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Monoclonal Antibodies

CRB-601 Combination Therapy for Cancer

Phase 1 & 2

Waitlist Available

Led By Jeff Clarke, 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 locally advanced or metastatic solid tumors that have progressed after at least one line of therapy or have no other standard therapy with proven clinical benefit available

Eastern Cooperative Oncology Group (ECOG) performance status (PS) greater or equal to 2

Must not have

History of and/or current cardiovascular events or conditions

Chronic severe liver disease or liver cirrhosis

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 6 months

Awards & highlights

No Placebo-Only Group

Summary

This trial aims to test the safety and effectiveness of a drug called CRB-601 in combination with immunotherapy or radiotherapy in patients with advanced solid tumors who have run out of treatment options. The

Who is the study for?

This trial is for patients with advanced solid tumors who have tried all other treatments. It's aimed at those whose cancers express a specific protein, avb8 integrin. Participants will receive the experimental drug CRB-601, alone or with immunotherapy and targeted radiotherapy.

What is being tested?

Researchers are testing CRB-601, an antibody targeting avb8 integrin in cancer cells, combined with anti-PD-1 immunotherapy and focused radiotherapy. They want to find the right dose of CRB-601 and see if it's safe and effective when used with these standard treatments.

What are the potential side effects?

Possible side effects include reactions to infusions such as fever or chills, fatigue, changes in blood tests indicating organ function issues, immune system responses that could affect healthy organs, and typical risks associated with radiation therapy.

Eligibility Criteria

Inclusion Criteria

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

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My cancer has spread and worsened after treatment, or there's no beneficial treatment left.

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My physical ability is limited but I can still take care of myself.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have a history of heart problems.

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I have chronic severe liver disease or cirrhosis.

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I currently have an infection that is ongoing.

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I do not have active blood clot issues, uncontrolled bleeding, or unmanaged diabetes.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 6 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~6 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 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

Characterize the safety of CRB-601 in combination anti-PD(L)1 therapy with or without single-lesion, immune priming SBRT

To evaluate the efficacy of CRB-601 in terms of DCR when administered in combination with anti-PD(L)-1 with or without single-lesion immune-priming SBRT

Secondary study objectives

To characterize the PK profile of CRB-601

To evaluate the preliminary antitumor activity of CRB-601 in combination with anti-PD(L)1 therapy with or without single-lesion, immune-priming SBRT

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

9Treatment groups

Experimental Treatment

Group I: Part C - Low dose CRB-601, anti-PD(L)-1 with or without SBRTExperimental Treatment3 Interventions

Participants will received a low dose of CRB-601(defined in Part A \& B), standard of care dose of anti-PD(L)-1 therapy with or without 3 x 8gy doses of immune priming SBRT focused on a single lesion (as determined in Part B).

Group II: Part C - High dose CRB-601, anti-PD(L)-1 with or without SBRTExperimental Treatment3 Interventions

Participants will received a high dose of CRB-601(defined in Part A \& B), standard of care dose of anti-PD(L)-1 therapy with or without 3 x 8gy doses of immune priming SBRT focused on a single lesion (as determined in Part B).

Group III: Part B/Cohort 2 low dose CRB-601, anti-PD(L)-1 therapy and SBRTExperimental Treatment3 Interventions

Participants will received a low dose of CRB-601(defined in Part A), standard of care dose of anti-PD(L)-1 therapy and 3 x 8gy doses of immune priming SBRT focused on a single lesion.

Group IV: Part B/Cohort 2 high dose CRB-601, anti-PD(L)-1 therapy and SBRTExperimental Treatment3 Interventions

Participants will received a high dose of CRB-601(defined in Part A), standard of care dose of anti-PD(L)-1 therapy and 3 x 8gy doses of immune priming SBRT focused on a single lesion.

Group V: Part B/Cohort 1: Dose level (low) CRB-601 monotherapy in combination with anti-PD(L)-1Experimental Treatment2 Interventions

Dose (defined in Part A) of CRB-601 administered intravenously in combination with anti-PD(L)-1 therapy dosed as per label.

Group VI: Part B/Cohort 1: Dose level (high) CRB-601 monotherapy in combination with anti-PD(L)-1Experimental Treatment2 Interventions

High dose CRB-601 (defined in Part A) of CRB-601 administered intravenously in combination with anti-PD(L)-1 therapy dosed per label.

Group VII: Part A: Dose 3 of CRB-601 monotherapyExperimental Treatment1 Intervention

Dose 3 of CRB-601 (30mg/Kg) administered intravenously every two weeks

Group VIII: Part A: Dose 2 of CRB-601 monotherapyExperimental Treatment1 Intervention

Dose 2 of CRB-601 (10mg/Kg) administered intravenously every two weeks

Group IX: Part A: Dose 1 CRB-601 monotherapyExperimental Treatment1 Intervention

Dose 1 of CRB-601 (3mg/Kg) administered intravenously every two weeks

0 / 6Eligibility criteria met