HPN328 for Small-cell Lung Cancer

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Small-cell Lung CancerHPN328 - Drug
Eligibility
18 - 100
All Sexes
What conditions do you have?
Select

Study Summary

This trial is testing a new drug, HPN328, to see if it is safe and effective in treating patients with advanced cancers associated with a protein called DLL3.

Eligible Conditions
  • Small-cell Lung Cancer

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

3 Primary · 2 Secondary · Reporting Duration: 3 years

2 years
Characterize the pharmacokinetics (PK) of HPN328
Determine MTD/RP2D
3 years
Assessment of Adverse Events by CTCAE 5.0 of HPN 328
Determine preliminary activity of HPN328
Determine the immunogenicity

Trial Safety

Safety Progress

1 of 3

Trial Design

2 Treatment Groups

Part 1 (Dose Escalation)
1 of 2
Part 2 (Dose Expansion)
1 of 2

Experimental Treatment

57 Total Participants · 2 Treatment Groups

Primary Treatment: HPN328 · No Placebo Group · Phase 1 & 2

Part 1 (Dose Escalation)
Drug
Experimental Group · 1 Intervention: HPN328 · Intervention Types: Drug
Part 2 (Dose Expansion)
Drug
Experimental Group · 1 Intervention: HPN328 · Intervention Types: Drug

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: 3 years

Who is running the clinical trial?

Harpoon TherapeuticsLead Sponsor
3 Previous Clinical Trials
310 Total Patients Enrolled

Eligibility Criteria

Age 18 - 100 · All Participants · 10 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
There is a disease for which no standard therapy exists, or the standard therapy is not considered appropriate by the investigator
If your hemoglobin level is 9 g/dL or greater, you are not allowed to receive any blood transfusions for the two weeks prior to screening.
The creatinine clearance is 50 mL/min or greater using the formula of Cockcroft and Gault.
The patient's total bilirubin level should be 1.5 mg/dL or less, regardless of the direct bilirubin level, unless the patient has documented Gilbert syndrome, in which case the maximum total serum bilirubin level should be 5 mg/dL.
(upper limit of normal) Aspartate and alanine transaminases (AST and ALT) are levels of certain enzymes that are measured to see how well the liver is working
People who have had at least one round of platinum-based chemotherapy and have then had a relapse are said to have SCLC.
This is a disease that has not responded to the usual treatment.
A person has an absolute neutrophil count (ANC) ≥1500 cells/μL if their neutrophil count is 1500 cells or more per microliter.
The person's platelet count is greater than or equal to 100,000 per microliter.