Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment Arm A: TORL-1-23 and paclitaxel | Experimental | Administered once every three weeks |
|
| Treatment Arm B: TORL-1-23 and carboplatin | Experimental | Administered once every three weeks |
|
| Treatment Arm C: TORL-1-23, paclitaxel, and carboplatin | Experimental | Administered once every three weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TORL-1-23 and paclitaxel | Combination Product | TORL-1-23 and paclitaxel |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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) | 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 | postoperative after Cycle 4 (Each cycle is 21 days) |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Treatment up to Cycle 8 (each cycle is 21 days) |
| To characterize duration of benefit for TORL-1-23 plus chemotherapy |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Caroline Labib, PharmD | Contact | 310-348-9636 | caroline.labib@torlbio.com |
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UCLA | Recruiting | Los Angeles | California | 90095 | United States |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| TORL-1-23 and carboplatin | Combination Product | TORL-1-23 and carboplatin |
|
| TORL-1-23, paclitaxel, and carboplatin | Combination Product | TORL-1-23, paclitaxel, and carboplatin |
|
Relapse free survival for participants |
| Measured up to 15 months after surgery |
| ID | Term |
|---|---|
| D005185 | Fallopian Tube Neoplasms |
| ID | Term |
|---|---|
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D005184 | Fallopian Tube Diseases |
| D000291 | Adnexal Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D017239 | Paclitaxel |
| D016190 | Carboplatin |
| ID | Term |
|---|---|
| D043823 | Taxoids |
| D043822 | Cyclodecanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D004224 | Diterpenes |
| D013729 | Terpenes |
| D056831 | Coordination Complexes |
Not provided
Not provided