Linker Information
General Information of This Linker
| Linker ID |
LIN0UGIEB
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| Linker Name |
An acid-cleavable linker
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| Antibody-Linker Relation |
Cleavable
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Each Antibody-drug Conjugate Related to This Linker
Full Information of The Activity Data of The ADC(s) Related to This Linker
FDA018 [Phase 3]
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
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| 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
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| 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.
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References