HCW9218 for Pancreatic Cancer

Recruiting at 5 trial locations

Overseen By Pallavi Chaturvedi

Age: 18+

Sex: Any

Trial Phase: Phase 1 & 2

Sponsor: ImmunityBio, Inc.

Must not be taking: Corticosteroids, Immunosuppressives, Herbals, others

Disqualifiers: Vascular disease, CNS metastases, Autoimmune, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

60 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Research Team

Paula Bradshaw, MSN, MBA, RN

Principal Investigator

VP, Clinical Business Operations

Eligibility Criteria

This trial is for adults over 18 with advanced or metastatic pancreatic cancer that's worsened after standard therapy, or those who can't tolerate first-line treatments. They must have a life expectancy of at least 12 weeks and be able to use birth control. People with significant recent vascular disease, HIV/AIDS, ongoing treatment side effects (except certain conditions), psychiatric issues affecting compliance, untreated brain metastases, or known allergies to similar drugs are excluded.

Inclusion Criteria

Provide signed informed consent and HIPAA authorization and agree to comply with all protocol-specified procedures and follow-up evaluations

My pancreatic cancer is advanced, cannot be surgically removed, and has not responded to or cannot tolerate standard treatments.

I am not pregnant and have had a negative pregnancy test within the last 14 days.

Exclusion Criteria

I have had an organ transplant from another person.

I am currently on IV antibiotics for an infection.

You have been diagnosed with HIV or AIDS.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Phase 1b Dose Escalation

Phase 1b dose escalation portion with up to 30 patients to determine the MTD using a 3+3 dose escalation design

12 months

Phase 2 Expansion

Phase 2 expansion cohort of up to 39 patients receiving HCW9218 monotherapy at the RP2D level

12 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

12 months

Treatment Details

Interventions

• HCW9218

Trial Overview The study tests HCW9218 in two phases: an initial dose-escalation phase for patients not eligible for surgery due to advanced disease and a later expansion phase focused on those with distant metastatic disease only. It's an open-label trial where everyone knows what treatment they're getting.

Participant Groups

Group I: HCW9218 Experimental Treatment 1 Intervention

Experimental Arm: HCW9218

Who Is Running the Clinical Trial?

ImmunityBio, Inc.

Lead Sponsor

Trials

75

Recruited

5,000+

Richard Adcock

ImmunityBio, Inc.

Chief Executive Officer since 2024

Information not available

Dr. Patrick Soon-Shiong

ImmunityBio, Inc.

Chief Medical Officer since 2021

MD

HCW Biologics

Lead Sponsor

Trials

2

Recruited

60+