Clinical trial NCT06545617: A Clinical Study to Observe How Well That BAT8006 Works on Patients With Platinum Resistance Ovarian Cancer
Official title: A Phase 1b/2, Multicenter, Open-Label Study of BAT8006, an Anti- FRα Antibody Drug Conjugate (ADC) for Platinum-resistant Ovarian Cancer Subjects
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE1
PHASE2
Conditions: Platinum-resistant Epithelial Ovarian Cancer
Fallopian Tube Cancer
Primary Peritoneal Cancer
Lead sponsor: Bio-Thera Solutions
Sponsor class: INDUSTRY
First posted: 2024-08-09
Enrollment: 170
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

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.

Primary outcomes:
measure: The maximum tolerated dose (MTD) and/or identify the recommended Phase 2 dose (RP2D) of BAT8006
timeFrame: At the end of Cycle 1 (each cycle is 21 days)
measure: The tolerability of BAT8006
timeFrame: From date of first dose administration until the date of clinical progression, adverse event, physician decisionor or date of death from any cause, whichever came first, assessed at most up to 27 months
measure: Adverse events（AE）
timeFrame: From signed ICF to 30 days after the last drug administration
measure: Physical examination
timeFrame: From signed ICF to 30 days after the last drug administration
measure: ECOG
timeFrame: From signed ICF to 30 days after the last drug administration
measure: Vital signs
timeFrame: From signed ICF to 30 days after the last drug administration
measure: Laboratory testings
timeFrame: From signed ICF to 30 days after the last drug administration
measure: Electrocardiogram（ ECG ）
timeFrame: From signed ICF to 30 days after the last drug administration
measure: Echo/MUGA
timeFrame: From signed ICF to 30 days after the last drug administration
measure: Ophthalmologic findings
timeFrame: From signed ICF to 30 days after the last drug administration
Secondary outcomes:
measure: The immunogenicity of BAT8006
timeFrame: Pre-dose of Cycle 1 to Cycle 1 Day 15, Pre-dose of Cycle 2, 4 until every 4 cycles
measure: Objective response rate (ORR)
timeFrame: From signed ICF to 30 days after the last drug administration
measure: Duration of response (DOR)
timeFrame: From signed ICF to 30 days after the last drug administration
measure: Best percent change in the sum of the longest diameters (SLD) of measurable tumors
timeFrame: From signed ICF to 30 days after the last drug administration
measure: Progression-free survival (PFS)
timeFrame: From signed ICF to 30 days after the last drug administration
measure: The pharmacokinetics (PK) profile of BAT8006（Maximum concentration (Cmax)）
timeFrame: Cycle 1 Day 1, 2, 3, 4, 8, 15, 22 to Cycle 2 Day 1; Cycle 3 Day 1, 2, 3, 4, 8, 15, 22 to Cycle 4/6/8/12/16/20/24/28/32 Day 1
measure: The pharmacokinetics (PK) profile of BAT8006（Time of Cmax (Tmax)）
timeFrame: Cycle 1 Day 1, 2, 3, 4, 8, 15, 22 to Cycle 2 Day 1; Cycle 3 Day 1, 2, 3, 4, 8, 15, 22 to Cycle 4/6/8/12/16/20/24/28/32 Day 1
measure: The pharmacokinetics (PK) profile of BAT8006（Area under the curve (AUC)）
timeFrame: Cycle 1 Day 1, 2, 3, 4, 8, 15, 22 to Cycle 2 Day 1; Cycle 3 Day 1, 2, 3, 4, 8, 15, 22 to Cycle 4/6/8/12/16/20/24/28/32 Day 1
measure: The pharmacokinetics (PK) profile of BAT8006（Terminal half-life (t½)）
timeFrame: Cycle 1 Day 1, 2, 3, 4, 8, 15, 22 to Cycle 2 Day 1; Cycle 3 Day 1, 2, 3, 4, 8, 15, 22 to Cycle 4/6/8/12/16/20/24/28/32 Day 1
Other outcomes:
Locations:
Study officials:
affiliation: The University of Oklahoma College of Medicine
name: Kathleen Moore
role: PRINCIPAL_INVESTIGATOR
References: