Castration-Resistant Prostate Cancer (CRPC)Phase 1/2BetaBartNCT07189871
177Lu-BetaBart in Patients With Relapsed/Refractory, Locally Advanced Inoperable, or Metastatic Solid Tumors
A Phase 1/2 study testing 177Lu-BetaBart and BetaBart + unlabeled BetaBart in people with Castration-Resistant Prostate Cancer (CRPC) and Colorectal Cancer, run by Radiopharm Theranostics, Ltd at 5 sites in United States.
Trial summary
This is a Phase 1/2a dose escalation and expansion study to determine the safety, tolerability, and preliminary clinical activity of 177LuBetaBart, a lutetium-labeled anti-B7-H3 monoclonal antibody, in patients with relapsed/refractory, locally advanced inoperable, or metastatic solid tumors Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Castration-Resistant Prostate Cancer (CRPC), Colorectal Cancer, NSCLC (Non-small Cell Lung Cancer)
- What is being tested?
- 177Lu-BetaBart and BetaBart + unlabeled BetaBart
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 61 participants
- Where
- 5 sitesUnited States
- Study dates
- 23 Feb 2026to Dec 2027
- Phase
- Phase 1/2
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
None listed.
Who cannot join
- History of prior organ transplant.
- Any other known, active malignancy, except for treated cervical intraepithelial neoplasia, or non-melanoma skin cancer.
- Have any medical condition that would, in the Investigator's judgment, prevent the participant's full participation in the clinical study due to safety concerns or compliance with clinical study procedures.
- Residual toxicity ≥ Grade 2 from prior anti-cancer therapy
- History of uncontrolled allergic reactions and/or known or expected hypersensitivity to protein therapeutics.
- Inadequate organ functions as reflected in laboratory parameters:
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- Estimated glomerular filtration rate (eGFR) < 50 mL/min
- Platelet count of < 100 x 109/L
- Absolute neutrophil count (ANC) < 1.5 x 109/L
- Hemoglobin < 9 g/dL
- Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) > 3 x upper limit of normal (ULN), or > 5 x ULN for participants with known liver metastases
- Total bilirubin > 1.5 x ULN
- Participants requiring blood product transfusion within 2 weeks of first dose of 177Lu-BetaBart.
- *Participants with CRPC who have received prior Lu-177-PSMA radioligand therapy.
- Clinically significant cardiovascular disease
- Participation in any other interventional investigational trial
- Participants who are pregnant or breastfeeding.
- Major surgery within 4 weeks prior to first dose of 177Lu-BetaBart.
- Received anti-cancer therapy, including chemotherapy, immunotherapy, radiation therapy, biologic, herbal therapy, or any investigational therapy or investigational device, ≤ 28 days prior to the first dose of 177Lu-BetaBart.
- Known active hepatitis B or known active hepatitis C infection.
- Any uncontrolled intercurrent illness or clinically significant uncontrolled condition(s)
- Untreated moderate to severe hydronephrosis
- For CRPC participants, prescence of a superscan by nuclear medicine/99mTc bone scan.
- Active autoimmune disease that has required systemic treatment within 90 days.
- Any other clinically significant comorbidities, which in the judgment of the investigator could compromise compliance with the protocol, interfere with the interpretation of study results, or predispose the subject to safety risks.
Trial locations and contacts
5 sites in 1 country. Contact the study team or a site near you to ask about taking part.
5 sites in 1 country
United States5 sites, 5 recruiting
- Recruiting
Dothan Hematology & Oncology
Dothan, Alabama, 36303
Juli Love, 334-305-0024, jlove@alocentclinical.com
- Recruiting
BAMF Health
Grand Rapids, Michigan, 49503
BAMF Clinical Trials Team, 616-330-2735, ResearchClinicalTeam@bamfhealth.com
- Recruiting
MD Anderson Cancer Center
Houston, Texas, 77030
Gita Dangol, 713-792-2913, gdangol@mdanderson.org
- Recruiting
Nebraska Cancer Specialists
Omaha, Nebraska, 68130
Marlene Bidwell, 402-691-5252, clinicaltrials@nebraskacancer.com
Hanna Hurz, 402-691-6974, clinicaltrials@nebraskacancer.com
- Recruiting
XCancer
Omaha, Nebraska, 68130
Tony Romero, 402-991-8468, tony@xcancer.com
About this study
Official title: A Phase 1/2a 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
This is a Phase 1/2a dose escalation and expansion study to determine the safety, tolerability, and preliminary clinical activity of 177LuBetaBart, a lutetium-labeled anti-B7-H3 monoclonal antibody, in patients with relapsed/refractory, locally advanced inoperable, or metastatic solid tumors
Read the detailed description
The main objectives of the study are to establish the safety, recommended Phase 2 dose (RP2D), pharmacokinetics (pk), and preliminary anti-tumour activity of 177Lu-BetaBart, a lutetium-labeled anti-B7-H3 monoclonal antibody, in patients with solid tumors who may benefit from this treatment and who meet the study eligibility criteria.
