PRT3789 for Solid Tumors

Recruiting at 31 trial locations

Overseen By Study Contact (Please Do Not Disclose Personal Information)

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Prelude Therapeutics

Must not be taking: CYP3A4 inhibitors, inducers

Disqualifiers: Cardiac disease, CNS metastases, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

226 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial is testing a new drug called PRT3789, which breaks down a protein in cancer cells, alone and with another drug, docetaxel. Docetaxel is a potent antitumor agent used in treating various cancers. It targets patients with advanced cancers that have lost a specific gene. The drug works by destroying a protein that helps cancer cells grow, potentially stopping the cancer from spreading.

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.

Eligibility Criteria

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

Willing and able to comply with all scheduled visits, treatment plan, laboratory tests, lifestyle considerations (including contraception requirements), and other study procedures

I am fully active or can carry out light work.

I am willing to provide a sample of my tumor.

Exclusion Criteria

I am not taking any strong or moderate drugs that affect liver enzymes.

I do not have uncontrolled heart issues, electrolyte disorders, or untreated brain metastases.

My solid tumor has a SMARCA2 mutation or lacks SMARCA2 protein.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Dose Escalation

Participants receive escalating doses of PRT3789 to determine the maximum tolerated dose (MTD) or recommended phase 2 dose (RP2D)

21 days per dose level

Multiple visits for dose administration and monitoring

Combination Treatment

Participants receive PRT3789 in combination with docetaxel to evaluate safety and efficacy

Up to 3 years

Regular visits for treatment and monitoring

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• PRT3789

Trial Overview PRT3789 is being tested to see how safe it is and what dose works best for treating these tumors. It's an early-phase study where researchers will slowly increase the dose to find the highest amount patients can take without serious side effects.

Participant Groups

Group I: PRT3789/Docetaxel Combination Experimental Treatment 2 Interventions

PRT3789 and Docetaxel will be administered by intravenous infusions

Group II: PRT3789 Monotherapy Experimental Treatment 1 Intervention

PRT3789 will be administered by intravenous infusion

Who Is Running the Clinical Trial?

Prelude Therapeutics

Lead Sponsor

Trials

11

Recruited

910+