NCT03476681

Study of NEO-201 in Solid Tumors Expansion Cohorts

Phase 1/2 With Expansion Cohorts in a Study of NEO-201 in Adults With Chemo-Resistant Solid Tumors

• Status: Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 121 (estimated)
• Sponsor: Precision Biologics, Inc · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The open label, first-in-human, phase 1, dose escalation component in refractory solid tumors has been completed. The Maximum Tolerated Dose and Recommended Phase 2 Dose (RP2D) was determined to be 1.5mg/kg. The Expansion Phase of this study is currently enrolling subjects with non small cell lung cancer (NSCLC), head and neck squamous cell carcinoma (HNSCC), cervical and uterine cancers who progressed on front line therapy. Subjects will be treated with NEO-201 at the RP2D (1.5 mg/kg) every 2 weeks in combination with pembrolizumab, given 1 day after the NEO-201, at 400 mg IV every 6 weeks.

Detailed description

The experimental drug called NEO-201 (the "study drug") is a monoclonal antibody that is being tested and is not approved for use in the United States by the FDA. As stated above the RP2D was determined at 1.5 mg/kg and in the current Expansion Phase it will be administered in combination with pembrolizumab. . A safety lead in will be conducted in the first 3 to 6 subjects to evaluate toxicity prior to expanding accrual. The safety lead-in will be 42 days in length, consisting of 1 dose of pembrolizumab and 3 doses of NEO-201 followed by a 2-week assessment for safety, in subjects with any of the expansion cohorts' targeted disease types. The third patient in the safety lead in must complete the 30-day assessment (1 dose of pembrolizumab and 3 doses of NEO-201 followed by a 2-week safety evaluation) and be evaluated for toxicity prior to treating additional patients. Following completion of the lead-in, expansion cohorts will accrue subjects with NSCLC, HNSCC, cervical and uterine cancers who progress on frontline therapy.

Conditions

• Non Small Cell Lung Cancer
• Head and Neck Squamous Cell Carcinoma
• Cervical Cancer
• Uterine Cancer

Interventions

Type	Name	Description
DRUG	NEO-201 in combination with pembrolizumab	NEO-201 will be given intravenously every 2 weeks in combination with pembrolizumab. In each cycle subjects will receive 3 doses of NEO 201 and one dose of pembrolizumab.

Timeline

• Start date: 2019-01-18
• Primary completion: 2028-01-15
• Completion: 2029-01-15
• First posted: 2018-03-26
• Last updated: 2025-04-24

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated drug study