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NCT05283330 | RECRUITING | Cervical Cancer

Safety and Tolerability of ²¹²Pb-DOTAM-GRPR1 in Adult Subjects With Recurrent or Metastatic GRPR-expressing Tumors
Sponsor:

Orano Med LLC

Brief Summary:

A Phase 1 SAD/MAD dose escalation and expansion study to determine the safety and effectiveness of ²¹²Pb-DOTAM-GRPR1 in subjects with various GRPR-expressing Tumors

Condition or disease

Cervical Cancer

Prostate Cancer Metastatic

Breast Cancer

Colon Cancer

NSCLC

Cutaneous Melanoma

Intervention/treatment

²¹²Pb-DOTAM-GRPR1

Phase

PHASE1

Detailed Description:

In this open-label, dose escalation and dose expansion single ascending dose (SAD) and multiple ascending dose (MAD) phase 1 study, adult subjects with recurrent or metastatic histologically confirmed GRPR-expressing tumors will be enrolled. In the dose escalation portion, a classic 3+3 design will be utilized. Dose escalation may proceed until the recommended MAD dose is determined. Up to four cohorts are expected to be enrolled. Once the recommended MAD dose is determined, no additional subjects will be enrolled in the SAD escalation portion and the MAD portion of the study will commence. Subjects will be treated with up to four cycles administered every 8 weeks.

Study Type : INTERVENTIONAL
Estimated Enrollment : 30 participants
Masking : NONE
Primary Purpose : TREATMENT
Official Title : A Phase 1 Open-Label Dose Escalation and Expansion Study to Determine the Safety, Tolerability, Dosimetry, and Preliminary Efficacy of ²¹²Pb-DOTAM-GRPR1 in Adult Subjects With Recurrent or Metastatic GRPR-expressing Tumors
Actual Study Start Date : 2022-12-22
Estimated Primary Completion Date : 2024-08
Estimated Study Completion Date : 2025-01

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
Criteria
Inclusion Criteria
  • * Male or female ≥18 years old with the following histologically confirmed metastatic or recurrent GRPR-expressing tumors
    • 1. Metastatic castrate resistant prostate cancer (mCRPC);
    • 2. HR+/HER2- breast cancer;
    • 3. Colorectal cancer;
    • 4. Cervical cancer;
    • 5. Cutaneous melanoma;
    • 6. Non-small-cell lung cancer (NSCLC).
    • * Biopsies must demonstrate the following on immunohistochemistry (IHC)
      • * 51-80% positively staining cells; and
      • * Moderate intensity of staining.
      • * Subjects with recurrent disease must have progressed on at least 2 prior systemic therapies.
      • * Presence of at least 1 site of measurable disease per RECIST 1.1 within 1 month prior to Cycle 1 Day 1. For subjects with prostate cancer, bone lesions may be used to fulfill the eligibility requirements per PCWG3 in lieu of measurable disease per RECIST 1.1.
      • * Eastern Cooperative Oncology Group (ECOG) status 0-2.
      • * Sufficient bone marrow capacity and organ function as defined by
        • 1. White blood cell (WBC) ≥2,500/ mm³
        • 2. Absolute neutrophil count (ANC) ≥1500/mm³
        • 3. Platelets ≥75,000/mm³
        • 4. Hemoglobin (HgB) ≥9.0 g/dL;
        Exclusion Criteria
        • * Previous whole-body radiotherapy or peptide receptor radionuclide therapy (PRRT) with either alpha or beta emitters, or subjects with mCRPC who have received radium-223 (²²³Ra).
        • * Known hypersensitivity to any component of ²¹²Pb-DOTAM-GRPR1.
        • * Exposure to any other GRPR-targeting therapeutic agents.
        • * History of chronic pancreatitis
        • * History of pneumonitis.
        • * Impaired cardiac function defined as
          • 1. New York Heart Association (NYHA) class III or IV;
          • 2. QTc \> 470 msec for females and QTc \>450 msec for males on screening electrocardiogram (ECG) or congenital long QT syndrome;
          • 3. Acute myocardial infarction or unstable angina pectoris \< 3 months prior to study enrollment.
          • * Cyclical chemotherapy, radiotherapy, or biologic therapy (e.g. antibodies), continuous or intermittent, small molecule therapeutics, or any investigational agents within a period which is ≤ 5 half-lives or ≤ 4 weeks (whichever is longer) prior to Day 1.
Safety and Tolerability of ²¹²Pb-DOTAM-GRPR1 in Adult Subjects With Recurrent or Metastatic GRPR-expressing Tumors

Location Details

NCT05283330

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How to Participate

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Locations

RECRUITING

United States, Illinois

Northwestern University Robert H Lurie Medical Research

Chicago, Illinois, United States, 60611

RECRUITING

United States, Kentucky

UK Markey Cancer Center

Lexington, Kentucky, United States, 40536

RECRUITING

United States, Maryland

Advanced Molecular Imaging and Therapy

Glen Burnie, Maryland, United States, 21061

RECRUITING

United States, Nebraska

XCancer Omaha / Urology Cancer Center

Omaha, Nebraska, United States, 68130