AB-16B5 Combined With Docetaxel in Subjects With Metastatic Non-Small Cell Lung Cancer (EGIA-002)
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|ClinicalTrials.gov Identifier: NCT04364620|
Recruitment Status : Recruiting
First Posted : April 28, 2020
Last Update Posted : April 21, 2021
|Condition or disease||Intervention/treatment||Phase|
|NSCLC Stage IV||Drug: AB-16B5 Drug: Docetaxel||Phase 2|
This is an open-label, single-arm, multi-center Phase II trial of AB-16B5 in combination with docetaxel in previously treated subjects with metastatic non-small cell lung cancer who have experienced disease progression following treatment with a platinum-containing doublet treatment and an anti-PD1 or PD-L1 immune checkpoint antibody, administered simultaneously or sequentially. Approximately 40 subjects will be enrolled in this trial and receive AB-16B5 at a dose of 12 mg/kg once weekly on Days 1, 8 and 15 combined with docetaxel at a dose of 75 mg/m2 once every 3 weeks on Day 1. One cycle of treatment will consist of 21 days (3 weeks). The safety profile of the AB-16B5 and docetaxel combination will be examined during a safety lead-in period with the first 8 subjects completing one cycle of treatment. No dose escalation will be performed but a decision to de-escalate the AB-16B5 dose could be made using the modified toxicity probability interval method.
Subjects will be evaluated every 6 weeks with radiographic imaging to assess response to treatment using Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria for determination of the objective response rate (ORR) and progression free survival (PFS). Paired tumor biopsies (pre-treatment and on-treatment) will be collected in all subjects. Study treatment will continue until there is evidence of disease progression, treatment-related adverse events of unacceptable severity, subject request for discontinuation or Investigator determination that further treatment is not in the subject's best interest. Treatment through progression will be allowed if the Investigator considers the subject to be clinically stable. Subjects who must discontinue docetaxel due to toxicity will continue on AB-16B5.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||40 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase II Study of AB-16B5 Combined With Docetaxel in Previously Treated Subjects With Metastatic Non-Small Cell Lung Cancer (EGIA-002)|
|Actual Study Start Date :||February 23, 2021|
|Estimated Primary Completion Date :||February 2022|
|Estimated Study Completion Date :||July 2022|
Experimental: Arm AB-16B5 and Docetaxel
AB-16B5 at a dose of 12 mg/kg once weekly on Days 1, 8 and 15 combined with docetaxel at a dose of 75 mg/m2 once every 3 weeks on Day 1.
AB-16B5 is an inhibitor of the epithelial to mesenchymal transition. It is a fully humanized monoclonal antibody of IgG2 isotype against tumor-associated secreted clusterin (TA-sCLU).
Docetaxel is an anticancer chemotherapy drug approved in the treatment of non-small cell lung cancer
- Objective response rate (ORR) [ Time Frame: 2 years ]The percentage of subjects with radiologically complete or partial response as determined by the investigator according to RECIST version 1.1.
- Safety and tolerability of the combination of AB-16B5 and docetaxel: number of subjects with an adverse event [ Time Frame: 2 years ]The number of subjects with an adverse event as a measure of safety and tolerability.
- Clinical benefit rate (CBR) [ Time Frame: 2 years ]The percentage of subjects with complete response (CR), partial response (PR) and stable disease (SD) as determined by the investigator according to RECIST version 1.1.
- Duration of response (complete response and partial response) [ Time Frame: 2 years ]The duration of complete and partial response as determined by the investigator according to RECIST version 1.1.
- Duration of stable disease [ Time Frame: 2 years ]The duration of stable disease as determined by the investigator according to RECIST version 1.1.
- Progression free survival (PFS) [ Time Frame: 2 years ]Progression free survival measured from the date of study enrolment to radiographically documented progression according to RECIST 1.1 or death from any cause (whichever occurs first).
- Overall survival (OS) [ Time Frame: 2 years ]Overall survival measured from date of study enrolment to death from any cause.
- Determination of plasma concentrations of AB-16B5 [ Time Frame: 2 years ]Noncompartmental analysis of pharmacokinetic data using standard approaches. The pharmacokinetic data may also be evaluated using a population pharmacokinetics approach.
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): NCT04364620
|Contact: Julie Laurin||514.858.7666 ext firstname.lastname@example.org|
|United States, Texas|
|The University of Texas MD Anderson Cancer Center||Recruiting|
|Houston, Texas, United States, 77030|
|Principal Investigator: Lauren A Byers, MD|
|Centre Hospitalier de l'Université de Montréal (CHUM)||Recruiting|
|Montréal, Quebec, Canada, H2X 3E4|
|Principal Investigator: Normand Blais, MD|
|Institut Universitaire de Cardiologie et de Pneumologie de Québec (IUCPQ)||Recruiting|
|Québec, Quebec, Canada, G1V 4G5|
|Principal Investigator: Catherine Labbé, MD|
|Centre Intégré de Santé et de Services Sociaux des Laurentides (Hôpital Régional de St-Jérôme)||Recruiting|
|Saint-Jérôme, Quebec, Canada, J7Z 5T3|
|Principal Investigator: Ghislain Cournoyer, MD|
|Study Director:||Julie Laurin||Alethia Biotherapeutics Inc.|