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Monoclonal Antibodies

HPN328 + Atezolizumab for Small Cell Lung Cancer

Phase 1 & 2

Recruiting

Research Sponsored by Harpoon Therapeutics

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Histologically or cytologically confirmed malignancy associated with expression of DLL3

Adequate renal function: Calculated creatinine clearance ≥50 mL/min using the formula of Cockcroft and Gault

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 4 years

Awards & highlights

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.

Who is the study for?

This trial is for adults with advanced cancers that show DLL3 protein, like small cell lung cancer. They must have good kidney and liver function, stable blood counts, and a tissue sample available. People can't join if they have untreated brain metastases, certain neurological conditions, severe allergies to specific drugs or components used in the study treatments, active autoimmune diseases or immune deficiencies.Check my eligibility

What is being tested?

The study is testing HPN328 alone and combined with Atezolizumab in patients whose cancers express the DLL3 protein. It's an early-phase trial to find out how safe these treatments are and how the body processes them.See study design

What are the potential side effects?

Possible side effects include reactions related to the immune system such as inflammation of organs (like lungs), infusion-related reactions which may cause symptoms during or after administration of treatment, allergic responses due to drug formulation ingredients.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My cancer shows DLL3 protein presence.

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My kidneys work well enough, with a creatinine clearance rate of 50 mL/min or more.

Select...

My liver tests are within the normal range.

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I can provide a tissue sample from a previous or new biopsy.

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My blood counts meet the required levels for treatment.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 4 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 4 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 4 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Frequency and severity of treatment-emergent AEs (TEAEs) graded according to NCI CTACAE version 5.0 (ASTCT grading criteria for CRS and ICANS).

Number and severity of DLTs following treatment with HPN328 as monotherapy or in combination with atezolizumab.

PK parameters of HPN328 as monotherapy or in combination with atezolizumab.

Secondary outcome measures

Best Overall Response (BOR)

Change from baseline in selected clinical laboratory parameters, vital signs, and ECGs.

Duration of extra-cranial response (EC-DOR)

+7 more

Side effects data

From 2019 Phase 3 trial • 1225 Patients • NCT02008227

36%

Fatigue

35%

Alopecia

24%

Diarrhoea

23%

Nausea

23%

Decreased appetite

22%

Anaemia

20%

Asthenia

19%

Cough

19%

Dyspnoea

16%

Myalgia

15%

Neutropenia

14%

Constipation

14%

Oedema peripheral

12%

Pyrexia

11%

Neuropathy peripheral

11%

Vomiting

11%

Stomatitis

10%

Arthralgia

Rash

Neutrophil count decreased

Dysgeusia

Paraesthesia

Headache

Pain in extremity

Peripheral sensory neuropathy

Insomnia

Mucosal inflammation

Back pain

Pneumonia

Febrile neutropenia

Abdominal pain

Dry skin

Lacrimation increased

Dizziness

Haemoptysis

Weight decreased

Malaise

Urinary tract infection

Nail disorder

Productive cough

Chest pain

Nasopharyngitis

Musculoskeletal pain

Bronchitis

Pruritus

Upper respiratory tract infection

Alanine aminotransferase increased

Aspartate aminotransferase increased

Influenza like illness

Respiratory tract infection

Musculoskeletal chest pain

Lower respiratory tract infection

Acute kidney injury

Depression

Lung infection

Dehydration

Chronic obstructive pulmonary disease

Atrial fibrillation

Syncope

Pleural effusion

100%

80%

60%

40%

20%

Study treatment Arm

Docetaxel

Atezolizumab

Trial Design

3Treatment groups

Experimental Treatment

Group I: HPN328 monotherapy dose escalation with extended dosing intervalsExperimental Treatment1 Intervention

HPN328 will be administered as a single agent, via IV infusion either once every 2 weeks (28-day cycle), or once every 3 weeks (21-day cycle).

Group II: HPN328 monotherapy dose escalationExperimental Treatment1 Intervention

HPN328 will be administered as a single agent once weekly via IV infusion during each 21 day cycle.

Group III: HPN328 dose escalation in combination with atezolizumabExperimental Treatment2 Interventions

SCLC patients will be treated with a combination regimen of HPN328 and atezolizumab. HPN328 will be administered once every 2 weeks via IV infusion during each 28-day cycle. Atezolizumab will be administered once every 4 weeks via IV infusion on Day 1 of each 28-day cycle.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Atezolizumab

2017

Completed Phase 3

~5860

0 / 5Eligibility criteria met

Find a Location

Who is running the clinical trial?

Harpoon TherapeuticsLead Sponsor

3 Previous Clinical Trials

296 Total Patients Enrolled

Media Library

Atezolizumab (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT04471727 — Phase 1 & 2

Small Cell Lung Cancer Research Study Groups: HPN328 monotherapy dose escalation with extended dosing intervals, HPN328 monotherapy dose escalation, HPN328 dose escalation in combination with atezolizumab

Small Cell Lung Cancer Clinical Trial 2023: Atezolizumab Highlights & Side Effects. Trial Name: NCT04471727 — Phase 1 & 2

Atezolizumab (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04471727 — Phase 1 & 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is the age bracket for this experiment limited to below 25 years of age?

"As indicated in the inclusion criteria, individuals enrolling into this trial need to be between 18 and 100 years old. Additionally, there are 38 trials for minors and 1,567 studies catering to adults over 65."

Answered by AI

What is the geographic spread of this clinical trial?

"This study can be accessed by patients at Roswell Park Comprehensive Cancer Center in Buffalo, NY; Memorial Sloan Kettering Cancer Center in New york City; and University Hospitals Cleveland Medical Centre in Cleveland, OH. Additionally, there are six other medical sites participating in this trial."

Answered by AI

How many individuals are participating in this medical experiment?

"The sponsor, Harpoon Therapeutics, necessitates a total of 57 qualified patients to participate in the trial at different sites such as Roswell Park Comprehensive Cancer Center and Memorial Sloan Kettering Cancer Center."

Answered by AI

What qualifications are necessary for enrollment in this medical experiment?

"Individuals with small cell lung carcinoma of any age between 18 to 100 years old are eligible for this trial. 57 patients need to be recruited in total."

Answered by AI

Are there any slots left for participants in this research?

"According to clinicaltrials.gov, the study is presently seeking enrollees, with its original posting on December 29th 2020 and most recent update occurring January 11th 2022."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Study in Patients With Advanced Cancers Associated With Expression of DLL3

2020. "Study in Patients With Advanced Cancers Associated With Expression of DLL3". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04471727.

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