Study on the Safety and Effectiveness of AI-081, a New Antibody Treatment for Advanced Solid Tumors
Sponsor: OncoC4, Inc.
ClinicalTrials ID:NCT06635785
This clinical trial is testing a new treatment called AI-081, which is designed to target and block two proteins, PD-1 and VEGF, that help cancer cells grow. The study aims to find out if AI-081 is safe and effective for people with advanced solid tumors.
Patient Parameters
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Program Overview
The BIPAVE-001 study is a clinical trial that is testing a new treatment called AI-081 for people with advanced solid tumors. AI-081 is a special type of antibody that targets two proteins, PD-1 and VEGF, which are involved in cancer growth. The study is divided into two parts: the first part is to find the best dose of AI-081 to use, and the second part is to see how well it works, either alone or with other standard treatments.
Description
AI-081 is a new type of treatment called a bispecific antibody, which means it can target two different proteins at once. In this study, AI-081 is being tested to see if it can help treat advanced solid tumors by blocking the proteins PD-1 and VEGF, which help cancer cells grow. The study has two main parts:
- Part A: This is the first time AI-081 is being tested in humans. The goal is to find the best dose to use in future studies.
- Part B: This part will test the safety and effectiveness of AI-081 at the best dose found in Part A, and one lower dose, either by itself or with other standard cancer treatments.
Participants in the study will receive AI-081 and will be monitored closely to see how their cancer responds and to check for any side effects.
Eligibility Criteria
Inclusion Criteria
- Must be 18 years or older.
- Can be male or female, but women who can have children must have a negative pregnancy test.
- Must be in good overall health, with a performance status score of 0 or 1, meaning fully active or restricted in physically strenuous activity but ambulatory.
- Must have a confirmed diagnosis of advanced solid tumors that have spread or cannot be removed by surgery.
- Must have at least one tumor that can be measured using standard criteria.
- Must have good organ function as shown by specific lab tests.
- Must agree to participate by signing a consent form.
- Women who can have children must agree to use effective birth control during the study and for 90 days after the last dose.
- Men must agree to use effective birth control during the study and for 90 days after the last dose.
Exclusion Criteria
- Cannot have any side effects from previous cancer treatments that are not resolved to a mild level, except for certain conditions like hair loss or mild nerve damage.
- Cannot be participating in another clinical trial or receiving other cancer treatments during the study.
- Cannot be on high doses of steroids or have brain or spinal cord cancer spread.
- Cannot have another type of cancer that required treatment in the last two years.
- Cannot have severe allergies or reactions to medications or infusions.
- Cannot have had recent serious heart problems, strokes, or other major health issues.
- Cannot have active infections needing treatment within two weeks before starting the study.
- Cannot have any condition that might interfere with the study or make participation unsafe.
- Cannot have mental health or substance abuse issues that would affect participation.
- Cannot be pregnant, breastfeeding, or planning to become pregnant or father a child during the study or within six months after.
- Cannot have tumors that are too close to important blood vessels or organs, or have a high risk of bleeding.
- Cannot have uncontrolled high blood pressure or certain heart or lung conditions.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| University of Florida UF Health Cancer Center | 32610 | Gainesville | Florida |
| Ocala Oncology Center PL DBA Florida Cancer Affiliates | 34474 | Ocala | Florida |
| AdventHealth Cancer Institute | 32804 | Orlando | Florida |
| Norton Cancer Center | 40202 | Louisville | Kentucky |
| Univeristy of Michigan Rogel Cancer Center | 48109 | Ann Arbor | Michigan |
| The Tisch Cancer Institute, Mount Sinai Medical Center | 10029 | New York | New York |
| University of North Carolina at Chapel Hill Cancer Center | 27599 | Chapel Hill | North Carolina |
| The Ohio State University James Cancer Center | 43210 | Columbus | Ohio |
| University of Pittusburgh Hillman Cancer Center | 15213 | Pittsburgh | Pennsylvania |
| Prisma Health | 29605 | Greenville | South Carolina |
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