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A Study of PF-08046052/SGN-EGFRd2 in Advanced Solid Tumors | Clinical Trials | Clareo Health

ACTIVE_NOT_RECRUITINGPHASE1

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

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

NCT05983133•Seagen, a wholly owned subsidiary of Pfizer

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

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•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)

Exclusion Criteria

•* 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
+14 more criteria

Locations (24)

Ronald Reagan UCLA Medical Center

Los Angeles, California, United States

UCLA Hematology/Oncology

Los Angeles, California, United States

Santa Monica UCLA Medical Center & Orthopaedic Hospital

Santa Monica, California, United States

UCLA Hematology/Oncology - Santa Monica

Santa Monica, California, United States

Moffitt Cancer Center McKinley Hospital

Tampa, Florida, United States

Moffitt Cancer Center

Tampa, Florida, United States

University of Iowa

Iowa City, Iowa, United States

Beth Israel Deaconess Medical Center

Boston, Massachusetts, United States

Karmanos Cancer Institute

Detroit, Michigan, United States

Karmanos Cancer Institute Weisberg Cancer Treatment Center

Farmington Hills, Michigan, United States

Key Dates

Start Date

November 14, 2023

Primary Completion Date

August 14, 2026

Completion Date

August 14, 2026

Last Updated

January 22, 2026

Enrollment

ACTUAL participants

Conditions

Colorectal NeoplasmsCarcinoma, Non-Small-Cell LungSquamous Cell Carcinoma of the Head and NeckPancreatic Ductal Adenocarcinoma

Interventions

PF-08046052

DRUG

A Study of Amivantamab and mFOLFOX6 or FOLFIRI Versus Cetuximab and mFOLFOX6 or FOLFIRI as First-line Treatment in Participants With KRAS/NRAS and BRAF Wild-type Unresectable or Metastatic Left-sided Colorectal Cancer

NCT06662786

Colorectal Neoplasms

View study

RECRUITING

KEYMAKER-U01 Umbrella Master Study: Studies of Investigational Agents With Either Pembrolizumab (MK-3475) Alone or With Pembrolizumab PLUS Chemotherapy in Participants With Non-small Cell Lung Cancer (NSCLC) (MK-3475-U01/KEYMAKER-U01)

NCT04165798

Carcinoma, Non-Small-Cell Lung

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: January 22, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

A Study of Amivantamab and mFOLFOX6 or FOLFIRI Versus Cetuximab and mFOLFOX6 or FOLFIRI as First-line Treatment in Participants With KRAS/NRAS and BRAF Wild-type Unresectable or Metastatic Left-sided Colorectal Cancer

KEYMAKER-U01 Umbrella Master Study: Studies of Investigational Agents With Either Pembrolizumab (MK-3475) Alone or With Pembrolizumab PLUS Chemotherapy in Participants With Non-small Cell Lung Cancer (NSCLC) (MK-3475-U01/KEYMAKER-U01)

A Study of JNJ-90301900 in Combination With Chemoradiation Followed by Consolidation Immunotherapy for Non-Small Cell Lung Cancer (NSCLC)

A Study of JNJ-89402638 for Metastatic Colorectal and Gastric Cancers

A Study of Adagrasib Plus Pembrolizumab Plus Chemotherapy vs. Placebo Plus Pembrolizumab Plus Chemotherapy in Participants With Previously Untreated Non-squamous Non-small Cell Lung Cancer With KRAS G12C Mutation (KRYSTAL-4)

Study of Pembrolizumab (MK-3475) Versus Chemotherapy in Chinese Participants With Stage IV Colorectal Cancer (MK-3475-C66)