OncoMatch/Clinical Trials/NCT05283330
Safety and Tolerability of ²¹²Pb-DOTAM-GRPR1 in Adult Subjects With Recurrent or Metastatic GRPR-expressing Tumors
Is NCT05283330 recruiting? Yes, currently enrolling (May 2026). This Phase 1 trial studies ²¹²Pb-DOTAM-GRPR1 for cervical cancer.
Treatment: ²¹²Pb-DOTAM-GRPR1 — A Phase 1 Open-Label, First-in-human, Dose Escalation and Expansion Study to Determine the Safety, Tolerability, Dosimetry, Pharmacokinetics, and Preliminary Efficacy of 212Pb-DOTAM-GRPR1 in Adult Participants with Recurrent or Metastatic GRPR-expressing Tumors
Check if I qualifyExtracted eligibility criteria
Cancer type
Cervical Cancer
Breast Carcinoma
Colorectal Cancer
Non-Small Cell Lung Carcinoma
Prostate Cancer
Glioblastoma
Biomarker criteria
Required: GRPR uptake in 203Pb-DOTAM-GRPR1 SPECT/CT greater than background
At least 1 identified measurable lesion must show GRPR uptake in 203Pb-DOTAM-GRPR1 SPECT/CT (uptake greater than that of the background) as assessed by the Investigator
Required: GRPR uptake in 203Pb-DOTAM-GRPR1 SPECT/CT in bone lesions greater than background
For participants with prostate cancer that do not have measurable soft tissue disease, 203Pb-DOTAM-GRPR1 uptake in bone lesions > uptake in background is acceptable for eligibility
Required: GRPR uptake in 203Pb-DOTAM-GRPR1 SPECT/CT in tumor lesion(s)
Presence of 203Pb-DOTAM-GRPR1 uptake by SPECT/CT scan in the tumor lesion(s) [GBM cohort]
Required: ESR1 expression >10% of tumor cell nuclei stain (>10%)
estrogen receptor/ER expression >10% of tumor cell nuclei stain, regardless of progesterone receptor/PgR expression
Disease stage
Required: Stage IV
Metastatic disease required
advanced or metastatic solid tumors (documented history of histologically confirmed diagnosis)
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Must have received: systemic therapy
All participants must have progressed on at least 2 prior systemic therapies, except for recurrent GB
Must have received: radiation therapy — standard therapy for GBM
after standard therapy that includes prior radiation therapy (RT) and at least 12 weeks from completion of RT prior to first administration of 212Pb-DOTAM-GRPR1
Lab requirements
Blood counts
WBC ≥3000/mm3; ANC ≥1500/mm3; platelets ≥100,000/mm3; Hb ≥9.0 g/dL
Kidney function
creatinine clearance (CLCR) ≥ 60 mL/min calculated as follows: CLCR = eGFR in ml/min/1.73 m2 calculated by MDRD x participant BSA in m2 ÷ 1.73
Liver function
ALT and AST ≤3x ULN or ≤ 5 x ULN in the presence of liver metastases; total bilirubin ≤1.5 x ULN, except Gilbert's disease ≤ 3 x ULN
Adequate bone marrow, hepatic, and renal function, as assessed by the following laboratory requirements
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- Northwestern University Robert H Lurie Medical Research · Chicago, Illinois
- UK Markey Cancer Center · Lexington, Kentucky
- Advanced Molecular Imaging and Therapy · Glen Burnie, Maryland
- XCancer Omaha / Urology Cancer Center · Omaha, Nebraska
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