Study to evaluate the efficacy and safety of the new drug INCA33890 in patients with cancer - Part 1a "At progressive dose"

Résumé de l'étude

In this study, we evaluate the efficacy of the tested substance, INCA33890, and we check whether it is effective, well tolerated, and safe. The main objective of this study is to evaluate the side effects and reactions that the tested substance may cause in your body. Therefore, different doses will be evaluated in this study to determine a safe and tolerable dose. The goal is also to understand how the tested substance spreads in your body and to obtain a preliminary indication of its efficacy in treating certain advanced and metastatic cancers. Your participation in this study could last up to 28 days for selection, followed by continuous treatment lasting up to 2 years, followed by 30 (+ 7) and 90 (+ 14) days for safety follow-up visits. We will invite you to make about 55 study visits (calculated for two years). An appointment lasts about 2 to 6 hours (depending on the examinations performed). In the first part, participants will receive INCA33890 at an initial dose defined by the protocol. If this dose is well tolerated, other groups of participants will receive an increased dose of INCA33890. The dose that the participant will receive will depend on (a) when the participant is included in the study and (b) the side effects that have been observed in participants included earlier in the study. The objective of this first part is to determine the highest dose(s) that participants in the INCA33890 study can take with the least possible side effects. In the second part of the study, participants will receive INCA33890 at the dose that has been determined to be safe and effective during the first part of the study. The objectives of this second part of the study are to obtain more information about the safety of INCA33890 and how it treats the tumor.

(BASEC)

Intervention étudiée

The study will be divided into 2 parts:

• in the first part, participants will receive INCA33890 at an initial dose defined by the protocol. If this dose is well tolerated, other groups of participants will receive an increased dose of INCA33890. The dose that the participant receives will depend on (a) when the participant is included in the study and (b) the side effects that have been observed in participants included earlier in the study. The objective of this first part is to determine the highest dose(s) that participants in the INCA33890 study can take with the least possible side effects. Different doses of INCA33890 will be tested in successive groups of participants during this first part of the study.

• in the second part of the study, participants will receive INCA33890 at the dose that has been determined to be safe and effective during the first part of the study. Multiple doses or dosing regimens may be studied in this part of the study, but each participant will receive a defined dose and dosing regimen for the entire study. Participants in this second part of the study will have different types of cancer. The types of cancer selected for the second part will depend on the cumulative data available at the time of starting this part of the study. The objectives of this second part of the study are to obtain more information about the safety of INCA33890, how it treats the tumor, and how it spreads in the body when administered to participants with certain types of cancer.

At the beginning, the investigational drug is administered twice a week by intravenous infusion (a way to administer a liquid into a vein).

Participants will undergo regular blood and urine tests, and the progression of their cancer will be monitored based on body imaging evaluations.

(BASEC)

Maladie en cours d'investigation

This is the first study in humans (phase 1) conducted to determine how a new investigational drug (INCA33890) acts in a small number of participants with cancer. The purpose is to help researchers understand what happens to the investigational drug in the body and whether there are side effects (unwanted medical problems). The study will include participants with cancer, a disease in which abnormal cells divide uncontrollably and can spread to other parts of the body. Participants in this study: • are diagnosed with cancer that has worsened during or after receiving prior standard treatment; • have not been able to tolerate or cannot receive the standard treatment(s); • are patients for whom there is no treatment likely to improve their condition; • are diagnosed with bladder, cervical, esophageal, stomach, skin, lung, ovarian, kidney, head and neck, breast, pancreatic, colon cancer and tissue lining the lungs and thoracic cavity (also called pleural mesothelium). It is planned to administer INCA33890 twice a week by intravenous infusion (a way to administer a liquid into a vein). The frequency may change to once a month based on the information collected during the study. INCA33890 will be administered until one of the following events occurs: • the participant's disease worsens; • a new anticancer treatment must be administered to the participant; • the participant can no longer tolerate the treatment; • the participant becomes pregnant; • the participant no longer wishes to participate in the study; • a significant event forces the participant to stop taking INCA33890; • until the end of the study.

(BASEC)

Sponsor

Incyte Biosciences International Sàrl Rue Docteur-Yersin 12 1110 Morges Switzerland

(BASEC)

Nom du comité d'éthique approbateur (pour les études multicentriques, uniquement le comité principal)

Commission cantonale d'éthique du Vaud

(BASEC)

Date d'approbation du comité d'éthique

23.10.2023

(BASEC)

Résultats de l'essai