A phase Ib/II clinical study on the safety, pharmacokinetic characteristics, and preliminary efficacy of SC0191 combination chemotherapy in patients with advanced ovarian cancer.
The phase 1b/2,multicenter, open-label study, contains 2 parts. Part 1 Dose Escalation of SC0191 combination chemotherapy: Part 1 will estimate the RP2D in dose escalation cohorts in patients withadvanced ovarian cancer. Part 2 Dose Expansion of SC0191 plus Chemotherapy.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
112
SC0191 PO will be taken on days 1-3, 8-10, and 15-17 of each 28 day cycle.
Gemcitabine 1000 mg/m² will be administered IV on days 1, 8, and 15 of each 28 day cycle.
Paclitaxel 80 mg/m² will be administered IV on days 1, 8, and 15 of each 28 day cycle.
To investigate the safety and tolerability of SC0191 in combination with gemcitabine or paclitaxel
ncidence and severity of adverse events (AEs), graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), version 5.0
Time frame: From the first dose of study treatment until 30 days after the last dose.
To identify the recommended Phase 2 dose (RP2D) of SC0191 in combination with gemcitabine or paclitaxel
Incidence and severity of dose-limiting toxicities (DLTs) in DLT-evaluable subjects during Cycle 1
Time frame: Through Cycle 1 (cycle is 28 days)
To investigate the plasma pharmacokinetics (PK) of SC0191 in combination with gemcitabine or paclitaxel
Plasma pharmacokinetics (PK) of SC0191 in combination with chemotherapy: Single Dose SC0191 Cmax, Tmax, t1/2,AUC0-24h, AUC0-last, CL/F, Vd/F, and steady state SC0191 Ctrough, Cmax,ss, Cavg,ss, Tmax,ss, AUC0-τ, Rac.
Time frame: Through Cycle 1 (cycle is 28 days)
To obtain estimates of clinical activity by determining the objective response rate (ORR) of SC0191 in combination with gemcitabine or paclitaxel
Objective response rate (ORR) as defined by Response Evaluation Criteria in Solid Tumors RECIST version 1.1
Time frame: Through completion
To obtain estimates of clinical activity by determining the time to CA125 progression of SC0191 in combination with gemcitabine or paclitaxel
Time to CA125 progression according to the Gynecologic Cancer Intergroup (GCIG) criteria
Time frame: Through completion
To obtain estimates of clinical activity by determining the progression-free survival (PFS) of SC0191 in combination with gemcitabine or paclitaxel
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Progression-free survival (PFS) as defined by RECIST version 1.1 and clinical criteria
Time frame: Through completion
To obtain estimates of clinical activity by determining the duration of response (DOR) of SC0191 in combination with gemcitabine or paclitaxel
Duration of response (DOR) as defined by Response Evaluation Criteria in Solid Tumors RECIST version 1.1
Time frame: Through completion
To obtain estimates of clinical activity by determining the disease control rate (DCR) of SC0191 in combination with gemcitabine or paclitaxel
Disease control rate (DCR) as defined by Response Evaluation Criteria in Solid Tumors RECIST version 1.1
Time frame: Through completion