Linker Information
General Information of This Linker
| Linker ID |
LIN0FTRKS
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| Linker Name |
A cleavable disulfide linker
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| Linker Type |
Unclear
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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
RG6148 [Phase 1 (discontinued)]
Identified from the Human Clinical Data
| Experiment 1 Reporting the Activity Date of This ADC | [1] | ||||
| Patients Enrolled |
Eligible participants must have ECOG 0-1, measurable HER2+ breast cancer refractory to prior therapies, and adequate organ function. Key exclusions include recent anticancer treatments (within 4 weeks), anthracycline exposure, active infections, CNS metastases, cardiac dysfunction (LVEF <50%), QTcF >470 ms, pregnancy, or uncontrolled comorbidities. The dose-expansion cohort limits prior chemotherapy regimens to two in the metastatic setting.
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| Administration Dosage |
DHES0815A will be administered via intravenous (IV) infusion on Day 1 of each 21-day cycle.
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| Related Clinical Trial | |||||
| NCT Number | NCT03451162 | Clinical Status | PHASE1 | ||
| Clinical Description |
A Phase I, Open-Label Study Evaluating the Safety, Tolerability, and Pharmacokinetics of Escalating Doses of DHES0815A in Patients With HER2-Positive Breast Cancer
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| Primary Endpoint |
The study evaluates safety outcomes including adverse events (AEs) and serious AEs (SAEs) graded per NCI CTCAE v4.0 from Day 1 to study end (up to 39 months), with severity ranging from Grade 1 (mild) to Grade 5 (fatal). Dose-limiting toxicities (DLTs) are assessed during the first 21 days, including cardiac, hematologic, and hepatic events. Treatment duration and cumulative dose are tracked, along with left ventricular ejection fraction (LVEF) changes via ECHO/MUGA scans at specified intervals.
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| Other Endpoint |
Pharmacokinetic analysis measures DHES0815A total antibody, conjugated PDB-MA, and unconjugated PDB-MA concentrations at multiple timepoints from Cycle 1 to study end (up to 39 months). Efficacy endpoints include objective response (CR/PR per RECIST v1.1), duration of response (DoR), and anti-drug antibody (ADA) incidence, with ADA-positive participants classified as treatment-induced or treatment-enhanced.
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RG6109 [Phase 1 (discontinued)]
Identified from the Human Clinical Data
| Experiment 1 Reporting the Activity Date of This ADC | [2] | ||||
| Patients Enrolled |
Eligible AML patients (excluding APL) must have ECOG 0-2 and adequate organ function. Arm A includes relapsed/refractory AML patients (≥18 years, ≤2 prior regimens), while Arm B enrolls treatment-naive patients (≥75 years or ≥65 years unfit for chemotherapy). Key exclusions include prior transplants, CNS leukemia, pulmonary diseases, recent investigational therapies, active infections (HCV/HBV/HIV), other recent malignancies, or QT prolongation risks.
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| Administration Dosage |
DCLL9718S will be administered as per the schedule specified in the respective arm.
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| Related Clinical Trial | |||||
| NCT Number | NCT03298516 | Clinical Status | PHASE1 | ||
| Clinical Description |
An Open-Label, Phase I, Dose-Escalation Study Evaluating the Safety and Tolerability of DCLL9718S in Patients With Relapsed or Refractory Acute Myeloid Leukemia (AML) or DCLL9718S in Combination With Azacitidine in Patients With Previously Untreated AML Unsuitable for Intensive Induction Chemotherapy
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| Primary Endpoint |
The study evaluates safety outcomes including adverse event rates over 3 years and dose-limiting toxicities during the first treatment cycle (21-28 days depending on arm) to determine maximum tolerated dose and recommended phase 2 dose for DCLL9718S.
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| Other Endpoint |
Pharmacokinetic parameters of DCLL9718S and azacitidine are analyzed over 3 years, including serum/plasma concentrations, AUC, Cmax, clearance, half-life, and volume of distribution. Efficacy assessments per IWG criteria measure complete remission rates (CR/CRi/CRp), overall response, duration of response, overall survival, event-free survival, progression-free survival, and anti-drug antibody development.
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References