Drug), phase II (Drug)
Eligibility criteria+138 characters
[...] study-related tests or procedures.
Has a life expectancy of >≥ 3 months.
With histologically or cytologically confirmed lo [...] , endometrial cancer, ovarian cancer, cervical cancer, etc.
SuggestedAgreed to provide archived tumor tissue specimens (unstained 10 surgical specimens [thickness 4-5μm] was suggested or fresh tissue samples of primary or metastatic sites within 3 years..
Note: Trop-2 expression was not used to confirm participant [...] rst-line chemotherapy), or no standard treatment available.
Subjects with HER2 low expression who have progressed after treatment with anti-HER2-ADC (such as T-DXd [...] [...]
Study description+719 characters
This is a Phase 1/2, first in human (FIH), open-label, multicenter study of GQ1010, a Trop-2 directed antibody-drug conjugate (ADC), in participants with previously treated, advanced solid tumors.
The study comprises 3 parts: a Phase 1a Dose Escalation, a Phase 1b Dose Expansion, and Phase 2 study.
[...]