AzTrials
AzTrials

Carcinoma, Non-Small-Cell LungPhase 1NCT06466187

A Study of SGN-MesoC2 in Advanced Solid Tumors

A Phase 1 study testing PF-08052666 in people with Carcinoma, Non-Small-Cell Lung and Ovarian Neoplasms, run by Seagen, a wholly owned subsidiary of Pfizer at 19 sites in 2 countries.

Terminated

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

Official record
Search all trials

Trial summary

This clinical trial is studying advanced solid tumors. Solid tumors are cancers that start in a part of your body like your lungs or liver instead of your blood. Once tumors have grown bigger in one place but haven't spread, they're called locally advanced. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
PF-08052666
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
19 participants
Where
19 sitesin 2 countries
Study dates
2 Aug 2024to 27 May 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

  • Aged 18 years or older.
  • Histologically- or cytologically-confirmed metastatic or locally advanced unresectable platinum-resistant ovarian cancer, NSCLC, pancreatic ductal adenocarcinoma, endometrial cancer, colorectal cancer, or mesothelioma, who have relapsed or progressed following standard therapies, or for which no standard therapies are available.
  • An Eastern Cooperative Oncology Group performance status score of 0 or 1.
  • At least 1 measurable lesion at baseline based on Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1).
  • Archival tumor tissue or a fresh tumor biopsy during the screening period.
  • Adequate hepatic, renal and bone marrow function.
  • Participants must not have received more than 2 lines of cytotoxic systemic therapy in the metastatic setting (Parts B and C only).

Who cannot join

  • Previously received or currently receiving any systemic anticancer therapy or focal radiotherapy within 4 weeks prior to the first dose of MesoC2 or within 2 weeks prior to the first dose of MesoC2 if the underlying disease had progressed on treatment.
  • Prior anti-MSLN antibody or MSLN-directed ADC (Part C only).
  • Unresolved toxicities from prior therapy greater than NCI CTCAE v5.0 grade 1 at the time of study treatment (except alopecia).
  • Inadequate hepatic dysfunction, renal function, or hematologic abnormalities.
  • Previously untreated brain metastases. Participants who received radiation or surgery for brain metastases are eligible if therapy was completed at least 4 weeks prior to study treatment initiation, and there was no evidence of central nervous system progression nor requirements for chronic corticosteroid therapy

Trial locations and contacts

19 sites in 2 countries.

19 sites in 2 countries

United States16 sites

  • University of Alabama at Birmingham

    Birmingham, Alabama, 35233

  • The University of Alabama at Birmingham

    Birmingham, Alabama, 35249

  • University of Alabama at Birmingham

    Birmingham, Alabama, 35249

  • The Board of Trustees of the University of Alabama for the University of Alabama at Birmingham

    Birmingham, Alabama, 35294

  • The University of Kansas Clinical Research Center

    Fairway, Kansas, 66205

  • The University of Kansas Hospital Cambridge North Tower A

    Kansas City, Kansas, 66160

  • The University of Kansas Hospital

    Kansas City, Kansas, 66160

  • The University of Kansas Medical Center Medical Office Building

    Kansas City, Kansas, 66160

  • Sarah Cannon Research Institute - Pharmacy

    Nashville, Tennessee, 37203

  • SCRI Oncology Partners

    Nashville, Tennessee, 37203

  • The University of Kansas Cancer Center - Indian Creek Campus

    Overland Park, Kansas, 66211

  • START San Antonio, LLC

    San Antonio, Texas, 78229

  • START Mountain Region, LLC

    West Valley City, Utah, 84119

  • The University of Kansas Cancer Center - Westwood

    Westwood, Kansas, 66205

  • The University of Kansas Cancer Center, Investigational Drug Services

    Westwood, Kansas, 66205

  • Atrium Health Wake Forest Baptist

    Winston-Salem, North Carolina, 27157

Other trials in United States

Canada3 sites

  • McGill University Health Centre

    Montreal, Quebec, H4A 3J1

  • University Health Network

    Toronto, Ontario, M5G 2C4

  • University Health Network, Princess Margaret Cancer Centre

    Toronto, Ontario, M5G 2M9

Other trials in Canada

About this study

Official title: A PHASE 1 OPEN-LABEL, MULTICENTER STUDY TO EVALUATE THE SAFETY, TOLERABILITY, PHARMACOKINETICS, AND ANTITUMOR ACTIVITY OF PF-08052666/SGN-MESOC2 IN PARTICIPANTS WITH ADVANCED SOLID TUMORS

This clinical trial is studying advanced solid tumors. Solid tumors are cancers that start in a part of your body like your lungs or liver instead of your blood. Once tumors have grown bigger in one place but haven't spread, they're called locally advanced. If your cancer has spread to other parts of your body, it's called metastatic. When a cancer has gotten so big it can't easily be removed or has spread to other parts of the body, it is called unresectable. These types of cancer are harder to treat.

