- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05304936
HCW9218 for Advanced Pancreatic Cancer
A Phase 1b/2 Study of HCW9218, a Bifunctional TGF-β Antagonist/IL-15 Protein Complex, for Advanced Pancreatic Cancer
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
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 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.
Study Type
Enrollment (Estimated)
Phase
- Phase 2
- Phase 1
Contacts and Locations
Study Contact
- Name: Pallavi Chaturvedi
- Phone Number: 207 9548422024
- Email: clinical@hcwbiologics.com
Study Locations
-
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Arizona
-
Scottsdale, Arizona, United States, 85258
- HonorHealth
-
-
Maryland
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Bethesda, Maryland, United States, 20892
- National Institute of Health/ National Cancer Institute
-
-
Missouri
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Saint Louis, Missouri, United States, 63110
- Washington University in St. Louis
-
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Ohio
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Cleveland, Ohio, United States, 44195
- Cleveland Clinic
-
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South Carolina
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Charleston, South Carolina, United States, 29425
- Medical University of South Carolina
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 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
- 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.
- Age > 18 years
- 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 within 2 weeks to meet this requirement]
- Calculated glomerular filtration rate (GFR)* >40 mL/min OR serum creatinine ≤ 1.5 × ULN
- Total bilirubin ≤ 2.0 × ULN or ≤ 3.0 × ULN for subjects with Gilbert's syndrome
- AST, ALT, ALP ≤ 2.5 × ULN or ≤ 5.0 × ULN if liver metastasis present *using the following Cockcroft & Gault equation to calculate the eGFR for this study.
eGFR 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 > 50% FEV1 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
Exclusion Criteria:
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 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 (e.g., demonstration of a QTc interval greater than or equal to 470 milliseconds by Fridericia's correction)
- Subjects with untreated CNS metastases are excluded. Subjects are eligible if CNS metastases are treated and subjects are neurologically stable for at least 2 weeks prior to enrollment. In addition, subjects must be either off corticosteroids, 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 surgical 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 antagonist, IL-15 or analogs
- Concurrent herbal or unconventional therapy (e.g., St. John's Wort)
- Known autoimmune disease requiring active treatment. Subjects s with a condition requiring systemic treatment with either corticosteroids (> 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: HCW9218
Experimental Arm: HCW9218
|
Bifunctional TGF-β antagonist/IL-15 protein complex
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Occurrence of Adverse Events and Treatment-Related Adverse Events
Time Frame: 12 Months
|
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)
Time Frame: 12 Months
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Objective Response Rate (ORR)
Time Frame: 12 Months
|
To evaluate objective response rate (ORR) per RECIST version 1.1
|
12 Months
|
Progression-Free Survival (PFS)
Time Frame: 12 Months
|
To assess the progression-free survival (PFS) per RECIST version 1.1
|
12 Months
|
Overall Survival (OS)
Time Frame: 12 Months
|
OS is defined as the time from first administration of study intervention to the date of death due to any cause.
|
12 Months
|
Duration of Response
Time Frame: 12 Months
|
Duration of response is the time from response to progression or death.
|
12 Months
|
Collaborators and Investigators
Sponsor
Investigators
- Study Director: Pallavi Chaturvedi, HCW Biologics
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- HCWPAN102
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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