The study is divided into 2 phases. Phase 1 is the dose escalation phase to establish the safety profile of 177Lu-BetaBart and to determine the maximum tolerated dose (MTD) and/or RP2D of 177Lu-BetaBart.
Phase 2a is the dose expansion phase to evaluate preliminary anti-tumor activity and to confirm the safety of 177Lu-BetaBart in select patient populations.
Each phase consists of a Screening Period, a Treatment Period, and a Safety and Long-term Follow-up Period. The estimated total time on study is 22 weeks excluding the Long-term Follow-up Period.
- Conditions
- Castration-Resistant Prostate Cancer (CRPC), Colorectal Cancer, NSCLC (Non-small Cell Lung Cancer), Ovarian Cancer, Cervical Cancer, Endometrial Cancer
- Being tested
- 177Lu-BetaBart, BetaBart + unlabeled BetaBart
- Keywords
- Castration-resistant prostate cancer (CRPC), colorectal cancer (CRC), non-small-cell lung cancer (NSCLC), small-cell lung cancer (SCLC), head and neck squamous cell carcinoma (HNSCC), ovarian cancer, cervical cancer, endometrial cancer, triple negative breast cancer (TNBC), esophageal squamous cell carcinoma (ESCC), B7-H3, 177Lu, radiotheranostics, radioligand therapy, radioimmunotherapy, monoclonal antibody, metastatic solid tumors, sarcoma
- Medical subject headings
- Colorectal Neoplasms, Carcinoma, Non-Small-Cell Lung, Ovarian Neoplasms, Uterine Cervical Neoplasms, Endometrial Neoplasms, Triple Negative Breast Neoplasms, Small Cell Lung Carcinoma, Esophageal Squamous Cell Carcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
177Lu-BetaBartDrug
Also called RV-01
177Lu-BetaBart administered intravenously (IV) every 6 weeks at escalating doses
BetaBart + unlabeled BetaBartDrug
177Lu-BetaBart + unlabeled BetaBart administered intravenously (IV) every 6 weeks at escalating doses
| Study group | Role | What they receive |
|---|---|---|
| Escalating doses of 177 Lu-BetaBart with or without BetaBart every 6 weeks | Experimental | Dose escalation and treatment and imaging period Receives: Drug: 177Lu-BetaBart; Drug: BetaBart + unlabeled BetaBart |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety and Tolerability of 177LuBetaBart
TEAEs as defined by CTCAE v5.0
Measured: 6 weeks
To assess the preliminary anti-tumor activity of 177Lu-BetaBart at the RP2D
ORR per RECIST v1.1 and iRECIST
Measured: Up to 30 weeks
To assess preliminary anti-tumor activity, as defined by biochemical response, in CRPC participants at the RP2D
Proportion of participants who achieve a best response of PSA50
Measured: Up to 30 weeks
Secondary outcomes (7)
To assess the preliminary anti-tumor activity of 177Lu-BetaBart
ORR per RECIST v1.1 and iRECIST
Measured: Up to 30 weeks
To assess preliminary anti-tumor activity, as defined by biochemical response, in CRPC participants
Proportion of participants who achieve a best response of PSA50
Measured: Up to 30 weeks
Assess biodistrubution, PK, and radiation dosimetry of 177Lu-BetaBart
Absorbed Radiation doses in critical organs
Measured: 6 weeks
Effect of Co-injection of unlabeled BetaBart on biodistribution of radiolabeled 177Lu-BetaBart
Absorbed Radiation doses in critical organs
Measured: 6 weeks
To assess preliminary anti-tumor activity, as defined by biochemical response, in CRPC participants who were previously treated with at least one ARSI
bPFS as assessed by PCWG3
Measured: Up to 30 weeks
Safety and Tolerability of 177LuBetaBart at the RP2D
TEAEs as defined by CTCAE v5.0
Measured: 6 weeks
Assess biodistribution, PK, and radiation dosimetry of 177Lu-BetaBart at the RP2D
Absorbed Radiation doses in critical organs
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Sep 2025
- Study start23 Feb 2026
- Primary completionDec 2027 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Castration-Resistant Prostate Cancer (CRPC)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- BOIN dose escalation during Phase 1 followed by dose expansion at RP2D during Phase 2a
- Masking
- None (open label)
- Enrolment
- 61 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Radiopharm Theranostics, Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Medpace, Inc.
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07189871
- Sponsor's protocol ID
- BetaBart-US-101
- Acronym
- BetaBart
- Status last verified
- Sep 2026
- First submitted
- 11 Sep 2025
- Last updated
- 1 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No