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

Active:	Yes
Cancer Type:	Solid Tumor Unknown Primary	NCT ID:	NCT05639751
Trial Phases:	Phase I	Protocol IDs:	PRT3789-01 (primary) NCI-2023-01949
Eligibility:	18 Years and older, Male and Female	Study Type:	Treatment
Study Sponsor:	Prelude Therapeutics
NCI Full Details:	http://clinicaltrials.gov/show/NCT05639751

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.

Objectives

This is an open-label, multi-center, dose-escalation, first in human, Phase 1 study of
PRT3789 as monotherapy and in combination with docetaxel, a SMARCA2 degrader, evaluating
participants with advanced or metastatic solid tumors with loss of SMARCA4 due to
truncating mutation and/or deletion. The study will evaluate escalating doses of PRT3789
until the MTD or RP2D is determined. Taking into account pharmacokinetic and
pharmacodynamic data from the preceding dose levels, the dose may be escalated until a
dose limiting toxicity is identified. Approximately 118 participants will be enrolled in
monotherapy, dose escalation, backfill, and combination cohorts.

Treatment Sites in Georgia

Winship Cancer Institute of Emory University
1365 Clifton Road NE
Building C
Atlanta, GA 30322
404-778-5180
winshipcancer.emory.edu

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