177Lu-BetaBart for Cancer

(BetaBart Trial)

Recruiting at 1 trial location

Overseen By Dimitris Voliotis, MD

Age: 18+

Sex: Any

Trial Phase: Phase 1 & 2

Sponsor: Radiopharm Theranostics, Ltd

Must be taking: ADT, ARSI

Must not be taking: Anticoagulants, Corticosteroids

Disqualifiers: Organ transplant, Active malignancy, Cardiovascular disease, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

61 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment called 177Lu-BetaBart, a type of radiopharmaceutical therapy, for individuals with solid tumors that have recurred or metastasized, making surgery difficult. The primary goal is to determine the treatment's safety and effectiveness for these cancers. Individuals with prostate, lung, or ovarian cancers who have not responded to standard treatments may be suitable candidates for this trial. As a Phase 1 trial, the research aims to understand how the treatment works in people, offering participants the opportunity to be among the first to receive this new therapy.

Is there any evidence suggesting that 177Lu-BetaBart is likely to be safe for humans?

Research shows that 177Lu-BetaBart is under evaluation for safety in treating advanced cancers. Early studies have shown promising results, particularly in targeting the B7-H3 protein, which appears in many tumors. This design aims to focus the treatment on cancer cells.

Since the trial is in its early stages (Phase 1/2), the primary goal is to assess how well patients tolerate the treatment. This phase involves close monitoring to ensure any side effects remain manageable and not harmful.

Although specific safety data from human trials is not yet available, the U.S. FDA has approved the study, indicating a basic level of confidence in its potential safety. It is important to remember that the treatment is still under careful evaluation for both risks and benefits. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Researchers are excited about 177Lu-BetaBart for cancer because it introduces a novel approach to treatment by using a radioisotope, Lutetium-177, to directly target cancer cells. Unlike traditional chemotherapy, which can affect both cancerous and healthy cells, 177Lu-BetaBart is designed to deliver radiation specifically to cancer cells, potentially minimizing damage to healthy tissue. This targeted mechanism not only promises greater precision in treating tumors but also holds the potential for fewer side effects compared to conventional cancer therapies.

What evidence suggests that 177Lu-BetaBart might be an effective treatment for cancer?

Research has shown that 177Lu-BetaBart targets a protein called B7-H3, commonly found on many cancer cells. This targeted approach delivers radiation directly to the tumor, potentially shrinking it. Early results from similar treatments, such as 177Lu-RAD202, demonstrated significant tumor shrinkage and longer survival in patients. Although 177Lu-BetaBart remains under study in this trial, its specific targeting of B7-H3 suggests it may effectively treat advanced cancers by focusing on cancer cells while sparing healthy tissue. ^{1 2 5 6 7}

Are You a Good Fit for This Trial?

This trial is for adults over 18 with various advanced solid tumors that have come back or spread and can't be removed by surgery. Participants must understand the study and agree to follow its procedures.

Inclusion Criteria

I am willing and able to follow all study procedures after giving informed consent.

I am 18 years old or older.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Dose Escalation

Phase 1 dose escalation to establish safety profile and determine maximum tolerated dose (MTD) using Bayesian Optimal Interval (BOIN) design

6 weeks

Multiple visits for dose administration and monitoring

Dose Expansion

Phase 2a dose expansion at the recommended Phase 2 dose (RP2D) to confirm safety and evaluate preliminary anti-tumor activity

Up to 30 weeks

Regular visits for treatment and assessment

Follow-up

Participants are monitored for safety and effectiveness after treatment

Long-term

What Are the Treatments Tested in This Trial?

Interventions

• 177Lu-BetaBart

Trial Overview

The trial is testing a radioactive drug called 177Lu-BetaBart, which targets cancer cells. It's in early stages (Phase 1/2a) to find safe doses and see if it works against different types of advanced cancers.

How Is the Trial Designed?

Group I: 177 Lu-BetaBart - Dose escalation and Phase 2a expansion Experimental Treatment 1 Intervention

Dose escalation and treatment and imaging period

Who Is Running the Clinical Trial?

Radiopharm Theranostics, Ltd

Lead Sponsor

Trials

4

Recruited

100+

Medpace, Inc.

Industry Sponsor

Trials

98

Recruited

30,400+

Dr. August J. Troendle

Medpace, Inc.

Chief Executive Officer since 1992

MD from the University of Maryland, School of Medicine; MBA from Boston University

Dr. Reinilde Heyrman

Medpace, Inc.

Chief Medical Officer since 2017

MD

Citations

1.

clinicaltrials.gov

clinicaltrials.gov/study/NCT07189871

Study Details | NCT07189871 | 177Lu-BetaBart in Patients ...

The purpose of this study is to establish the safety profile, biodistribution, pharmacokinetics (pk), and radiation dosimetry of 177Lu-BetaBart, ...

2.

tipranks.com

tipranks.com/news/company-announcements/medpace-and-radiopharm-launch-promising-cancer-study-with-177lubetabart

Medpace and Radiopharm Launch Promising Cancer ...

' The study aims to evaluate the safety and preliminary effectiveness of 177LuBetaBart in treating various advanced cancers, highlighting its ...

3.

radiopharmtheranostics.com

radiopharmtheranostics.com/new-rad202-data-confirms-positive-tumor-uptake/

New RAD202 data confirms positive tumor uptake

• Treatment with 177Lu-RAD202 results in a relevant tumor volume reduction and survival benefit, further pronounced with fractionated ...

4.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/41307700/

Efficacy, toxicity, and clinical outcomes of 177Lu-PSMA ...

Conclusions: 177Lu-PSMA-617 at 5.5 GBq per cycle was safe and effective, achieving survival comparable to studies using 7.4 GBq with fewer ...

5.

prnewswire.com

prnewswire.com/apac/news-releases/atomvie-global-radiopharma-and-radiopharm-theranostics-partner-to-develop-and-manufacture-177lu-betabart-radioantibody-for-treatment-of-multiple-solid-tumors-302276857.html

AtomVie Global Radiopharma and Radiopharm ...

177 Lu-BetaBart is the first targeted radiopharmaceutical in development against the 4Ig subtype of B7-H3, which is the most common subtype expressed on human ...

6.

radiopharmtheranostics.com

radiopharmtheranostics.com/rad-reports-positive-preclinical-lu177-b7h3-mab-data/

RAD Reports Positive Preclinical Lu177-B7H3-mAb Data

Radiopharm Theranostics Receives IND approval from US FDA to Initiate Phase I Therapeutic Clinical Study to target B7H3 with Betabart (RV-01) · Dr. Oliver ...

7.

adisinsight.springer.com

adisinsight.springer.com/trials/700377362

A Phase 1/2a Study of the Safety, Tolerability, and Preliminary ...

A Phase 1/2a Study of the Safety, Tolerability, and Preliminary Clinical Activity of 177LuBetaBart, a 177Lu-Labeled Anti-B7-H3 Monoclonal Antibody, ...