Trial Title:
PRT3789 Monotherapy and in Combo w/Docetaxel in Participants w/Advanced or Metastatic Solid Tumors w/SMARCA4 Mutation
NCT ID:
NCT05639751
Condition:
Advanced Solid Tumor
Metastatic Solid Tumor
Non-small Cell Lung Cancers
SMARCA4 Gene Mutation
Conditions: Official terms:
Neoplasms
Carcinoma, Non-Small-Cell Lung
Docetaxel
Conditions: Keywords:
Advanced Solid Tumors
BRG1
BRM
Metastatic Solid Tumors
Non-Small Cell Lung Cancers
NSCLC
PRT3789
SMARCA2 Degrader
SMARCA4
Docetaxel
Study type:
Interventional
Study phase:
Phase 1
Overall status:
Recruiting
Study design:
Allocation:
Non-Randomized
Intervention model:
Sequential Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
PRT3789
Description:
PRT3789 will be administered by intravenous infusion
Arm group label:
PRT3789 Monotherapy
Arm group label:
PRT3789/Docetaxel Combination
Intervention type:
Drug
Intervention name:
Docetaxel
Description:
Docetaxel will be administered by intravenous infusion
Arm group label:
PRT3789/Docetaxel Combination
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.
Detailed description:
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 186 participants will be enrolled in
monotherapy, dose escalation, backfill, and combination cohorts.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- Willing and able to comply with all scheduled visits, treatment plan, laboratory
tests, lifestyle considerations (including contraception requirements), and other
study procedures
- Histologically confirmed advanced, recurrent, or metastatic solid tumor malignancy
with any mutation of SMARCA4 (dose escalation and combination cohorts) and loss of
function mutation of SMARCA4 (backfill cohorts) by local testing that have either
progress on or ineligible for standard of care therapy
- Must have measurable or non-measureable (but evaluable) disease per RECIST v1.1 for
dose escalation and combination cohorts
- Must have measureable diseases per RECIST v1.1 for backfill cohort
- Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1
- Willing to provide either archival or fresh tumor tissue sample
- Adequate organ function (hematology, renal, and hepatic)
Exclusion Criteria:
- Participants with solid tumors with known concomitant SMARCA2 mutation or loss of
protein expression
- Clinically significant or uncontrolled cardiac disease, uncontrolled electrolyte
disorders, uncontrolled or symptomatic central nervous system (CNS) metastases or
leptomeningeal disease
- History of another malignancy within 3 years except for adequately treated basal
cell or squamous cell skin cancer, superficial bladder cancer, prostate
intraepithelial neoplasm, carcinoma in situ of the cervix, or other noninvasive or
indolent malignancies, or malignancies previously treated with curative intent and
not on active therapy or expected to require treatment or recurrence during the
study
- Concurrent treatment with strong or moderate CYP3A4 inhibitor or inducer
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
University of California, Davis Comprehensive Cancer Center
Address:
City:
Sacramento
Zip:
95817
Country:
United States
Status:
Recruiting
Facility:
Name:
UCLA Hematology/Oncology - Santa Monica
Address:
City:
Santa Monica
Zip:
90404
Country:
United States
Status:
Recruiting
Facility:
Name:
Smilow Cancer Hospital Phase 1 Unit
Address:
City:
New Haven
Zip:
06511
Country:
United States
Status:
Recruiting
Facility:
Name:
AdventHealth Medical Group Oncology Research at Celebration
Address:
City:
Celebration
Zip:
34747
Country:
United States
Status:
Recruiting
Facility:
Name:
Winship Cancer Institute
Address:
City:
Atlanta
Zip:
30322
Country:
United States
Status:
Recruiting
Facility:
Name:
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Address:
City:
Baltimore
Zip:
21287
Country:
United States
Status:
Recruiting
Facility:
Name:
Massachusetts General Hospital
Address:
City:
Boston
Zip:
02114
Country:
United States
Status:
Recruiting
Facility:
Name:
Dana Farber Cancer Institute
Address:
City:
Boston
Zip:
02215
Country:
United States
Status:
Recruiting
Facility:
Name:
Washington University School of Medicine - Siteman Cancer Center
Address:
City:
Saint Louis
Zip:
63110
Country:
United States
Status:
Recruiting
Facility:
Name:
Laura & Isaac Perlmutter Cancer Center at NYU Langone Health
Address:
City:
New York
Zip:
10016
Country:
United States
Status:
Recruiting
Facility:
Name:
New York Presbyterian Hospital - Columbia University Medical Center
Address:
City:
New York
Zip:
10032
Country:
United States
Status:
Recruiting
Facility:
Name:
Memorial Sloan Kettering Cancer Center
Address:
City:
New York
Zip:
10065
Country:
United States
Status:
Recruiting
Facility:
Name:
University Hospitals Cleveland Medical Center
Address:
City:
Cleveland
Zip:
44106
Country:
United States
Status:
Recruiting
Facility:
Name:
Cleveland Clinic
Address:
City:
Cleveland
Zip:
44195
Country:
United States
Status:
Recruiting
Facility:
Name:
Providence Cancer Institute Franz Clinic
Address:
City:
Portland
Zip:
97213
Country:
United States
Status:
Recruiting
Facility:
Name:
The University of Texas MD Anderson Cancer Center
Address:
City:
Houston
Zip:
77030
Country:
United States
Status:
Recruiting
Facility:
Name:
NEXT Virginia
Address:
City:
Fairfax
Zip:
22031
Country:
United States
Status:
Recruiting
Facility:
Name:
lnstitut Bergonie Centre Regionale de Lutte Contre le cancer, Service Oncologie-Medicale
Address:
City:
Bordeaux
Zip:
33000
Country:
France
Status:
Recruiting
Facility:
Name:
Centre Leon Berard
Address:
City:
Lyon Cedex 08
Zip:
69373
Country:
France
Status:
Recruiting
Facility:
Name:
lnstitut Paoli Calmettes
Address:
City:
Marseille
Zip:
13009
Country:
France
Status:
Recruiting
Facility:
Name:
Institut Gustave Roussy
Address:
City:
Villejuif Cedex
Zip:
94805
Country:
France
Status:
Recruiting
Facility:
Name:
Leids Universitair Medisch Centrum
Address:
City:
Leiden
Zip:
2333 ZA
Country:
Netherlands
Status:
Recruiting
Facility:
Name:
National University Hospital
Address:
City:
Singapore
Zip:
119074
Country:
Singapore
Status:
Recruiting
Facility:
Name:
National Cancer Centre Singapore
Address:
City:
Singapore
Zip:
168583
Country:
Singapore
Status:
Recruiting
Facility:
Name:
START Barcelona - HM Nou Delfos
Address:
City:
Barcelona
Zip:
08023
Country:
Spain
Status:
Recruiting
Facility:
Name:
START MADRID - FJD Hospital Universitario Fundacion Jimenez Diaz
Address:
City:
Madrid
Zip:
28040
Country:
Spain
Status:
Recruiting
Facility:
Name:
Hospital Universitario HM Sanchinarro
Address:
City:
Madrid
Zip:
28050
Country:
Spain
Status:
Recruiting
Start date:
May 2, 2023
Completion date:
March 2026
Lead sponsor:
Agency:
Prelude Therapeutics
Agency class:
Industry
Source:
Prelude Therapeutics
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05639751
