QUILT 3.071: NANT Colorectal Cancer (CRC) Vaccine

NCT03563157 | Terminated Phase 1 Results DMC FDA Drug

• 1 other identifier: QUILT-3.071
• Study Type: interventional
• Target: 2
• Locations: 1 country
• Sites: 1

Brief Summary

QUILT 3.071 NANT Colorectal Cancer (CRC) Vaccine: This is a Phase 1b/2 study investigating the effect of NANT CRC vaccine vs regorafenib in subjects with CRC who were previously treated with SOC.

Conditions

Colorectal Cancer Metastatic; mCRC

Keywords

Colorectal Cancer; Metastatic Colorectal Cancer

Outcome Measures

Primary Outcomes (1)

• Number of Participants With Treatment-emergent Adverse Events (AEs) and Serious AEs (SAEs)

  Graded Using the National Cancer Institute(NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 4.03

  30 days after last dose, up to 6 months or until they experience confirmed progressive disease or unacceptable toxicity, withdrawn consent, or if the Investigator feels it is no longer in their best interest.

Secondary Outcomes (7)

• Objective Response Rate by RECIST Version 1.1 and irRC

  Tumors were assessed at screening, and tumor response will be assessed every 8 weeks during the induction phase, and every 12 weeks during the maintenance phase until disease progression, up to 4 months

• Progression Free Survival by RECIST Version 1.1 and irRC

  Tumors were assessed at screening, and tumor response was assessed every 8 weeks during the induction phase, and every 12 weeks during the maintenance phase until disease progression or death (any cause) whichever occurred first, up to 9 months.

• Duration of Response (DOR) by RECIST Version 1.1 and irRC

  Tumors were assessed at screening, and tumor response will be assessed every 8 weeks during the induction phase, and every 12 weeks during the maintenance phase until confirmed disease progression, up to 4 months

• Overall Survival

  Participants were assessed from screening to death.

• Disease Control Rate (Confirmed Complete Response, Partial Response, or Stable Disease Lasting for at Least 2 Months) by RECIST Version 1.1.

  Tumors were assessed at screening, and tumor response will be assessed every 8 weeks during the induction phase, and every 12 weeks during the maintenance phase until confirmed disease progression, up to 4 months

Study Arms (2)

NANT Colorectal Cancer (CRC) Vaccine

EXPERIMENTAL

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.

Biological: Aldoxorubicin Hydrochloride; Biological: ALT-803; Biological: ETBX-011; Biological: ETBX-021; Biological: ETBX-051; Biological: ETBX-061; Biological: GI-4000; Biological: GI-6207; Biological: GI-6301; Biological: haNK; Drug: Avelumab; Drug: Capecitabine; Drug: Cetuximab; Drug: Cyclophosphamide; Drug: 5-Fluorouracil; Drug: Leucovorin; Drug: Nab-paclitaxel; Drug: Oxaliplatin; Drug: Regorafenib; Procedure: SBRT

Regorafenib

ACTIVE COMPARATOR

Regorafenib will be administered to subjects in this study.

Drug: Regorafenib

Interventions

Aldoxorubicin Hydrochloride BIOLOGICAL

Aldoxorubicin Hydrochloride HCI

NANT Colorectal Cancer (CRC) Vaccine

ALT-803 BIOLOGICAL

Recombinant human super agonist interleukin-15 (IL-15) complex \[also known as IL-15N72D;IL-15RaSu/IgG1 Fe complex1\]

NANT Colorectal Cancer (CRC) Vaccine

ETBX-011 BIOLOGICAL

Ad5 \[E1-, E2b-\]-CEA

NANT Colorectal Cancer (CRC) Vaccine

ETBX-021 BIOLOGICAL

Ad5 \[E1-, E2b-\]-\[HER2\]

NANT Colorectal Cancer (CRC) Vaccine

ETBX-051 BIOLOGICAL

Ad5 \[E1-, E2b-\]-Brachyury

NANT Colorectal Cancer (CRC) Vaccine

ETBX-061 BIOLOGICAL

Ad5 \[E1-, E2b-\]-mucin 1 \[MUC1\]

NANT Colorectal Cancer (CRC) Vaccine

GI-4000 BIOLOGICAL

RAS yeast

NANT Colorectal Cancer (CRC) Vaccine

GI-6207 BIOLOGICAL

CEA yeast

NANT Colorectal Cancer (CRC) Vaccine

GI-6301 BIOLOGICAL

Brachyury yeast

NANT Colorectal Cancer (CRC) Vaccine

haNK BIOLOGICAL

haNK™, NK-92 \[CD16.158V, ER IL-2\]

NANT Colorectal Cancer (CRC) Vaccine

Avelumab DRUG

BAVENCIO® injection

NANT Colorectal Cancer (CRC) Vaccine

Capecitabine DRUG

XELODA® tablets

NANT Colorectal Cancer (CRC) Vaccine

Cetuximab DRUG

ERBITUX® injection

NANT Colorectal Cancer (CRC) Vaccine

Cyclophosphamide DRUG

Cyclophosphamide Capsules

NANT Colorectal Cancer (CRC) Vaccine

5-Fluorouracil DRUG

5-FU; Fluorouracil Injection

NANT Colorectal Cancer (CRC) Vaccine

Leucovorin DRUG

Leucovorin Calcium

NANT Colorectal Cancer (CRC) Vaccine

Nab-paclitaxel DRUG

ABRAXANE® for Injectable Suspension \[paclitaxel protein-bound particles for injectable suspension\] \[albumin-bound\]

