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CAR T-cell Therapy

Part C Dose Expansion - Cohort 5 for Solid Tumors

Phase 1 & 2

Recruiting

Led By Ari Rosenberg, MD

Research Sponsored by Corbus Pharmaceuticals Inc.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

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.

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 6 months

Awards & highlights

Study Summary

This trial aims to find a safe and effective dose of CRB-701 for people with solid tumors that have a protein called nectin-4. It will determine the right dose of CRB

Who is the study for?

This trial is for individuals with solid tumors that have a protein called nectin-4. Participants will need to visit the clinic for intravenous infusions and undergo blood tests, CT or MRI scans to monitor effects on their tumors.Check my eligibility

What is being tested?

The study is testing CRB-701 in patients with solid tumors. It aims to determine the safe and effective dosage of CRB-701 when administered alone and its effectiveness against various cancers.See study design

What are the potential side effects?

While specific side effects are not listed, common ones associated with cancer treatments include fatigue, nausea, pain at infusion site, allergic reactions, and changes in blood counts leading to increased infection risk.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

My cancer expresses nectin-4 and has worsened after treatment or has no other treatment options.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 6 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 6 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 6 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

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

Maximum observed plasma concentration of CRB-701 [total ADC] (Cmax)

Maximum observed plasma concentration of Total CRB-701 antibody [Tab] (Cmax)

Maximum observed plasma concentration of free MMAE (Cmax)

+8 more

Trial Design

11Treatment groups

Experimental Treatment

Group I: Part C Dose Expansion - Cohort 5Experimental Treatment1 Intervention

Recommended Phase 2 dose of CRB-701 and schedule, intravenous infusion over 30 mins

Group II: Part C Dose Expansion - Cohort 4Experimental Treatment1 Intervention

Recommended Phase 2 dose of CRB-701 and schedule, intravenous infusion over 30 mins

Group III: Part C Dose Expansion - Cohort 3Experimental Treatment1 Intervention

Recommended Phase 2 dose of CRB-701 and schedule, intravenous infusion over 30 mins

Group IV: Part C Dose Expansion - Cohort 2Experimental Treatment1 Intervention

Recommended Phase 2 dose and schedule of CRB-701, intravenous infusion over 30 mins

Group V: Part C Dose Expansion - Cohort 1Experimental Treatment1 Intervention

Recommended Phase 2 dose and schedule of CRB-701, intravenous infusion over 30 mins

Group VI: Part B Dose Optimization: CRB-701 low doseExperimental Treatment1 Intervention

Selected Low dose of CRB-701, intravenous infusion over 30 mins, once every three weeks

Group VII: Part B Dose Optimization: CRB-701 High doseExperimental Treatment1 Intervention

Selected high dose of CRB-701, intravenous infusion over 30 mins, dose schedule 1

Group VIII: Part A Dose Escalation - CRB-701 Dose Level 4Experimental Treatment1 Intervention

CRB-701 Dose Level 4, intravenous infusion over 30 mins, dose schedule 1

Group IX: Part A Dose Escalation - CRB-701 Dose Level 3Experimental Treatment1 Intervention

CRB-701 Dose Level 3, intravenous infusion over 30 mins, dose schedule 1

Group X: Part A Dose Escalation - CRB-701 Dose Level 2Experimental Treatment1 Intervention

CRB-701 Dose Level 2, intravenous infusion over 30 mins, Dose schedule 1

Group XI: Part A Dose Escalation - CRB-701 Dose Level 1Experimental Treatment1 Intervention

CRB-701 Dose level 1, intravenous infusion over 30 mins, Dose schedule 1

0 / 1Eligibility criteria met

Find a Location

Who is running the clinical trial?

Corbus Pharmaceuticals Inc.Lead Sponsor

7 Previous Clinical Trials

1,246 Total Patients Enrolled

CSPC Zhongnuo Pharmaceutical (Shijiazhuang) Co., Ltd.Industry Sponsor

12 Previous Clinical Trials

1,348 Total Patients Enrolled

Ian Hodgson, PhDStudy DirectorCorbus International Ltd

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

In how many medical institutions is this clinical examination currently being conducted?

"At present, this research is being conducted at 7 sites. These include Huntersville, Chicago, Los Angeles, and several additional locations. Opting for a nearby site when enrolling can reduce the need for extensive travel."

Answered by AI

Are eligible patients able to enroll in this ongoing trial at the present time?

"According to information available on clinicaltrials.gov, this particular study is not actively seeking participants. It was initially listed on 2/20/2024 and last revised on 2/12/2024. However, it's essential to note that while this specific trial has paused enrollment, there are currently 150 other trials actively seeking eligible individuals for participation."

Answered by AI

What is the primary objective that this medical study aims to achieve?

"As per the sponsor, Corbus Pharmaceuticals Inc., this research will primarily focus on confirming the safety and tolerability of CRB-701 within a period extending up to 6 months. Additionally, it aims to establish the Maximum Tolerated Dose (MTD) and Predicted Anticipated Biological Effect Level (PADR). Secondary objectives involve evaluating parameters such as the maximum plasma concentration of total ADC post-administration of single or multiple doses, time taken to reach peak concentrations for Total CRB-701 antibody [Tab], characterizing adverse events utilizing NCI CTCAE v5.0 severity grading following treatment with either CRB"

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

2024. "A Phase 1/2 Study to Investigate CRB-701 in Solid Tumors". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06265727.

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