AB-16B5 Combined With Docetaxel in Subjects With Metastatic Non-Small Cell Lung Cancer (EGIA-002)

NCT04364620 | Completed Phase 2 Results FDA Drug

• 1 other identifier: AB-16B5-201
• Study Type: interventional
• Target: 35
• Locations: 2 countries
• Sites: 5

Brief Summary

This Phase II study will recruit 40 metastatic non-small cell lung cancer patients who failed treatment with a platinum-containing doublet treatment and an anti-PD1 or PD-L1 immune checkpoint antibody, administered simultaneously or sequentially. All recruited patients will receive AB-16B5 at a dose of 12 mg/kg once weekly combined with docetaxel at a dose of 75 mg/m2 once every 3 weeks.

Conditions

NSCLC Stage IV

Keywords

Lung cancer; Chemotherapy

Outcome Measures

Primary Outcomes (1)

• Objective Response Rate (ORR)

  Objective response rate (ORR) was defined as the percent of subjects documented to have a confirmed complete response (CR) or partial response (PR) as per RECIST 1.1 where Complete Response (CR): disappearance of all target lesions; Partial Response (PR): at least a 30% decrease in the sum of diameters of target lesions.

  Every 6 weeks until the date of objectively documented progression for up to 2 years.

Secondary Outcomes (6)

• Clinical Benefit Rate (CBR)

  Every 6 weeks until the date of objectively documented progression for up to 2 years.

• Duration of Response (DOR)

  Every 6 weeks until the date of objectively documented progression for up to 2 years.

• Duration of Clinical Benefit

  Every 6 weeks until the date of objectively documented progression for up to 2 years.

• Duration of Stable Disease

  Every 6 weeks until the date of objectively documented progression for up to 2 years.

• Progression Free Survival (PFS)

  Every 6 weeks until the date of objectively documented progression for up to 2 years.

Study Arms (1)

Arm AB-16B5 and Docetaxel

EXPERIMENTAL

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.

Drug: AB-16B5; Drug: Docetaxel

Interventions

AB-16B5 DRUG

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).

Arm AB-16B5 and Docetaxel

Docetaxel DRUG

Docetaxel is an anticancer chemotherapy drug approved in the treatment of non-small cell lung cancer

Arm AB-16B5 and Docetaxel

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subjects (male or non-pregnant female) must be ≥ 18 years of age on the day of signing the informed consent.
• Subjects with a histologically or cytologically confirmed diagnosis of (Stage III-IV) non-small cell lung cancer (NSCLC) and with at least one measurable lesion defined by RECIST 1.1.
• Subjects must have experienced a disease progression following treatment with an anti-PD1 or PD-L1 immune checkpoint antibody and a platinum-containing doublet treatment, administered simultaneously or sequentially.
• Subjects with a targetable driver mutation in EGFR or ALK gene will be allowed on trial after failing all available targeted therapies and having experienced a disease progression following treatment with an anti-PD1 or PD-L1 immune checkpoint antibody and a platinum-containing doublet treatment, administered simultaneously or sequentially.
• Subjects must have adequate organ and immune function
• Subjects must have a tumor lesion amenable for biopsies with no contraindication for biopsy.
• Subjects must have an Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 2.
• Subjects must have a life expectancy of at least 3 months.
• Subjects must have recovered from the toxic effects resulting from the most recent cancer treatment to Grade 1 or less. If the subjects underwent major surgery or received radiation therapy, they must have recovered from the complications and/or toxicity.
• Female subjects of childbearing potential must have a negative serum pregnancy test within 72 hours prior to the first dose of study treatment.
• Subjects (both male and female) of reproductive potential must be willing to practice highly effective methods of contraception throughout the study and for up to 90 days after the last dose of study medication. Abstinence is acceptable if this is the subject's usual lifestyle.
• Female subjects are not considered of childbearing potential if they have a history of surgical sterility or evidence of post-menopausal status defined as any of the following:
• ≥ 45 years of age and has not had menses for more than 2 years.
• Amenorrhoeic for less than 2 years without hysterectomy and oophorectomy and a follicle stimulating hormone (FSH) value in the postmenopausal range at screening.
• Post hysterectomy, oophorectomy or tubal ligation. Documented hysterectomy or oophorectomy must be confirmed with medical records of the actual procedure or by ultrasound. Tubal ligation must be confirmed with medical records of the actual procedure.

