A Phase I/II Study to Investigate the Safety, Pharmacokinetics, and Efficacy of CRB-701, an Antibody-drug Conjugate Targeting Nectin-4, in Patients With Advanced Solid Tumors

Study Identifier:
CRB-701-01
CT.gov Identifier:
NCT06265727
EudraCT Identifier:
202452000000
EU Trial (CTIS) Number:
N/A
Study Contact Information:
(210) 593-5651 or [email protected]
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Study Summary

The goal of this clinical trial is to define a safe and effective dose of CRB-701 for participants with solid tumors that are expressing a protein called nectin-4. The main questions it aims to answer are: What is the the safe and effective dose of CRB-701 when used alone? What cancers can be treated effectively with CRB-701? Participants will be asked to attend clinic and be given a intravenous infusion of CRB-701 on its own. They will have blood tests and other assessments to measure whether CRB-701 will have CT or MRI scans to measure the effect on tumors. To evaluate SYS6002 is used in combination with recombinant anti-PD-1 fully human monoclonal antibody injection for advanced urothelial cancer and other advanced solid tumors To evaluate the safety, efficacy and pharmacokinetics of CRB-701 in patients with advanced solid tumors associated with high Nectin-4 expression. To evaluate the safety, pharmacokinetics and efficacy of CRB-701 in patients with advanced solid tumors known to be associated with high Nectin-4 expression The Part A dose escalation of the study evaluated four predetermined doses (1.8 mg/kg, 2.7 mg/kg, 3.6 mg/kg and 4.5 mg/kg Q3W) and is followed by Part B (dose optimization) and Part C (dose expansion) that will determine recommended/optimized doses and seek preliminary efficacy signals. To determine the maximum tolerated dose and the optimal doses for phase II evaluation

To report dose escalation and early dose optimization results from a phase 1/2 study in adults with solid tumours known to express Nectin-4

Nectin-4 positivity was evaluated using retrospective H-scores

Safety, tolerability and antitumour activity were assessed.

Medical Condition
The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.
  • Solid Tumor
    • Phase
    The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
    I/II
    Sex
    Female & Male
    Age
    18+ years
    Study Drug
  • Drug: Experimental: Part A Dose Escalation - CRB-701 Dose Level 1
    • Study Status
    Indicates the current recruitment status or the expanded access status
    Recruiting

    Requirements information
    Inclusion criteria
    • Confirmed diagnosis of select advanced or metastatic nectin-4 expressing solid tumors that have progressed having exhausted all appropriate lines of therapy or have no other standard therapy with proven clinical benefit. In Part C, HNSCC participants may enroll as first-line therapy.
    Exclusion criteria
    • - Active of uncontrolled CNS metastases
    • - History of solid tumors other than the diseases under study
    • - History of and/or current cardiovascular events or conditions in the previous 6 months
    • - Pre-existing >/= Grade 2 neuropathy
    • - Hemoglobin A1C (HbA1C) >/= 8%, uncontrolled diabetes mellitus or know diabetic
    • neuropathy
    • - Active ocular disease at baseline
    • - Chronic severe liver disease or live cirrhosis
    • - Interstitial lung disease or pneumonitis within 6 months on initiating treatment on
    • study
    • - Other significant cormorbidities.

    Clinical Study Information for Healthcare Providers

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    Study Locations

    Location
    Investigator
    Status
    Condition(s) Treated at Site
    Location
    START Madrid, Spain (FJD)
    Madrid, Spain, 28040
    Investigator
    Bernard Doger de Speville
    Status
    Recruiting
    Condition(s) Treated at Site
    Solid Tumor