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Advanced Pancreatic CarcinomaPhase 1/2NCT05304936

HCW9218 for Advanced Pancreatic Cancer

A Phase 1/2 study testing HCW9218, Gemcitabine (GEM) and Nab-paclitaxel in people with Advanced Pancreatic Carcinoma, run by ImmunityBio, Inc. at 5 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Advanced Pancreatic Carcinoma
What is being tested?
HCW9218, Gemcitabine (GEM) and Nab-paclitaxel
Could I receive a placebo?
No, everyone receives an active treatment
How many people
21 participants
Where
5 sitesUnited States
Study dates
17 Oct 2022to 15 Feb 2025
Phase
Phase 1/2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Subjects must meet all of the following criteria for inclusion in the study (to be verified by Sponsor prior to subject enrollment):
  • Histologically or cytologically confirmed unresectable, advanced/metastatic disease pancreatic cancer that has progressed on standard first-line (or second- or later line) systemic therapy (excepting progression within 6 months of end of adjuvant systemic chemotherapy); or that can no longer be treated with first-line systemic therapy due to subject's intolerance.
  • For dose escalation phase (Phase 1b), distant metastatic disease or advanced disease and not a candidate for down staging to resection For expansion phase (Phase 2), distant metastatic disease only
  • Measurable disease by CT, MRI, PET-CT (Positron Emission Tomography) or other methods described in Section 7.2., as assessed by RECIST v1.1.
  • Prior radiation is allowed if the index lesion(s) remains outside of the treatment field or has progressed since prior treatment. Radiation therapy must have been completed at least 4 weeks prior to the baseline scan.
  • Resolved acute effects of any prior therapy to baseline or Grade ≤ 1 NCI CTCAE v5.0 except for AEs not constituting a safety risk by Investigator judgment.
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  • Age > 18 years
  • Performance status: ECOG (Eastern Cooperative Oncology Group) performance status of 0, 1 or 2 (Section 20.2).
  • A life expectancy of at least 12 weeks.
  • Laboratory tests performed within 14 days of treatment start:
  • Absolute neutrophil count (AGC/ANC) ≥ 1,500/μL (≥1.5 × 109/L)
  • Platelets ≥ 100,000/μL (≥ 100 × 109/L) [Subjects may be transfused not more than 1 unit of platelets within 2 weeks to meet this requirement]
  • Hemoglobin ≥ 9 g/dL (>90g/L) [Subjects may be transfused not more than 2 units of pRBCs (packed red blood cell) within 2 weeks to meet this requirement]
  • Calculated glomerular filtration rate (GFR)* >40 mL/min OR serum creatinine ≤ 1.5 × ULN (upper limit of normal)
  • Total bilirubin ≤ 2.0 × ULN (upper limit of normal) or ≤ 3.0 × ULN (upper limit of normal) for subjects with Gilbert's syndrome
  • AST (aspartate aminotransferase), ALT (alanine aminotransferase), ALP (alkaline phosphatase) ≤ 2.5 × ULN (upper limit of normal) or ≤ 5.0 × ULN (upper limit of normal) if liver metastasis present *using the following Cockcroft \& Gault equation to calculate the eGFR (epidermal growth factor receptor) for this study. eGFR (epidermal growth factor receptor) in mL/min = [(140-age in years) × (weight in kg) × F]/(serum creatinine in mg/dL × 72), where F =1 if male; and 0.85 for female.
  • Adequate pulmonary function with PFTs (Pulmonary Function Test) > 50% FEV1 (forced expiratory volume at one second) if symptomatic or prior known impairment.
  • Negative serum pregnancy test within 14 days of treatment start if female and of childbearing potential (non-childbearing is defined as greater than one year postmenopausal or surgically sterilized).
  • Female subjects of childbearing potential must adhere to using a medically accepted method of birth control prior to screening and agree to continue its use for at least 28 days after the last dose of HCW9218 or be surgically sterilized (e.g., hysterectomy or tubal ligation) and males must agree to use a barrier method of birth control and agree to continue its use for at least 28 days after the last dose of HCW9218.
  • Provide signed informed consent and HIPAA authorization and agree to comply with all protocol-specified procedures and follow-up evaluations.

