Description:
An open-label, Phase 1/2 study of HPN328 as monotherapy to assess the safety, tolerability
and PK in patients with advanced cancers associated with expression of DLL3.
Title
- Brief Title: Study in Patients With Advanced Cancers Associated With Expression of DLL3 Who Have Failed Standard Available Therapy
- Official Title: A Phase 1/2 Open-label, Multicenter, Dose Escalation and Dose Expansion Study of the Safety, Tolerability, and PK of HPN328 in Patients With Advanced Cancers With Expression of DLL3 Who Have Failed Standard Available Therapy
Clinical Trial IDs
- ORG STUDY ID:
HPN328-4001
- NCT ID:
NCT04471727
Conditions
Interventions
Drug | Synonyms | Arms |
---|
HPN328 | | Part 1 (Dose Escalation) |
Purpose
An open-label, Phase 1/2 study of HPN328 as monotherapy to assess the safety, tolerability
and PK in patients with advanced cancers associated with expression of DLL3.
Trial Arms
Name | Type | Description | Interventions |
---|
Part 1 (Dose Escalation) | Experimental | HPN328 is IV administered once weekly for about 1 hour. Doses will vary between cohorts as MTD is being determined. | |
Part 2 (Dose Expansion) | Experimental | HPN328 is IV administered once weekly for about 1 hour at the recommended phase 2 dose (2) established in Part 1. | |
Eligibility Criteria
Major Inclusion Criteria:
1. Histologically or cytologically confirmed malignancy associated with expression of
DLL3:
- SCLC that has relapsed following at least 1 line of platinum-based chemotherapy
- Malignancy other than SCLC with pathologic demonstration of high-grade
neuroendocrine features or demonstration of DLL3 expression in a tumor sample,
and that the patient has 1 of the following:
- Disease that is relapsed/refractory to standard systemic therapy,
- Disease for which standard therapy does not exist, or
- Disease where standard therapy is not considered appropriate by the Investigator
2. Available archival tissue sample or fresh biopsy tissue sample must be available for
shipment prior to enrollment. Patients with no available tumor tissue, who cannot
safely undergo a biopsy may be eligible if they have documentation of DLL3 expression
in a tumor sample from a prior biopsy.
3. Adequate hematologic status, including:
- Absolute neutrophil count (ANC) ≥1500 cells/μL
- Platelet count ≥100,000/μL
- Hemoglobin ≥9 g/dL (no transfusions allowed within 2 weeks prior to screening)
4. Adequate renal function, including:
-Calculated creatinine clearance ≥50 mL/min using the formula of Cockcroft and Gault
5. Adequate liver function, including
- Total bilirubin ≤1.5 x upper limit of normal (ULN), regardless of direct
bilirubin, unless the patient has documented Gilbert syndrome in which case the
maximum total serum bilirubin should be 5 mg/dL
- Aspartate and alanine transaminase (AST and ALT) ≤3 x ULN
Major Exclusion Criteria:
1. Untreated brain metastases. Participants must have completed treatment for brain
metastasis, and be neurologically stable off steroids, for at least 7 days prior to
first dose of study drug
2. Patients with glioma or other primary CNS malignancy
3. Patients with spinal cord compression or symptomatic/uncontrolled epidural disease.
Patients with previously treated spinal cord compression or epidural disease may be
eligible if stable for at least 1 week prior to first dose of study drug.
4. Active neurologic paraneoplastic syndrome.
5. Uncontrolled pleural effusion, pericardial effusion, or ascites requiring recurrent
drainage procedures (e.g., biweekly or more frequently).
Maximum Eligible Age: | 100 Years |
Minimum Eligible Age: | 18 Years |
Eligible Gender: | All |
Healthy Volunteers: | No |
Primary Outcome Measures
Measure: | Assessment of Adverse Events by CTCAE 5.0 of HPN 328 |
Time Frame: | 3 years |
Safety Issue: | |
Description: | Assess safety and tolerability at increasing dose levels of HPN328 in successive cohorts of patients with solid tumors associated with DLL3 expression by adverse events (CTCAE v5.0) |
Secondary Outcome Measures
Measure: | Determine preliminary activity of HPN328 |
Time Frame: | 3 years |
Safety Issue: | |
Description: | Evaluate preliminary efficacy of HPN328 based on disease assessment using RECISTv1.1 |
Measure: | Determine the immunogenicity |
Time Frame: | 3 years |
Safety Issue: | |
Description: | Evaluate the immunogenicity of HPN328 assessing Anti-drug Antibodies in blood serum |
Details
Phase: | Phase 1/Phase 2 |
Primary Purpose: | Interventional |
Overall Status: | Recruiting |
Lead Sponsor: | Harpoon Therapeutics |
Trial Keywords
- Lung Cancer
- Small-Cell Lung Cancer
- DLL3
- Harpoon
- TriTAC
- Prostate Cancer
- Neuroendocrine Tumors
- High Grade Neuroendrocrine Features
- Delta Like Canonical Notch Ligand 3
Last Updated
August 30, 2021