HCW9218 for Pancreatic Cancer

No longer recruiting at 6 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new treatment called HCW9218 for individuals with pancreatic cancer that has spread or cannot be surgically removed. The goal is to assess the treatment's effectiveness and determine the appropriate dose. Suitable candidates have advanced or metastatic pancreatic cancer and have tried other treatments that were ineffective or discontinued. As a Phase 1/Phase 2 trial, this research aims to understand how the treatment works in people and measure its effectiveness in an initial group, offering participants a chance to contribute to groundbreaking cancer treatment advancements.

Do I have to stop taking my current medications for the trial?

The trial does not specify if you need to stop taking your current medications. However, you cannot use certain treatments like anti-cancer therapy, herbal supplements, or immunosuppressive medications close to the trial start. It's best to discuss your specific medications with the trial team.

Is there any evidence suggesting that HCW9218 is likely to be safe for humans?

Research has shown that HCW9218 has been tested for safety in earlier studies. One study with patients who had advanced solid tumors evaluated HCW9218 for safety and its effect on tumors, assessing the drug's impact and patient safety. Another lab study found that HCW9218 helped fight pancreatic tumors and worked well with chemotherapy, a common cancer treatment.

While these results are encouraging, HCW9218 remains in the early stages of clinical trials for pancreatic cancer. Researchers are still determining the safest dose for people. Due to its early stage, there is limited information on long-term tolerance in humans. However, the trials aim to ensure the drug's safety and effectiveness before proceeding further. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Unlike the standard treatments for pancreatic cancer, which typically involve chemotherapy, radiation, and surgery, HCW9218 stands out because it uses a unique approach to target the disease. This experimental treatment is designed to harness the body's immune system by enhancing the activity of certain immune cells to specifically attack cancer cells. Researchers are excited about HCW9218 because it offers a novel mechanism of action that could potentially lead to more effective and less toxic treatment options for patients with pancreatic cancer. This innovative strategy aims to improve outcomes by directly engaging the body's natural defenses, offering hope for better management of this challenging condition.

What evidence suggests that HCW9218 might be an effective treatment for pancreatic cancer?

Research shows that HCW9218 may help treat certain cancers by strengthening the body's immune system to fight tumor cells. Studies have found that HCW9218 works better when combined with traditional chemotherapy for various solid tumors. Early results from a clinical trial showed that 50% of patients had stable disease, meaning their cancer did not worsen. Additionally, about 21% of patients experienced stable disease without serious side effects. These early signs suggest HCW9218 could be a helpful option for advanced pancreatic cancer, but more research is needed to confirm these benefits. ^{1 3 4 6 7}

Who Is on the Research Team?

Paula Bradshaw, MSN, MBA, RN

Principal Investigator

VP, Clinical Business Operations

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Citations

1. sciencedirect.com sciencedirect.com/science/article/pii/S1525001622000259

Immunotherapeutic HCW9218 augments anti-tumor activity ... Together, these data show that HCW9218 enhanced the efficacy of chemotherapies against multiple types of solid tumors by augmenting immune ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT05304936

NCT05304936 | HCW9218 for Advanced Pancreatic Cancer The study involves a Phase 1b dose escalation portion with up to 30 patients to determine the MTD using a 3+3 dose escalation design and to designate a dose ...

3. investors.hcwbiologics.com investors.hcwbiologics.com/news-releases/news-release-details/investigator-sponsor-hcw-biologics-phase-1-clinical-trial

Investigator Sponsor of HCW Biologics' Phase 1 Clinical Trial ... 50% (4/8) patients evaluated in post-treatment assessments exhibited stable disease following HCW9218 treatment. Patients showed stable disease ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11048089/

Targeted Therapy for Highly Desmoplastic and ... While modest clinical efficacy was achieved in 21% of patients (13/61 patients achieved stable disease), there were records of dose-limiting ...

5. synapse.patsnap.com synapse.patsnap.com/drug/68bb41ad87314ad487f3e615c2038be9

HCW-9218 - Drug Targets, Indications, Patents Long‐term survival studies also showed that HCW9218 treatment improved physical performance without compromising the health span of naturally aged mice. Thus, ...

6. clinicalstudies.info.nih.gov clinicalstudies.info.nih.gov/protocoldetails.aspx?id=000930-C&&query=

NIH Clinical Center: Search the Studies Objective: To test a study drug (HCW9218) in people with advanced pancreatic cancer. Eligibility: People aged 18 years and older with advanced pancreatic cancer ...

7. hollingscancercenter.org hollingscancercenter.org/clinical-trials/Info.aspx?id=103518

Clinical Trials Evaluate the safety profile of HCW9218 in treated subjects. Determine the 6-month progression-free survival (PFS) rate of evaluable subjects treated with ...