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Safety and Preliminary Efficacy of SNK01 in Combination With Trastuzumab or Cetuximab in Subjects With Advanced HER2 or EGFR Cancers

NCT04464967 · Status: WITHDRAWN · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL

Last updated 2021-05-12

No results posted yet for this study

Summary

The purpose of the Phase 1/2a study is to evaluate the safety and tolerability of SNK01 in combination with trastuzumab or cetuximab in order to determine the maximum tolerated dose (MTD)/recommended Phase 2 dose (RP2D), and the preliminary efficacy for each combination regimen.

Conditions

Interventions

BIOLOGICAL

SNK01

Patient-specific ex vivo expanded autologous natural killer cells

DRUG

Trastuzumab

HER2 receptor antagonistic, humanized immunoglobulin G subclass 1 (IgG1) monoclonal antibody

DRUG

Cetuximab

EGFR antagonist, chimeric immunoglobulin G subclass 1 (IgG1) monoclonal antibody

Sponsors & Collaborators

  • NKGen Biotech, Inc.

    lead INDUSTRY

Principal Investigators

  • Paul Y. Song, MD · NKGen Biotech, Inc.

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-03-31
Primary Completion
2022-08-31
Completion
2023-02-28
FDA Drug
Yes

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Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04464967 on ClinicalTrials.gov