Actively Recruiting
177Lu-BetaBart 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
92 weeks
Total Duration
On this page
Sponsors
R
Radiopharm Theranostics, Ltd
Lead Sponsor
M
Medpace, Inc.
Collaborating Sponsor
AI-Summary
What this Trial Is About
A Phase 1/2a Dose Escalation and Expansion Study of the Safety, Tolerability, and Preliminary Clinical Activity of 177LuBetaBart, a 177Lu-Labeled Anti-B7-H3 Monoclonal Antibody, in Patients with Relapsed/Refractory, Locally Advanced Inoperable, or Metastatic Solid Tumors
CONDITIONS
Official 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
- 18 years of age or older
- Histopathologically confirmed diagnosis of CRPC, CRC, NSCLC, SCLC, HNSCC, ovarian cancer, cervical cancer, endometrial cancer, TNBC, or ESCC
- For CRPC, documented progressive disease with castrate testosterone levels and progression by PSA, soft tissue, bone disease, or PSMA PET imaging
- Metastatic disease documented by conventional imaging or PSMA PET imaging for CRPC
- Progression after androgen deprivation therapy and at least one androgen receptor signaling inhibitor for CRPC
- Prior radiation therapy allowed with evaluation for risk of increased myelotoxicity
- Liver metastases allowed if limited lesions and uptake criteria met
- Prior taxane-based chemotherapy allowed but not required for CRPC
- Documented disease progression during or after the most recent anticancer therapy
- At least one measurable target lesion according to RECIST v1.1 (except CRPC)
- ECOG performance status of 0 to 2
- Life expectancy of at least 4 months
- Negative pregnancy test and not breastfeeding for participants of child-bearing potential
- Use of effective contraception during study and for 6 months after last dose for participants of child-bearing potential and male participants able to father a child
- Prior radiation therapy more than 28 days before first dose allowed
- Participants with stable, treated brain metastases allowed under specified conditions
You will not qualify if you...
- History of organ transplant
- Active malignancy other than treated cervical intraepithelial neoplasia or non-melanoma skin cancer
- Medical conditions preventing full participation or compliance
- Residual toxicity grade 2 or higher from prior anticancer therapy (except alopecia and peripheral neuropathy)
- History of uncontrolled allergic reactions or hypersensitivity to study drug or components
- Inadequate organ function based on laboratory values
- Blood transfusion within 2 weeks prior to first dose
- Prior Lu-177-PSMA radioligand therapy for CRPC
- Significant cardiovascular disease including recent heart attack, unstable angina, heart failure, arrhythmias, or low ejection fraction
- Participation in another interventional trial for cancer treatment
- Pregnancy or breastfeeding
- Major surgery within 4 weeks before first dose
- Anti-cancer 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 recent systemic treatment
- Other significant comorbidities that could affect safety or study compliance
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
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
CONTACT
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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