This study will assess the safety, tolerability and efficacy of every-2-week dosing of QLF31907 injection in patients with advanced melanoma and urothelial carcinoma.
This study is divided into two parts. The first part is the safety and tolerability observation period, mainly observing the safety and tolerability of QLF31907. The second part is mainly the efficacy observation period, further evaluating the efficacy and safety of QLF31907 in patients with advanced melanoma and urothelial carcinoma.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
66
Intravenous infusion once every two weeks. The dose administered in part 2 will depend on the outcome of part 1.
Peking University Cancer Hospital
Beijing, Beijing Municipality, China
RECRUITINGFujian Cancer Hospital
Fuzhou, Fujian, China
NOT_YET_RECRUITINGThe Second Xiangya Hospital of Central South University
Changsha, Hunan, China
(part 1)Dose-limiting toxicity(DLT)
Time frame: 28days
(part 2) Objective response rate(ORR)
Time frame: up to 2 years
(part 2) Safety index: adverse event(AE), serious adverse event (SAE), treatment-related adverse event(TRAE)
Time frame: up to 2 years
(part 2) Progression-free survival(PFS)
Time frame: up to 2 years
(part 2) Overall survival(OS)
Time frame: up to 2 years
(part 2) Maximum observed plasma concentration (Cmax)
Time frame: up to 2 years
(part 2) Positive rate of anti-drug antibody(ADA)
Time frame: up to 2 years
Lu Si, MD
CONTACT
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Jilin Cancer Hospital
Changchun, Jilin, China
NOT_YET_RECRUITINGThe First Hospital of Jilin University
Changchun, Jilin, China
NOT_YET_RECRUITINGWest China Hospital
Chengdu, Sichuan, China
NOT_YET_RECRUITING