177Lu-PSMA (177Lu-PNT2002) in PSMA-Positive Adenoid Cystic Carcinoma

Launched by SIDNEY KIMMEL COMPREHENSIVE CANCER CENTER AT JOHNS HOPKINS · Mar 14, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment called 177Lu-PSMA for patients with adenoid cystic carcinoma (ACC), a rare type of cancer that can return or spread but cannot be treated with surgery. The trial aims to understand how well this treatment works and involves enrolling 10 participants who will undergo special imaging tests to assess their condition. If the initial phase is successful, more patients may be invited to continue in the study, where they will receive the treatment and have regular check-ups, including blood tests and scans, for about two years.

To be eligible for this trial, participants must be at least 18 years old and have a confirmed diagnosis of recurrent or metastatic ACC that cannot be treated with surgery or radiation. They should have measurable disease visible on a specific type of imaging test and must be in reasonable overall health. Participants will need to agree to certain safety measures, including using birth control if they are of childbearing age. Importantly, this trial is not yet recruiting participants, but it offers a potential new option for those with limited treatment choices for their cancer.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Histologic confirmation of ACC (primary or metastatic tumor). Central review not required but local pathology review required (at Johns Hopkins or Stanford).
• • Patients must have recurrent or metastatic ACC with measurable disease per RECIST 1.1, not amenable to definitive surgery or radiotherapy.
• • Patients must have at least 1 lesion positive on PSMA-PET, as defined by standard uptake value (SUV) ratio of tumor to liver greater than one.
• • Patient can have any or no prior systemic therapies.
• • At least 28 days must have elapsed between last anti-cancer treatment administration and the initiation of study treatment, or at least 5 half-lives of the prior systemic therapy must have elapsed (whichever is shorter).
• • Patient must have resolution of all previous treatment related toxicities to CTCAE version 5.0 grade of ≤ 2.
• • Patient must be ≥ 18 years of age.
• • Patient must have an Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2.
• • For female patients with childbearing potential or male patients with partners of childbearing potential, agreement to use barrier contraceptive method (condom) and to continue its use for 6 months from receiving the last dose of 177Lu-PSMA. Female patients with childbearing potential will undergo a urine pregnancy test. Pregnant female participants are excluded.
• • Patient must have the ability to understand and the willingness to sign a written informed consent document.
• Exclusion Criteria:
• • Spinal cord compression or impending spinal cord compression.
• • Suspected pulmonary and/or liver metastases (greater \>10 mm in largest axis).
• • Unable to lie flat during or tolerate PET/CT.
• • Refusal to sign informed consent.
• • Any medical comorbidities that might preclude safe participation in the study.
• Additional inclusion criteria only relevant if Cohort 2 participants enrolled:
• * Adequate bone marrow reserve and organ function as demonstrated by complete blood count and chemistry panel completed within the prior 28 days demonstrating:
• • 1. Platelet count of \>100 x109/L
• • 2. White blood cell (WBC) count \> 3,000/mL
• • 3. Neutrophil count of \> 1,500/mL
• • 4. Hemoglobin ≥ 10 g/dL
• • 5. Estimated glomerular filtration rate (eGFR) \> 50 mL/min based upon Chronic Kidney Disease- Epidemiology Collaboration (CKD-EPI) equation. Due to safety concerns relating to renal clearance and toxicity of 177Lu-PSMA, patients with estimated GFR between 50 - 60 mL/min will require a 99mTc-TPA GFR test and only patients with non-obstructive pathology will be included in the study.
• • 6. Aspartate transaminase (AST) and alanine aminotransferase (ALT) ≤5 x upper limit of normal (ULN), total bilirubin \< 3 x ULN
• • 7. Total bilirubin \< 3 x ULN (except if confirmed history of Gilbert's disease)
• • 8. Serum albumin \> 30 g/L
• Additional exclusion criteria only relevant if Cohort 2 participants enrolled:
• • Inadequate bone marrow reserve and organ function as detailed in eligibility criteria.
• • Patient is participating in a concurrent investigative treatment protocol involving radiotherapy, surgery, or systemic anti-cancer agents.
• • Patient receiving any other investigational agents.