PRT3789 for Solid Tumors
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a new treatment, PRT3789, for individuals with advanced or metastatic solid tumors. The study aims to assess the safety and tolerability of PRT3789, both alone and in combination with another drug, docetaxel. Researchers seek to determine the optimal dose and understand how the body processes the treatment. The trial is recruiting participants with a specific tumor change called the SMARCA4 mutation who have not responded to other treatments. As a Phase 1 trial, this research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive this new therapy.
Will I have to stop taking my current medications?
The trial requires that you do not take strong or moderate CYP3A4 inhibitors or inducers (types of drugs that affect how your body processes certain medications). If you are on these medications, you may need to stop them before joining the trial.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research has shown that PRT3789 appears safe for humans so far. Early data suggest that, when used alone, PRT3789 is generally well-tolerated. In a study with 65 patients, the treatment did not cause severe side effects, and most side effects were manageable.
When combined with docetaxel, a common cancer drug, PRT3789 also appears safe. No reports of serious side effects or problems with the drug combination have emerged at the doses studied. This is promising for those considering joining the trial, as early findings suggest the treatment is safe at this stage.12345Why are researchers excited about this trial's treatments?
Unlike standard treatments for solid tumors, which typically include chemotherapy and targeted therapies, PRT3789 stands out due to its novel mechanism and administration method. PRT3789 is an innovative drug that targets specific pathways involved in tumor growth, potentially offering a more precise attack on cancer cells. Researchers are excited about its use both as a monotherapy and in combination with Docetaxel, a well-known chemotherapy drug, because this combination could enhance the effectiveness of treatment by exploiting different mechanisms of action to combat tumors more efficiently. The intravenous infusion of PRT3789 ensures that the drug is delivered directly into the bloodstream, potentially increasing its impact on the tumor cells while minimizing side effects.
What evidence suggests that this trial's treatments could be effective for solid tumors?
Previous studies have shown that PRT3789 holds promise in treating certain types of cancer. It targets a protein called SMARCA2, which is often overactive in tumors with the SMARCA4 mutation. Early results revealed that out of 26 patients with advanced cancer, 7 experienced tumor shrinkage. This is encouraging because these patients had already tried many treatments without success. In this trial, some participants will receive PRT3789 as a monotherapy, while others will receive it in combination with docetaxel, a common chemotherapy drug, to assess its enhanced effectiveness. Overall, researchers are closely monitoring PRT3789 for its potential to treat difficult tumors.23467
Are You a Good Fit for This Trial?
This trial is for adults with advanced or metastatic solid tumors that have a specific genetic change called SMARCA4 mutation. They should be in fairly good health (ECOG 0 or 1), have tried other treatments without success, and can provide a tumor sample. People with certain other cancers, heart issues, uncontrolled electrolyte disorders, or brain metastases cannot join.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Dose Escalation
Participants receive escalating doses of PRT3789 to determine the maximum tolerated dose (MTD) or recommended phase 2 dose (RP2D)
Combination Treatment
Participants receive PRT3789 in combination with docetaxel to evaluate safety and efficacy
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- PRT3789
Find a Clinic Near You
Who Is Running the Clinical Trial?
Prelude Therapeutics
Lead Sponsor