Study of CTX-471 in Patients With Neural Cell Adhesion Molecule (NCAM) Positive Neuroendocrine Neoplasms
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorCompass Therapeutics
About this trial
This study will enroll patients with central lab confirmed NCAM (CD56 IHC) positive metastatic neuroendocrine neoplasms that have progressed after standard of care treatment. CTX-471 to be administered as an intravenous (IV) infusion at either 0.3 mg/kg or 0.6 mg/kg every 2 weeks until disease progression or unacceptable toxicity. The study will be conducted in two stages. In Stage 1, 18 patients will be accrued for each dose level. If there are less than 2 objective responses in these 18 patients at either dose level, the dose level will be stopped. Otherwise, an additional 22 patients will be accrued in Stage 2 with 11 patients for each dose level.
Eligibility criteria
Qualifiers
Age 18 years or older.
Positive immunohistochemical staining for NCAM (defined as ≥ 1% of malignant cells with membranous/cytoplasmic staining of any intensity) on an archived (≤ 3 months) or freshly taken biopsy specimen (centrally tested) with histologically confirmed diagnosis of metastatic tumors.
Locally advanced unresectable or metastatic neuroendocrine neoplasm (NEN) defined by World Health Organization (WHO) (Rindi et al 2022) Grade 3 neuroendocrine tumor (NET) or neuroendocrine carcinoma (NEC) (Ki-67 > 20% and/or > 20 mitoses/10 hpf) and confirmed by histopathology or cytology (eg, gastroentero-pancreatic NECs (GEP-NEC) and lung NEC, other rare sites of origin such as genitourinary, gynecological, larynx, thyroid, or unknown origin).
Patients must have received at least one prior line of chemotherapy and must have exhausted any other standard-of-care treatment option.
Disqualifiers
Diagnosis of well differentiated G1/G2 neuroendocrine neoplasm.
Prior history of interstitial lung disease.
Prior treatment of CD137 targeted therapy (investigational and approved).
Symptomatic or uncontrolled central nervous system and brain metastasis or active leptomeningeal disease. Patients with equivocal findings or with confirmed brain metastases are eligible for the study provided that they are asymptomatic and radiologically and neurologically stable without the need for corticosteroid treatment or seizure prophylaxis for ≥4 weeks before the first dose of study drug. Prior treatment with either surgery or radiation is permitted and all patients with a history of central nervous system (CNS) or brain lesions require imaging during screening to confirm stability.
Trial design
Treatments tested in this trial
- CTX-471
Treatment groups
58 Participants
are divided into 2 treatment groupsLocations
Sponsors and collaborators
Source ClinicalTrials.gov