A Phase 1B/2 Study to Investigate the Safety and Efficacy of TORL-1-23 with Chemotherapy Given Before Initial Surgery in Women with Advanced Stage Ovarian Cancer
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
60
TORL-1-23 and paclitaxel
TORL-1-23 and carboplatin
TORL-1-23, paclitaxel, and carboplatin
Providence St. Jude Medical Center
Fullerton, California, United States
RECRUITINGCity of Hope
Irvine, California, United States
RECRUITINGUniversity of Southern California
Los Angeles, California, United States
Characterize the safety and feasibility of TORL-1-23 in combination with chemotherapy by analyzing the incidence of treatment emergent adverse events and serious adverse events.
Incidence of Grade greater than or equal to 3 (using CTCAE V5.0) treatment-emergent adverse event (TEAE) and related serious adverse event (SAE)
Time frame: Treatment during Cycle 1 to Cycle 4 (Each cycle is 21 days)
To assess the efficacy of neoadjuvant TORL-1-23 in combination with chemotherapy
Determination of percentage CRS3 score for each treatment arm
Time frame: postoperative after Cycle 4 (Each cycle is 21 days)
To assess the tolerability of TORL-1-23 in combination with chemotherapy
Safety assessed by incidence of intolerable Grade 2 and Grade greater than or equal to 3 TEAE and related SAE.
Time frame: Treatment up to Cycle 8 (each cycle is 21 days)
To characterize duration of benefit for TORL-1-23 plus chemotherapy
Relapse free survival for participants
Time frame: Measured up to 15 months after surgery
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UCLA
Los Angeles, California, United States
RECRUITINGThe Mayo Clinic
Rochester, Minnesota, United States
RECRUITINGMt Sinai Hospital
New York, New York, United States
RECRUITINGDuke University
Durham, North Carolina, United States
RECRUITING