Trials / Unknown
UnknownNCT06055348
SC0191 Plus Chemotherapy in Advanced Ovarian Canceradvanced Ovarian Cancer
A Phase Ib/II Clinical Study on the Safety, Pharmacokinetic Characteristics, and Preliminary Efficacy of SC0191 Combination Chemotherapy in Patients With Advanced Ovarian Cancer.
- Status
- Unknown
- Phase
- Phase 1 / Phase 2
- Study type
- Interventional
- Enrollment
- 112 (estimated)
- Sponsor
- Biocity Biopharmaceutics Co., Ltd. · Industry
- Sex
- Female
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
A phase Ib/II clinical study on the safety, pharmacokinetic characteristics, and preliminary efficacy of SC0191 combination chemotherapy in patients with advanced ovarian cancer.
Detailed description
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | SC0191 | SC0191 PO will be taken on days 1-3, 8-10, and 15-17 of each 28 day cycle. |
| DRUG | Gemcitabine | Gemcitabine 1000 mg/m² will be administered IV on days 1, 8, and 15 of each 28 day cycle. |
| DRUG | Paclitaxel | Paclitaxel 80 mg/m² will be administered IV on days 1, 8, and 15 of each 28 day cycle. |
Timeline
- Start date
- 2023-10-30
- Primary completion
- 2025-08-30
- Completion
- 2025-11-30
- First posted
- 2023-09-26
- Last updated
- 2023-09-26
Source: ClinicalTrials.gov record NCT06055348. Inclusion in this directory is not an endorsement.