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

• Status: Not yet recruiting
• Trial end date: 2025-01-01
• Target enrollment: 0
• Participant gender: All

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

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Orano Med LLC

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.

• Eastern Cooperative Oncology Group (ECOG) status 0-2.

• Life expectancy of at least 12 weeks in the opinion of the investigator at the time of screening.

• 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.