Informations générales (source: ClinicalTrials.gov)
A Phase 1 Open-Label, Multi-Center, Safety and Efficacy Study of PRT3789 as Monotherapy and in Combination With Docetaxel in Participants With Advanced or Metastatic Solid Tumors With a SMARCA4 Mutation
Interventional
Phase 1
Prelude Therapeutics (Voir sur ClinicalTrials)
mai 2023
mars 2026
28 juin 2025
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.
Etablissements
| Les établissements d'Île-de-France ayant mis à jour leurs données Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| CLCC INSTITUT GUSTAVE ROUSSY | Benjamin BESSE | 12/06/2024 21:07:55 | Contacter | ||
| Les établissements sans correspondance certaine dans le répertoire FINESS dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
| Centre Leon Berard - 69373 - Lyon Cedex 08 - France | Contact (sur clinicalTrials) | ||||
| lnstitut Bergonie Centre Regionale de Lutte Contre le cancer, Service Oncologie-Medicale - 33000 - Bordeaux - France | Contact (sur clinicalTrials) | ||||
| lnstitut Paoli Calmettes - 13009 - Marseille - France | Contact (sur clinicalTrials) | ||||
| Oncopole Claudius Regaud IUCT ONCOPOLE - 31059 - Toulouse - France | Contact (sur clinicalTrials) | ||||
Critères
Tous
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)
- 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)
- 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