Study on the Safety and Effects of ONC-392 Alone and with Anti-PD-1 in Advanced Solid Tumors and Non-Small Cell Lung Cancer
Sponsor: OncoC4, Inc.
ClinicalTrials ID:NCT04140526
This clinical trial is testing a new drug, ONC-392, both by itself and in combination with another drug, pembrolizumab, to see if it is safe and effective for treating advanced solid tumors and non-small cell lung cancer (NSCLC).
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Program Overview
This study is the first time ONC-392, a new type of cancer treatment, is being tested in humans. It involves giving the drug through an IV to patients with advanced or spreading solid tumors and non-small cell lung cancer. The study will test ONC-392 alone and in combination with pembrolizumab, a drug already used to treat some cancers, to find the best dose and see how well it works.
Description
ONC-392 is a new drug designed to help the immune system fight cancer by targeting a specific protein called CTLA-4. This protein helps regulate immune cells, and blocking it can enhance the body's ability to attack cancer cells. However, treatments targeting CTLA-4 can have side effects, so this study aims to find a balance between effectiveness and safety.
The study has several parts:
- Part A: Tests different doses of ONC-392 alone in patients with various advanced solid tumors to find the best dose for future studies.
- Part B: Tests ONC-392 with a standard dose of pembrolizumab in patients with advanced solid tumors.
- Part C: Includes different groups of patients with specific types of cancer, such as pancreatic cancer, triple-negative breast cancer, and non-small cell lung cancer, to test ONC-392 alone or with pembrolizumab.
- Part D: Focuses on patients with a specific type of cancer called adenoid cystic carcinoma, testing ONC-392 alone.
- Part E: Tests ONC-392 with another drug, docetaxel, in patients with non-small cell lung cancer resistant to PD-1 treatments.
The study aims to understand how well ONC-392 works alone and in combination with other treatments, and to identify any side effects.
Eligibility Criteria
Inclusion Criteria
- Must have a confirmed diagnosis of non-small cell lung cancer or other types of advanced or spreading cancers that cannot be treated with local therapies.
- For Part A, patients with any type of advanced solid tumor are eligible.
- For Part B, patients with cancers where pembrolizumab is a standard treatment are eligible.
- For Part C, patients with specific cancers like pancreatic, breast, lung, and others are eligible.
- For Part D, patients with adenoid cystic carcinoma that has worsened within 12 months are eligible.
- Must have measurable disease according to specific medical criteria.
- Must be 18 years or older.
- Must have a good performance status, meaning they are fully active or have some restrictions but can still do light work.
- Must have adequate organ function based on blood tests.
- Must agree to participate and sign a consent form.
- Women of childbearing potential must have a negative pregnancy test.
- Must agree to use effective contraception during the study and for 90 days after the last dose.
Exclusion Criteria
- Cannot participate if they have not recovered from side effects of previous cancer treatments.
- Cannot be in another clinical trial at the same time.
- Cannot be on high doses of steroids.
- Cannot have active brain or spinal cord cancer spread.
- Cannot have an active infection requiring IV treatment within 14 days before starting the study.
- Cannot have any condition or treatment that might interfere with the study results or participation.
- Cannot have psychiatric or substance abuse issues that would affect participation.
- Cannot be pregnant or breastfeeding.
- For certain parts of the study, cannot participate if not suitable for pembrolizumab treatment.
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