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 (Jun 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
Treatments studied
Other
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
Showing up to 5 US sites.
See all sites on ClinicalTrials.gov →Frequently asked questions
Is NCT05283330 currently recruiting?
Yes, this trial is currently recruiting patients.
Is prior treatment required for enrollment?
Yes. Patients must have previously received systemic therapy and radiation therapy.
Does this trial require GRPR?
Yes, GRPR uptake in 203Pb-DOTAM-GRPR1 SPECT/CT greater than background is a required biomarker for enrollment.
Does this trial require GRPR?
Yes, GRPR uptake in 203Pb-DOTAM-GRPR1 SPECT/CT in bone lesions greater than background is a required biomarker for enrollment.
Does this trial require GRPR?
Yes, GRPR uptake in 203Pb-DOTAM-GRPR1 SPECT/CT in tumor lesion(s) is a required biomarker for enrollment.
What disease stage is eligible?
Stage IV is required (metastatic disease required).
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 qualify