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SMARCA2 degrader

PRT3789 for Solid Tumors

Phase 1

Recruiting

Research Sponsored by Prelude Therapeutics

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline through approximately 3 years

Awards & highlights

Study Summary

This trial will assess a new cancer drug to determine safety, side effects, how it works, and what dose is safe to use.

Who is the study for?

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.Check my eligibility

What is being tested?

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.See study design

What are the potential side effects?

Since PRT3789 is new and this trial aims to discover its safety profile, potential side effects are not fully known yet. However, participants may experience typical drug-related reactions like fatigue, nausea, allergic responses or more serious conditions depending on their individual reaction.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline through approximately 3 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline through approximately 3 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline through approximately 3 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Dose limiting toxicity (DLT) of PRT3789 monotherapy and in combination with docetaxel

Maximum tolerated dose (MTD)/ Recommended phase 2 dose (RP2D) of PRT3789 monotherapy and in combination with docetaxel

Safety and tolerability of PRT3789 monotherapy and in combination with docetaxel: AEs, CTCAE Assessments

Secondary outcome measures

Efficacy of PRT3789 monotherapy and in combination with docetaxel: Clinical benefit rate (CBR)

Efficacy of PRT3789 monotherapy and in combination with docetaxel: Duration of response (DOR)

Efficacy of PRT3789 monotherapy and in combination with docetaxel: Objective response rate (ORR)

+4 more

Trial Design

2Treatment groups

Experimental Treatment

Group I: PRT3789/Docetaxel CombinationExperimental Treatment2 Interventions

PRT3789 and Docetaxel will be administered by intravenous infusions

Group II: PRT3789 MonotherapyExperimental Treatment1 Intervention

PRT3789 will be administered by intravenous infusion

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Docetaxel

1995

Completed Phase 4

~5620

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Prelude TherapeuticsLead Sponsor

8 Previous Clinical Trials

537 Total Patients Enrolled

Media Library

PRT3789 (SMARCA2 degrader) Clinical Trial Eligibility Overview. Trial Name: NCT05639751 — Phase 1

Non-Small Cell Lung Cancer Research Study Groups: PRT3789/Docetaxel Combination, PRT3789 Monotherapy

Non-Small Cell Lung Cancer Clinical Trial 2023: PRT3789 Highlights & Side Effects. Trial Name: NCT05639751 — Phase 1

PRT3789 (SMARCA2 degrader) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05639751 — Phase 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are new enrollees still being accepted for this trial?

"Clinicaltrials.gov reports that this medical experiment is currently accepting participants. It was first publicized on February 1st 2023 and the most recent update was made a month later, also on February 1st of the same year."

Answered by AI

How many individuals have joined the research study thus far?

"Correct. Data hosted on clinicaltrials.gov reveals that this medical study, which first appeared online on February 1st 2023, is actively recruiting participants. Approximately 86 candidates need to be sourced from a single site for the trial to move forward."

Answered by AI

Has PRT3789 been validated by the U.S. Food and Drug Administration?

"Due to being a Phase 1 trial with limited supporting evidence, PRT3789's safety rating was assessed as 1 on our team's scale."

Answered by AI

What objectives is this clinical trial set to achieve?

"The primary outcome of this clinical trial will be to assess the dose-limiting toxicity (DLT) of PRT3789, spanning from baseline to approximately 3 years. As secondary objectives, investigators will evaluate efficacy based on objective response rate (ORR), duration of response (DOR), and progression-free survival (PFS). ORR is defined as best overall response either complete or partial; DOR is measured from time of initial observed response until disease progression or death due to any cause; PFS as assessed by RECIST v1.1 evaluates duration from Day 1 up until first disease progression, discontinuation because of disease"

Answered by AI

Recent research and studies

clinicaltrials.govStudy

PRT3789 Monotherapy and in Combo w/Docetaxel in Participants w/Advanced or Metastatic Solid Tumors w/SMARCA4 Mutation

2023. "PRT3789 Monotherapy and in Combo w/Docetaxel in Participants w/Advanced or Metastatic Solid Tumors w/SMARCA4 Mutation". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05639751.