Antibody Information
General Information of This Antibody
| Antibody ID | ANTI0BRIIW |
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| Antibody Name | huE22 |
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| Antigen Name | EFNA4 |
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-06647263 [Phase 1 (discontinued)]
Identified from the Human Clinical Data
| Experiment 1 Reporting the Activity Date of This ADC | [1] | ||||
| Efficacy Data | Objective Response Rate (ORR) |
10.4
8.3 % |
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| Patients Enrolled |
Eligibility criteria include advanced/metastatic solid tumors refractory to standard therapy (Part 2 focuses on triple-negative breast cancer), ECOG PS 0-1, and adequate organ function. Exclusions involve active brain metastases, recent major surgery/radiotherapy/systemic therapy, or uncontrolled infections.
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| Administration Dosage |
Part 1- PF-06647263 will be administered intravenously in either a 21 day cycle or weekly in cohorts of 2 or more patients starting at a dose of 0.015 mg/kg. Increases in dose will continue until MTD is determined.Part 2- Patients with triple negative breast cancer will be treated at the MTD or Recommended Phase 2 dose selected in Part 1.
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| Related Clinical Trial | |||||
| NCT Number | NCT02078752 | Clinical Status | PHASE1 | ||
| Clinical Description |
A FIRST-IN-HUMAN PHASE 1, DOSE ESCALATION, SAFETY AND PHARMACOKINETIC STUDY OF PF-06647263 IN ADULT PATIENTS WITH ADVANCED SOLID TUMORS
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| Primary Endpoint |
The primary outcomes include dose-limiting toxicities (DLTs) in Part 1, defined as hematologic (e.g., grade 4 neutropenia, febrile neutropenia) or non-hematologic (e.g., bilirubin increase ≥2×ULN, grade ≥3 toxicities) adverse events during the first treatment cycle, and objective response rate (ORR) in Part 2, assessed per RECIST v1.1 criteria for complete or partial response in target and non-target lesions.
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| Other Endpoint |
Secondary outcomes encompass treatment-emergent adverse events (AEs), serious AEs (SAEs), vital sign abnormalities, pharmacokinetic parameters (AUC, Cmax, Tmax, CL, Vss, t½) for PF-06647263, total antibody, and unconjugated payload, laboratory test abnormalities, immunogenicity (anti-drug antibodies), clinical benefit response (CBR), progression-free survival (PFS), and overall survival (OS) stratified by EFNA4 expression.
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| Experiment 2 Reporting the Activity Date of This ADC | [2] | ||||
| Efficacy Data | Objective Response Rate (ORR) |
10.40
9.10 % |
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| Patients Enrolled |
Advanced solid tumors resistant to standard therapy or for which no standard therapy.
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| Administration Dosage |
Every 3 weeks (Q3W) or every week (QW), following a modified toxicity probability interval (mTPI) method (initial dosing: 0.015 mg/kg Q3W).
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| Related Clinical Trial | |||||
| NCT Number | NCT02078752 | Clinical Status | Phase 1 | ||
| Clinical Description |
A first-in-human phase 1, dose escalation, safety and pharmacokinetic study of PF-06647263 in adult patients with advanced solid tumors.
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| Primary Endpoint |
Six (10.00%) patients achieved a confirmed partial response and 22 (36.70%) patients had stable disease. No correlations were observed between tumor responses and EFNA4 expression levels. Study findings showed manageable safety and favorable PK for PF-06647263 administered QW at the RP2D,with preliminary evidence of limited antitumor activity in patients with TNBC and ovarian cancer.
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| Other Endpoint |
The RP2D was determined to be 0.015 mg/kg QW.
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| Experiment 3 Reporting the Activity Date of This ADC | [3] | ||||
| Related Clinical Trial | |||||
| NCT Number | NCT02078752 | Clinical Status | Phase 1 | ||
| Clinical Description |
A first-in-human phase 1, dose escalation, safety and pharmacokinetic study of PF-06647263 in adult patients with advanced solid tumors.
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References