Antibody-drug Conjugate Information
General Information of This Antibody-drug Conjugate (ADC)
| ADC ID |
DRG0EGQMP
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| ADC Name |
BAT8006
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| Synonyms |
BAT8006
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| Organization |
Bio-Thera Solutions (Originator)
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| Drug Status |
Phase 3
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| Drug-to-Antibody Ratio |
7~8
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| Antibody Name |
Anti-FRα antibody
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Antibody Info | ||||
| Antigen Name |
Folate receptor alpha (FOLR1)
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Antigen Info | ||||
| Payload Name |
Exatecan
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Payload Info | ||||
| Therapeutic Target |
DNA topoisomerase 1 (TOP1)
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Target Info | ||||
| Linker Name |
A cleavable linker
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Linker Info | ||||
| Conjugate Type |
Undisclosed
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The indication landscape of This ADC(2027 Update)
The clinical trial pipeline of This ADC(2027 Update)
| Indication | Phase 1 | Phase 1/2 | Phase 2 | Phase 2/3 | Phase 3 | New Drug Application | Approved | ||||||
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| Fallopian tube cancer |
1 Trials
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1 Trials
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| Ovarian cancer |
1 Trials
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1 Trials
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1 Trials
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| Peritoneal cancer |
1 Trials
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1 Trials
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| Unspecific solid tumor |
1 Trials
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ADC-specific functional property(2027 Update)
Circulating Stability
| Incubation Time | 4days | Release | <0.03% | Reference |
[1]
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| Incubation Medium | monkey serum | ||||
| Description |
Less than 0.03% of the payload was released from BAT8006 when incubated with human or monkey plasma for 4 days in 37oC, suggesting the stability of BAT8006 in blood circulation.
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| Incubation Time | 4days | Release | <0.03% | Reference |
[1]
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| Incubation Medium | human serum | ||||
| Description |
Less than 0.03% of the payload was released from BAT8006 when incubated with human or monkey plasma for 4 days in 37oC, suggesting the stability of BAT8006 in blood circulation.
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Bystander Killing Effect
| Bystander Killing Effect | Description | Reference |
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| yes |
In an in vitro bystander killing assay, proliferation of FRalpha-negative cells was potently inhibited by addition of culture medium of BAT8006-treated FRalpha-positive cells, but not that of BAT8006-treated FRalpha-negative cells, indicating the bystander killing effect of the released payload in the culture medium.
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[1]
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General Information of The Activity Data Related to This ADC
Identified from the Human Clinical Data
Full List of Activity Data of This Antibody-drug Conjugate
Identified from the Human Clinical Data
| Experiment 1 Reporting the Activity Date of This ADC | [2] | ||||
| 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 | ||||
| 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 | [2] | ||||
| 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.
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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 | ||||
| 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 | [3] | ||||
| 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 | ||||
| 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 | [4] | ||||
| 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. | ||||
References