Study of CTX-471 in Patients With Neural Cell Adhesion Molecule (NCAM) Positive Neuroendocrine Ne… (NCT07684170) | Clinical Trial Compass
Not Yet RecruitingPhase 2
Study of CTX-471 in Patients With Neural Cell Adhesion Molecule (NCAM) Positive Neuroendocrine Neoplasms
58 participantsStarted 2026-09
Plain-language summary
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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. 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.
. A washout period of 4 weeks or at least 5-fold half-life of the last dose (whichever is shorter) of prior systemic therapy prior to receiving the first dose of CTX-471.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Evaluate the clinical activity of CTX-471
Timeframe: Baseline until confirmed disease progression (up to 1 year)
2
Evaluate the safety of CTX-471
Timeframe: From first dose of CTX-471 (Cycle 1 Day 1, Cycle = 2 weeks) until 30 days after the last dose of CTX-471
3
Determine the recommended phase 2 dose (RP2D) for CTX-471
Timeframe: From first dose of CTX-471 (Cycle 1 Day 1, Cycle = 2 weeks) until 30 days after the last dose of CTX-471
. Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.
. At least one measurable lesion definable by MRI or CT scan per RECIST version 1.1 criteria.
. All toxicities related to previous anti-cancer therapies have resolved to (CTCAE) Grade 1 prior to trial treatment administration (except for alopecia, peripheral neuropathy, fatigue and endocrinopathies controlled by replacement therapy which must be CTCAE Grade 2 and amenorrhea/menstrual disorders which can be any grade).
Exclusion criteria
. 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.
. Prior solid organ transplantation and/ or an allogeneic tissue transplant.
. Active hepatitis B virus (HBV), hepatitis C virus (HCV) or human immunodeficiency virus (HIV) infection or a positive serological test at Screening within 35 days of dosing with CTX-471.
. HIV-infected patients must be on anti-retroviral therapy (ART) and have a well-controlled HIV infection/disease defined as:
. Active autoimmune disease or medical conditions requiring chronic steroid (ie, \> 10 mg/day prednisone or equivalent) or immunosuppressive therapy. Patients with a prior history of autoimmune disease may be eligible following discussion with the Medical Monitor.