New Trials Target Brain, Bladder, Ovarian and Other Cancers

New clinical trials are opening or progressing in several hard-to-treat cancers, including pediatric brain tumors, colorectal cancer, ovarian cancer, bladder cancer and leukemia.

These studies are testing treatments designed to be more targeted, less toxic or better tailored to individual tumors. In children and young adults with brain cancer, a new therapy will deliver radiation directly into the tumor, while other trials explore new drug combinations, cell therapies, and tumor-matching technologies.

Although still in early phases, each trial represents a step toward expanding options and improving care for patients who often face limited paths forward with standard treatments.

FDA Clears Reyobiq Trial for Pediatric Brain Cancer

The U.S. Food and Drug Administration (FDA) has cleared the investigational new drug application for Reyobiq (rhenium Re186 obisbemeda) for the treatment of pediatric patients with supratentorial recurrent, refractory, or progressive high-grade glioma (HGG) and ependymoma, according to a news release from Plus Therapeutics.

Reyobiq delivers high-dose radiation directly into the tumor using convection-enhanced delivery (CED), which helps protect healthy brain tissue by bypassing the blood-brain barrier.

The trial, called ReSPECT-PBC, will enroll patients ages 6 to 21 (and some up to 25) with recurrent or progressive HGG or ependymoma. The trial will evaluate safety and dosing in phase 1 and effectiveness in phase 2.

Visit respect-trials.com to stay updated on enrollment.

UroGen Completes Enrollment in Phase 3 UGN-103 Bladder Cancer Trial

UroGen Pharma has completed patient enrollment in its phase 3 UTOPIA clinical trial of UGN-103 (mitomycin) for intravesical solution, a next-generation formulation in development for the treatment of recurrent low-grade intermediate-risk non-muscle invasive bladder cancer (LG-IR-NMIBC).

The study includes 99 patients receiving weekly bladder instillations of UGN-103 for six weeks. The main goal is to measure complete response at three months, with follow-up for up to a year.

UGN-103 uses RTGel®, a hydrogel-based delivery system designed to keep medication in the bladder longer. It is intended to offer similar benefits to Zusduri (another UroGen mitomycin therapy) but with faster preparation and easier use.

For more information on the UTOPIA study, visit clinicaltrials.gov using the trial ID: NCT06331299.

First Patient Dosed in Phase 2 Trial in Colorectal Cancer

The first patient has been dosed in the phase 2 clinical trial evaluating the efficacy of leronlimab in patients with relapsed or refractory microsatellite stable colorectal cancer, according to a news release from CytoDyn.

The trial is enrolling patients across multiple sites with support from Syneos Health. Dr. Ben Weinberg of Georgetown University is serving as the lead investigator.

Leronlimab is an experimental antibody designed to block CCR5, a protein that may play a role in cancer spread and immune system behavior.

This study builds on earlier research suggesting potential benefit in patients with relapsed colorectal cancer, as well as prior studies in metastatic triple-negative breast cancer.

CytoDyn hopes this study will help determine how broadly leronlimab’s mechanism of action may apply to other solid tumors.

CERo Reports No DLTs in First CER-1236 AML Patient

CERo Therapeutics has completed the initial safety evaluation of the first patient in its phase 1 trial of CER-1236, a first-in-class engineered T-cell therapy for acute myeloid leukemia (AML), according to a news release from the company.

The patient experienced no dose-limiting toxicities during the 28-day observation period. A second patient with AML has consented to enroll and is expected to be dosed soon.

CER-1236 targets TIM4L, a previously unexplored pathway, and works through a phagocytic mechanism. The treatment is manufactured from a patient’s own cells.

The trial, called CertainT-1, is evaluating safety and early signs of efficacy in patients with relapsed/refractory AML, measurable residual disease, or TP53-mutated AML or myelodysplastic syndromes.

Outcomes being tracked include side effects, response rates and measurable residual disease. CERo also plans to begin a second trial of CER-1236 in solid tumors later this year.

For more information on the study, please visit clinicaltrials.gov using the trial ID: NCT06834282.

Allarity Doses Second Patient in Ovarian Cancer Trial of Stenoparib

Allarity Therapeutics has dosed the second patient in its phase 2 trial evaluating stenoparib for advanced, recurrent ovarian cancer that is resistant to or ineligible for platinum-based chemotherapy, according to a news release from the company.

This trial targets patients with few treatment options, aiming to assess stenoparib’s safety and potential benefit. Earlier data showed the drug was well tolerated and provided durable responses with twice-daily dosing.

Stenoparib is an oral therapy that blocks both PARP and WNT signaling pathways — key drivers in many cancers. Its dual mechanism may offer a more targeted and less toxic alternative to chemotherapy.

The trial also supports further development of Allarity’s Drug Response Predictor, a tool designed to identify patients most likely to respond based on gene expression in their tumors.

Rapid early enrollment signals strong interest from investigators and reflects ongoing need for better therapies in this difficult-to-treat cancer population.

References:

• “Plus Therapeutics Announces FDA Clearance of its Investigational New Drug Application using REYOBIQTM for the Treatment of Childhood Brain Cancer” by Plus Therapeutics
• “UroGen Announces Completion of Enrollment in the Phase 3 UTOPIA Clinical Trial of UGN-103 for the Treatment of Recurrent Low-Grade Intermediate-Risk Non-Muscle Invasive Bladder Cancer” by UroGen Pharma
• “CytoDyn Announces First Patient Dosed in Phase II Oncology Trial Evaluating Leronlimab in Metastatic Colorectal Cancer” by CytoDyn Inc.
• “CERo Therapeutics Completes Initial Safety Evaluation in First Patient Treated with CER-1236 in Phase 1 Trial for AML” by CERo Therapeutics
• “Allarity Therapeutics Announces Dosing of Second Patient in New Phase 2 Trial of Stenoparib in Advanced Ovarian Cancer” by Allarity Therapeutics

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