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

NCT05639751 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 135

Last updated 2025-10-16

No results posted yet for this study

Summary

This is a Phase 1 dose-escalation study of PRT3789, a SMARCA2 degrader, in participants with advanced or metastatic solid tumors with loss of SMARCA4 due to truncating mutation and/or deletion. The purpose of this study is to evaluate the safety, tolerability, pharmacokinetic (PK), and pharmacodynamic (PD) of PRT3789 monotherapy and in combination with docetaxel, describe any dose limiting toxicities (DLTs), define the dosing schedule, and to determine the maximum tolerated dose (MTD) and recommended phase 2 dose (RP2D) to be used in subsequent development of PRT3789.

Conditions

  • Advanced Solid Tumor
  • Metastatic Solid Tumor
  • Non-small Cell Lung Cancers
  • SMARCA4 Gene Mutation

Interventions

DRUG

PRT3789

PRT3789 will be administered by intravenous infusion

DRUG

Docetaxel

Docetaxel will be administered by intravenous infusion

Sponsors & Collaborators

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-05-02
Primary Completion
2025-10-01
Completion
2025-10-01
FDA Drug
Yes

Countries

  • United States
  • France
  • Netherlands
  • Singapore
  • Spain

Study Locations

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Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05639751 on ClinicalTrials.gov