HCW9218 for Advanced Pancreatic Cancer

NCT05304936 | Completed Phase 1 DMC FDA Drug

• 1 other identifier: HCWPAN102
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 5

Brief 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.

Conditions

Advanced Pancreatic Carcinoma

Outcome Measures

Primary Outcomes (2)

• 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

  12 Months

• 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

  12 Months

Secondary Outcomes (4)

• Objective Response Rate (ORR)

  12 Months

• Progression-Free Survival (PFS)

  12 Months

• Overall Survival (OS)

  12 Months

• Duration of Response

  12 Months

Study Arms (1)

HCW9218

EXPERIMENTAL

Experimental Arm: HCW9218

Drug: HCW9218; Drug: Gemcitabine (GEM); Drug: Nab-paclitaxel

Interventions

HCW9218 DRUG

Bifunctional TGF-β (Transforming Growth Factor Beta) antagonist/IL-15 (Interleukin-15) protein complex

HCW9218

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

HCW9218

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

HCW9218

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• ImmunityBio, Inc.: lead

Study Sites (5)

HonorHealth

Scottsdale, Arizona, 85258, United States

Location

National Institute of Health/ National Cancer Institute

Bethesda, Maryland, 20892, United States

Location

Washington University in St. Louis

St Louis, Missouri, 63110, United States

Location

Cleveland Clinic

Cleveland, Ohio, 44195, United States

Location

Medical University of South Carolina

Charleston, South Carolina, 29425, United States

Location

MeSH Terms

Interventions

Gemcitabine; 130-nm albumin-bound paclitaxel

Intervention Hierarchy (Ancestors)

Heterocyclic Compounds; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring

Study Officials

• Paula Bradshaw, MSN, MBA, RN

  VP, Clinical Business Operations

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 11, 2022
• First Posted: March 31, 2022
• Study Start: October 17, 2022
• Primary Completion: February 15, 2025
• Study Completion: February 15, 2025
• Last Updated: April 15, 2026

Record last verified: 2026-04

Locations

US (5)