Actively Recruiting
A Phase 1/2a Study of the Safety, Tolerability, and Preliminary Activity of 177LuBetaBart, a 177Lu-Labeled Anti-B7-H3 Monoclonal Antibody, in Patients With Relapsed/Refractory, Locally Advanced Inoperable, or Metastatic Solid Tumors
Led by Radiopharm Theranostics, Ltd · Updated on 2026-03-27
61
Participants Needed
4
Research Sites
N/A
Total Duration
On this page
Sponsors
R
Radiopharm Theranostics, Ltd
Lead Sponsor
M
Medpace, Inc.
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating 177Lu-BetaBart, a 177Lu-labeled anti-B7-H3 monoclonal antibody, in patients with various relapsed or refractory solid tumors that are locally advanced, inoperable, or metastatic. This Phase 1/2a study aims to understand the safety, tolerability, how the drug moves through and affects the body, and early signs of anti-tumor activity. Eligible participants include adults 18 and older with cancers such as castration-resistant prostate cancer, colorectal cancer, lung cancers, head and neck cancer, ovarian, cervical, endometrial, triple negative breast cancer, and esophageal squamous cell carcinoma who have shown disease progression after recent treatments. The study has two main parts: a Phase 1 dose escalation phase to find the maximum tolerated or recommended dose using a Bayesian design, and a Phase 2a dose expansion phase at that recommended dose to confirm safety and observe preliminary anti-tumor effects. Participants receive 177Lu-BetaBart through intravenous infusions every six weeks. Each phase includes a screening period, treatment and imaging period, and a safety and long-term follow-up period to closely monitor outcomes and side effects. During the study, participants undergo assessments including imaging for disease evaluation, laboratory tests for organ function and drug effects, and monitoring of side effects for up to 30 weeks. Key outcomes include determining the suitable dose for future studies, tracking adverse events, and measuring anti-tumor activity through objective response rates and biochemical responses in prostate cancer. Pharmacokinetics, radiation dosimetry, and biokinetics of the drug are also measured at specified time points. Safety and tolerability are evaluated continuously, with follow-up to monitor long-term effects and overall health.
CONDITIONS
Brief Title
177Lu-BetaBart in Patients With Relapsed/Refractory, Locally Advanced Inoperable, or Metastatic Solid Tumors
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Willing and able to provide informed consent and comply with study procedures
- Adults 18 years of age or older
- Histopathologically confirmed diagnosis of CRPC, colorectal cancer, NSCLC, SCLC, HNSCC, ovarian cancer, cervical cancer, endometrial cancer, triple negative breast cancer, or esophageal squamous cell carcinoma
- Documented disease progression during or after most recent anticancer therapy
- At least one measurable target lesion (except for CRPC)
- ECOG performance status of 2 or less
- Life expectancy of at least 4 months
- Negative pregnancy test and not breastfeeding for participants of child-bearing potential
- Agree to use effective contraception during the study and for 6 months after last dose
- Prior radiation therapy allowed if received more than 28 days before first dose
- Stable and treated brain metastases allowed under specified conditions
- Prior taxane-based chemotherapy allowed for CRPC participants
You will not qualify if you...
- History of prior organ transplant
- Active malignancy other than certain treated conditions
- Medical conditions preventing full participation due to safety or compliance concerns
- Residual toxicity grade 2 or higher from prior anticancer therapy (except alopecia and peripheral neuropathy)
- Known or expected hypersensitivity to 177Lu-BetaBart or related proteins
- Inadequate organ function as defined by specific laboratory parameters
- Blood transfusion within 2 weeks of first dose
- Prior Lu-177-PSMA radioligand therapy for CRPC participants
- Significant cardiovascular disease
- Participation in another interventional cancer trial at consent
- Pregnancy or breastfeeding
- Major surgery within 4 weeks prior to first dose
- Recent anticancer therapy within 28 days prior to first dose
- Active hepatitis B or C infection
- Uncontrolled infections or illnesses
- Untreated moderate to severe hydronephrosis
- Presence of superscan on bone scan
- Active autoimmune disease requiring systemic treatment within 90 days
- Other significant comorbidities compromising study compliance or safety
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 screening and enrollment visit
Duration - Up to 30 weeks
Participants receive 177Lu-BetaBart by intravenous infusion every 6 weeks as part of dose escalation or dose expansion to evaluate safety and preliminary anti-tumor activity.
Infusions every 6 weeks with imaging assessments during treatment
Duration - Up to 30 weeks
Participants are monitored for safety, tolerability, and long-term effects after treatment ends.
Visits for safety monitoring and assessments following treatment
Trial Site Locations
Total: 4 locations
1
Dothan Hematology & Oncology
Dothan, Alabama, United States, 36303
Actively Recruiting
2
BAMF Health
Grand Rapids, Michigan, United States, 49503
Actively Recruiting
3
Nebraska Cancer Specialists
Omaha, Nebraska, United States, 68130
Actively Recruiting
4
XCancer
Omaha, Nebraska, United States, 68130
Actively Recruiting
Research Team
D
Dimitris Voliotis, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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