177Lu-BetaBart in Patients With Relapsed/Refractory, Locally Advanced Inoperable, or Metastatic Solid Tumors
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
Who can join
As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.
- Age
- 18 Years and older
- Sex
- All sexes
- Healthy volunteers
- Not accepted
- Compensation
- Not stated
Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.
What to expect
No one can promise a trial will help you personally — that is what the research is trying to find out.
What participation involves
Not stated in the study description — ask the study team about visits and procedures.
- Compensation
- Not stated
- Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
- Participants are monitored closely by the research team throughout the study.
- Some participants may receive access to an investigational treatment, which is still being studied.
- Your participation helps researchers learn whether this approach could help future patients.
About this study
In plain language
This study tests the safety, side effects, and early signs of benefit of 177Lu-BetaBart, an antibody that carries radiation to target a protein called B7-H3. It is for adults with certain solid cancers that have come back, resist treatment, cannot be removed by surgery, or have spread.
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
Compensation is read from the study's own description and may be missing — always confirm with the study team.
Eligibility
Who can join
- Be at least 18 years old and have a tissue-confirmed cancer of the prostate, colon or rectum, lung, head or neck, ovary, cervix, uterus lining, breast, or esophagus. Only certain types qualify.
- Cancer must have worsened during or after the latest treatment. Standard treatments must have failed, caused side effects you cannot tolerate, or be unlikely to help.
- Have at least one tumor that can be measured on scans. You must be able to care for yourself and be out of bed or a chair for at least half the day. The study doctor must expect you to live at least 4 months.
- Prostate cancer must have worsened despite hormone-lowering treatment and at least one drug that blocks male hormone signals. Blood tests or scans must show worsening, and scans must show spread.
- Breast cancer must be triple-negative, meaning tests show it lacks certain hormone receptors and is HER2-negative.
- If cancer has spread to the liver, there must be no more than 3 spots. Each must be no more than 2 cm across its shorter side and meet the study's scan uptake rule.
- If you can become pregnant, you must have a negative pregnancy test, not be breastfeeding, and agree to use highly effective birth control.
- Previously treated cancer in the brain must be stable on scans and in symptoms for at least 28 days. You must have no history of cancer in the lining around the brain or spinal cord, or pressure on the spinal cord.
Who can't join
- A past organ transplant or another active cancer, except treated abnormal cells on the cervix or non-melanoma skin cancer.
- Ongoing moderate or worse side effects from past cancer treatment, uncontrolled allergic reactions, or a known or expected allergy to protein-based treatments.
- Blood tests showing low blood cell counts or poor kidney or liver function; a need for blood products within 2 weeks before the first dose; or untreated moderate to severe kidney swelling from blocked urine flow.
- Serious heart or blood vessel disease, an uncontrolled illness, or another health problem that the study doctor believes could make the study unsafe or interfere with participation or results.
- Pregnancy or breastfeeding; active hepatitis B or C; or an autoimmune disease, where the body attacks itself, needing whole-body treatment within 90 days.
- Major surgery within 4 weeks, or cancer treatment or an experimental treatment or device within 28 days before the first dose.
- Taking part in another study that tests a treatment or procedure.
- For prostate cancer: past Lu-177-PSMA radiation treatment, or a bone scan pattern called a 'superscan.'
Simplified for readability. The official criteria below are what the study team uses.
