Antibody-drug Conjugate Information
General Information of This Antibody-drug Conjugate (ADC)
| ADC ID |
DRG0PEVVH
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| ADC Name |
FDA018
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| Synonyms |
FDA018; FDA018-ADC; F0024
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| Organization |
Fudan-Zhangjiang Bio-Pharmaceutical (Originator)
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| Drug Status |
Phase 3
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| Drug-to-Antibody Ratio |
7.6
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| Antibody Name |
Anti-Trop-2 mAb
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Antibody Info | ||||
| Antigen Name |
Tumor-associated calcium signal transducer 2 (TACSTD2); Programmed cell death 1 ligand 1 (PD-L1)
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Antigen Info | ||||
| Payload Name |
SN-38
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Payload Info | ||||
| Therapeutic Target |
DNA topoisomerase 1 (TOP1)
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Target Info | ||||
| Linker Name |
An acid-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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| Breast cancer |
1 Trials
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1 Trials
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| Colorectal cancer |
1 Trials
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| Endometrial cancer |
1 Trials
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| Gastric cancer |
1 Trials
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| Lung cancer |
1 Trials
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| Oesophageal cancer |
1 Trials
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| Ovarian cancer |
1 Trials
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| Unspecific solid tumor |
1 Trials
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| Urothelial cancer |
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 |
Key eligibility: Adults with taxane-pretreated TNBC (ER/PR<1%, HER2-negative) eligible for ICC chemotherapy (ECOG 0-1, measurable lesions per RECIST 1.1). Exclusions: active CNS metastases, prior TROP-2/topoisomerase I inhibitors, HIV/HBV/HCV positivity, recent anti-tumor treatments (4 weeks), major surgery (4 weeks), or pregnancy. Requires adequate organ function and tumor tissue availability.
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| Administration Dosage |
Subjects will receive FDA018-ADC 10 mg/kg of body weight via intravenous (IV) infusion on Day1 and 8 of a 21-day cycle in follow-up period until disease progression, unacceptable toxicity or death.
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| Related Clinical Trial | |||||
| NCT Number | NCT06519370 | Clinical Status | PHASE3 | ||
| Clinical Description | A Phase 3, Open-label, Randomised Study of FDA018-ADC Versus Investigator's Choice of Chemotherapy in Patients Who Recurred During or After Taxane Therapy in Locally Advanced or Metastatic Triple-negative Breast Cancer | ||||
| Primary Endpoint |
Primary endpoints assess PFS (time from randomization to progression per RECIST 1.1 by BICR or death) and OS (time to death from any cause) over 24 months in TNBC patients.
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| Other Endpoint |
Secondary objectives include investigator-assessed PFS, ORR (confirmed CR/PR rates), DoR (response duration), DCR (CR+PR+SD rates), treatment-emergent AEs (CTCAE v5.0 graded), and immunogenicity (ADA presence) for FDA018-ADC, all evaluated over 24 months.
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| Experiment 2 Reporting the Activity Date of This ADC | [2] | ||||
| Patients Enrolled |
Key eligibility: Adults (18-75) with advanced solid tumors (TNBC/UC/NSCLC/SCLC/etc.) refractory to standard therapy (ECOG 0-1, measurable disease per RECIST 1.1). Exclusions: prior Trop-2 therapy, irinotecan hypersensitivity, uncontrolled comorbidities (cardiac/respiratory/diabetes), active infections (HBV/HCV/HIV), recent anti-tumor treatments (4 weeks), major surgery (4 weeks), or pregnancy. Requires adequate organ function and tumor tissue availability.
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| Administration Dosage |
FDA018-ADC will be administered via IV infusion on Day 1, 15 and 22 of a 35-Day cycle (Cycle 1) and on Day 1, 15 and 22 of a 35-Day cycle (Cycle 1) and on Day 1 and 8 of a 21-day cycle (Cycle 2 ~ Cycle 5) in dose escalation phase, and on Day 1 and 8 of a 21-day cycle (Cycle 1 ~ Cycle 6) in dose expansion phase, and Day 1 and 8 of a 21-day cycle in follow-up period until disease progression, unacceptable toxicity or death.
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| Related Clinical Trial | |||||
| NCT Number | NCT05174637 | Clinical Status | PHASE1 | ||
| Clinical Description | A PhaseIStudy to Evaluate the Safety, Tolerability, Pharmacokinetics and Efficacy of FDA018-ADC in Patients with Advanced Solid Tumors | ||||
| Primary Endpoint |
Primary objectives evaluate dose-limiting toxicity (DLT) per NCI CTCAE v5.0 and determine maximum tolerated dose (MTD) within 35 days post-first dose, where MTD is defined as the highest dose level below which ≥2/3-6 patients experience DLTs attributable to FDA018.
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| Other Endpoint |
Secondary endpoints assess pharmacokinetics (Tmax, t1/2, Cmax, AUC for Total Antibody/SN-38 metabolites/FDA018-ADC over 17 weeks), immunogenicity (ADA detection via ELISA up to 60 months), and efficacy (ORR, PFS, DOR, OS per RECIST 1.1 over 60 months).
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| Experiment 3 Reporting the Activity Date of This ADC | [3] | ||||
| Related Clinical Trial | |||||
| NCT Number | NCT05174637 | Clinical Status | Phase 1 | ||
| Clinical Description | A phase study to evaluate the safety, tolerability, pharmacokinetics and efficacy of FDA018-ADC in patients with advanced solid tumors. | ||||
References