NANT Colorectal Cancer (CRC) Vaccine

Oxaliplatin DRUG

ELOXATIN® injection

NANT Colorectal Cancer (CRC) Vaccine

Regorafenib DRUG

STIVARGA® tablets

NANT Colorectal Cancer (CRC) Vaccine; Regorafenib

SBRT PROCEDURE

Stereotactic body radiation therapy

NANT Colorectal Cancer (CRC) Vaccine

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥ 18 years.
• Able to understand and provide a signed informed consent that fulfills the relevant IRB or IEC guidelines.
• Histologically-confirmed recurrent or metastatic CRC previously treated with fluoropyrimidine-, oxaliplatin- and irinotecan-based chemotherapy, an anti-VEGF biological therapy, and if RAS wild-type, an anti-EGFR therapy; or subjects who are ineligible for these therapies.
• ECOG performance status of 0 or 1.
• Have at least 1 measurable lesion of ≥ 1.0 cm.
• Must have a recent FFPE tumor biopsy specimen following the conclusion of the most recent anticancer treatment and be willing to release the specimen for prospective and exploratory tumor molecular profiling. If an historic specimen is not available, the subject must be willing to undergo a biopsy during the screening period, if considered safe by the Investigator. If safety concerns preclude collection of a biopsy during the screening period, a tumor biopsy specimen collected prior to the conclusion of the most recent anticancer treatment may be used.
• Must be willing to provide blood samples prior to the start of treatment on this study for prospective tumor molecular profiling and exploratory analyses.
• Must be willing to provide a tumor biopsy specimen 8 weeks after the start of treatment for exploratory analyses, if considered safe by the Investigator.
• Ability to attend required study visits and return for adequate follow-up, as required by this protocol.
• Agreement to practice effective contraception for female subjects of child-bearing potential and non-sterile males. Female subjects of child-bearing potential must agree to use effective contraception for up to 1 year after completion of therapy, and non- sterile male subjects must agree to use a condom for up to 4 months after treatment. Effective contraception includes surgical sterilization (eg, vasectomy, tubal ligation), two forms of barrier methods (eg, condom, diaphragm) used with spermicide, IUDs, and abstinence.
• Phase 2 single-arm component only
• Must have progressed on or after regorafenib treatment in the randomized phase 2 portion of the study OR progressed or experienced unacceptable toxicity on SoC and regorafenib prior to enrollment on the study.

You may not qualify if:

• MSI-high or MMR-deficient tumors eligible for, but not yet treated with, a PD-1 inhibitor.
• Serious uncontrolled concomitant disease that would contraindicate the use of the investigational drugs used in this study or that would put the subject at high risk for treatment-related complications.
• Systemic autoimmune disease (eg, lupus erythematosus, rheumatoid arthritis, Addison's disease, or autoimmune disease associated with lymphoma).
• History of organ transplant requiring immunosuppression.
• History of or active inflammatory bowel disease (eg, Crohn's disease, ulcerative colitis).
• Inadequate organ function, evidenced by the following laboratory results:
• ANC \< 1,000 cells/mm\^3.
• Uncorrectable grade 3 anemia (hemoglobin \< 8 g/dL)
• Platelet count \< 75,000 cells/mm\^3.
• Total bilirubin \> ULN (unless the subject has documented Gilbert's syndrome).
• AST (SGOT) or ALT (SGPT) \> 2.5 × ULN (\> 5 × ULN in subjects with liver metastases).
• ALP \> 2.5 × ULN (\> 5 × ULN in subjects with liver metastases, or \>10 × ULN in subjects with bone metastases).
• Serum creatinine \> 2.0 mg/dL or 177 μmol/L.
• Serum anion gap \> 16 mEq/L or arterial blood with pH \< 7.3.
• Uncontrolled hypertension (systolic \> 160 mm Hg and/or diastolic \> 110 mm Hg) or clinically significant (ie, active) cardiovascular disease, cerebrovascular accident/stroke, or myocardial infarction within 6 months prior to first study medication; unstable angina; congestive heart failure of New York Heart Association grade 2 or higher; or serious cardiac arrhythmia requiring medication. Subjects with uncontrolled hypertension should be medically managed on a stable regimen to control hypertension prior to study entry.

Sponsors & Collaborators

• ImmunityBio, Inc.: lead

Study Sites (1)

Chan Soon-Shiong Institute for Medicine

El Segundo, California, 90245, United States

Location

MeSH Terms

Conditions

Colorectal Neoplasms

Interventions

ALT-803; yeast-CEA vaccine; avelumab; Capecitabine; Cetuximab; Cyclophosphamide; Fluorouracil; Leucovorin; 130-nm albumin-bound paclitaxel; Oxaliplatin; regorafenib

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Intervention Hierarchy (Ancestors)

Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Uracil; Pyrimidinones; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Phosphoramide Mustards; Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Hydrocarbons; Organic Chemicals; Phosphoramides; Organophosphorus Compounds; Formyltetrahydrofolates; Tetrahydrofolates; Folic Acid; Pterins; Pteridines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Coenzymes; Enzymes and Coenzymes; Coordination Complexes

Results Point of Contact

• Title: Sandeep Bobby Reddy, Chief Medical Officer
• Organization: ImmunityBio

Bobby.Reddy@Immunitybio.com

855-797-9277

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 22, 2018
• First Posted: June 20, 2018
• Study Start: September 28, 2018
• Primary Completion: April 21, 2019
• Study Completion: August 21, 2019
• Last Updated: December 11, 2024
• Results First Posted: December 11, 2024

Record last verified: 2024-12

Locations

US (1)