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

Sponsor: Corbus Pharmaceuticals Inc.

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT06265727

Patient View

This Phase 1/2 trial evaluates CRB-701, a nectin-4 targeted ADC, in advanced solid tumors. It involves dose escalation to determine MTD and RP2D, followed by expansion cohorts. Eligible participants have nectin-4 expressing tumors with limited treatment options. Exclusions include CNS metastases, cardiovascular issues, and severe comorbidities.

Patient Parameters

Program 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 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.

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 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 determine the RP2D of CRB-701 by evaluating two dose levels of CRB-701 by using a time-to-event Bayesian optimal Phase 2 (TOP) 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 RP2D dose of CRB-701 will be evaluated in five planned expansion cohorts using Simon's optimal two-stage design.

Eligibility Criteria

Inclusion Criteria

  • Confirmed diagnosis of select advanced or metastatic nectin-4 expressing solid tumors that have progressed following at least one line of therapy or have no other standard therapy with proven clinical benefit.

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.

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