Health TrialsbyHealthPanel

First-in-human Study of CRB-601-01 to Treat Patients With Advanced Solid Tumor.

ConditionSolid Tumor
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorCorbus Pharmaceuticals Inc.

About this trial

The purpose of this study is to determine the safety, blood concentrations and treatment effect of CRB-601 in combination with immunotherapy in patients who have advanced solid tumors (cancer) and have exhausted other therapeutic options.CRB-601 targets a protein called avb8 integrin which is expressed by some cancers and not others. This study will focus on tumor types which are know to highly or moderately express this protein.

Researchers will evaluate the side effects caused by treatment, levels of CRB-601 in the blood, and the effect on the participant cancer. This will help researchers understand the right dose of CRB-601 to use for treatment and whether it is an effective treatment to combine with standard of care treatments such as immunotherapy. It will also help the researchers understand whether combining CRB-601 with standard-of-care immunotherapy and immune-priming radiotherapy is a safe and effective approach to treat cancer.

Participants in the study will receive CRB-601 via an infusion every two weeks either alone or in combination with immunotherapy.

There will be assessments to check on the participants general health status (including blood tests) and adverse effects. Participants will also receive regular CT or MRI scans to evaluate the effect of CRB-601 on their cancer. Participants will continue to visit the clinic every two weeks while they are receiving benefit from treatment. If their cancer progresses, participants will be asked to continue to be followed-up by the researchers to understand long-term outcomes, even if they receive other treatments.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Measurable disease on imaging as assessed by RECIST 1.1 Eastern Cooperative Oncology Group (ECOG) performance status (PS) greater or equal to 2.

Life expectancy of more than 12 weeks.

Adequate hematologic and end-organ function.

Disqualifiers

History of solid tumor malignancies other than the disease under study within 3 years of study enrollment

History of and/or current cardiovascular events or conditions

Chronic severe liver disease or liver cirrhosis

Systemic autoimmune disease

Trial design

Design model

Factorial

Treatments tested in this trial

  • CRB-601 monoclonal antibody

    Drug

    CRB-601

  • Anti-PD-1 monoclonal antibody

    Drug

    Anti-PD(L)-1 used as per label

Treatment groups

156 Participants
are divided into 8 treatment groups

8

Treatment groups

See each treatment group below.

Group A: Part A: Dose 1 CRB-601 monotherapyExperimental treatment 1 intervention
Group B: Part A: Dose 2 of CRB-601 monotherapyExperimental treatment 1 intervention
Group C: Part A: Dose 3 of CRB-601 monotherapyExperimental treatment 1 intervention
Group D: Part B/Cohort 1: Dose level (low) CRB-601 in combination with anti-PD(L)-1Experimental treatment 2 interventions
Group E: Part B/Cohort 2: Dose level (high) CRB-601 in combination with anti-PD(L)-1Experimental treatment 2 interventions
Group F: Part B/Expansion: Dose level (defined in Part B/ Safety Le) CRB-601 in combination with anti-PD(L)-1Experimental treatment 2 interventions
Group G: Part C - Low dose CRB-601 in combination with anti-PD(L)-1Experimental treatment 2 interventions
Group H: Part C - High dose CRB-601 in combination with anti-PD(L)-1Experimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

Occurance of Dose-limiting toxicities

Time frame
28 days
2

Characterize the safety of CRB-601 in combination anti-PD(L)1 therapy

Incidence of treatment emergent adverse events and clinically significant changes in laboratory parameters, ECG, vital signs and physical exam findings over treatment duration

Time frame
6 months
3

To evaluate the efficacy of CRB-601 in terms of DCR when administered in combination with anti-PD(L)-1

Disease Control Rate (Complete Responses plus Partial Responses plus Stable Disease for at least 4 months as determined by the Investigator using RECIST 1.1.

Time frame
6 months

Secondary outcomes

1

To evaluate the preliminary antitumor activity of CRB-601 in combination with anti-PD(L)1 therapy

Calculation of the Overall Response Rate (CR + PR + SD as determined by the Investigator using RECIST 1.1)

Time frame
6 months
2

To characterize the PK profile of CRB-601

Serum concentrations of CRB-601 expressed as Area under the curve (AUC)

Time frame
28 Days
3

To characterize the PK profile of CRB-601

Serum concentrations of CRB-601 expressed as Concentration max (Cmax)

Time frame
28 Days

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Corbus Pharmaceuticals Inc.

Lead sponsor

Source ClinicalTrials.gov
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