Neuroendocrine NeoplasmPhase 2NCT07684170
Study of CTX-471 in Patients With Neural Cell Adhesion Molecule (NCAM) Positive Neuroendocrine Neoplasms
A Phase 2 study testing CTX-471 in people with Neuroendocrine Neoplasm and Neuroendocrine Carcinomas, run by Compass Therapeutics.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Neuroendocrine Neoplasm, Neuroendocrine Carcinomas, Neuroendocrine Tumors
- What is being tested?
- CTX-471
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 58 participants
- Where
- No sites listed yet
- Study dates
- Sep 2026to Sep 2029
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
- Patients with histologically confirmed prostate NEC are not required to have received prior androgen deprivation therapy (ADT) or castrated levels of testosterone.
- 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.
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- The eligibility of patients who received unapproved drugs will be determined by discussion with the Sponsor Medical Monitor.
- 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).
- Adequate organ function and laboratory values:
- Adequate bone marrow function defined by absolute neutrophil (ANC) of ≥ 1.5×109/L, platelet count of ≥ 100.0×109/L, and hemoglobin of ≥ 9.0 g/dL (with or without transfusion).
- Adequate hepatic function defined as serum total bilirubin ≤ 1.5 × ULN, AST/ALT ≤ 2.5 × ULN (or ≤ 5 × ULN in patients with liver metastases or ≤3 x ULN for patients with Gilbert's syndrome).
- Adequate renal function defined as creatinine clearance ≥ 30 mL/min by Cockcroft-Gault equation.
- Females of childbearing potential (FOCBP) should have a negative serum pregnancy within 72 hours prior to receiving the first dose of study medication.
- FOCBP must agree to use adequate contraception as outlined in study documentation, starting with the first dose of study medication through 120 days after the last dose of study medication.
- Male patients of childbearing potential must agree to use an adequate method of contraception as outlined in study documentation, starting with the first dose of study medication through 120 days after the last dose of study medication.
- Capable of understanding and complying with protocol requirements.
- Signed and dated institutional review board (IRB) approved informed consent form (ICF) before any protocol-directed screening procedures are performed.
Who cannot join
- 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.
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- Hepatitis B surface antigen (HBsAg) positive patients are eligible if they have received HBV antiviral therapy for at least 4 weeks and have undetectable HBV viral load prior to randomization.
- HBV+ patients should remain on anti-viral therapy throughout study intervention and follow local guidelines for HBV anti-viral therapy post completion of study intervention.
- History of HCV infection is eligible if HCV viral load is undetectable at screening.
- HCV+ patients must have completed curative anti-viral therapy at least 4 weeks prior to randomization.
- HIV-infected patients must be on anti-retroviral therapy (ART) and have a well-controlled HIV infection/disease defined as:
- Patients on ART must have a CD4+ T-cell count < 350 cells/mm3 at time of screening.
- Patients on ART must have achieved and maintained virologic suppression defined as confirmed HIV RNA level below 50 copies/mL or the lower limit of qualification (below the limit of detection) using the locally available assay at the time of screening and for at least 12 weeks prior to screening.
- Patients on ART must have been on a stable regimen, without changes in drugs or dose modification, for at least 4 weeks prior to study entry (Day 1).
- 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.
- Systemic therapy with immunosuppressive agents within 7 days before the start of CTX-471 treatment. Topical, intranasal, intraocular, or inhaled corticosteroids and physiologic replacement for patients with adrenal insufficiency are allowed (≤ 10 mg/day prednisone or equivalent).
- Congestive heart failure (> New York Heart Association Class II), active coronary artery disease, unevaluated new onset angina within 3 months or unstable angina (angina symptoms at rest) or clinically significant cardiac arrhythmias.
- Other systemic conditions or organ abnormalities that in the opinion of the Investigator may interfere with the conduct and/or interpretation of the current study.
- Has received prior radiotherapy within 2 weeks of start of study treatment.
- Patients must have recovered from all radiation-related toxicities and not require corticosteroids.
- Has received a live or live-attenuated vaccine within 30 days prior to the first dose of study medication.
- Administration of killed vaccines are allowed.
- Has a known additional malignancy that is progressing or has required active treatment within the past 3 years.
- Patients with basal cell carcinoma of the skin, squamous cell carcinoma of the skin, or carcinoma in situ, excluding carcinoma in situ of bladder, that have undergone potentially curative therapy are not excluded.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: A Phase 2, Open-Label Study of CTX-471 in Patients With NCAM Positive Tumors
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.
