Dose-escalation Study of Lupartumab Amadotin (BAY1129980)
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|ClinicalTrials.gov Identifier: NCT02134197|
Recruitment Status : Terminated
First Posted : May 9, 2014
Last Update Posted : December 24, 2018
The purpose of this study is to evaluate:
- The side effects of BAY1129980 when given every 21 days different dose levels.
- Determine the dose level of BAY1129980 that should be tested in future clinical research studies.
- Measure how much BAY1129980 is in the blood at specific times after administration.
- If treatment with BAY1129980 shows any effect on reducing the tumor growth.
- If there are specific biomarkers that might be able to explain why some patients respond to treatment and others do not.
- If treatment with BAY1129980 causes an immune response from the body against the drug (immunogenicity).
|Condition or disease||Intervention/treatment||Phase|
|Neoplasms||Drug: Lupartumab Amadotin (BAY1129980)||Phase 1|
The relatively restricted C4.4a expression pattern provides a target for the selective delivery of a cytotoxic drug to C4.4.a-expressing tumor cells by means of a suitable antibody-drug conjugate. The subject population eligible for the current study will be those subjects with advanced malignancies known to express C4.4a, which are refractory to standard therapy or those without standard therapy or actively refusing any treatment, which would be regarded as standard and in whom, in the opinion of the investigator, experimental therapy with BAY1129980 may be beneficial.Depending on the number of dose-escalating steps and the occurrence of DLTs, the planned numbers of subjects could vary.It is expected that up to 90 subjects may participate in the dose-expansion phase of the study and up to 6-9 subjects may particpate in the dose re-esclation phase.The study assessments in the expansion phase of the study are identical to those in the dose-escalation phase.
Amendment # 3 includes changes to DLT criteria (hematological and non-hematological) and allows for frequent follow-up for subjects experiencing drug-related liver toxicity that warrants dose reduction or dose interruptions.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||70 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||An Open-label Phase I Dose-escalation Study to Evaluate the Safety, Tolerability, Maximum Tolerated Dose, Pharmacokinetics, and Pharmacodynamics of the Anti-C4.4a Antibody Drug Conjugate BAY1129980 in Subjects With Advanced Solid Tumors Known to Express C4.4a|
|Actual Study Start Date :||May 22, 2014|
|Actual Primary Completion Date :||August 30, 2018|
|Actual Study Completion Date :||August 30, 2018|
Experimental: Lupartumab Amadotin (BAY1129980)
Dose escalation with consecutive expansion at MTD (maximum tolerated dose) with BAY1129980.
Drug: Lupartumab Amadotin (BAY1129980)
Starting dose is 0.15mg/kg intravenous (I.V.) administration every 21 days.
- Maximum tolerated dose (MTD) [ Time Frame: 21 days ]MTD is defined as the maximum dose at which the incidence of DLTs (dose limiting toxicities) during Cycle 1 is below 20%, or the maximum dose administered, whichever is achieved first during dose escalation.
- Number of participants with adverse events as a measure of safety and tolerability [ Time Frame: Up to 2 years ]
- C4.4a expression levels in tumour tissue as measured by immunohistochemistry (IHC) [ Time Frame: Baseline ]
- Tumor response evaluation following RECIST 1.1 criteria [ Time Frame: Up to 2 years ]
- Plasma concentration of BAY1129980 characterized by AUC (0-tlast) [ Time Frame: 2 years ]
- Antidrug and antibody titer [ Time Frame: Baseline and up to 2 years ]
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): NCT02134197
|United States, California|
|La Jolla, California, United States, 92093|
|Stanford, California, United States, 94305|
|United States, Colorado|
|Aurora, Colorado, United States, 80045|
|United States, District of Columbia|
|Washington, District of Columbia, United States, 20007-2197|
|United States, Georgia|
|Gainesville, Georgia, United States, 32610|
|United States, Kansas|
|Westwood, Kansas, United States, 66205|
|United States, New Jersey|
|Hackensack, New Jersey, United States, 07601|
|United States, New York|
|Buffalo, New York, United States, 14263|
|New York, New York, United States|
|United States, North Carolina|
|Durham, North Carolina, United States, 27710|
|United States, Pennsylvania|
|Philadelphia, Pennsylvania, United States, 19104|
|United States, Tennessee|
|Nashville, Tennessee, United States, 37203|
|United States, Texas|
|Dallas, Texas, United States, 75230|
|Houston, Texas, United States, 77030|
|United States, Washington|
|Seattle, Washington, United States, 98109-1023|
|Edmonton, Alberta, Canada, T6G 1Z2|
|Hamilton, Ontario, Canada, L8V 5C2|
|London, Ontario, Canada, N6A 4L6|
|Study Director:||Bayer Study Director||Bayer|