drugset / Trial / NCT04464967
Safety and Preliminary Efficacy of SNK01 in Combination With Trastuzumab or Cetuximab in Subjects With Advanced HER2 or EGFR Cancers
Non-randomizedParallel-groupOpen-labelTreatment
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.
Timeline
- Start
- 2021-03
- Primary completion
- 2022-08
- Completion
- 2023-02
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Cetuximab | Monoclonal antibody | 250 mg/m2 | — |
| Subject | TROCULEUCEL | Cell therapy | — | — |
| Subject | Trastuzumab | Monoclonal antibody | 6 mg/kg | — |
Indications
HER2 positive breast carcinoma
cervical cancer
colorectal cancer
endometrial cancer
esophageal cancer
head and neck squamous cell carcinoma
malignant pancreatic neoplasm
metastatic malignant neoplasm
non-small cell lung carcinoma
ovarian cancer
sarcoma
triple-negative breast carcinoma
urinary bladder cancer