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CAR T-cell Therapy

CRB-701 for Cancer

Phase 1 & 2
Recruiting
Led By David Pinato, 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
Must not have
Active of uncontrolled CNS metastases
History of solid tumors other than the diseases under study
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 6 months
Awards & highlights
No Placebo-Only Group

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

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have brain metastases that are not currently under control.
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I have had cancer types other than the one currently being studied.
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I have moderate to severe nerve damage.
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My HbA1C is 8% or higher, or I have uncontrolled diabetes or diabetic neuropathy.
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I currently have an eye condition.
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I have chronic severe liver disease or cirrhosis.

Timeline

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

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
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 study objectives
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

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

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

Find a Location

Who is running the clinical trial?

Corbus Pharmaceuticals Inc.Lead Sponsor
8 Previous Clinical Trials
1,402 Total Patients Enrolled
CSPC Zhongnuo Pharmaceutical (Shijiazhuang) Co., Ltd.Industry Sponsor
16 Previous Clinical Trials
1,931 Total Patients Enrolled
David Pinato, MDPrincipal InvestigatorImperial College London
~280 spots leftby Jan 2027
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