- Being tested
- CTX-471
- Medical subject headings
- Neuroendocrine Tumors, Carcinoma, Neuroendocrine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CTX-471Drug
Patients will receive CTX-471 as an intravenous (IV) infusion every 2 weeks until disease progression or unacceptable toxicity.
| Study group | Role | What they receive |
|---|---|---|
| Dose Level 0.3 mg/kg | Experimental | Not described Receives: Drug: CTX-471 |
| Dose Level 0.6 mg/kg | Experimental | Not described Receives: Drug: CTX-471 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluate the clinical activity of CTX-471
Objective Response Rate (ORR) (Percentage of Participants With Objective Response) as per Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1
Measured: Baseline until confirmed disease progression (up to 1 year)
Evaluate the safety of CTX-471
Incidence of treatment emergent adverse events (TEAEs), treatment-related AEs (TREAEs), and serious adverse events (SAEs)
Measured: From first dose of CTX-471 (Cycle 1 Day 1, Cycle = 2 weeks) until 30 days after the last dose of CTX-471
Determine the recommended phase 2 dose (RP2D) for CTX-471
Efficacy, exposure, safety events, and markers of response will be aggregated to select a Phase 2 dose
Measured: From first dose of CTX-471 (Cycle 1 Day 1, Cycle = 2 weeks) until 30 days after the last dose of CTX-471
Secondary outcomes (13)
Duration of Response (DOR) as per Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1
Measured: From the date of first confirmed PR or CR until date of progression or death, whichever occurs first (up to 1 year)
Disease Control Rate (DCR) as per Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1
Measured: From first dose of CTX-471 (Cycle 1 Day 1,Cycle = 2 weeks) until until disease progression or death, whichever occurs first (up to 1 year)
Progression-Free Survival (PFS) as per Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1
Measured: From first dose of CTX-471(Cycle 1 Day 1,Cycle = 2 weeks ) until disease progression or death, whichever occurs first (up to 1 year)
Median Progression-Free Survival (PFS) as per Response Evaluation Criteria in Solid Tumors(RECIST) Version 1.1
Measured: From first dose of CTX-471(Cycle 1 Day 1, Cycle = 2weeks ) until date of progression or death, whichever occurs first, for 50% of the study population, including time intervals of at 6 months and 12 months.
Median Overall Survival (OS)
Measured: From first dose of CTX-471 (Cycle 1 Day 1,Cycle = 2weeks) until death for 50% of the study population, including time intervals at 6 months and 12 months.
Maximum serum concentration (Cmax) of CTX-471
Measured: From first dose of CTX-471 (Cycle 1 Day 1,Cycle = 2 weeks) until treatment discontinuation (up to 1 year)
Time of maximum observed serum concentration (Tmax) of CTX-471
Measured: From first dose of CTX-471 (Cycle 1 Day 1, Cycle = 2 weeks) until treatment discontinuation (up to 1 year)
Trough serum concentration (Ctrough) of CTX-471
Measured: From first dose of CTX-471 (Cycle 1 Day 1, Cycle = 2 weeks) until treatment discontinuation (up to 1 year)
Area under the serum concentrations of CTX-471 versus time curve (AUC) for CTX-471
Measured: From first dose of CTX-471 (Cycle 1 Day 1,Cycle = 2 weeks) until treatment discontinuation (up to 1 year)
Clearance (CL) of serum concentrations of CTX-471
Measured: From first dose of CTX-471 (Cycle 1 Day 1, Cycle = 2 weeks) until treatment discontinuation (up to 1 year)
Volume of distribution (Vd) of serum concentrations of CTX-471
Measured: From first dose of CTX-471 (Cycle 1 Day 1, Cycle = 2 weeks) until treatment discontinuation (up to 1 year)
Half-life (t1/2) of serum concentrations of CTX-471
Measured: From first dose of CTX-471 (Cycle 1 Day 1, Cycle = 2 weeks) until treatment discontinuation (up to 1 year)
Assess the immunogenicity of CTX-471
Screen for the presence and development of antibodies against CTX-471
Measured: From first dose of CTX-471 (Cycle 1 Day 1, Cycle = 2 weeks) until end of treatment visit (up to 1 year)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jul 2026
- Study startSep 2026 (estimated)
- Primary completionSep 2028 (estimated)
- Study completionSep 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neuroendocrine NeoplasmStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 58 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Compass Therapeutics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07684170
- Sponsor's protocol ID
- CTX-471-002
- Status last verified
- Jun 2026
- First submitted
- 17 Jun 2026
- Last updated
- 6 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 6 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2, Open-Label Study of CTX-471 in Patients With NCAM Positive Tumors
- ClinicalTrials.gov ID
- NCT07684170
- Acronym / sponsor ID
- CTX-471-002
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 58 participants (estimated)
- Lead sponsor
- Compass TherapeuticsIndustry (pharma, biotech, devices)
- Study start
- Sep 2026 (estimated)
- Primary completion
- Sep 2028 (estimated)
- Study completion
- Sep 2029 (estimated)
- First posted
- 6 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dose Level 0.3 mg/kg | Experimental | Drug: CTX-471 |
| Dose Level 0.6 mg/kg | Experimental | Drug: CTX-471 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (19 listed)
- 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.
