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
UCLA
Los Angeles, California, United States
RECRUITINGCharacterize 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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