Fallopian Tube Cancers, FIGO Stage III and IV Ovarian Cancer, Primary Peritoneal Cancer
Conditions
Brief summary
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
Interventions
COMBINATION_PRODUCTTORL-1-23 and paclitaxel
TORL-1-23 and paclitaxel
COMBINATION_PRODUCTTORL-1-23 and carboplatin
TORL-1-23 and carboplatin
COMBINATION_PRODUCTTORL-1-23, paclitaxel, and carboplatin
TORL-1-23, paclitaxel, and carboplatin
Sponsors
TORL Biotherapeutics, LLC
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Eastern Cooperative Oncology Group (ECOG) performance status 0 to 1 * Histologically or cytologically confirmed diagnosis of epithelial ovarian, primary peritoneal or fallopian tubes cancer * FIGO Stage III or IV * Positive for claudin 6 (CLDN6) expression * Adequate organ function
Exclusion criteria
* Clear cell, mucinous, sarcomatous, mixed histology, low-grade/borderline, or non-epithelial ovarian cancers * Prior systemic treatment for the disease under study * Prior surgery * Prior radiation therapy to the abdomen or pelvis * Current recipient or receipt within 5-half-lives of C1D1 of any of the following: chemotherapy, biologic/targeted therapy, herbal medications or supplements, immunomodulator therapy for any disease indication. * History of noninfectious pneumonitis/interstitial lung disease (ILD) within 6 months of first dose of study drug. * Active, progressive, or symptomatic brain metastases * Participants considered poor medical risks due to serious, uncontrolled medical conditions, active infections, or nonmalignant systemic diseases * Pregnant or breastfeeding women
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. | Treatment during Cycle 1 to Cycle 4 (Each cycle is 21 days) | Incidence of Grade greater than or equal to 3 (using CTCAE V5.0) treatment-emergent adverse event (TEAE) and related serious adverse event (SAE) |
| To assess the efficacy of neoadjuvant TORL-1-23 in combination with chemotherapy | postoperative after Cycle 4 (Each cycle is 21 days) | Determination of percentage CRS3 score for each treatment arm |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| To assess the tolerability of TORL-1-23 in combination with chemotherapy | Treatment up to Cycle 8 (each cycle is 21 days) | Safety assessed by incidence of intolerable Grade 2 and Grade greater than or equal to 3 TEAE and related SAE. |
| To characterize duration of benefit for TORL-1-23 plus chemotherapy | Measured up to 15 months after surgery | Relapse free survival for participants |
Countries
United States
Contacts
CONTACTCaroline Labib, PharmD
Outcome results
None listed