NCT04364620

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

A Phase II Study of AB-16B5 Combined With Docetaxel in Previously Treated Subjects With Metastatic Non-Small Cell Lung Cancer (EGIA-002)

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 35 (actual)
• Sponsor: Alethia Biotherapeutics · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

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.

Conditions

• NSCLC Stage IV

Interventions

Type	Name	Description
DRUG	AB-16B5	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).
DRUG	Docetaxel	Docetaxel is an anticancer chemotherapy drug approved in the treatment of non-small cell lung cancer

Timeline

• Start date: 2021-02-23
• Primary completion: 2023-12-31
• Completion: 2023-12-31
• First posted: 2020-04-28
• Last updated: 2025-04-06
• Results posted: 2025-04-06

Locations

5 sites across 2 countries: United States, Canada

Regulatory

• FDA-regulated drug study