Study of NEO-201 in Solid Tumors Expansion Cohorts

Part of paid clinical trials in Bethesda, Maryland.

Sponsor
Precision Biologics, Inc
Study ID
NCT03476681
Phase
PHASE1/PHASE2
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • NEO-201 in combination with pembrolizumab — DRUG
    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.

Study Details

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.

Key Dates

Start date
Jan 18, 2019
Status verified
May 2024
Primary completion
Jan 15, 2028
Completion
Jan 15, 2029

Study Design

Enrollment
121 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: NEO-201 in combination with pembrolizumab
    Subjects will receive 3 doses NEO-201 in combination with one dose of pembrolizumab in a 42 day cycle. This course will be repeated in the absence of disease progression or unacceptable toxicity.

Primary Outcome Measure

Determine the safety of the combination of NEO-201 with pembrolizumab the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0. [ Time Frame: 1.5 years ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
National Cancer InstituteBethesdaMaryland20892
Ann McCoy, RN
[email protected]
240-760-6021
Erica Redmond, BSN,RN
[email protected]
240-858-3783
INOVA Schar Cancer InstituteFairfaxVirginia22031
Mahwish Bari
[email protected]
571-472-1796
Christina Annunziata, MD, PhD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Bethesda, MD

By condition
Cervical cancerHead and neck cancerLung cancerEndometrial cancer
By specialty
OncologyGynecologic oncologyWomen's healthENTLung oncologyLung disease
By research site
National Cancer Institute· Bethesda, MDINOVA Schar Cancer Institute· Fairfax, VA

Related Studies