NCT03563170

QUILT-3.072: NANT Hepatocellular Carcinoma (HCC) Vaccine

Molecularly Informed Integrated Immunotherapy Combining Innate High-affinity Natural Killer (haNK) Cell Therapy w/ Adenoviral & Yeast-based Vaccines to Induce T-cell Responses in Subjects w/ Advanced, Unresectable & Untransplantable HCC

• Status: Withdrawn
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: ImmunityBio, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a phase 1b/2 study to evaluate the safety and efficacy of metronomic combination therapy in subjects with advanced, unresectable, and untransplantable HCC.

Detailed description

Treatment will be administered in two phases, an induction and a maintenance phase. Subjects will continue induction treatment for up to 1 year. Those who have a CR in the induction phase will enter the maintenance phase of the study. Subjects who experience ongoing SD or an ongoing PR at 1 year may enter the maintenance phase at the Investigator's and Sponsor's discretion. Subjects may remain in the maintenance phase of the study for up to 1 year. Treatment in the study will be discontinued if the subject experiences confirmed PD or unacceptable toxicity (not corrected with dose reduction), withdraws consent, undergoes liver transplantation or surgical resection, or if the Investigator feels it is no longer in the subject's best interest to continue treatment. Subjects with an initial assessment of PD may, at the discretion of the Investigator, continue to receive study treatment until PD is confirmed. The maximum time on study treatment is 2 years.

Conditions

• Hepatocellular Carcinoma Non-resectable
• Hepatocellular Carcinoma Recurrent

Interventions

Type	Name	Description
BIOLOGICAL	ETBX-011	Ad5 \[E1-, E2b-\]-CEA
BIOLOGICAL	GI-4000	Vaccine derived from recombinant Saccharomyces cerevisiae yeast expressing mutant RAS proteins
BIOLOGICAL	haNK for infusion	NK-92 \[CD16.158V, ER IL-2\]
BIOLOGICAL	avelumab	Recombinant human anti-PD-L1 IgG1 monoclonal antibody
DRUG	Capecitabine	5'-deoxy-5-fluoro-N-\[(pentyloxy) carbonyl\]-cytidine
DRUG	Cyclophosphamide	anhydrous
DRUG	5-Fluorouracil	5-FU; Fluorouracil
DRUG	Leucovorin	Leucovorin calcium salt
DRUG	nab-Paclitaxel	ABRAXANE® \[paclitaxel protein-bound particles for injectable suspension\] \[albumin-bound\]
DRUG	Sorafenib	NEXAVAR® tablets, for oral use
PROCEDURE	SBRT	Stereotactic Body Radiation Therapy
BIOLOGICAL	Aldoxorubicin hydrochloride	HCl
BIOLOGICAL	ETBX-051	Ad5 \[E1-, E2b-\]-Brachyury vaccine
BIOLOGICAL	ETBX-061	Ad5 \[E1-, E2b-\]-mucin 1 \[MUC1\] vaccine
BIOLOGICAL	GI-6207	CEA yeast vaccine
BIOLOGICAL	GI-6301	Brachyury yeast vaccine
DRUG	Cetuximab	ERBITUX® injection, for IV infusion)
BIOLOGICAL	N-803	Recombinant human super agonist IL-15 complex \[also known as IL-15N72D:IL- 15RαSu/IgG1 Fc complex\]

Timeline

• Start date: 2018-05-25
• Primary completion: 2019-08-23
• Completion: 2019-08-23
• First posted: 2018-06-20
• Last updated: 2021-03-18

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study