A Phase 1 Study of PF-08046052/SGN-EGFRd2 in Advanced Solid Tumors

Status: Recruiting
Location: See all (24) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 1
SUMMARY

This study will test the safety of a drug called PF-08046052/SGN-EGFRd2 in participants with advanced solid tumors. It will also study the side effects of this drug. A side effect is anything a drug does to the body besides treating the disease. Participants will have cancer that cannot be removed (unresectable) or has spread through the body (metastatic). This study will have three parts. Parts A and B of the study will find out how much PF-08046052/SGN-EGFRd2 should be given to participants. Part C will use the dose found in parts A and B to find out how safe PF-08046052/SGN-EGFRd2 is and if it works to treat solid tumor cancers.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Tumor types:

‣ For Part A: Participants must have disease that is relapsed, refractory, or be intolerant to standard of care therapies, and in the judgement of the investigator must have no appropriate standard therapy available at the time of enrollment. Participants must have histologically- or cytologically confirmed metastatic or unresectable solid malignancy from one of the following tumor types:

• Colorectal cancer (CRC)

∙ Non-small cell lung cancer (NSCLC)

∙ Head and neck squamous cell cancer (HNSCC)-non-nasopharyngeal subtype ONLY; nasopharyngeal subtype is not eligible.

⁃ For Part B: Participants must have disease that is relapsed, refractory, or be intolerant to standard of care therapies, and in the judgement of the investigator must have no appropriate standard therapy available at the time of enrollment.

• The tumor type(s) to be enrolled in dose optimization will be identified by the sponsor from among those specified in Part A.

⁃ For Part C: Participants must have disease that is relapsed or refractory or be intolerant to standard of care therapies as specified below, unless contraindicated:

• CRC

‣ Participants must have unresectable locally advanced or metastatic CRC.

⁃ Prior therapy: Participants must have received prior fluoropyrimidine, oxaliplatin and irinotecan. Participants with defective mismatch repair and microsatellite instability high (dMMR/MSI-H) should have received prior treatment with pembrolizumab, a nivolumab-containing regimen, or other available anti-PD-1 (programmed cell death protein 1) or anti PD L1 (programmed cell death 1 ligand) agents.

∙ NSCLC

‣ Participants must have unresectable locally advanced or metastatic NSCLC.

⁃ Prior therapy: Participants must have received platinum-based therapy and at least 1 PD-1/PD-L1 inhibitor. These agents may have been administered either as single agents or in combination. Participants with an activating mutation or rearrangement (eg, EGFR, anaplastic lymphoma kinase \[ALK\], etc.) must have received available targeted agents if eligible by biomarker status and local standard of care.

∙ HNSCC

‣ Participants must have unresectable locally advanced or metastatic HNSCC - non-nasopharyngeal subtype ONLY; nasopharyngeal subtype is not eligible.

⁃ Prior therapy: Participants must have received platinum-based therapy and a PD-1/PD-L1 inhibitor, if eligible by biomarker status and local standard of care. These agents may have been administered either as single agents or in combination.

∙ Pancreatic ductal adenocarcinoma (PDAC)

‣ Participants must have unresectable locally advanced or metastatic PDAC.

⁃ Prior therapy: Participants must have received gemcitabine- or FOLFIRINOX-based therapy.

• Participants should provide archival tumor tissue if available and also agree to biopsies, if medically feasible

• An Eastern Cooperative Oncology Group (ECOG) Performance Status score of 0 or 1.

• Measurable disease at baseline per RECIST 1.1 criteria.

Locations
United States
California
Ronald Reagan UCLA Medical Center
RECRUITING
Los Angeles
UCLA Hematology/Oncology
RECRUITING
Los Angeles
Santa Monica UCLA Medical Center & Orthopaedic Hospital
RECRUITING
Santa Monica
UCLA Hematology/Oncology - Santa Monica
RECRUITING
Santa Monica
Florida
Moffitt Cancer Center
RECRUITING
Tampa
Moffitt Cancer Center McKinley Hospital
RECRUITING
Tampa
Iowa
University of Iowa
RECRUITING
Iowa City
Massachusetts
Beth Israel Deaconess Medical Center
RECRUITING
Boston
Michigan
Karmanos Cancer Institute
RECRUITING
Detroit
Karmanos Cancer Institute Weisberg Cancer Treatment Center
RECRUITING
Farmington Hills
North Carolina
Atrium Health Wake forest Baptist
RECRUITING
Winston-salem
Atrium Health Wake forest Baptist
RECRUITING
Winston-salem
Wake Forest Baptist Medical Center / Wake Forest University
RECRUITING
Winston-salem
New Jersey
Hackensack University Medical Center
RECRUITING
Hackensack
John Theurer Cancer Center at Hackensack University Medical Center
RECRUITING
Hackensack
Ohio
University Hospitals Cleveland Medical Center
RECRUITING
Cleveland
Oregon
Providence Cancer Institute Franz Clinic
RECRUITING
Portland
Providence Portland Medical Center
RECRUITING
Portland
Texas
MD Anderson Cancer Center - University of Texas
RECRUITING
Houston
The University of Texas MD Anderson Cancer Center
RECRUITING
Houston
Utah
Huntsman Cancer Hospital, University of Utah
RECRUITING
Salt Lake City
Huntsman Cancer Institute, University Of Utah
RECRUITING
Salt Lake City
Other Locations
United Kingdom
University College London Hospital, NIHR UCLH Clinical Research Facility
RECRUITING
London
The Christie NHS Foundation Trust
RECRUITING
Manchester
Contact Information
Primary
Seagen Pfizer CT.gov Call Center
ClinicalTrials.gov_Inquiries@pfizer.com
1-800-718-1021
Time Frame
Start Date: 2023-11-14
Estimated Completion Date: 2030-01-09
Participants
Target number of participants: 290
Treatments
Experimental: PF-08046052/SGN-EGFRd2
PF-08046052/SGN-EGFRd2 monotherapy
Sponsors
Leads: Seagen, a wholly owned subsidiary of Pfizer

This content was sourced from clinicaltrials.gov

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