Antibody Information
General Information of This Antibody (ID: ANTI0GDFDN)
| Antibody Name | hu28 |
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| Antigen Name | Notch-3 |
Antigen Info | ||||
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Each Antibody-drug Conjugate Related to This Antibody
Full Information of The Activity Data of The ADC(s) Related to This Antibody
PF-06650808 [Phase 1 (discontinued)]
Identified from the Human Clinical Data
| Experiment 1 Reporting the Activity Date of This ADC | [1] | ||||
| Patients Enrolled |
Inclusion requires advanced/metastatic solid tumors resistant to standard therapy or TNBC with Notch3 expression, measurable lesions, and organ function. Exclusion includes recent surgery/radiation (4 weeks), symptomatic brain metastases needing steroids, or prior same-mechanism treatment.
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| Administration Dosage |
Dose Escalation Phase [Part 1] - PF-06650808 will be administered at doses starting at 0.2 mg/kg. Increases in dose will continue until MTD is determined.Dose Expansion Phase [Part 2] - Patients will be treated at the MTD or Recommended Phase 2 dose selected in Part 1.
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| Related Clinical Trial | |||||
| NCT Number | NCT02129205 | Clinical Status | PHASE1 | ||
| Clinical Description |
A PHASE 1 DOSE ESCALATION STUDY EVALUATING THE SAFETY AND TOLERABILITY OF PF-06650808 IN PATIENTS WITH ADVANCED SOLID TUMORS
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| Primary Endpoint |
This section defines Dose-limiting Toxicities (DLT) assessed during Part 1 over 21 days, categorized into hematologic (Grade 4 neutropenia >7 days, febrile neutropenia, thrombocytopenia with bleeding) and non-hematologic (Grade ≥3 toxicities, treatment delays >2 weeks). It also outlines Objective Response criteria (complete/partial response) based on RECIST v1.1 for Part 1 and 2, covering target/non-target lesion assessments every 6 weeks until progression or 3 years.
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| Other Endpoint |
This segment details Treatment-Emergent Adverse Events (TEAEs) over 3 years, including serious AEs (death, hospitalization, disability), lab abnormalities (hematology, chemistry, urinalysis), and vital signs criteria (BP, pulse rate). Pharmacokinetic parameters (Cmax, Tmax, AUCtau, CL, Vss, t1/2) for ADC components are provided, along with anti-drug antibody (ADA) testing and survival metrics (PFS, OS) for Part 2.
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| Experiment 2 Reporting the Activity Date of This ADC | [2] | ||||
| Efficacy Data | Objective Response Rate (ORR) |
9.68
16.67 21.43 % |
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| Patients Enrolled |
Locally advanced/metastatic solid tumors resistant to standard therapy or with no available standard therapy; Eastern Cooperative Oncology Group (ECOG) performance score (PS) 01; a life expectancy 12 weeks; and adequate bone marrow, hepatic, and renal function.
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| Administration Dosage |
Intravenously every 3 weeks (Q3W) starting at a dose of 0.20 mg/kg to be escalated up to 6.40 mg/kg, following the modified continual reassessment method (mCRM).
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| Related Clinical Trial | |||||
| NCT Number | NCT02129205 | Clinical Status | Phase 1 | ||
| Clinical Description |
A phase 1 dose escalation study evaluating the safety and tolerability of PF-06650808 In patients with advanced solid tumors.
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| Primary Endpoint |
OrR=9.68% for all response-evaluable patients (N=3/31), ORR=16.67% for patients with breast cancer (N=3/18), ORR=21.43% for patients with ER+ breast cancer (N=3/14). Five patients with advanced BC achieved PR as best overall response (BOR): 2 at 2.0 mg/kg, 1 at 2.4 mg/kg, and 2 at 3.6 mg/kg.
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| Other Endpoint |
The maximum tolerated dose (MTD) was estimated to be 2.40 mg/kg.
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| Experiment 3 Reporting the Activity Date of This ADC | [3] | ||||
| Related Clinical Trial | |||||
| NCT Number | NCT02129205 | Clinical Status | Phase 1 | ||
| Clinical Description |
A phase 1 dose escalation study evaluating the safety and tolerability of PF-06650808 in patients with advanced solid tumors.
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References