Evaluating the safety of a new treatment for certain cancer types

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This Phase 1 clinical trial aims to assess the safety and tolerability of ²¹²Pb-DOTAM-GRPR1 in adult patients with recurrent or metastatic tumors that express GRPR. The study employs a single ascending dose (SAD) and multiple ascending dose (MAD) design, where participants will receive escalating doses of the treatment to determine the maximum tolerated dose. Up to four cohorts of patients will be enrolled, and those who meet the eligibility criteria will be treated with up to four cycles of the intervention, administered every 8 weeks. The trial will focus on various cancer types, including prostate, breast, cervical, colorectal, and non-small-cell lung cancer.

Why it matters

Who can join: the full rules

1. Adult participants (age ≥ 18 years old) with any of the following advanced or metastatic solid tumors (documented history of histologically confirmed diagnosis):

   1. Metastatic castration-resistant prostate cancer (mCRPC) including neuroendocrine prostate cancer (NEPC) (enrolled only in SAD and MAD Q6W)
   2. HR+/HER2- breast cancer (estrogen receptor/ER expression \>10% of tumor cell nuclei stain, regardless of progesterone receptor/PgR expression); HER2-negative including HER2-low (as per relevant ASCO/CAP guidelines)
   3. Colorectal cancer
   4. Cervical cancer
   5. Non-small-cell lung cancer (NSCLC)
   6. Recurrent glioblastoma (only enrolled in MAD Q4W cohorts) with evidence of recurrent disease (RD) demonstrated by disease progression using modified Response Assessment in Neuro-Oncology (RANO 2.0) criteria. Note: If surgery is performed for GBM recurrence, pre-surgery MRI will be used for confirmation of RD and residual and measurable disease post-surgery is not required but surgery must have confirmed the recurrence diagnosis by MRI.
2. Capable of giving signed informed consent
3. All participants must have progressed on at least 2 prior systemic therapies, except for recurrent GB
4. For participants with mCRPC: Prior orchiectomy and/or ongoing androgen deprivation therapy and a castrate level of serum testosterone (\<50 ng/dL or \<1.7 nmol/L)
5. Presence of at least 1 measurable lesion per RECIST 1.1 as assessed by the Investigator (not applicable for GBM). 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.
6. 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.
7. Eastern Cooperative Oncology Group (ECOG) status 0-1. Participants with ECOG status of 2 may be approved on a case-by-case basis in discussion with the Sponsor.
8. Adequate bone marrow, hepatic, and renal function, as assessed by the following laboratory requirements:

   1. White blood cell (WBC) ≥3000/ mm3 (≥ 3 x 109/L)
   2. Absolute neutrophil count (ANC) ≥1500/mm3 (≥1.5 x 109/L)
   3. Platelets ≥100,000/mm3 (≥ 100 x 109/L)
   4. Hemoglobin (Hb) ≥9.0 g/dL
   5. Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤3x upper limit of normal (ULN) or ≤ 5 x ULN in the presence of liver metastases
   6. Total bilirubin: ≤1.5 x ULN, except if documented history of Gilbert's disease who are eligible if total bilirubin ≤ 3 x ULN
   7. Adequate renal function defined by creatinine clearance (CLCR) ≥ 60 mL/min calculated as follows: CLCR = eGFR in ml/min/1.73 m2 calculated by the Modified Diet in Renal Disease (MDRD) x participant body surface area (BSA) in m2 ÷ 1.73
   8. Serum amylase and/or lipase ≤1.5 x ULN
9. For women of childbearing potential (WOCBP) and men with partners of childbearing potential: be willing to use highly effective methods of contraception or sexual abstinence, if part of participant's lifestyle, throughout the study and for 7 months for WOCBP, 4 months for men after the last \[212Pb\]Pb-DOTAM-GRPR1 administration or for 10 days following \[203Pb\]Pb-DOTAM-GRPR1 administration and participant is not proceeding to 212Pb-DOTAM-GRPR1 treatment, as outlined in protocol.

   Participants with Recurrent Glioblastoma:
10. Having first or second glioblastoma recurrence, 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. In case surgery has been performed for GBM recurrence, the surgery has to be completed at least 4 weeks prior to 212Pb-DOTAM-GRPR1 treatment start, with post-surgery recovery without any complications related to surgical procedure.
11. Presence of 203Pb-DOTAM-GRPR1 uptake by SPECT/CT scan in the tumor lesion(s).
12. Presence of Gadolinium enhancement in the MRI in the tumor lesion(s) shown at the time of diagnosis of tumor recurrence.

Where it's running

• UK Markey Cancer Center
  Lexington, Kentucky, United States Recruiting
• Advanced Molecular Imaging and Therapy
  Glen Burnie, Maryland, United States Recruiting
• Nebraska Cancer Specialists (Midwest Cancer Center - Legacy)
  Omaha, Nebraska, United States Recruiting
• XCancer Omaha / Urology Cancer Center
  Omaha, Nebraska, United States Recruiting
• Northwestern University Robert H Lurie Medical Research
  Chicago, Illinois, United States Active not recruiting
• University of Iowa Health Care
  Iowa City, Iowa, United States Not yet recruiting

Study contacts

• Study coordinator: Orano Med LLC
• Email: clinicaltrials@oranomed.com
• Phone: 469-638-0744

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.