Condition: HR-positive, HER2-negative Breast Cancer · TNBC - Triple-Negative Breast Cancer · Prostate Cancer · Sponsor: CoRegen, Inc.
The goal of this Phase 1/2a observational study is to evaluate the safety and tolerability of CRG-150 in relapsed/refractory HR+HER2- breast cancer, Triple Negative Breast Cancer (TNBC) and prostate cancer. The main questions it aims to answer are: Phase 1 * Incidence of DLTs * Incidence of CRG-150 related AEs and SAEs * Select the Recommended Phase 2 Dose (RP2D), as determined through the dose escalation process for the specified indications Phase 2a * HR+HER2- Breast Cancer and TNBC: Overall Response Rate (ORR) (CR+PR) using FDG PET/CT and RECIST 1.1 by Investigator assessment * Prostate Cancer: ORR per PCWG3-modified RECIST 1.1 by Investigator assessment Participants will be required to perform study procedures and assessments, and will also receive the following study treatments: • CRG-150 cells at the assigned dose
This description comes directly from the study's public registry record.
Kerry VP, Clinical Operations · 1-401-651-2920 · KBiron@coregen.com
Suzanne Director, Clinical Operations · spetrossian@coregen.com
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Source record: clinicaltrials.gov/study/NCT07730125