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

Phase 1

Recruiting

• Conditions: Solid Tumor, Adult

• Registration Number: NCT06265727
• Lead Sponsor: Corbus Pharmaceuticals Inc.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2024-2-8
• Last Update Posted: 2 September 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 420

Inclusion Criteria

Inclusion Criteria:<br><br> - Confirmed diagnosis of select advanced or metastatic nectin-4 expressing solid<br> tumors that have progressed following at least one line of therapy or have no other<br> standard therapy with proven clinical benefit.<br><br>Exclusion Criteria:<br><br> - Active of uncontrolled CNS metastases<br><br> - History of solid tumors other than the diseases under study<br><br> - History of and/or current cardiovascular events or conditions in the previous 6<br> months<br><br> - Pre-existing >/= Grade 2 neuropathy<br><br> - Hemoglobin A1C (HbA1C) >/= 8%, uncontrolled diabetes mellitus or know diabetic<br> neuropathy<br><br> - Active ocular disease at baseline<br><br> - Chronic severe liver disease or live cirrhosis<br><br> - Interstitial lung disease or pneumonitis within 6 months on initiating treatment on<br> study<br><br> - Other significant cormorbidities.

Exclusion Criteria

Not provided

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Part A: To confirm the safety and tolerability and determine MTD and PADR for CRB-701;Part B & C : To evaluate efficacy in terms of Disease Control Rate (DCR);Part B & C: To evaluate efficacy in terms of Objective Response Rate (ORR)

Secondary Outcome Measures

Name	Time	Method
Parts A, B, % C: To characterize the safety profile of CRB-701;Maximum observed plasma concentration of CRB-701 [total ADC] (Cmax);Maximum observed plasma concentration of free MMAE (Cmax);Maximum observed plasma concentration of Total CRB-701 antibody [Tab] (Cmax);Time to reach Cmax of Total CRB-701 [Total ADC] (Tmax);Time to reach Cmax of free MMAE (Tmax);Time to reach Cmax of Total CRB-701 antibody [Tab] (Tmax);Time to reach Cmax of Total CRB-701 antibody [Tab] (Cmax);Total Area Under the plasma concentration-time curve of Total CRB-701 [total ADC] (AUC);Total Area Under the plasma concentration-time curve of free MMAE (AUC);Total Area Under the plasma concentration-time curve of Total CRB-701 antibody [Tab] (AUC)