Study of NTB-928 in R/R OC

Phase 1RecruitingNCT07690189

TeneoSeven, Inc.90 enrolled

Overview

The goal of this clinical trial is to determine if NTB-928 can be given safely to adult females with ovarian cancer that has come back (relapsed) or stopped responding to treatment (refractory), how NTB-928 moves through the body, and how the immune system reacts to it. The study will also look for early signs of anti-cancer activity of NTB-928. The main questions the study aims to answer are: * What side effects do participants experience when receiving NTB-928, including side effects that limit how much of it can be safely given? * How is NTB-928 processed by the body at different dose levels? * Does the immune system react to NTB-928 during treatment? * What dose of NTB-928 can be given safely that shows early signs of activity against ovarian cancer?

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Relapsed/Refractory Ovarian Carcinoma

Interventions

Eligibility

Sex: FEMALEMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Aged 18 years or older * Have a confirmed diagnosis of ovarian cancer, including high-grade serous, high-grade endometrioid, low-grade serous, or clear cell ovarian cancer, or carcinosarcoma of the ovary. Patients with mucinous carcinoma are not eligible. * Have relapsed or refractory ovarian cancer and have already received standard treatments known to provide benefit; participants are eligible if they have platinum-refractory, platinum-resistant, or platinum-sensitive ovarian cancer (with clearly documented ineligibility for further platinum chemotherapy). * Are able to understand the study requirements and are willing to provide written informed consent * Are willing to use effective birth control during the study and for a period after the last dose of study treatment, if of childbearing potential Exclusion Criteria: * Have another active cancer that could interfere with assessment of this study treatment * Have received another investigational drug or certain cancer treatments within a recent period before starting this study * Are pregnant or breastfeeding

Locations (4)

The University of Alabama

Birmingham, Alabama, United States

RECRUITING

University of Nebraska Medical Center

Omaha, Nebraska, United States

RECRUITING

START Northwell, LLC

Lake Success, New York, United States

RECRUITING

Start Ccbd, Llc

Fort Worth, Texas, United States

RECRUITING

Outcomes

Primary Outcomes

Number of dose-limiting toxicities (DLTs) within the first cycle of treatment with NTB-928

Time frame: Up to 35 days

Number of participants with adverse events (AEs) and serious adverse events (SAEs), by severity and relatedness to NTB-928