Official eligibility criteria
1. Participants ≥ 18 years of age. 2. Participants with a documented history of histopathologically confirmed CRPC\*, CRC, NSCLC, SCLC, HNSCC, ovarian cancer, cervical cancer, endometrial cancer, TNBC, or ESCC. a. \*Progressive CRPC defined by at least one of the following criteria: i. Two consecutive increases in PSA measured at least 1 week apart. ii. Soft tissue progression defined as a ≥20% increase in the sum of the diameter or the appearance of one or more new lesions by computed tomography (CT)/magnetic resonance imaging (MRI). iii. Progression of bone disease defined by Prostate Cancer Working Group 3 (PCWG3) as evaluable disease or new bone lesions by bone scan. iv. Identification of new soft tissue or bone lesions on prostate-specific membrane antigen (PSMA) positron emission tomography (PET) imaging. b. \*Metastatic disease defined as either or both of the following: i. Documented M1 disease on conventional imaging ii. Identification of bone lesion(s), extra-pelvic soft tissue lesion(s), or visceral metastases on PSMA PET imaging with an FDA-approved imaging agent c. \*Progression following treatment with ADT and at least one ARSI . e. Participants with liver metastases if they meet the following criteria: i. ≤3 lesions ii. All lesions must be ≤2 cm in the short axis iii. SUVmean ≥2 x that of liver parenchyma g. Participants with TNBC if pathology results confirm the following: i. Estrogen receptor expression \<1%, ii. Progesterone receptor expression \<1%, iii. Human epidermal growth factor receptor 2 (HER2) negative, defined as IHC 0 or 1+, or IHC 2+ with negative in situ hybridization (ISH) 3. Participants must have documented disease progression during or after their most recent line of anticancer therapy. Participants must be refractory to or intolerant of standard of care therapy or have no standard of care therapy available that is likely to provide clinical benefit. 4. Must have at least 1 measurable target lesion according to RECIST v1.1. 5. Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2 6. Participants must have a life expectancy of ≥ 4 months in the opinion of the Investigator. 7. Participants of child-bearing potential (CBP) must have a negative β-hCG test and must not be breastfeeding. 8. Participants of CBP must agree to use a highly effective method of contraception. 9. Participants with previously treated brain metastases are eligible to participate if: * they are neurologically and radiologically stable for at least 28 days prior to the first dose of 177Lu-BetaBart; and * have no history of leptomeningeal disease or spinal cord compression. Exclusion Criteria: 1. History of prior organ transplant. 2. Any other known, active malignancy, except for treated cervical intraepithelial neoplasia, or non-melanoma skin cancer. 3. 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. 4. Residual toxicity ≥ Grade 2 from prior anti-cancer therapy 5. History of uncontrolled allergic reactions and/or known or expected hypersensitivity to protein therapeutics. 6. Inadequate organ functions as reflected in laboratory parameters: * 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 7. Participants requiring blood product transfusion within 2 weeks of first dose of 177Lu-BetaBart. 8. \*Participants with CRPC who have received prior Lu-177-PSMA radioligand therapy. 9. Clinically significant cardiovascular disease 10. Participation in any other interventional investigational trial 11. Participants who are pregnant or breastfeeding. 12. Major surgery within 4 weeks prior to first dose of 177Lu-BetaBart. 13. 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. 14. Known active hepatitis B or known active hepatitis C infection. 15. Any uncontrolled intercurrent illness or clinically significant uncontrolled condition(s) 16. Untreated moderate to severe hydronephrosis 17. For CRPC participants, prescence of a superscan by nuclear medicine/99mTc bone scan. 18. Active autoimmune disease that has required systemic treatment within 90 days. 19. 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.
Study sites (5)
AL
- Dothan Hematology & Oncology · Dothan, AL 36303Juli Love · Study contact · 334-305-0024 · jlove@alocentclinical.comMore trials in Dothan
MI
- BAMF Health · Grand Rapids, MI 49503BAMF Clinical Trials Team · Study contact · 616-330-2735 · ResearchClinicalTeam@bamfhealth.comMore trials in Grand Rapids
NE
- Nebraska Cancer Specialists · Omaha, NE 68130Marlene Bidwell · Study contact · 402-691-5252 · clinicaltrials@nebraskacancer.comHanna Hurz · Study contact · 402-691-6974 · clinicaltrials@nebraskacancer.comMore trials in Omaha
- XCancer · Omaha, NE 68130Tony Romero · Study contact · 402-991-8468 · tony@xcancer.comMore trials in Omaha
TX
- MD Anderson Cancer Center · Houston, TX 77030Gita Dangol · Study contact · 713-792-2913 · gdangol@mdanderson.orgMore trials in Houston