Study on 177Lu-BetaBart for Patients with Advanced or Hard-to-Treat Solid Tumors

Sponsor: Radiopharm Theranostics, Ltd

Sponsor score: 0

ClinicalTrials ID:NCT07189871

This clinical trial is testing a new treatment called 177Lu-BetaBart for patients with advanced solid tumors that have returned or are difficult to treat. The study aims to determine the safety and effectiveness of this treatment in shrinking tumors.

Patient Parameters

Parameter	Options

Program Overview

The study is exploring a new treatment, 177Lu-BetaBart, for patients with advanced solid tumors that have either come back after treatment or are difficult to treat. The trial is divided into two phases: Phase 1 focuses on finding a safe dose, while Phase 2a tests the treatment's effectiveness in reducing tumors. Participants must be adults with specific types of cancer, such as prostate, colorectal, lung, or breast cancer, and must have experienced disease progression after previous treatments.

Description

This clinical trial is investigating the safety and potential benefits of a new treatment called 177Lu-BetaBart for patients with advanced solid tumors. The study is divided into two parts:

Phase 1: This phase aims to find a safe dose of 177Lu-BetaBart by gradually increasing the dose given to participants. Researchers will monitor participants closely to ensure the treatment is safe and to identify any side effects.
Phase 2a: In this phase, researchers will use the safe dose identified in Phase 1 to evaluate how well 177Lu-BetaBart works in shrinking tumors. Participants will receive the treatment and undergo regular imaging tests to assess the treatment's impact on their cancer.

Eligible participants include adults with specific types of cancer, such as prostate, colorectal, lung, head and neck, ovarian, cervical, endometrial, breast, or esophageal cancer. Participants must have experienced disease progression after their most recent cancer treatment and must not have any standard treatment options available that are likely to be beneficial.

The study involves a screening period to determine eligibility, a treatment period where participants receive 177Lu-BetaBart, and a follow-up period to monitor long-term safety and effectiveness. Participants will need to provide informed consent and agree to follow study procedures, including regular visits and tests.

Eligibility Criteria

Inclusion Criteria

Adults aged 18 or older.
Diagnosed with specific types of advanced solid tumors, such as prostate, colorectal, lung, or breast cancer.
Cancer must have progressed after previous treatments.
Must have at least one measurable tumor.
Good overall health with a performance status score of 2 or lower.
Life expectancy of at least 4 months.
Women of childbearing potential must have a negative pregnancy test and agree to use effective contraception during the study and for 6 months after.
Men must agree to use contraception and not donate sperm during the study and for 6 months after.
Previous radiation therapy must have been completed more than 28 days before starting the study treatment.
Participants with treated brain metastases may be eligible if stable for at least 28 days before starting the study treatment.

Exclusion Criteria

History of organ transplant.
Active cancer other than the types being studied, except for certain skin cancers or cervical conditions.
Medical conditions that prevent full participation in the study.
Severe allergic reactions to similar treatments.
Poor organ function as indicated by specific blood tests.
Recent blood transfusions or certain treatments within 2 weeks of starting the study.
Significant heart disease or abnormal heart rhythms.
Participation in another clinical trial for cancer treatment.
Pregnant or breastfeeding women.
Major surgery within 4 weeks of starting the study.
Active hepatitis B or C infection.
Uncontrolled infections or other serious health conditions.

Locations

FACILITY	ZIP	CITY	STATE
Dothan Hematology & Oncology	36303	Dothan	Alabama
BAMF Health	49503	Grand Rapids	Michigan
Nebraska Cancer Specialists	68130	Omaha	Nebraska
XCancer	68130	Omaha	Nebraska

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