PRT3789 Monotherapy and in Combo w/Docetaxel in Participants w/Advanced or Metastatic Solid Tumors w/SMARCA4 Mutation
Solid Tumor
Unknown Primary
18 Years and older, Male and Female
PRT3789-01 (primary)
NCI-2023-01949
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 186 participants will be enrolled in
monotherapy, dose escalation, backfill, and combination cohorts.
Eligibility
- 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)
Treatment Sites in Georgia
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