Trials / Withdrawn
WithdrawnNCT04464967
Safety and Preliminary Efficacy of SNK01 in Combination With Trastuzumab or Cetuximab in Subjects With Advanced HER2 or EGFR Cancers
A Phase 1/2a, Open-Label, Multi-Center Study Evaluating the Safety and Anti-Tumor Activity of Ex Vivo Expanded, Autologous Natural Killer Cells (SNK01) in Combination With Trastuzumab or Cetuximab in Subjects With Advanced/Metastatic HER2- or EGFR-Expressing Cancers
- Status
- Withdrawn
- Phase
- Phase 1 / Phase 2
- Study type
- Interventional
- Enrollment
- 0 (actual)
- Sponsor
- NKGen Biotech, Inc. · Industry
- Sex
- All
- Age
- 18 Years – 75 Years
- Healthy volunteers
- Not accepted
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
- Advanced Solid Tumor
- Metastatic Cancer
- HER2-positive Breast Cancer
- HER2-positive Gastric Cancer
- HER-2 Protein Overexpression
- Esophageal Cancer
- Ovarian Cancer
- Endometrium Cancer
- Bladder Cancer
- Pancreatic Cancer
- Colorectal Cancer
- Non Small Cell Lung Cancer
- EGF-R Positive Non-Small Cell Lung Cancer
- Head and Neck Squamous Cell Carcinoma
- Triple Negative Breast Cancer
- Cervical Cancer
- Sarcoma
Interventions
| Type | Name | Description |
|---|---|---|
| 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 |
Timeline
- Start date
- 2021-03-01
- Primary completion
- 2022-08-01
- Completion
- 2023-02-01
- First posted
- 2020-07-09
- Last updated
- 2021-05-12
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT04464967. Inclusion in this directory is not an endorsement.