You may not qualify if:

• Subjects who have received prior therapy with AB-16B5.
• Subjects who have received prior therapy with docetaxel for the treatment of NSCLC.
• Subjects who are currently participating or has participated in a study of an investigational agent or using an investigational device within 21 days prior to the first dose of study treatment. The 21-day window should be calculated using the last dose of an antineoplastic investigational agent or last use of an investigational device with antineoplastic intent.
• Subjects who have received any anti-cancer treatment within 3 weeks or radiation therapy within 2 weeks prior to receiving the first dose of study treatment or who have not recovered from adverse events to Grade 1 or less. Subjects with alopecia are eligible to participate.
• Subjects who are expected to require any other form of systemic or localized antineoplastic therapy while on the trial. This includes maintenance therapy with another agent or radiation therapy.
• Subjects who are receiving a dose \> 10 mg/day of prednisone (or equivalent) within 7 days prior to the first dose of study treatment or any other form of immunosuppressive medication (corticosteroid pre-treatment and/or post-treatment of docetaxel is allowed).
• Subjects who require treatment with a strong CYP3A4 inhibitor (e.g., ketoconazole, itraconazole, clarithromycin, atazanavir, indinavir, nefazodone, nelfinavir, ritonavir, saquinavir, telithromycin and voriconazole). Subjects may be included if there is an alternate treatment with a weak CYP3A4 inhibitor and they are willing to change at least 7 days prior to the first dose of study treatment.
• Subjects who have another malignancy that is progressing or requires active treatment. Exceptions include basal cell carcinoma of the skin, squamous cell carcinoma of the skin or in situ cervical cancer.
• Subjects who have known active central nervous system metastases and/or carcinomatous meningitis. Subjects with previously treated brain metastases may participate if they have been clinically stable for at least 2 weeks prior to the first dose of study treatment, if they have no evidence of new or enlarging brain metastases and if they are not receiving a dose \> 10 mg/day of prednisone (or equivalent) within 7 days prior to the first dose of study treatment.
• Subjects with clinically significant ECG abnormalities.
• Subjects who have received or will receive a live vaccine within 30 days prior to the first dose of study treatment.
• Subjects with a known history of human immunodeficiency (HIV).
• Subjects with an active Hepatitis B or C infection.
• Subjects with an active infection requiring antibiotic therapy.
• Subjects with a known history of alcohol or other substance abuse within the last year.

Sponsors & Collaborators

• Alethia Biotherapeutics: lead

Study Sites (5)

The University of Texas MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Hôpital Maisonneuve-Rosemont

Montreal, Quebec, H1T 2M4, Canada

Location

Centre Hospitalier de l'Université de Montréal (CHUM)

Montreal, Quebec, H2X 3E4, Canada

Location

Institut Universitaire de Cardiologie et de Pneumologie de Québec (IUCPQ)

Québec, Quebec, G1V 4G5, Canada

Location

Centre Intégré de Santé et de Services Sociaux des Laurentides (Hôpital Régional de St-Jérôme)

Saint-Jérôme, Quebec, J7Z 5T3, Canada

Location

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung; Lung Neoplasms

Interventions

Docetaxel

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes

Results Point of Contact

• Title: Dr. Julie Laurin, Vice-President, Drug Development
• Organization: Alethia Biotherapeutics ULC

julie.laurin@alethiabio.com

514-581-8125

Study Officials

• Julie Laurin

  Alethia Biotherapeutics Inc.

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 23, 2020
• First Posted: April 28, 2020
• Study Start: February 23, 2021
• Primary Completion: December 31, 2023
• Study Completion: December 31, 2023
• Last Updated: April 6, 2025
• Results First Posted: April 6, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1); CA (4)