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HCW9218 · 1 trial · 1 indication
Evaluate the safety profile (as outlined by incidence of adverse events (AEs) based on CTCAE v5) of HCW9218 monotherapy in subjects with advanced/metastatic pancreatic cancer who have progressed on or are intolerant of standard first-line therapy
Determine the maximum tolerated dose (MTD) and designate the recommended Phase 2 dose level (RP2D) for Phase 2 study of HCW9218 in HCW9218-treated subjects
| Arm | Type | Description |
|---|---|---|
| HCW9218 | EXPERIMENTAL | Experimental Arm: HCW9218 |
| Name | Type | Description |
|---|---|---|
| HCW9218 | DRUG | Bifunctional TGF-β (Transforming Growth Factor Beta) antagonist/IL-15 (Interleukin-15) protein complex |
| Gemcitabine (GEM) | DRUG | Gemcitabine is administered as a combination chemotherapy regimen for the treatment of advanced/metastatic pancreatic cancer in accordance with standard-of-care dosing and schedule per protocol |
| Nab-paclitaxel | DRUG | Nab-paclitaxel is administered as a combination chemotherapy regimen for the treatment of advanced/metastatic pancreatic cancer in accordance with standard-of-care dosing and schedule per protocol |
Inclusion Criteria Subjects must meet all of the following criteria for inclusion in the study (to be verified by Sponsor prior to subject enrollment): 1. Histologically or cytologically confirmed unresectable, advanced/metastatic disease pancreatic cancer that has progressed on standard first-lin...
HCW9218 is an investigational small molecule being studied for the treatment of advanced pancreatic carcinoma. It is currently in Phase 1 clinical development and has not been approved by regulatory authorities. The drug is being evaluated in patients with this advanced form of pancreatic cancer.
HCW9218 is being developed by ImmunityBio, Inc., a biopharmaceutical company traded on the NASDAQ under the ticker symbol IBRX. The company is conducting clinical research to evaluate the safety and efficacy of this investigational small molecule in patients with advanced pancreatic carcinoma.
HCW9218 is in Phase 1 clinical development. A Phase 1 trial has been completed, which enrolled 21 patients with advanced pancreatic carcinoma. The drug remains investigational and is not yet approved for any use. Further clinical studies would be needed to establish its safety and effectiveness.
HCW9218 has one completed clinical trial registered under NCT05304936, titled "HCW9218 for Advanced Pancreatic Cancer." This Phase 1 study enrolled 21 participants in the United States with advanced pancreatic carcinoma. The trial was not randomized, double-blind, or controlled, and did not use biomarker selection.
HCW9218 is not FDA approved. It is an investigational drug currently in Phase 1 clinical development for advanced pancreatic carcinoma. A Phase 1 trial has been completed, but the drug has not received marketing approval from the FDA or any other regulatory authority.