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Colorectal NeoplasmsPhase 1NCT05983133

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

A Phase 1 study testing PF-08046052 in people with Colorectal Neoplasms and Carcinoma, Non-Small-Cell Lung, run by Seagen, a wholly owned subsidiary of Pfizer at 24 sites in 2 countries.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
PF-08046052
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
68 participants
Where
24 sitesin 2 countries
Study dates
14 Nov 2023to 16 Apr 2026
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
Show all 23Show fewer
  • 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.

Who cannot join

  • History of another malignancy within 3 years before the first dose of study treatment, or any evidence of residual disease from a previously diagnosed malignancy. Exceptions are malignancies with a negligible risk of metastasis or death
  • Known active central nervous system metastases or leptomeningeal disease. Participants with previously treated brain metastases may participate provided they are
  • clinically stable for at least 4 weeks prior to study entry after brain metastases treatment,
  • they have no new or enlarging brain metastases,
  • and are off of corticosteroids prescribed for symptoms associated with brain metastases for at least 7 days prior to the first dose of study drug.
  • Treatment with an aminobisphosphonate IV (eg ibandronate, pamidronate, zoledronate, etc.) within 4 weeks of the first dose of study treatment.
  • Participants with history of thromboembolic phenomena within 6 months prior to the first dose of study intervention, or with contraindication to thromboembolism prophylaxis (if clinically indicated) for a previous history of thrombus.

Trial locations and contacts

24 sites in 2 countries.

24 sites in 2 countries

United States22 sites

  • Beth Israel Deaconess Medical Center

    Boston, Massachusetts, 02215

  • University Hospitals Cleveland Medical Center

    Cleveland, Ohio, 44106

  • Karmanos Cancer Institute

    Detroit, Michigan, 48201

  • Karmanos Cancer Institute Weisberg Cancer Treatment Center

    Farmington Hills, Michigan, 48334

  • Hackensack University Medical Center

    Hackensack, New Jersey, 07601

  • John Theurer Cancer Center at Hackensack University Medical Center

    Hackensack, New Jersey, 07601

  • MD Anderson Cancer Center - University of Texas

    Houston, Texas, 77030

  • The University of Texas MD Anderson Cancer Center

    Houston, Texas, 77030

  • University of Iowa

    Iowa City, Iowa, 52242

  • Ronald Reagan UCLA Medical Center

    Los Angeles, California, 90095

  • UCLA Hematology/Oncology

    Los Angeles, California, 90095

  • Providence Cancer Institute Franz Clinic

    Portland, Oregon, 97213

  • Providence Portland Medical Center

    Portland, Oregon, 97213

  • Huntsman Cancer Hospital, University of Utah

    Salt Lake City, Utah, 84112

  • Huntsman Cancer Institute, University Of Utah

    Salt Lake City, Utah, 84112

  • University of Utah

    Salt Lake City, Utah, 84112

  • Santa Monica UCLA Medical Center & Orthopaedic Hospital

    Santa Monica, California, 90404

  • UCLA Hematology/Oncology - Santa Monica

    Santa Monica, California, 90404

  • Moffitt Cancer Center McKinley Hospital

    Tampa, Florida, 33612

  • Moffitt Cancer Center

    Tampa, Florida, 33612

  • Atrium Health Wake forest Baptist

    Winston-Salem, North Carolina, 27157

  • Wake Forest Baptist Medical Center / Wake Forest University

    Winston-Salem, North Carolina, 27157

Other trials in United States

United Kingdom2 sites

  • University College London Hospital, NIHR UCLH Clinical Research Facility

    London, W1T 7HA

  • The Christie NHS Foundation Trust

    Manchester, M20 4BX

Other trials in United Kingdom

About this study

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

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.

