Clinical trial · Interventional
A Clinical Study to Observe How Well That BAT8006 Works on Patients With Platinum Resistance Ovarian Cancer
A Phase 1b/2, Multicenter, Open-Label Study of BAT8006, an Anti- FRα Antibody Drug Conjugate (ADC) for Platinum-resistant Ovarian Cancer Subjects
NCT06545617CI-TRIAL-00100308withdrawnPhase 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
Why stopped (as posted): Reconsideration of the subsequent international development of BAT8006
Summary
Brief summary (as posted)
This is a Phase 1b/2, open-label, 2-part, global study designed to investigate the anti-tumor activity as well as the safety and efficacy of BAT8006 in subjects with platinum resistance ovarian cancer
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Fallopian Tube Cancer | Malignant Fallopian Tube Neoplasm | ALIAS | 0.90 |
| Platinum-resistant Epithelial Ovarian Cancer | — | UNRESOLVED | — |
| Primary Peritoneal Cancer | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| BAT8006 for Injection | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- type
- ACTIVE_COMPARATOR
- label
- Cohort 1
- description
- BAT8006 for Injection does according to protocol (frequency: Q3W)
- interventionNames
- Drug: BAT8006 for Injection
- type
- ACTIVE_COMPARATOR
- label
- Cohort 2
- description
- BAT8006 for Injection does according to protocol (frequency: Q3W)
- interventionNames
- Drug: BAT8006 for Injection
- type
- ACTIVE_COMPARATOR
- label
- Cohort 3
- description
- BAT8006 for Injection does according to protocol (frequency: Q3W)
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. Able to give voluntary informed consent and understand the study and are willing to follow and complete all the study required procedures. 2. Women ≥ 18 years old. 3. Subjects with histologically or cytologically confirmed platinum-resistant, advanced or metastatic epithelial ovarian cancer, primary peritoneal cancer or fallopian tube cancer. 4. Presence of at least one measurable lesion per RECIST v1.1. that was not in a prior radiation or other locally treated area. 5. Life expectancy ≥ 3 months. 6. Adequate hematological, liver, kidney and coagulation function. Exclusion Criteria 1. Females who are pregnant or nursing. 2. Had major surgery within 28 days of the Screening visit. 3. History of autologous transplantation ≤ 3 months 4. History of severe infection deemed clinically significant by the PI or designee within 4 weeks or signs and symptoms of any active infection within 2 weeks prior to the first dose of study drug. 5. History of human immunodeficiency virus (HIV) infection. 6. Active hepatitis B or C. 7. Any other serious underlying medical. 8. Received cancer-directed therapy within the timeframes. 9. Subjects have other active malignancies within 5 years prior to the first dose. 10. Known allergies, hypersensitivity, or intolerance to the study drug or its excipients. 11. Vaccinated with any live-attenuated vaccine within 4 weeks. 12. Subjects with known history of psychiatric disorders, drug abuse, alcoholism or drug addiction. 13. Subjects who are estimated by the investigator to have poor compliance with the clinical study or who have other factors that are not appropriate to participate in the study in the opinion of the investigator.
References
Publications (0)
Data not yet available
No reference posted for this study.