NCT05304936

HCW9218 for Advanced Pancreatic Cancer

A Phase 1b/2 Study of HCW9218, a Bifunctional TGF-β (Transforming Growth Factor Beta) Antagonist/IL-15 (Interleukins) Protein Complex, for Advanced Pancreatic Cancer

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 21 (actual)
• Sponsor: ImmunityBio, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a Phase 1b/2, open-label, multi-center, competitive enrollment and dose-escalation study of HCW9218 in patients with advanced/metastatic pancreatic cancer.

Detailed description

The study involves a Phase 1b dose escalation portion with up to 30 patients to determine the MTD (maximum tolerated dose) using a 3+3 dose escalation design and to designate a dose level for the Phase 2 expansion phase (RP2D). The Phase 2 portion of the study will consist of an expansion cohort of up to 39 patients receiving HCW9218 monotherapy at the RP2D level. An additional independent Phase 2 cohort of patients receiving HCW9218 at the RP2D level in sequence with gemcitabine and nab-paclitaxel will also be considered.

Conditions

• Advanced Pancreatic Carcinoma

Interventions

Type	Name	Description
DRUG	HCW9218	Bifunctional TGF-β (Transforming Growth Factor Beta) antagonist/IL-15 (Interleukin-15) protein complex
DRUG	Gemcitabine (GEM)	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
DRUG	Nab-paclitaxel	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

Timeline

• Start date: 2022-10-17
• Primary completion: 2025-02-15
• Completion: 2025-02-15
• First posted: 2022-03-31
• Last updated: 2026-04-15

Locations

5 sites across 1 country: United States

Regulatory

• FDA-regulated drug study