Being tested
PF-08046052
Keywords
CRC, Colon Cancer, Rectal Cancer, NSCLC, HNSCC, PDAC, Seattle Genetics
Medical subject headings
Colorectal Neoplasms, Carcinoma, Non-Small-Cell Lung, Squamous Cell Carcinoma of Head and Neck, Colonic Neoplasms, Rectal Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • PF-08046052Drug

    Also called SGN-EGFRd2

    Given into the vein (IV; intravenously)

Study groups in NCT05983133
Study groupRoleWhat they receive
PF-08046052/SGN-EGFRd2ExperimentalPF-08046052/SGN-EGFRd2 monotherapy
Receives: Drug: PF-08046052

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of participants with adverse events (AEs)

    An AE is any untoward medical occurrence in a clinical study subject, temporally associated with the use of study intervention, whether or not considered related to the study intervention

    Measured: Through 90 days after last study treatment, up to approximately 1 year

  2. Number of participants with laboratory abnormalities

    Measured: Through 30-37 days after last study treatment, up to approximately 1 year

  3. Number of participants with dose limiting toxicities (DLTs)

    Measured: Up to 35 days

  4. Number of participants with DLTs by dose level

    Measured: Up to 35 days

Secondary outcomes (10)

  1. Number of participants with antidrug antibodies (ADAs)

    To be summarized using descriptive statistics

    Measured: Through 30-37 days after last study treatment, up to approximately 1 year

  2. Pharmacokinetic (PK) parameter - Area under the curve (AUC)

    To be summarized using descriptive statistics

    Measured: Through 30-37 days after last study treatment, up to approximately 1 year

  3. PK parameter - Maximum concentration (Cmax)

    To be summarized using descriptive statistics

    Measured: Through 30-37 days after last study treatment, up to approximately 1 year

  4. PK parameter - Time to maximum concentration (Tmax)

    To be summarized using descriptive statistics

    Measured: Through 30-37 days after last study treatment, up to approximately 1 year

  5. PK parameter - Apparent terminal half-life (t1/2)

    To be summarized using descriptive statistics

    Measured: Through 30-37 days after last study treatment, up to approximately 1 year

  6. PK parameter - Trough concentration (Ctrough)

    To be summarized using descriptive statistics

    Measured: Through 30-37 days after last study treatment, up to approximately 1 year

  7. Objective response rate (ORR)

    ORR is defined as the proportion of participants with an objective response per Response Evaluation in Solid Tumors (RECIST) 1.1 per investigator. A participant is determined to have an objective response if, based on RECIST 1.1, they achieve a complete response (CR) or partial response (PR) after initiation of treatment and at or prior to the EOT disease assessment.

    Measured: Up to approximately 2 years

  8. Duration of response (DOR)

    DOR is defined as the time from start of the first documentation of objective tumor response (CR or PR) to the first documentation of tumor progression per RECIST 1.1 or to death due to any cause, whichever comes first

    Measured: Up to approximately 2 years

  9. Progression-free survival (PFS)

    PFS is defined as the time from start of SGN-EGFRd2 to first documentation of disease progression or death due to any cause, whichever comes first

    Measured: Up to approximately 2 years

  10. Overall survival (OS)

    OS is defined as the time from start of SGN-EGFRd2 to date of death due to any cause

    Measured: Up to approximately 3 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Aug 2023
  2. Study start14 Nov 2023
  3. Primary completion16 Apr 2026
  4. Study completion16 Apr 2026

Why it stopped: The trial was terminated for strategic reasons. The decision was not based on any safety concerns

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Sequential
Masking
None (open label)
Enrolment
68 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05983133
Sponsor's protocol ID
SGNEGFRd2-001
Other IDs
C5841001
Status last verified
Apr 2026
First submitted
1 Aug 2023
Last updated
5 May 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No: Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical\_trials/trial\_data\_and\_results/data\_requests.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing PF-08046052 in people with Colorectal Neoplasms and Carcinoma, Non-Small-Cell Lung, run by Seagen, a wholly owned subsidiary of Pfizer at 24 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 23 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 5 May 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 24 sites in United States, United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was stopped early (reason given: The trial was terminated for strategic reasons. The decision was not based on any safety concerns). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of participants with adverse events (AEs) (time frame: Through 90 days after last study treatment, up to approximately 1 year). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05983133.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 May 2026.

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