HCW9218 in Select Advanced Solid Tumors | NCT05322408

NCT05322408

Protocol Section

Identification Module

Results Section

Participant Flow Module

Annotation Section

No data available

No data is available for this block.

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module

Status Module

Label	Type	Description	Intervention Names
Administer HCW9218	Experimental	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	Drug: HCW9218

Name	Type	Description	Arm Group Labels	Other Names
HCW9218	Drug	HCW9218 at the assigned dose level is administered as a subcutaneous injection once every 3 weeks for a minimum of 2 treatment cycles unless medically contraindicated.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
The Primary Objective of the Dose Finding Component is to Determine the Maximum Tolerated Dose (MTD) of HCW9218	Given that little to no toxicity is expected, the MTD will be determined using an adaptation of the continual reassessment method (CRM) (O'Quigley, 1996) starting with 1 patient cohorts.	through study completion, an average of 12 months

Secondary Outcomes

Measure	Description	Time Frame
Estimate Response Rate (Complete Response (CR), Partial Response (PR) or Stable Disease (SD)	Response rate will be estimated by a simple proportion with 95% confidence limits if sufficient numbers exist	3 months after 1st dose
Estimate Response Rate (Complete Response (CR), Partial Response (PR) or Stable Disease (SD)

Eligibility Module

Eligibility Criteria

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

Name	Affiliation	Role
Melissa Geller, MD	Masonic Cancer Center, Univeristy of Minnesota	Principal Investigator

Facility	Status	City	State	ZIP	Country	Contacts
Masonic Cancer Center - University of Minnesota		Minneapolis	Minnesota	55455	United States

Arm/Group Information

ID	Title	Description
FG000	HCW9218 Dose Level -1	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 HCW9218: HCW9218 at the assigned dose level is administered as a subcutaneous injection once every 3 weeks for a minimum of 2 treatment cycles unless medically contraindicated.
FG001	HCW9218 Dose Level 1	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 HCW9218: HCW9218 at the assigned dose level is administered as a subcutaneous injection once every 3 weeks for a minimum of 2 treatment cycles unless medically contraindicated.
FG002	HCW9218 Dose Level 2	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 HCW9218: HCW9218 at the assigned dose level is administered as a subcutaneous injection once every 3 weeks for a minimum of 2 treatment cycles unless medically contraindicated.
FG003	HCW9218 Dose Level 3	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 HCW9218: HCW9218 at the assigned dose level is administered as a subcutaneous injection once every 3 weeks for a minimum of 2 treatment cycles unless medically contraindicated.
FG004	HCW9218 Dose Level 4	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 HCW9218: HCW9218 at the assigned dose level is administered as a subcutaneous injection once every 3 weeks for a minimum of 2 treatment cycles unless medically contraindicated.

Baseline Characteristics Module

Arm/Group Information

ID	Title	Description
BG000	HCW9218 Dose Level 1	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 HCW9218: HCW9218 at the assigned dose level is administered as a subcutaneous injection once every 3 weeks for a minimum of 2 treatment cycles unless medically contraindicated.

Units	Counts
Participants	BG000

Baseline Measures

Title	Description	Population Description	Parameter Type	Dispersion Type	Unit of Measure	Calculate Percentage	Denominator Units Selected	Denominators	Classes
Age, Categorical			Count of Participants

Outcome Measures Module

Outcome Measures

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

The Primary Objective of the Dose Finding Component is to Determine the Maximum Tolerated Dose (MTD) of HCW9218

Given that little to no toxicity is expected, the MTD will be determined using an adaptation of the continual reassessment method (CRM) (O'Quigley, 1996) starting with 1 patient cohorts.

Posted

Number

mg/kg

through study completion, an average of 12 months

ID	Title	Description
OG000	Administer HCW9218	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 HCW9218: HCW9218 at the assigned dose level is administered as a subcutaneous injection once every 3 weeks for a minimum of 2 treatment cycles unless medically contraindicated.

Adverse Events Module

Arm/Groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	HCW9218 Dose Level 1	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 HCW9218: HCW9218 at the assigned dose level is administered as a subcutaneous injection once every 3 weeks for a minimum of 2 treatment cycles unless medically contraindicated.

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot_SAP	Yes	Yes	No	Study Protocol and Statistical Analysis Plan	Mar 29, 2023	Jun 10, 2025	Prot_SAP_000.pdf
ICF	No	No	Yes	Informed Consent Form	Nov 8, 2023	Jun 10, 2025	ICF_001.pdf