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Cancer Vaccine

SBRT for Colorectal Cancer

Phase 1 & 2

Waitlist Available

Research Sponsored by ImmunityBio, Inc.

Eligibility Criteria Checklist

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

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 2 years

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a new vaccine for colorectal cancer against the current standard of care to see if it is more effective.

Eligible Conditions

Colorectal Cancer

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 2 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~2 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 years for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Incidence of treatment-emergent AEs and SAEs, graded using the NCI CTCAE Version 4.03

Overall Response Rate, as determined by the percentage of patients achieving Partial or Complete Response per RECIST 1.1

Progression Free Survival from baseline to progression, per RECIST 1.1

Secondary study objectives

DCR for Phase 1b, Phase 2 Randomized, and Phase 2 Single Arm Component

DOR for Phase 1b, Phase 2 Randomized, and Phase 2 Single Arm Component

ORR for Phase 1b and Phase 2 Randomized Component

+3 more

Awards & Highlights

No Placebo-Only Group

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

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: NANT Colorectal Cancer (CRC) VaccineExperimental Treatment20 Interventions

A combination of agents will be administered to subjects in this study: Aldoxorubicin HCI, ETBX-011, ETBX-021, ETBX-051, ETBX-061, GI-4000, GI-6207, GI-6301, haNK, N-803, Avelumab, Capecitabine, Cetuximab, Cyclophosphamide, 5-Fluorouracil, Leucovorin, Nab-paclitaxel, Oxaliplatin, Regorafenib, SBRT.

Group II: RegorafenibActive Control1 Intervention

In subjects with metastatic CRC who have been previously treated with standard-of-care (SOC) therapy.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

ALT-803

2016

Completed Phase 2

~170

GI-4000

2006