Antibody Information
General Information of This Antibody
| Antibody ID | ANTI0CPGYS |
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| Antibody Name | Anti-FRα antibody |
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| Antigen Name | FRα |
Antigen Info | ||||
| Click to Show/Hide the Sequence Information of This Antibody | ||||||
Each Antibody-drug Conjugate Related to This Antibody
Full Information of The Activity Data of The ADC(s) Related to This Antibody
BAT8006 [Phase 3]
Identified from the Human Clinical Data
| Experiment 1 Reporting the Activity Date of This ADC | [1] | ||||
| Efficacy Data | Objective Response Rate (ORR) |
41.70%
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| Patients Enrolled |
Eligible participants aged 18-75 with advanced solid tumors (platinum-resistant ovarian cancer, NSCLC, etc.) must have measurable lesions (RECIST 1.1), ECOG 0-1, adequate organ function, and FRalpha-positive tumors (for expansion cohorts). Exclusions include recent systemic therapy, unresolved toxicities, active infections (HIV/HBV/HCV), uncontrolled cardiovascular disease, severe bleeding/thrombosis history, CNS metastases requiring treatment, pregnancy, or conditions compromising compliance.
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| Administration Dosage |
Intravenous infusion, once every 3 weeks (Q3W), the recommended infusion time of the first cycle is ≥90 minutes, if no infusion reaction occurs, the subsequent cycle can be completed within 30~120 minutes.
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| Related Clinical Trial | |||||
| NCT Number | NCT05378737 | Clinical Status | PHASE1 | ||
| Clinical Description |
A Multicenter, Open Phase I Clinical Study to Evaluate the Safety, Tolerability, and Pharmacokinetic Characteristics of BAT8006 for Injection in Patients With Advanced Solid Tumors
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| Primary Endpoint |
The study evaluates dose-limiting toxicity (DLT) and maximum tolerated dose (MTD) of the investigational drug, with DLT defined as grade ≥3 toxicities within 21 days of first administration, and MTD identified as the highest dose level where ≤1/6 subjects experience DLT.
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| Other Endpoint |
Pharmacokinetic (PK) analysis focuses on Cmax during the first six 21-day treatment cycles, assessing drug exposure and concentration-time profiles.
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| Experiment 2 Reporting the Activity Date of This ADC | [1] | ||||
| Efficacy Data | Disease control rate (DCR) |
86.10%
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| Patients Enrolled |
Eligible participants aged 18-75 with advanced solid tumors (platinum-resistant ovarian cancer, NSCLC, etc.) must have measurable lesions (RECIST 1.1), ECOG 0-1, adequate organ function, and FRalpha-positive tumors (for expansion cohorts). Exclusions include recent systemic therapy, unresolved toxicities, active infections (HIV/HBV/HCV), uncontrolled cardiovascular disease, severe bleeding/thrombosis history, CNS metastases requiring treatment, pregnancy, or conditions compromising compliance.
Click to Show/Hide
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| Administration Dosage |
Intravenous infusion, once every 3 weeks (Q3W), the recommended infusion time of the first cycle is ≥90 minutes, if no infusion reaction occurs, the subsequent cycle can be completed within 30~120 minutes.
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| Related Clinical Trial | |||||
| NCT Number | NCT05378737 | Clinical Status | PHASE1 | ||
| Clinical Description |
A Multicenter, Open Phase I Clinical Study to Evaluate the Safety, Tolerability, and Pharmacokinetic Characteristics of BAT8006 for Injection in Patients With Advanced Solid Tumors
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| Primary Endpoint |
The study evaluates dose-limiting toxicity (DLT) and maximum tolerated dose (MTD) of the investigational drug, with DLT defined as grade ≥3 toxicities within 21 days of first administration, and MTD identified as the highest dose level where ≤1/6 subjects experience DLT.
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| Other Endpoint |
Pharmacokinetic (PK) analysis focuses on Cmax during the first six 21-day treatment cycles, assessing drug exposure and concentration-time profiles.
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| Experiment 3 Reporting the Activity Date of This ADC | [2] | ||||
| Patients Enrolled |
Eligible participants must be ≥18 years old with platinum-resistant ovarian, peritoneal, or fallopian tube cancer, measurable lesions per RECIST v1.1, and adequate organ function. Exclusions include pregnancy, recent surgery or transplants, active infections, HIV/hepatitis B/C, prior malignancies, allergies to BAT8006, live vaccines within 4 weeks, or conditions undermining compliance.
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| Administration Dosage |
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.
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| Related Clinical Trial | |||||
| NCT Number | NCT06545617 | Clinical Status | PHASE1|||PHASE2 | ||
| Clinical Description |
A Phase 1b/2, Multicenter, Open-Label Study of BAT8006, an Anti- FRalpha Antibody Drug Conjugate (ADC) for Platinum-resistant Ovarian Cancer Subjects
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| Primary Endpoint |
This study aims to determine the maximum tolerated dose (MTD) and recommended Phase 2 dose (RP2D) of BAT8006, assessing dose-limiting toxicities (DLTs) and overall tolerability. Safety evaluations include monitoring adverse events (AEs), physical examinations, ECOG score changes, vital signs, laboratory results, ECG, Echo/MUGA, and ophthalmologic findings, tracked from informed consent through 30 days post-treatment, up to 27 months.
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| Other Endpoint |
Immunogenicity of BAT8006 will be evaluated by measuring ADA/NAb levels, while efficacy endpoints include objective response rate (ORR), duration of response (DOR), best percentage change in tumor size, and progression-free survival (PFS). Pharmacokinetics (PK) parameters such as Cmax, Tmax, AUC, and terminal half-life (t½) will be analyzed across multiple cycles.
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| Experiment 4 Reporting the Activity Date of This ADC | [3] | ||||
| Related Clinical Trial | |||||
| NCT Number | NCT05378737 | Clinical Status | Phase 1 | ||
| Clinical Description |
A multicenter, open phase 1 clinical study to evaluate the safety, tolerability, and pharmacokinetic characteristics of BAT8006 for injection in patients with advanced solid tumors.
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References