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Monoclonal Antibodies

AB-16B5 + Docetaxel for Non-Small Cell Lung Cancer

Phase 2
Waitlist Available
Research Sponsored by Alethia Biotherapeutics
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 years
Awards & highlights

Study Summary

This trial will study a new cancer treatment for people who have failed other treatments. The new treatment is a combination of two drugs given weekly and every three weeks, respectively.

Eligible Conditions
  • Non-Small Cell Lung Cancer (Stage IV)

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Objective response rate (ORR)
Safety and tolerability of the combination of AB-16B5 and docetaxel: number of subjects with an adverse event
Secondary outcome measures
Clinical benefit rate (CBR)
Determination of plasma concentrations of AB-16B5
Duration of response (complete response and partial response)
+3 more

Side effects data

From 2014 Phase 4 trial • 32 Patients • NCT01301729
59%
Leukopenia
56%
Neutropenia
34%
Hypoaesthesia
31%
Agranulocytosis
22%
Alopecia
22%
Asthenia
19%
Pyrexia
16%
Nail disorder
16%
Oedema peripheral
16%
Diarrhoea
16%
Hypophagia
13%
Neurotoxicity
13%
Alanine aminotransferase increased
13%
Cough
13%
Vomting
9%
Headache
9%
Musculoskeletal pain
9%
Aspartate aminotransferase increased
9%
Chest discomfort
9%
Rash
9%
Pigmentation disorder
9%
Nausea
9%
Bone marrow failure
9%
Anaemia
6%
Transaminases increased
6%
Insomnia
6%
Constipation
6%
Mouth ulceration
6%
Nasopharyngitis
6%
Paronychia
6%
Flushing
6%
Face oedema
6%
Thrombocytopenia
3%
Infection
3%
Upper respiratory tract infection
3%
Completed suicide
3%
Cataract
100%
80%
60%
40%
20%
0%
Study treatment Arm
Trastuzumab

Trial Design

1Treatment groups
Experimental Treatment
Group I: Arm AB-16B5 and DocetaxelExperimental Treatment2 Interventions
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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
AB-16B5
2021
Completed Phase 2
~50
Docetaxel
FDA approved

Find a Location

Who is running the clinical trial?

Alethia BiotherapeuticsLead Sponsor
2 Previous Clinical Trials
32 Total Patients Enrolled
Julie LaurinStudy DirectorAlethia Biotherapeutics Inc.

Media Library

AB-16B5 (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT04364620 — Phase 2
Non-Small Cell Lung Cancer Research Study Groups: Arm AB-16B5 and Docetaxel
AB-16B5 (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04364620 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Have any other exploratory studies been conducted involving AB-16B5?

"As of now, the AB-16B5 drug is being studied in 320 active trials. Of these trials, 126 are currently in Phase 3 and many of them originate from Fuzhou, Fujian. However, there are 22388 sites across the world undertaking research on this medication."

Answered by AI

How many participants have signed up for this clinical research?

"Presently, this clinical trial is not actively searching for prospective patients. Initially posted on February 23rd 2021 and last updated November 9th 2022, it has been put on pause. If you are looking into alternative studies, there are 1,912 trials recruiting participants with carcinoma non-small cell lung cancer and 320 trials that require AB-16B5 recipients."

Answered by AI

What aims is this trial attempting to accomplish?

"The primary target outcome of this two-year analysis is the Objective Response Rate (ORR). Secondary metrics encompass Overall Survival (OS), Clinical Benefit Rate (CBR), and Duration of Stable Disease, as evaluated using RECIST version 1.1 guidelines."

Answered by AI

What are the safety concerns associated with AB-16B5?

"AB-16B5 achieved a safety score of 2 after our team at Power evaluated the data from this Phase 2 trial. While there is evidence to suggest that it can be considered safe, there are no studies yet confirming its efficacy."

Answered by AI

Are there still vacancies for prospective participants in this research?

"The information available from clinicaltrials.gov reveals that, while initially posted on February 23rd 2021 and most recently edited on November 9th 2022, this trial is no longer enrolling participants. Fortunately, there are 2232 other trials actively recruiting right now."

Answered by AI

Has this investigation been extended to multiple locations within the United States?

"Presently, this clinical trial is hosted across 5 centres. These are located in Montréal and Houston as well as an additional five sites. To limit the amount of travelling needed to participate, it is advised that patients aim to select a site closest them."

Answered by AI

For what is the therapeutic application of AB-16B5 most commonly prescribed?

"AB-16B5 is primarily used to combat various types of cancer, such as sarcoma and oesophageal neoplasms. It may also be employed in more general circumstances where a patient has an advanced directive."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
AB-16B5 Combined With Docetaxel in Subjects With Metastatic Non-Small Cell Lung Cancer (EGIA-002)
2021. "AB-16B5 Combined With Docetaxel in Subjects With Metastatic Non-Small Cell Lung Cancer (EGIA-002)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04364620.
~8 spots leftby Apr 2025
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