This phase 1/2 trial will investigate the safety of 9-ING-41, for treatment-resistant cancers.
The main outcome will be the number of treatment-related adverse events (TRAEs). This trial is recruiting in the United States.
Some cancers may not respond to conventional treatment. Treatment-resistant cancers are called refractorycancers. It is unclear why certain cancers are refractory. Some evidence suggests that an enzyme called GSK-3ß may be involved. GSK-3ß is involved in tumor progression. It may also promote resistance to chemotherapy (CT) in many cancers. 9-ING-41 is an experimental drug that blocks an enzyme called GSK-3ß. 9-ING-41 has been tested in animal models of cancer. It slowed tumor growth in combination with CT drugs. It has not yet been tested in humans.
This trial will investigate the safety of 9-ING-41, for treatment-resistant cancers. The main outcome will be the number of TRAEs.
Who are they looking for?
This trial will recruit 250 patients. Patients must have advanced refractory cancer. Participants must have adequate organ function. Women of childbearing potential must use contraception during and for 90 days after the trial. Men with partners of childbearing potential must use a condom during and for 90 days after the trial during intercourse.
Pregnant or breastfeeding women cannot participate. Patients with cardiovascular conditions or another cancer cannot take part in the trial. Patients with progressive brain tumors are excluded from the trial. Other exclusion criteria include taking drugs that block metabolizing enzymes, current side effects from previous treatments.
How will it work
This trial will have 2 parts. Patients will receive 9-ING-41 at increasing dose levels in the first phase. Once the maximum tolerated dose is determined, phase 2 will start. In phase 2, 9-ING-41 will be combined with a CT drug. The study will last up to 3 years.