General Information of This Antibody
Antibody ID
ANI0AKOIB
Antibody Name
PF-06478924
Synonyms
RN926
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Antibody Type
Monoclonal antibody (mAb)
Antibody Subtype
Humanized IgG1-kappa
Antigen Name
Tumor-associated calcium signal transducer 2 (TACSTD2)
 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-06664178 [Phase 1 (discontinued)]
Identified from the Human Clinical Data
Click To Hide/Show 2 Activity Data Related to This Level
Experiment 1 Reporting the Activity Date of This ADC [1]
Patients Enrolled
Eligible patients had advanced/metastatic solid tumors refractory to standard therapy (Part 2 required NSCLC/ovarian/breast cancer with target expression), ECOG 0-1, and adequate organ function, excluding those with active CNS metastases, recent anticancer therapies, or uncontrolled infections.
Administration Dosage
Part 1 - PF-06664178 will be administered intravenously every 21 days in cohorts of 2 or more patients starting at a dose of 0.15 mg/kg. Increases in dose will continue until MTD is determined.Part 2 - patients with select tumor types (Non Small Cell Lung Cancer ovarian cancer, and breast cancer ) will be treated at the MTD selected in Part 1.
Related Clinical Trial
NCT Number NCT02122146  Clinical Status PHASE1
Clinical Description
A Phase 1, Dose Escalation Study Of Pf-06664178 In Patients With Locally Advanced Or Metastatic Solid Tumors
Primary Endpoint
The study assesses first-cycle dose-limiting toxicities (DLTs) to determine MTD, along with treatment-emergent adverse events (TEAEs) and laboratory abnormalities (hematology, chemistry, coagulation, urinalysis) monitored at multiple timepoints during cycles 1-4 and follow-up.
Other Endpoint
Key outcomes include tumor response per RECIST 1.1, immunogenicity (anti-PF-06664178 antibodies), pharmacokinetics (Cmax, AUCtau, CL, Vss, halflife for PF-06664178, total antibody, and unconjugated payload), Trop-2 expression levels, and drug accumulation ratios across all study parts.
Experiment 2 Reporting the Activity Date of This ADC [2]
Efficacy Data Objective Response Rate (ORR)
0%
Patients Enrolled
Advanced solid tumors resistant to standard therapy, or for which no other therapy was available, and at least one measurable lesion defined by Response Evaluation Criteria in Solid Tumors (RECIST version 1.1).
Administration Dosage
Once every 21 days as an intravenous infusion over approximately 60 min, doses starting from 0.15 mg/kg to 6.14 mg/kg.
Related Clinical Trial
NCT Number NCT02122146  Clinical Status Phase 1
Clinical Description
A phase 1, dose escalation study of Pf-06664178 in patients with locally advanced or metastatic solid tumors.
Primary Endpoint
In the 29 response-evaluable patients,the best overall response observed was limited to stable disease (SD) in 11 patients(37.90%) with PR or CR.
Other Endpoint
Doses explored ranged from 0.15 mg/kg to 4.80 mg/kg. Doses of 3.60 mg/kg,4.20 mg/kg and 4.80 mg/kg were considered intolerable due to DLTs. MTD and RP2D were not determined.
References
Ref 1 A Study Of PF-06664178 In Patients With Advanced Solid Tumors
Ref 2 A phase 1, dose-escalation study of PF-06664178, an anti-Trop-2/Aur0101 antibody-drug conjugate in patients with advanced or metastatic solid tumors. Invest New Drugs. 2018 Oct;36(5):836-847.