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
This trial does not accept healthy volunteersQualifiers
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
Design model
Parallel
Treatments tested in this trial
CTX-471
DrugPatients will receive CTX-471 as an intravenous (IV) infusion every 2 weeks until disease progression or unacceptable toxicity.
Treatment groups
58 Participants
are divided into 2 treatment groupsGroup A: Dose Level 0.3 mg/kgExperimental treatment 1 intervention
Group B: Dose Level 0.6 mg/kgExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
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
Time frame
Baseline until confirmed disease progression (up to 1 year)2
Evaluate the safety of CTX-471
Incidence of treatment emergent adverse events (TEAEs), treatment-related AEs (TREAEs), and serious adverse events (SAEs)
Time frame
From first dose of CTX-471 (Cycle 1 Day 1, Cycle = 2 weeks) until 30 days after the last dose of CTX-4713
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
Time frame
From first dose of CTX-471 (Cycle 1 Day 1, Cycle = 2 weeks) until 30 days after the last dose of CTX-471Secondary outcomes
1
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)2
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)3
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)4
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.Locations
Sponsors and contacts
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Source ClinicalTrials.gov
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