Who cannot join

  • Subjects with any of the following criteria are excluded from participation in the study (to be verified by Sponsor prior to subject enrollment):
  • History of clinically significant vascular disease, including any of the following within 6 months prior to start of study treatment: MI (myocardial infarction) or unstable angina, percutaneous coronary intervention, bypass grafting, ventricular arrhythmia requiring medication, stroke or transient ischemic attack, symptomatic peripheral arterial disease.
  • Marked baseline prolongation of QT/QTc interval (corrected QT interval) (e.g., demonstration of a QTc interval (corrected QT interval) greater than or equal to 470 milliseconds by Fridericia's correction).
  • Subjects with untreated CNS (Central Nervous System) metastases are excluded. Subjects are eligible if CNS (Central Nervous System) metastases are treated and subjects are neurologically stable for at least 2 weeks prior to enrollment. In addition, subjects must be either off corticosteroid, or on a stable or decreasing dose of ≤ 10 mg daily prednisone (or equivalent).
  • Anti-cancer treatment including surgery, radiotherapy, chemotherapy, other immunotherapy, or investigational therapy within 14 days before treatment start.
  • Other prior malignancy except for the following: adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, adequately treated Stage I or II cancer from which the subject is currently in complete remission, or any other cancer from which the subject has been disease-free for 3 years after surgery treatment.
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  • Known hypersensitivity or history of allergic reactions attributed to compounds of similar chemical or biologic composition to the agents used in the study.
  • Prior therapy with TGF-β (Transforming Growth Factor Beta) antagonist, IL-15 (interleukin-15) or analogs.
  • Concurrent herbal or unconventional therapy (e.g., St. John's Wort)
  • Known autoimmune disease requiring active treatment. Subjects with a condition requiring systemic treatment with either corticosteroid (> 10 mg daily prednisone equivalent) or other immunosuppressive medications within 14 days of enrollment. Inhaled or topical steroids, and adrenal replacement steroid doses ≤ 10 mg daily prednisone equivalent, are permitted in the absence of active autoimmune disease.
  • Active systemic infection requiring parenteral antibiotic therapy. All prior infections must have resolved following optimal therapy.
  • Prior organ allograft or allogeneic transplantation
  • Known HIV-positive or AIDS
  • Women who are pregnant or nursing
  • Any ongoing toxicity from prior anti-cancer treatment that, in the judgment of the Investigator may interfere with study treatment. All toxicities attributed to prior anti-cancer therapy other than peripheral neuropathy, alopecia, and fatigue must resolve to grade 1 (NCI CTCAE v5.0) or baseline before administration of the study treatment.
  • Psychiatric illness/social situations that would limit compliance with study Requirements.
  • Other illness or a medical issue that in the opinion of the Investigator would exclude the subject from participating in this study.

Trial locations and contacts

5 sites in 1 country.

5 sites in 1 country

United States5 sites

  • National Institute of Health/ National Cancer Institute

    Bethesda, Maryland, 20892

  • Medical University of South Carolina

    Charleston, South Carolina, 29425

  • Cleveland Clinic

    Cleveland, Ohio, 44195

  • HonorHealth

    Scottsdale, Arizona, 85258

  • Washington University in St. Louis

    St Louis, Missouri, 63110

Other trials in United States

About this study

Official title: 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

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.

Read the 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.

Being tested
HCW9218, Gemcitabine (GEM), Nab-paclitaxel

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • HCW9218Drug

    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-paclitaxelDrug

    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

Study groups in NCT05304936
Study groupRoleWhat they receive
HCW9218ExperimentalExperimental Arm: HCW9218
Receives: Drug: HCW9218; Drug: Gemcitabine (GEM); Drug: Nab-paclitaxel

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Occurrence of Adverse Events and Treatment-Related Adverse Events

    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

    Measured: 12 Months

  2. Determine the maximum tolerated dose (MTD)

    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

    Measured: 12 Months

Secondary outcomes (4)

  1. Objective Response Rate (ORR)

    To evaluate objective response rate (ORR) per RECIST version 1.1

    Measured: 12 Months

  2. Progression-Free Survival (PFS)

    To assess the progression-free survival (PFS) per RECIST version 1.1

    Measured: 12 Months

  3. Overall Survival (OS)

    OS is defined as the time from first administration of study intervention to the date of death due to any cause.

    Measured: 12 Months

  4. Duration of Response

    Duration of response is the time from response to progression or death.

    Measured: 12 Months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted31 Mar 2022
  2. Study start17 Oct 2022
  3. Primary completion15 Feb 2025
  4. Study completion15 Feb 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Sequential
Masking
None (open label)
Enrolment
21 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05304936
Sponsor's protocol ID
HCWPAN102
Status last verified
Apr 2026
First submitted
11 Mar 2022
Last updated
15 Apr 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing HCW9218, Gemcitabine (GEM) and Nab-paclitaxel in people with Advanced Pancreatic Carcinoma, run by ImmunityBio, Inc. at 5 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 20 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 15 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 5 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Occurrence of Adverse Events and Treatment-Related Adverse Events (time frame: 12 Months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05304936.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Apr 2026.

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