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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
All Individual Drugs Already Approved
Approved for 10 Other Conditions
No Placebo-Only Group

Summary

This trial tests AB-16B5 and docetaxel in lung cancer patients who didn't respond to previous treatments. AB-16B5 is a new drug, and docetaxel is a chemotherapy drug. The goal is to see if this combination works better for these patients.

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

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Objective response rate (ORR)
Safety and tolerability of the combination of AB-16B5 and docetaxel: number of subjects with an adverse event
Secondary study objectives
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%
Alanine aminotransferase increased
13%
Neurotoxicity
13%
Cough
13%
Vomting
9%
Musculoskeletal pain
9%
Headache
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

Awards & Highlights

All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
Approved for 10 Other Conditions
This treatment demonstrated efficacy for 10 other conditions.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

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
~7 spots leftby Dec 2025
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