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Trial Title:
A Clinical Study to Observe How Well That BAT8006 Works on Patients With Platinum Resistance Ovarian Cancer
NCT ID:
NCT06545617
Condition:
Platinum-resistant Epithelial Ovarian Cancer
Fallopian Tube Cancer
Primary Peritoneal Cancer
Conditions: Official terms:
Ovarian Neoplasms
Carcinoma, Ovarian Epithelial
Fallopian Tube Neoplasms
Exatecan
Study type:
Interventional
Study phase:
Phase 1/Phase 2
Overall status:
Not yet recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
BAT8006 for Injection
Description:
Intravenous infusion: once every three weeks.The infusion time in the first cycle is
recommended to be ≥ 90 minutes. If no infusion reaction occurs, the subsequent cycle can
be completed within 30~60 minutes.
Arm group label:
Cohort 1
Arm group label:
Cohort 2
Arm group label:
Cohort 3
Other name:
Recombinant humanized anti-FRα monoclonal antibody-Exatecan conjugate
Summary:
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
Detailed description:
Part 1 is a Dose Finding Study. The RP2D will be confirmed in Part 1, and this RP2D will
be further evaluated in Part 2. In Part 1, PK samples will be collected and analyzed to
support the determination of RP2D. Three dose cohorts are planned. Subjects will be
assigned to these three dosages in parallel.
Part 2 will expose subjects at the RP2D confirmed in Part 1.
Criteria for eligibility:
Criteria:
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.
Gender:
Female
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Start date:
January 31, 2025
Completion date:
January 31, 2028
Lead sponsor:
Agency:
Bio-Thera Solutions
Agency class:
Industry
Source:
Bio-Thera Solutions
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06545617
