A Clinical Study to Observe How Well That BAT8006 Works on Patients With Platinum Resistance Ovarian Cancer

Bio-Thera Solutions

Status and phase: Withdrawn; Phase 2; Phase 1

Conditions: Primary Peritoneal Cancer; Platinum-resistant Epithelial Ovarian Cancer; Fallopian Tube Cancer

Treatments: Drug: BAT8006 for Injection

Study type: Interventional

Funder types: Industry

Identifiers

NCT06545617

BAT-8006-002-CR

Details and patient eligibility

About

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

Full 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.

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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0 participants in 3 patient groups

Cohort 1

Active Comparator group

Description:

BAT8006 for Injection does according to protocol (frequency: Q3W)

Treatment:

Drug: BAT8006 for Injection

Cohort 2

Active Comparator group

Description:

BAT8006 for Injection does according to protocol (frequency: Q3W)

Treatment:

Drug: BAT8006 for Injection

Cohort 3

Active Comparator group

Description:

BAT8006 for Injection does according to protocol (frequency: Q3W)

Treatment:

Drug: BAT8006 for Injection