Patients in this study must have cancer that has come back or did not get better with treatment. Patients must have a solid tumor cancer that can't be treated with standard of care drugs.

Read more

This clinical trial uses an experimental drug called PF-08052666/SGN-MesoC2. PF-08052666/SGN-MesoC2 is a type of antibody-drug conjugate (ADC). ADCs are designed to stick to cancer cells and kill them. They may also stick to some normal cells.

This study will have 3 parts. Part A and Part B of the study will find out how much PF-08052666/SGN-MesoC2 should be given to participants. Part C will use the information from Parts A and B to see if PF-08052666/SGN-MesoC2 is safe and if it works to treat solid tumor cancers.

Being tested
PF-08052666
Keywords
NSCL, Lung Neoplasm, Cancer of Ovary, Ovarian Cancer, Colorectal Cancer, Colorectal Tumors, Endometrial, Seattle Genetics
Medical subject headings
Carcinoma, Non-Small-Cell Lung, Ovarian Neoplasms, Colorectal Neoplasms, Mesothelioma, Lung Neoplasms

What participants receive

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

  • PF-08052666Drug

    Also called HBM9033; SGN-MesoC2

    Given into the vein (IV; intravenously)

Study groups in NCT06466187
Study groupRoleWhat they receive
PF-08052666ExperimentalPF-08052666 monotherapy
Receives: Drug: PF-08052666

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 participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention.

    Measured: Through 30-37 days after the last dose of study treatment, 48 Months

  2. Number of participants with laboratory abnormalities

    Measured: Through 30-37 days after the last dose of study treatment, 48 Months

  3. Number of participants with dose modifications

    Frequency of dose modifications (eg, dose delay, treatment interruptions, dose reductions and treatment discontinuations) due to AEs

    Measured: Up to 4 months

  4. Number of participants with dose-limiting toxicities (DLTs)

    Incidence of dose-limiting toxicities (DLTs)

    Measured: Cycle 1 (21 days)

Secondary outcomes (11)

  1. Objective response rate (ORR)

    ORR is defined as the proportion of participants in the relevant analysis set with best response of complete response (CR) or partial response (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1.

    Measured: Approximately 1 year 4 months

  2. Best response

    The best timepoint response achieved for the subject during the protocol specified period according to RECIST V1.1.

    Measured: Approximately 1 year 4 months

  3. Duration of response (DOR)

    DOR is defined as the time interval from first occurrence of documented objective response to the time of progressive disease (PD) according to RECIST v1.1 or death from any cause, whichever comes first.

    Measured: Approximately 1 year 4 months

  4. Disease control rate (DCR)

    DCR is defined as the proportion of participants with best response of CR, PR or stable disease (SD) according to RECIST v1.1.

    Measured: Approximately 1 year 4 months

  5. Progression-free survival (PFS)

    PFS is defined as the time from first dosing to the first occurrence of PD according to RECIST v1.1 or death from any cause, whichever comes first.

    Measured: Approximately 1 year 4 months

  6. Overall survival (OS)

    Overall survival (OS) defined as the time from first dosing to death.

    Measured: Approximately 1 year 4 months

  7. Pharmacokinetic (PK) parameter - Area under the serum concentration (AUC)

    Measured: Cycles 1, 2, and 3 (each cycle is up to 21 days)

  8. Pharmacokinetic (PK) parameter - Maximum serum concentration (Cmax)

    Measured: Cycles 1, 2, and 3 (each cycle is up to 21 days)

  9. Pharmacokinetic (PK) parameter - Time to reach maximum serum concentration (Tmax)

    Measured: Cycles 1, 2, and 3 (each cycle is up to 21 days)

  10. Pharmacokinetic (PK) parameter - Half-life

    Measured: Cycles 1, 2, and 3 (each cycle is up to 21 days)

  11. Number of participants with antidrug antibodies

    Measured: Cycles 1, 2, and 3 (each cycle is up to 21 days)

Timeline

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

  1. First posted20 Jun 2024
  2. Study start2 Aug 2024
  3. Primary completion27 May 2026
  4. Study completion27 May 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
19 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06466187
Sponsor's protocol ID
C5991001
Other IDs
SGNMesoC2-001
Status last verified
Jul 2026
First submitted
11 Jun 2024
Last updated
7 Jul 2026
Results posted
No
Data monitoring committee
Yes
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-08052666 in people with Carcinoma, Non-Small-Cell Lung and Ovarian Neoplasms, run by Seagen, a wholly owned subsidiary of Pfizer at 19 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 7 inclusion and 5 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 7 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 19 sites in United States, Canada. 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 30-37 days after the last dose of study treatment, 48 Months). 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 NCT06466187.

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 7 Jul 2026.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Keep searching with a free account

You’ve used your 3 free searches for this session. Log in or create a free AzTrials account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in
A Study of SGN-MesoC2 in Advanced Solid Tumors | AzTrials