HuMax-AXL-ADC Safety Study in Patients With Solid Tumors
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|ClinicalTrials.gov Identifier: NCT02988817|
Recruitment Status : Recruiting
First Posted : December 9, 2016
Last Update Posted : November 28, 2018
|Condition or disease||Intervention/treatment||Phase|
|Ovarian Cancer Cervical Cancer Endometrial Cancer Non Small Cell Lung Cancer Thyroid Cancer Melanoma Sarcoma||Biological: HuMax-AXL-ADC||Phase 1 Phase 2|
The trial consists of two parts; a dose escalation part (phase I, first in- human (FIH)) and an expansion part (phase IIa).
The dose escalation part has two dose escalation arms: the first arm investigates a once every 3 weeks (1Q3W) dosing schedule and the second arm investigates a three administrations over 4 weeks (3Q4W) dosing schedule.
The Expansion part of the trial will further explore the recommended phase 2 dose and dosing regimens of HuMax-AXL-ADC as determined in Part 1
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||292 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||First-in-human, Open-label, Dose-escalation Trial With Expansion Cohorts to Evaluate Safety of Axl-specific Antibody-drug Conjugate (HuMax®-AXL-ADC) in Patients With Solid Tumors|
|Actual Study Start Date :||December 2016|
|Estimated Primary Completion Date :||February 2021|
|Estimated Study Completion Date :||June 2021|
All arms of the trial (both in escalation and expansion phase) will be administered HuMax-AXL-ADC
All arms of the trial (both in escalation and expansion phase) will be administered (HuMax-AXL-ADC)
- Dose Limiting Toxicities (DLTs) [ Time Frame: Dose Limiting Toxicities will be assessed from first treatment cycle (3 or 4 weeks) ]As this is a phase I trial the main objective is to assess the recommended phase 2 dose of HuMax-AXL-ADC
- Adverse events (AEs) [ Time Frame: At end of trial (up to 24 months) ]As this is a phase I trial the main objective is to assess the safety and tolerability of HuMax-AXL-ADC throughout the treatment periods of the patients participating in the trial.
- Pharmacokinetic (PK) parameters, Cmax [ Time Frame: At end of trial (up to 10 months) ]
- Anti-tumor activity measured by tumor shrinkage (based on computerized tomography [CT]-scan evaluations), change in Cancer Antigen (CA) 125. [ Time Frame: At end of trial (up to 12 months) ]
- Pharmacokinetic (PK) parameters, AUC [ Time Frame: At end of trial (up to 10 months) ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02988817
|Contact: Mika Bohlbro||+45 3377 firstname.lastname@example.org|
Show 33 Study Locations
|Principal Investigator:||Ignace Vergote, Professor||Universitair Ziekenhuizen Leuven|