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 (Jun 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
Treatments studied
Chemotherapy
Other
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)
Demographics
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 →Frequently asked questions
Is NCT06247995 currently recruiting?
Yes, this trial is currently recruiting patients.
Are there prior therapy exclusions?
Yes. Prior capecitabine, therapeutic radiopharmaceutical, external beam radiation therapy disqualifies patients from enrollment.
Does this trial require ESR1?
Yes, ESR1 overexpression is a required biomarker for enrollment.
Does this trial require ERBB2?
Yes, ERBB2 negative is a required biomarker for enrollment.
Does this trial require GRPR?
Yes, GRPR overexpression is a required biomarker for enrollment.
Is there an age limit?
Yes. Patients must be 100 years or younger.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualifyRelated pages