A Phase 1/2 Open-label, Multicenter, Dose Escalation and Dose Expansion Study of the Safety, Tolerability, and Pharmacokinetics of HPN328 Monotherapy and HPN328 With Atezolizumab or Ifinatamab Deruxtecan (I-DXd) in Patients With Advanced Cancers Associated With Expression of Delta-like Canonical Notch Ligand 3 (DLL3).
Who is this study for? Patients with advanced cancers associated with expression of DLL3
What treatments are being studied? HPN328
Status: Recruiting
Location: See all (11) locations...
Intervention Type: Biological
Study Type: Interventional
Study Phase: Phase 1/Phase 2
SUMMARY
This study will investigate the maximum tolerated dose, the recommended dose for expansion (RDE), safety, efficacy, and pharmacokinetics of gocatamig alone, gocatamig with Atezolizumab and gocatamig with I-DXd in participants with advanced cancers associated with expression of Delta-like Canonical Notch Ligand 3 (DLL3).
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
∙ The main inclusion criteria include but are not limited to the following:
• Has a histologically or cytologically confirmed malignancy associated with expression of Delta-like Canonical Notch Ligand 3 (DLL3)
• Has small cell lung cancer (SCLC) which is relapsed/refractory following at least 1 prior line of systemic therapy that included platinum-based chemotherapy
• Has Neuroendocrine Prostate Cancer (NEPC; de novo or treatment-emergent) which is relapsed/refractory to standard systemic therapy
• Has high-grade neuroendocrine tumor types other than SCLC and NEPC, with at least one of the following:
‣ Disease that is relapsed/refractory to standard systemic therapy
⁃ Disease for which standard therapy does not exist
⁃ Disease for which standard therapy is not considered appropriate by the Investigator
• Must be able to provide archival tissue sample or fresh biopsy tissue sample
Locations
United States
California
Cedar-Sinai Medical Center, Samuel Oschin Comprehensive Cancer Institute
RECRUITING
Los Angeles
University of California San Francisco
RECRUITING
San Francisco
Colorado
University of Colorado
RECRUITING
Aurora
Massachusetts
Dana Farber Cancer Institute
RECRUITING
Boston
Michigan
Karmanos Cancer Center
RECRUITING
Detroit
New York
Roswell Park Comprehensive Cancer Center
RECRUITING
Buffalo
Memorial Sloan Kettering Cancer Center
RECRUITING
New York
Ohio
University Hospitals Cleveland Medical Center
RECRUITING
Cleveland
Oregon
Providence
RECRUITING
Portland
Tennessee
Tennessee Oncology
RECRUITING
Nashville
Wisconsin
Medical College of Wisconsin
RECRUITING
Milwaukee
Contact Information
Primary
Toll Free Number
Trialsites@msd.com
1-888-577-8839
Time Frame
Start Date:2020-12-14
Estimated Completion Date:2027-11-03
Participants
Target number of participants:232
Treatments
Experimental: Gocatamig monotherapy dose escalation with 1 week dosing interval
Participants will receive gocatamig once weekly (Q1W) via intravenous (IV) infusion during each 21-day cycle. Dose escalation may continue until one or more RDEs are identified, participant discontinuation or the Sponsor decides to stop enrollment.
Experimental: Gocatamig monotherapy dose escalation with 2 week dosing interval
Participants will receive gocatamig via IV infusion once every 2 weeks (Q2W) of a 28-day cycle. Dose escalation may continue until one or more RDEs are identified, participant discontinuation, or the Sponsor decides to stop enrollment.
Experimental: Gocatamig monotherapy dose escalation with 3 week dosing interval
Participants will receive gocatamig via IV infusion once every 3 weeks (Q3W) of a 21-day cycle. Dose escalation may continue until one or more RDEs are identified, participant discontinuation, or the Sponsor decides to stop enrollment.
Experimental: Gocatamig dose escalation with atezolizumab
Small cell lung cancer (SCLC) participants will receive gocatamig via IV infusion Q2W during each 28-day cycle and Atezolizumab via IV infusion every 4 weeks (Q4W) on Day 1 of each 28-day cycle. Dose escalation may continue until one or more RDEs are identified, participant discontinuation, or the Sponsor decides to stop enrollment.
Experimental: Gocatamig dose escalation in combination with I-DXd
SCLC participants will receive gocatamig via IV infusion Q2W during each 42-day cycle and I-DXd via IV infusion Q3W on Day 1 and Day 22 of each 42-day cycle. Dose escalation may continue until one or more RDEs are identified, participant discontinuation, or the Sponsor decides to stop enrollment.