Clinical trial · Interventional
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.
NCT06055348CI-TRIAL-00069948unknownPhase 1 / Phase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
A phase Ib/II clinical study on the safety, pharmacokinetic characteristics, and preliminary efficacy of SC0191 combination chemotherapy in patients with advanced ovarian cancer.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Advanced Ovarian Cancer | Malignant Ovarian Neoplasm | CURATED_BROADER | 0.78 |
| Serous Ovarian Cancer | Ovarian Serous Adenocarcinoma | ALIAS | 0.90 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Gemcitabine | Drug | Gemcitabine | ALIAS |
| Paclitaxel | Drug | Paclitaxel | ALIAS |
| SC0191 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Arm A (SC0191 + Gemcitabine).
- description
- 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.
- interventionNames
- Drug: SC0191
- Drug: Gemcitabine
- type
- EXPERIMENTAL
- label
- Arm B (SC0191 + Paclitaxel).
- description
- SC0191 PO will be taken on days 1-3, 8-10, and 15-17 of each 28 day cycle. Paclitaxel 80 mg/m² will be administered IV on days 1, 8, and 15 of each 28 day cycle.
- interventionNames
- Drug: SC0191
- Drug: Paclitaxel
Primary outcomes (2)
- measure
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. Histologically or cytologically confirmed advanced ovarian cancer that has failed or intolerant or not applicable to standard treatment (applicable to the dose escalation phase of stage Ib); 2. Histologically or cytologically confirmed advanced high-grade serous ovarian cancer, platinum-resistant or platinum-refractory recurrent ovarian cancer (applicable to the dose expansion phase of stage II); 3. There is at least one measurable lesion that meets the definition of RECIST 1.1; 4. Voluntarily participate in clinical trials and sign informed consent; 5. Age ≥18 years; 6. ECOG score of 0 to 1; 7. Predicted life expectancy ≥3 months; 8. Adequate bone marrow, liver biochemistry, renal function, and coagulation status. 9. Female patients who agree to use adequate contraceptive measures. Exclusion Criteria: 1. Received chemotherapy, radiotherapy, immunotherapy or biological therapy, steroid therapy or other investigational drugs \<28 days prior to the first dose of study treatment. 2. Patients who have not fully recovered from surgery according to the investigator's judgment.; 3. Patients who have previously received WEE1 inhibitor treatment; 4. Unresolved AEs or toxicities due to previous treatments; 5. Patients with contraindications or a history of severe allergies to gemcitabine or paclitaxel; 6. Known malignant CNS disease other than neurologically stable, treated brain metastases; 7. Other medical conditions or systemic diseases not suitable to participate; 8. The need for long-term therapeutic doses of anticoagulant or antiplatelet drugs; 9. Received CYP3A4 moderate or strong inhibitors or CYP3A4 moderate or strong inducers within 14 days; 10. Pregnant or lactating women.
References
Publications (0)
Data not yet available
No reference posted for this study.