Study of NEO-201 in Solid Tumors Expansion Groups
Sponsor: Precision Biologics, Inc
ClinicalTrials ID:NCT03476681
This clinical trial is testing a new drug called NEO-201, combined with pembrolizumab, in patients with certain advanced cancers that have not responded to initial treatments. The study aims to find out if this combination can help control the cancer.
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Program Overview
This study is exploring the use of a new drug, NEO-201, in combination with pembrolizumab, for treating patients with advanced non-small cell lung cancer, head and neck cancer, cervical cancer, and uterine cancer. These patients have cancers that have not responded to standard treatments. NEO-201 will be given every two weeks, and pembrolizumab will be given every six weeks. The study is currently enrolling patients to see if this combination can help manage their cancer.
Description
NEO-201 is an experimental drug that is not yet approved by the FDA. It is being tested in combination with pembrolizumab to see if it can help treat certain advanced cancers. The study is in its expansion phase, meaning it is now enrolling more patients to further test the treatment's effectiveness and safety.
Initially, a small group of 3 to 6 patients will receive the treatment to ensure it is safe. This involves one dose of pembrolizumab and three doses of NEO-201 over 42 days, followed by a safety assessment. If this phase is successful, more patients with the specified cancers will be enrolled to receive the treatment.
The study is open to patients with advanced non-small cell lung cancer, head and neck cancer, cervical cancer, and uterine cancer that have progressed after initial treatments. The goal is to determine if the combination of NEO-201 and pembrolizumab can help control these cancers.
Eligibility Criteria
Inclusion Criteria
- Must be 18 years or older.
- Have a confirmed diagnosis of advanced non-small cell lung cancer, head and neck cancer, cervical cancer, or uterine cancer that has progressed after standard treatments.
- Tumor must show a specific marker called NEO-201 antigen.
- Not eligible for surgery or radiation that could cure the cancer.
- For non-small cell lung cancer, tumors must have certain genetic features or have been treated with specific drugs before.
- For cervical cancer, tumors must have a certain score or genetic features.
- For head and neck cancer, previous treatment with pembrolizumab is allowed.
- For uterine cancer, must have tried a specific drug combination unless unsafe.
- Must provide a tumor sample for testing.
- Must have measurable disease.
- Must give informed consent to participate.
- Must have a performance status that allows for daily activities.
- Must have adequate blood counts and organ function.
- Must have recovered from previous treatments.
- Must agree to use birth control during and after the study.
Exclusion Criteria
- Have uncontrolled brain metastases or central nervous system disease.
- Have allergies to similar drugs as NEO-201 or pembrolizumab.
- Have had major surgery within 14 days before joining the study.
- Are taking other experimental drugs.
- Cannot provide a tumor sample or are unwilling to undergo a biopsy.
- Have uncontrolled illnesses like infections, diabetes, or heart problems.
- Are at high risk of infection due to low white blood cell counts.
- Are HIV-positive and on antiretroviral therapy.
- Have other serious medical or psychiatric conditions.
- Are pregnant or breastfeeding.
Additional criteria for those receiving pembrolizumab:
- Have an immune deficiency or are on high-dose steroids or immunosuppressive drugs.
- Have an active autoimmune disease needing treatment in the past 2 years.
- Have had severe immune-related side effects from previous treatments.
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