TORL-1-23 + Chemotherapy for Ovarian Cancer
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial explores whether a new treatment, TORL-1-23, combined with chemotherapy, is safe and effective for women with advanced ovarian cancer. It tests different combinations of TORL-1-23 with standard chemotherapy drugs like paclitaxel and carboplatin. The goal is to determine if these combinations work better before surgery. Women with advanced-stage epithelial ovarian cancer who have not received previous treatments may be suitable candidates for this trial. As a Phase 1 trial, this research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive this new treatment.
Will I have to stop taking my current medications?
The trial requires that you have not received chemotherapy, biologic/targeted therapy, or immunomodulator therapy recently. If you are currently on these types of medications, you may need to stop them before joining the trial.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research shows that TORL-1-23 is generally well-tolerated by patients with advanced ovarian cancer and has a manageable safety profile. Common side effects include tiredness, nerve damage that can cause pain or weakness, and hair loss. In patients who have undergone many previous treatments, TORL-1-23 was safe and showed effectiveness against tumors. Among patients with gynecologic cancers, nausea was the most common side effect, affecting about 68.4% of patients, similar to other strong chemotherapy drugs. Overall, TORL-1-23 shows promise, but like all treatments, it has some side effects.12345
Why are researchers excited about this trial's treatments?
Unlike the standard treatments for ovarian cancer, which typically involve surgery and chemotherapy with drugs like paclitaxel and carboplatin, TORL-1-23 is a novel therapeutic approach that researchers find promising. TORL-1-23 may offer a unique mechanism of action, potentially targeting cancer cells more effectively when combined with traditional chemotherapy agents. This could enhance the overall treatment efficacy and possibly reduce side effects by allowing for lower doses of chemotherapeutic drugs. Researchers are excited because this combination might improve outcomes for patients who have limited options with current therapies.
What evidence suggests that this trial's treatments could be effective for ovarian cancer?
Research has shown that TORL-1-23 holds promise for treating advanced ovarian cancer. In earlier studies, TORL-1-23 helped shrink tumors in half of the patients. This trial will evaluate TORL-1-23 in different combinations: one arm will receive TORL-1-23 with paclitaxel, another with carboplatin, and a third with both paclitaxel and carboplatin. This approach is especially hopeful for those with CLDN6-positive tumors, a specific type of cancer cell. When combined with paclitaxel and carboplatin, two common chemotherapy drugs, TORL-1-23 has shown manageable side effects while remaining effective. These findings suggest TORL-1-23 could be a strong option for treating advanced ovarian cancer.12467
Are You a Good Fit for This Trial?
This trial is for women with advanced ovarian cancer, including cancers of the fallopian tubes and peritoneum. Participants must be in stage III or IV, test positive for CLDN6 expression, have a performance status indicating they can perform daily activities with some effort or less (ECOG ≤2), and have organs that are functioning well.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive TORL-1-23 with chemotherapy every three weeks for up to 8 cycles
Surgery
Interval cytoreductive surgery is performed after neoadjuvant chemotherapy
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- TORL-1-23
Trial Overview
The study tests TORL-1-23 combined with chemotherapy drugs paclitaxel and carboplatin before initial surgery to see if it's safe and effective against advanced ovarian cancer. It's an early-phase trial where patients receive this combination treatment regimen.
How Is the Trial Designed?
3
Treatment groups
Experimental Treatment
Administered once every three weeks
Administered once every three weeks
Administered once every three weeks
Find a Clinic Near You
Who Is Running the Clinical Trial?
TORL Biotherapeutics, LLC
Lead Sponsor
Citations
A Study to Investigate the Safety and Efficacy of TORL-1-23 ...
Histologically or cytologically confirmed diagnosis of epithelial ovarian, primary peritoneal or fallopian tubes cancer; FIGO Stage III or IV ...
2.
onclive.com
onclive.com/view/torl-1-23-is-tolerable-active-in-heavily-pretreated-cldn6-advanced-ovarian-cancer-other-solid-tumorsTORL-1-23 Is Tolerable, Active in Heavily Pretreated ...
TORL-1-23 showed promising efficacy in CLDN6-positive advanced solid tumors, with the highest ORR of 50% at 2.4 mg/kg in ovarian cancer patients ...
Management of Advanced Ovarian Cancer
Researchers evaluated TORL-1-23 in a phase I study (NCT05103683) in patients with advanced ovarian, endometrial, testicular, and lung cancer [118]. TORL-1-23 ...
4.
ucla.clinicaltrials.researcherprofiles.org
ucla.clinicaltrials.researcherprofiles.org/ovarian-cancerUCLA Ovarian Cancer Clinical Trials for 2026 — Los Angeles
A Phase 2 study to evaluate the safety and efficacy of TORL-1-23 in patients with advanced ovarian cancer. Los Angeles, California and other ...
TORL BioTherapeutics Presents Updated Phase 1 Results ...
TORL-1-23 Demonstrates Clinically Meaningful, Durable and Confirmed Responses with a Generally Manageable Safety Profile in Patients with ...
Antibody–drug conjugates as targeted therapy for treating ...
In terms of safety, in the gynecologic cohort nausea was the most common AE occurring in 68.4% of patients, similar to highly emetogenic chemotherapy agents. Gr ...
TORL-1-23 + Chemotherapy for Ovarian Cancer
The study tests TORL-1-23 combined with chemotherapy drugs paclitaxel and carboplatin before initial surgery to see if it's safe and effective ...
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