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Recruiting NCT06265727

A Phase 1/2 Study to Investigate CRB-701 in Solid Tumors

Phase I / Phase II Interventional Solid Tumor, Adult

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: CRB-701, Anti-PD-1.
Who it may be relevant to
Registry conditions: Solid Tumor, Adult. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States, France, Italy, Moldova, Romania +2
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

A Phase 1/2 Study to Investigate the Safety, Pharmacokinetics, and Efficacy of CRB-701, an Antibody-drug Conjugate Targeting Nectin-4, in Patients With Advanced Solid Tumors

Overview

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? 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. They will have blood tests, CT or MRI Scans, and other assessments to measure whether CRB-701 has an effect on tumors.

Detailed description

This is a three-part open-label, Phase 1/2 clinical trial designed to evaluate the safety, PK, and efficacy of CRB-701 in participants with advanced solid tumors expressing nectin-4.

Part A will include solid tumor types known to express nectin-4. Dose escalation will be guided by the Bayesian optimal interval (BOIN) design to determine the Maximum Tolerated Dose (MTD) of CRB-701. Four (4) dose groups are pre-determined. Dose escalation/de-escalation decisions are made based on the occurrence of DLT.

Part B will evaluate two dose levels of CRB-701 alone and in combination with anti-PD-1 by using a time-to-event Bayesian optimal Phase 2 study design to optimize the dose of CRB-701 in one or more separate cohorts of participants with nectin-4-positive tumors.

During Part C, the recommended dose level of CRB-701 for further exploration defined in Part B will explore CRB-701 alone or combined with anti-PD-1 in up to seven separate cohorts of participants with advanced tumors known to express Nectin-4.

Interventions

  • Drug CRB-701
    Nectin-4 targeted Antibody Drug Conjugate (ADC)
  • Drug Anti-PD-1
    checkpoint inhibitor

Primary outcome measures

  • Part A: To confirm the safety and tolerability and determine MTD and PADR for CRB-701 [Time frame: 21 days]
  • Part B & C: To evaluate efficacy in terms of Objective Response Rate (ORR) [Time frame: Up to 6 months]
Secondary outcome measures (12)
  • Parts A, B, & C: To characterize the safety profile of CRB-701 [Time frame: Up to 6 months]
  • Maximum observed plasma concentration of CRB-701 [total ADC] (Cmax) [Time frame: Approximately 9 weeks]
  • Maximum observed plasma concentration of free MMAE (Cmax) [Time frame: Approximately 9 weeks]
  • Part B & C : To evaluate efficacy in terms of Disease Control Rate (DCR) [Time frame: Up to 6 months]
  • Maximum observed plasma concentration of Total CRB-701 antibody [Tab] (Cmax) [Time frame: Approximately 9 weeks]
  • Time to reach Cmax of Total CRB-701 [Total ADC] (Tmax) [Time frame: Approximately 9 weeks]
  • Time to reach Cmax of free MMAE (Tmax) [Time frame: Approximately 9 weeks]
  • Time to reach Cmax of Total CRB-701 antibody [Tab] (Tmax) [Time frame: Approximately 9 weeks]
  • Time to reach Cmax of Total CRB-701 antibody [Tab] (Cmax) [Time frame: Approximately 9 weeks]
  • Total Area Under the plasma concentration-time curve of Total CRB-701 [total ADC] (AUC) [Time frame: Approximately 9 weeks]
  • Total Area Under the plasma concentration-time curve of free MMAE (AUC) [Time frame: Approximately 9 weeks]
  • Total Area Under the plasma concentration-time curve of Total CRB-701 antibody [Tab] (AUC) [Time frame: Approximately 9 weeks]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Sequential
Masking
Open label
Primary purpose
Treatment

Study locations

United States · 15 centers
  • O'Neal Comprehensive Cancer Center at University of Alabama-Birmingham — Birmingham
  • City of Hope Cancer Center — Duarte
  • Moores Cancer Centre at UC San Diego Health — San Diego
  • Helen Diller Family Comprehensive Cancer Center - UCSF — San Francisco
  • Rocky Mountain Cancer Centres — Denver
  • Yale Cancer Center — New Haven
  • Florida Cancer Specialists — Orlando
  • University of Chicago — Chicago
  • … and 7 more centers
United Kingdom · 9 centers
  • University of Birmingham NHS Foundation Trust — Birmingham
  • University of Cambridge NHS Foundation Trust — Cambridge
  • Velindre Cancer Centre — Cardiff
  • Leeds University Hospitals NHS Trust — Leeds
  • Guy's and St Thomas' Clinical Research Facility — London
  • Imperial Experimental Cancer Medicine Centre — London
  • The Christie Hospital — Manchester
  • University of Liverpool - Clatterbridge Medical Centre — Metropolitan Borough of Wirral
  • … and 1 more center
France · 4 centers
  • ICM-Val d'Aurelle — Montpellier
  • CHU de Poitiers — Poitiers
  • Institut de Cancerologie de l'Ouest — Saint-Herblain
  • Gustave Roussy — Villejuif
Italy · 4 centers
  • Careggi University Hospital — Florence
  • European Institute of Oncology IRCCS — Milan
  • Fondazione Policlinico Gemelli, IRCCS — Rome
  • Centro Richerche Cliniche di Verona — Verona
Romania · 4 centers
  • Aresnsia Research Clinic Bucharest — Bucharest
  • Aresnsia Research Clinic Cluj-Napoca — Cluj-Napoca
  • Centrul de Oncologie Sf. Nectarie — Iași
  • Centrul de Oncologie Euroclinic — Iași
Spain · 4 centers
  • Barcelona IOB Hospital Quironsalud (NEXT) — Barcelona
  • Vall d-Hebron Institut d'Oncologia — Barcelona
  • Fundacion Jimenez Diaz (START) — Madrid
  • Hospital Clinico Universitario de Valencia — Valencia
Moldova · 1 center
  • Institute of Oncology/ARENSIA Exploratory Medicine — Chisinau

Identifiers

NCT: NCT06265727 · CRB-701-01

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