OncoMatch/Clinical Trials/NCT07189871
177Lu-BetaBart in Patients With Relapsed/Refractory, Locally Advanced Inoperable, or Metastatic Solid Tumors
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
Is NCT07189871 recruiting? Yes, currently enrolling (Oct 2026). This Phase 1/2 trial studies multiple treatments including 177Lu-BetaBart and BetaBart + unlabeled BetaBart for castration-resistant prostate cancer (crpc).
Treatment: 177Lu-BetaBart · BetaBart + unlabeled BetaBart — 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
Check if I qualifyExtracted eligibility criteria
Treatments studied
Radioligand therapy
Other
Cancer type
Prostate Cancer
Colorectal Cancer
Non-Small Cell Lung Carcinoma
Ovarian Cancer
Cervical Cancer
Endometrial Cancer
Triple-Negative Breast Cancer
Breast Carcinoma
Small Cell Lung Cancer
Head and Neck Squamous Cell Carcinoma
Esophageal Carcinoma
Sarcoma
Biomarker criteria
Required: ESR1 expression (absence)
TNBC if pathology results confirm: Estrogen receptor expression <1%
Required: PR (PGR) expression (absence)
TNBC if pathology results confirm: Progesterone receptor expression <1%
Required: HER2 (ERBB2) wild-type (absence)
TNBC if pathology results confirm: HER2 negative, defined as IHC 0 or 1+, or IHC 2+ with negative in situ hybridization (ISH)
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Prior therapy
Must have received: androgen deprivation therapy — CRPC
Progression following treatment with ADT and at least one ARSI
Must have received: androgen receptor signaling inhibitor — CRPC
Progression following treatment with ADT and at least one ARSI
Cannot have received: Lu-177-PSMA radioligand therapy
Participants with CRPC who have received prior Lu-177-PSMA radioligand therapy
Lab requirements
Blood counts
Platelet count ≥ 100 x 10^9/L; ANC ≥ 1.5 x 10^9/L; Hemoglobin ≥ 9 g/dL
Kidney function
eGFR ≥ 50 mL/min
Liver function
ALT or AST ≤ 3 x ULN (≤ 5 x ULN for participants with known liver metastases); total bilirubin ≤ 1.5 x ULN
Inadequate organ functions as reflected in laboratory parameters: eGFR < 50 mL/min; Platelet count < 100 x 10^9/L; ANC < 1.5 x 10^9/L; Hemoglobin < 9 g/dL; ALT or AST > 3 x ULN (> 5 x ULN for participants with known liver metastases); Total bilirubin > 1.5 x ULN
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- Dothan Hematology & Oncology · Dothan, Alabama
- BAMF Health · Grand Rapids, Michigan
- Nebraska Cancer Specialists · Omaha, Nebraska
- XCancer · Omaha, Nebraska
- MD Anderson Cancer Center · Houston, Texas
Showing up to 5 US sites.
See all sites on ClinicalTrials.gov →Frequently asked questions
Is NCT07189871 currently recruiting?
Yes, this trial is currently recruiting patients.
Are there prior therapy exclusions?
Yes. Prior Lu-177-PSMA radioligand therapy disqualifies patients from enrollment.
Does this trial require ESR1?
Yes, ESR1 expression is a required biomarker for enrollment.
Does this trial require PGR?
Yes, PGR expression is a required biomarker for enrollment.
Does this trial require ERBB2?
Yes, ERBB2 wild-type is a required biomarker for enrollment.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
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