Antibody-drug Conjugate Information
General Information of This Antibody-drug Conjugate (ADC)
| ADC ID |
DRG0OMORU
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| ADC Name |
FZ-AD004
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| Synonyms |
FZ-AD004; F0040
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| Organization |
Fudan-Zhangjiang Bio-Pharmaceutical (Originator)
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| Drug Status |
Phase 1
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| Structure |
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| Antibody Name |
Anti-TROP2 antibody
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Antibody Info | ||||
| Antigen Name |
Tumor-associated calcium signal transducer 2 (TACSTD2)
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Antigen Info | ||||
| Payload Name |
DXd
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Payload Info | ||||
| Payload Target |
DNA topoisomerase 1 (TOP1)
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Target Info | ||||
| Linker Name |
Mc-Val-Ala-PABC double self-immolative linker
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Linker Info | ||||
| Conjugate Type |
Random Cysteines
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| Combination Type |
BB05
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2027 Update
The indication landscape of This ADC
2027 Update
The clinical trial pipelines of This ADC
| Indication | Phase 1 | Phase 2 | Phase 3 | Approved | ||
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| Unspecific solid tumor |
1 Trials
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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 | [1] | ||||
| Patients Enrolled |
This study is one single group of participants with advanced solid tumors.
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| Administration Dosage |
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| Related Clinical Trial | |||||
| NCT Number | NCT05914545 | Clinical Status | Phase 1 | ||
| Clinical Description | This study is one single group of participants with advanced solid tumors. It is the first time the drug has been used in humans. There will be two parts including Dose Escalation and Dose Expansion to evaluate the safety, tolerability, pharmacokinetics, and clinical activity of FZ-AD004. | ||||
| Experiment 2 Reporting the Activity Date of This ADC | [2] | ||||
| Patients Enrolled |
Eligible patients (aged 18-75, ECOG 0-1) must have advanced solid tumors, measurable lesions per RECIST 1.1, and ≥12-week life expectancy. Exclusions include recent major surgery (within 4 weeks), active CNS metastases, prior malignancies (5 years), steroid use (within 2 weeks), pregnancy/lactation, or conditions compromising study integrity. Contraception is required during and post-treatment.
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| Administration Dosage |
Dose Escalation:Subjects will receive an intravenous infusion of FZ-AD004 in a dose escalation until confirmed progression, unaccepted toxicity, or any criterion for withdrawal from the study. Dose Expansion:Subject will receive a single dose of FZ-AD004 at 1-2 dose level on Day1 of each cycles.
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| Related Clinical Trial | |||||
| NCT Number | NCT05914545 | Clinical Status | PHASE1 | ||
| Clinical Description | A PhaseIStudy to Evaluate the Safety, Tolerability, Pharmacokinetics and Efficacy of FZ-AD004 in Patients with Advanced Solid Tumors | ||||
| Primary Endpoint |
The primary objectives are to assess DLT (within 21 days of first cycle), determine MTD/RDEs, and monitor AE incidence throughout the trial. Secondary efficacy endpoints include ORR (CR + PR per RECIST 1.1), PFS (time from first dose to PD/death), DoR (response duration from CR/PR to PD), and OS (time from first dose to death), evaluated over 60 months.
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| Other Endpoint |
Pharmacokinetic analyses focus on t1/2, Cmax, AUC (0-∞), and Tmax measurements for Total Antibody, Free DXd, and FZ-AD004 over 17 weeks. Immunogenicity is assessed via ADA detection. Key efficacy outcomes include PFS (time to PD/death), DoR (duration of response), and OS (time to death), all evaluated over 60 months per RECIST 1.1.
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References