OncoMatch/Clinical Trials/NCT06247995
A Phase I/II, Dose Finding and Optimization Study of [177Lu]Lu-NeoB in Combination With Capecitabine in Patients With GRPR+, ER+, HER2- Metastatic Breast Cancer After Progression on Previous Endocrine Therapy in Combination With a CDK4/6 Inhibitor.
Is NCT06247995 recruiting? Yes, currently enrolling (May 2026). This Phase 1/2 trial studies multiple treatments including [68Ga]Ga-NeoB and [177Lu]Lu-NeoB for breast cancer.
Treatment: [68Ga]Ga-NeoB · [177Lu]Lu-NeoB · Capecitabine — In the phase I part, to determine the recommended doses (RD) and dosing regimens of \[177Lu\]Lu-NeoB in combination with capecitabine in adult patients with gastrin releasing peptide receptor positive, estrogen receptor-positive, human epidermal growth factor receptor-2 negative metastatic breast cancer after progression on previous endocrine therapy in combination with a CDK4/6 inhibitor. In the phase II part, to evaluate the preliminary anti-tumor activity of two different doses/regimens of \[177Lu\]Lu-NeoB in combination with capecitabine (dose optimization).
Check if I qualifyExtracted eligibility criteria
Cancer type
Breast Carcinoma
Biomarker criteria
Required: ESR1 overexpression (ER expression >10% of tumor cell nuclei stain)
ER+ breast cancer (ER expression >10% of tumor cell nuclei stain (regardless of PgR expression))
Required: HER2 (ERBB2) negative (IHC 0, 1+, or 2+ with negative ISH)
HER2-negative (as per ASCO-CAP guidelines Wolff et al 2018) breast cancer defined as a negative in situ hybridization test (ISH) or an IHC status of 0, 1+ or 2+. If IHC is 2+, a negative ISH (e.g., FISH, CISH, or SISH) is required.
Required: GRPR overexpression ([68Ga]Ga-NeoB uptake greater than physiological liver uptake at PET/CT or PET/MRI)
at least one target lesion...with [68Ga]Ga-NeoB uptake greater than the physiological uptake of the liver at PET/CT or PET/MRI
Disease stage
Metastatic disease required
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Must have received: endocrine therapy — metastatic
radiologically confirmed progression of disease after the most recent therapy
Must have received: CDK4/6 inhibitor — metastatic
at least one included endocrine therapy in combination with a CDK4/6i
Cannot have received: capecitabine (capecitabine)
Participant has received prior treatment with capecitabine
Cannot have received: therapeutic radiopharmaceutical
Participant has received any prior treatment with a therapeutic radiopharmaceutical
Cannot have received: external beam radiation therapy
Exception: to more than 25% of the bone marrow
Prior External Beam Radiation Therapy (EBRT) to more than 25% of the bone marrow
Lab requirements
Blood counts
ANC ≥ 1.5 × 10^9/L; platelets ≥ 100 × 10^9/L; hemoglobin ≥ 9.0 g/dL; INR ≤ 1.5
Kidney function
eGFR ≥ 60 ml/min/1.73m2 (CKD-EPI equation)
Liver function
Total bilirubin < 1.5 × ULN (except Gilbert's syndrome ≤ 3.0 × ULN or direct bilirubin ≤ 1.5 × ULN); ALT/AST < 2.5 × ULN (no liver mets) or < 5 × ULN (with liver mets); serum lipase ≤ 1.5 × ULN
Cardiac function
LVEF ≥ 50%; no significant cardiac disease or ECG abnormalities; resting QTcF < 450 msec (male) or < 460 msec (female); no uncontrolled hypertension (SBP ≥ 160 mmHg and/or DBP ≥ 100 mm Hg)
adequate bone marrow and organ function as defined by the following laboratory values...see full criteria
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- UCLA Medical Center · Los Angeles, California
- Hoag Memorial Hospital Presbyterian · Newport Beach, California
- Mayo Clinic - Rochester · Rochester, Minnesota
- Uni Of TX MD Anderson Cancer Cntr · Houston, Texas
- University Of Wisconsin · Madison, Wisconsin
Showing up to 5 US sites. See all sites on ClinicalTrials.gov →
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