HCW9218 in Select Advanced Solid Tumors

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University of Minnesota (UMN)

Status and phase

Active, not recruiting
Phase 1

Conditions

Solid Tumor

Treatments

Drug: HCW9218

Study type

Interventional

Funder types

Other

Identifiers

NCT05322408
2021LS143

Details and patient eligibility

About

This is a single center, Phase I dose finding study of HCW9218 for the treatment of advanced/metastatic solid tumor cancer (except pancreatic and primary brain cancers). HCW9218 is a novel bi-functional fusion protein complex administered by subcutaneous (SC) injection. It is comprised of a soluble fusion of two human TGFβRII domains, human tissue factor, and human IL-15, and a second soluble fusion of two human TGFβRII domains and a sushi domain of human IL-15Rα. HCW9218 activates IL-15R signaling on effector immune cells and the dimeric TGFβRII functions as a "trap" for all three human TGF-β isoforms.

Enrollment

18 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Histologically or cytologically confirmed advanced/metastatic solid tumor cancer (except pancreatic and primary brain cancers), has failed at least 2 prior lines of therapy given either in the recurrent or metastatic setting and must be refractory to or intolerant of existing therapy(ies) known to provide clinical benefit for their condition.
  • Measurable disease per RECIST v 1.1.
  • Acute effects of any prior therapy must have resolved to baseline or Grade ≤1 NCI CTCAE v5 except for AEs not constituting a safety risk by enrolling Investigator judgment.
  • Age 18 years or older at the time of consent.
  • ECOG Performance Status 0 or 1.
  • Evidence of adequate organ function within 14 days prior to enrollment as defined in Section 4.1.6.
  • Adequate pulmonary function with PFTs >50% FEV1 if symptomatic or known impairment.
  • Sexually active persons of child-bearing potential or with partners of childbearing potential must agree to use a highly effective form of contraception (refer to Section 4.1.10 for acceptable methods) for at least 28 days after the last dose of HCW9218.
  • Provides voluntary written consent prior to the performance of any research related activity.

Exclusion criteria

  • Pregnant or breastfeeding.
  • 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 or equal to 470 milliseconds by Fridericia's correction).
  • Known or suspected untreated CNS metastases.
  • 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 use of St. John's wort and and/or other herbal CYP modulators within 7 days of Day 1. Must agree to not use during study treatment through the end of treatment visit to be eligible.
  • Known autoimmune disease requiring active treatment. Persons 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.
  • 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 design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

18 participants in 1 patient group

Administer HCW9218
Experimental group
Description:
Administer HCW9218 as monotherapy at assigned dose by SC injection once every 3 weeks. Dose Level -1 - 0.1 mg/kg - (start) 0.25 mg/kg - 0.5 mg/kg - 0.8 mg/kg - 1.2 mg/kg
Treatment:
Drug: HCW9218

Trial contacts and locations

1

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Central trial contact

Cancer Center Info Nurse

Data sourced from clinicaltrials.gov

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