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HCW9218 in Select Advanced Solid Tumors
Phase 1 trial testing HCW9218 in Solid Tumor in 18 participants. Completed in 28 February 2025.
| Lead sponsor | Masonic Cancer Center, University of Minnesota |
|---|---|
| Phase | Phase 1 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 18 |
| Start date | 1 April 2022 |
| Primary completion | 2 January 2025 |
| Estimated completion | 28 February 2025 |
| Sites | 1 location across United States |
Masonic Cancer Center, University of Minnesota
18 and older, any sex, with Solid Tumor. Patients with the condition only — healthy volunteers not accepted.
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
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.
| Group | Value | 95% CI |
|---|---|---|
| Administer HCW9218 | 1.2 |
Response rate will be estimated by a simple proportion with 95% confidence limits if sufficient numbers exist
| Group | Value | 95% CI |
|---|---|---|
| HCW9218 Dose Level 1 | 1 | |
| HCW9218 Dose Level 2 | 1 | |
| HCW9218 Dose Level 3 | 1 | |
| HCW9218 Dose Level 4 | 5 |
Response rate will be estimated by a simple proportion with 95% confidence limits if sufficient numbers exist
| Group | Value | 95% CI |
|---|---|---|
| HCW9218 Dose Level 1 | 0 | |
| HCW9218 Dose Level 2 | 0 | |
| HCW9218 Dose Level 3 | 0 | |
| HCW9218 Dose Level 4 | 0 |
Response rate will be estimated by a simple proportion with 95% confidence limits if sufficient numbers exist
| Group | Value | 95% CI |
|---|---|---|
| HCW9218 Dose Level 1 | 0 | |
| HCW9218 Dose Level 2 | 0 | |
| HCW9218 Dose Level 3 | 0 | |
| HCW9218 Dose Level 4 | 0 |
Estimated with Kaplan-Meier curves
| Group | Value | 95% CI |
|---|---|---|
| HCW9218 Dose Level 1 | 67 | 5 – 95 |
| HCW9218 Dose Level 2 | 67 | 5 – 95 |
| HCW9218 Dose Level 3 | 67 | 5 – 95 |
| HCW9218 Dose Level 4 | 78 | 36 – 94 |
Estimated with Kaplan-Meier curves
| Group | Value | 95% CI |
|---|---|---|
| HCW9218 Dose Level 1 | 33 | 1 – 77 |
| HCW9218 Dose Level 2 | 0 | 0 – 100 |
| HCW9218 Dose Level 3 | 0 | 0 – 100 |
| HCW9218 Dose Level 4 | 11 | 1 – 39 |
Estimated with Kaplan-Meier curves
| Group | Value | 95% CI |
|---|---|---|
| HCW9218 Dose Level 1 | 33 | 1 – 77 |
| HCW9218 Dose Level 2 | 0 | 0 – 100 |
| HCW9218 Dose Level 3 | 0 | 0 – 100 |
| HCW9218 Dose Level 4 | 11 | 1 – 39 |
Estimated with Kaplan-Meier curves
| Group | Value | 95% CI |
|---|---|---|
| HCW9218 Dose Level 1 | 33 | 1 – 77 |
| HCW9218 Dose Level 2 | 33 | 1 – 77 |
| HCW9218 Dose Level 3 | 33 | 1 – 77 |
| HCW9218 Dose Level 4 | 67 | 28 – 88 |
Time frame: 1 year. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.
| Reaction | System | HCW9218 Dose Level 1 | HCW9218 Dose Level 2 | HCW9218 Dose Level 3 | HCW9218 Dose Level 4 |
|---|---|---|---|---|---|
| Other | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | — | — | — | — |
| Febrile Neutropenia | Infections and infestations | — | — | — | — |
| Ascites | General disorders | — | — | — | — |
| Other, specify - C.Diff Infection | Infections and infestations | — | — | — | — |
| Urinary Tract Obstruction | Infections and infestations | — | — | — | — |
| Colonic obstruction - Partial bowel obstruction | Gastrointestinal disorders | — | — | — | — |
| Thromboembolic event | Cardiac disorders | — | — | — | — |
| Acute Kidney Injury | Renal and urinary disorders | — | — | — | — |
| Reaction | System | HCW9218 Dose Level 1 | HCW9218 Dose Level 2 | HCW9218 Dose Level 3 | HCW9218 Dose Level 4 |
|---|---|---|---|---|---|
| Injection site reaction | General disorders | — | — | — | — |
| Flu like symptoms | General disorders | — | — | — | — |
| Fever | General disorders | — | — | — | — |
| Lymphocyte count decreased | Investigations | — | — | — | — |
| Aspartate aminotransferase increased | Investigations | — | — | — | — |
| Hypoalbuminemia | Metabolism and nutrition disorders | — | — | — | — |
| Hypocalcemia | Metabolism and nutrition disorders | — | — | — | — |
| Fatigue | General disorders | — | — | — | — |
| White blood cell decreased | Investigations | — | — | — | — |
| Activated partial thromboplastin time prolonged | Investigations | — | — | — | — |
| Creatinine increased | Investigations | — | — | — | — |
| Platelet count decreased | Investigations | — | — | — | — |
| Blood bicarbonate decreased | Investigations | — | — | — | — |
| Weight loss | Investigations | — | — | — | — |
| Hyponatremia | Metabolism and nutrition disorders | — | — | — | — |
| Anemia | Blood and lymphatic system disorders | — | — | — | — |
| Dyspnea | Respiratory, thoracic and mediastinal disorders | — | — | — | — |
| Anorexia | Metabolism and nutrition disorders | — | — | — | — |
| Hypomagnesemia | Metabolism and nutrition disorders | — | — | — | — |
| Eosinophilia | Blood and lymphatic system disorders | — | — | — | — |
| Nausea | Gastrointestinal disorders | — | — | — | — |
| Vomiting | Gastrointestinal disorders | — | — | — | — |
| Constipation | Gastrointestinal disorders | — | — | — | — |
| Chronic kidney disease | Renal and urinary disorders | — | — | — | — |
| Hyperhidrosis | Skin and subcutaneous tissue disorders | — | — | — | — |
| Alkaline phosphatase increased | Investigations | — | — | — | — |
| Blood lactate dehydrogenase increased | Investigations | — | — | — | — |
| Alanine aminotransferase increased | Investigations | — | — | — | — |
| Blood bilirubin increased | Investigations | — | — | — | — |
| Hypermagnesemia | Metabolism and nutrition disorders | — | — | — | — |
| Hypokalemia | Metabolism and nutrition disorders | — | — | — | — |
| Back pain | Musculoskeletal and connective tissue disorders | — | — | — | — |
| Generalized muscle weakness | Musculoskeletal and connective tissue disorders | — | — | — | — |
| Headache | Nervous system disorders | — | — | — | — |
| Proteinuria | Renal and urinary disorders | — | — | — | — |
| Sinus tachycardia | Cardiac disorders | — | — | — | — |
| Disease progression | General disorders | — | — | — | — |
| INR increased | Investigations | — | — | — | — |
| Neutrophil count decreased | Investigations | — | — | — | — |
| Dehydration | Metabolism and nutrition disorders | — | — | — | — |
Most-reported serious reactions: Other, Febrile Neutropenia, Ascites, Other, specify - C.Diff Infection, Urinary Tract Obstruction, Colonic obstruction - Partial bowel obstruction, Thromboembolic event, Acute Kidney Injury.
Data from ClinicalTrials.gov NCT05322408 adverse events section.
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.
8 peer-reviewed publications reference this trial (live from Europe PMC):
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