Key exclusion criteria (24 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CTX-471Patients will receive CTX-471 as an intravenous (IV) infusion every 2 weeks until disease progression or unacceptable toxicity. | Drug | Dose Level 0.3 mg/kg, Dose Level 0.6 mg/kg |
Primary outcome
Evaluate the clinical activity of CTX-471
Time frame: Baseline until confirmed disease progression (up to 1 year)
Objective Response Rate (ORR) (Percentage of Participants With Objective Response) as per Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1
Evaluate the safety of CTX-471
Time frame: From first dose of CTX-471 (Cycle 1 Day 1, Cycle = 2 weeks) until 30 days after the last dose of CTX-471
Incidence of treatment emergent adverse events (TEAEs), treatment-related AEs (TREAEs), and serious adverse events (SAEs)
Determine the recommended phase 2 dose (RP2D) for CTX-471
Time frame: From first dose of CTX-471 (Cycle 1 Day 1, Cycle = 2 weeks) until 30 days after the last dose of CTX-471
Efficacy, exposure, safety events, and markers of response will be aggregated to select a Phase 2 dose
13 secondary outcomes
Duration of Response (DOR) as per Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1
Time frame: From the date of first confirmed PR or CR until date of progression or death, whichever occurs first (up to 1 year)
Disease Control Rate (DCR) as per Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1
Time frame: From first dose of CTX-471 (Cycle 1 Day 1,Cycle = 2 weeks) until until disease progression or death, whichever occurs first (up to 1 year)
Progression-Free Survival (PFS) as per Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1
Time frame: From first dose of CTX-471(Cycle 1 Day 1,Cycle = 2 weeks ) until disease progression or death, whichever occurs first (up to 1 year)
Median Progression-Free Survival (PFS) as per Response Evaluation Criteria in Solid Tumors(RECIST) Version 1.1
Time frame: From first dose of CTX-471(Cycle 1 Day 1, Cycle = 2weeks ) until date of progression or death, whichever occurs first, for 50% of the study population, including time intervals of at 6 months and 12 months.
Median Overall Survival (OS)
Time frame: From first dose of CTX-471 (Cycle 1 Day 1,Cycle = 2weeks) until death for 50% of the study population, including time intervals at 6 months and 12 months.
Maximum serum concentration (Cmax) of CTX-471
Time frame: From first dose of CTX-471 (Cycle 1 Day 1,Cycle = 2 weeks) until treatment discontinuation (up to 1 year)
Time of maximum observed serum concentration (Tmax) of CTX-471
Time frame: From first dose of CTX-471 (Cycle 1 Day 1, Cycle = 2 weeks) until treatment discontinuation (up to 1 year)
Trough serum concentration (Ctrough) of CTX-471
Time frame: From first dose of CTX-471 (Cycle 1 Day 1, Cycle = 2 weeks) until treatment discontinuation (up to 1 year)
Area under the serum concentrations of CTX-471 versus time curve (AUC) for CTX-471
Time frame: From first dose of CTX-471 (Cycle 1 Day 1,Cycle = 2 weeks) until treatment discontinuation (up to 1 year)
Clearance (CL) of serum concentrations of CTX-471
Time frame: From first dose of CTX-471 (Cycle 1 Day 1, Cycle = 2 weeks) until treatment discontinuation (up to 1 year)
Volume of distribution (Vd) of serum concentrations of CTX-471
Time frame: From first dose of CTX-471 (Cycle 1 Day 1, Cycle = 2 weeks) until treatment discontinuation (up to 1 year)
Half-life (t1/2) of serum concentrations of CTX-471
Time frame: From first dose of CTX-471 (Cycle 1 Day 1, Cycle = 2 weeks) until treatment discontinuation (up to 1 year)
Assess the immunogenicity of CTX-471
Time frame: From first dose of CTX-471 (Cycle 1 Day 1, Cycle = 2 weeks) until end of treatment visit (up to 1 year)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jul 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing CTX-471 in people with Neuroendocrine Neoplasm and Neuroendocrine Carcinomas, run by Compass Therapeutics.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 19 inclusion and 24 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 6 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Compass Study Email (617-500-8099, CTX-471-002@compasstherapeutics.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluate the clinical activity of CTX-471 (time frame: Baseline until confirmed disease progression (up to 1 year)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jul 2026.