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The safety and efficacy of this agent(s), or use in this setting, has not been established or is subject to confirmation. For an agent(s) whose safety and efficacy has not been established or confirmed, future regulatory approval or commercial availability is not guaranteed.

Clinical Trial Details

Geo Regions

Category

Other or Multiple Cancer Types

Mesothelin-Targeted Antibody Drug Conjugate

PF-08052666 (SGN-MesoC2) is an investigational compound. Its safety and efficacy have not been established.

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

Phase 1

NCT06466187

Active enrolling

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Locations

United States

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Study design
Participant Group/Arm

EXPERIMENTAL: PF-08052666

PF-08052666 monotherapy

Intervention/Treatment

DRUG: PF-08052666

Given into the vein (IV; intravenously)
Study design table for Clinical Trial
Key eligibility criteria
Inclusion criteria
  • An Eastern Cooperative Oncology Group (ECOG) Performance Status score of 0 or 1.
  • Participants must have histologically- or cytologically-confirmed metastatic or locally advanced unresectable ovarian cancer, non-small cell lung cancer (NSCLC), pancreatic adenocarcinoma, endometrial cancer (EC), colorectal cancer (CRC), mesothelioma.
  • Must have at least one measurable lesion at baseline based on RECIST v1.1.
  • Archival tumor tissue is required, or, if unavailable, a fresh tumor biopsy (if it is safe and feasible) during the screening period.
  • Participants weighing ≥40 kg
  • Additional inclusion criterion for platinum resistant ovarian cancer (PROC) participants: Histologically or cytologically documented invasive epithelial ovarian, primary peritoneal, or fallopian tube cancer (tumors with pseudomyxomatous or mucinous histology are excluded) or advanced predominantly epithelioid peritoneal, must have relapsed or progressed following local standard therapies or for which no standard therapy is available.
  • Platinum prior exposure unless it is contraindicated or not available.
  • Participants with known FRa high expression, must have progressed after mirvetuximab soravtansine or other FRa-directed therapy) unless contraindicated or not available. Participants whose cancer is associated with homologous recombination deficiency (HRD)-positive status must have been exposed to PARP inhibitors, unless contraindicated or not available.
  • Additional inclusion criterion for pancreatic ductal adenocarcinoma (PDAC) participants (Part A only): Histologically or cytologically documented, locally advanced unresectable or metastatic pancreatic adenocarcinoma, including recurrence of previously resected disease.
  • Participant must have progressed after standard cytotoxic therapies, or for which no standard therapy is available. Participants must have received fluoropyrimidine-, oxaliplatin-, and irinotecan-based chemotherapy, gemcitabine and nab-paclitaxel combination or gemcitabine-based chemotherapy.
  • Additional inclusion criterion for NSCLC participants (Part A only): Histologically or cytologically confirmed advanced and/or metastatic NSCLC, must have progressed after standard therapies, or for which no standard therapy is available.
  • Participants do not need to have expression of MSLN in tumor to be selected for Part C enrollment unless retrospective analysis of the immunohistochemistry (IHC) data in dose escalation suggests it as a requirement.
  • a. If participants have a specific mutation for which standard therapy is available (eg, ALK, ROS1, MET, NTRK, BRAF V600E, EGFR Exon 20 ins, RET, KRAS G12C, HER2), they must have documented progression after treatment with appropriate tyrosine kinase inhibitor or other agent and have documented progression after platinum doublet chemotherapy treatment, unless not tolerated, contraindicated, or not available.
  • b. If participants do not have a specific mutation for which standard therapy is available, they must have documented progression after treatment with a check point inhibitor and platinum based chemotherapy, unless not tolerated, contraindicated, or not available.
  • Additional inclusion criterion for CRC participants (Part A only): Histologically confirmed metastatic or locally advanced colorectal adenocarcinoma.
  • Participant must have progressed after standard therapy, or for which no standard therapy is available. Participants must have received fluoropyrimidine-, oxaliplatin-, and irinotecan-based chemotherapy, unless not tolerated, contraindicated, or not available.
  • Participants with microsatellite instability (MSI)-H/mismatch repair deficient (dMMR) tumors must have received treatment with a PD-1 mAb, unless not tolerated or available. If participants have an BRAF mutation or other mutations, they must have documented progression after treated with appropriate therapies (eg, encorafenib + cetuximab), unless not tolerated or available. Particpants with HER2 positive tumors, must have received treatment with HER2-directed therapies (eg, tucatinib + trastuzumab), unless not tolerated or available.
  • Participants do not need to have expression of MSLN in tumor to be selected for Part C enrollment unless retrospective analysis of the IHC data in dose escalation suggests it as a requirement.
  • Additional inclusion criteria for EC participants (Part A only): Participant must have received at least 1 line of platinum-based chemotherapy.
  • Participant must have received up to 2 lines of systemic therapy in metastatic setting.
  • If appropriate by biomarker status (including but not limited to microsatellite instability \[MSI\] and dMMR status) and available per local SOC, must have received a prior PD-1 inhibitor and/or the combination of pembrolizumab and lenvatinib, unless not tolerated.
  • Additional inclusion criteria for mesothelioma participants (Part A only): Histologically or cytologically confirmed advanced and/or metastatic mesothelioma, must have progressed after standard therapies, or for which no standard therapy is available.
  • Additional inclusion criteria for all tumor types (Parts B and C only): Participants must have histologically- or cytologically-confirmed metastatic or locally advanced unresectable ovarian cancer, non-small cell lung cancer (NSCLC), pancreatic adenocarcinoma, endometrial cancer (EC), colorectal cancer (CRC), or mesothelioma.
  • Participants must not have received more than 2 lines of cytotoxic systemic therapy in metastatic setting.
Exclusion criteria
  • Participants previously received or is currently receiving the following anticancer medications or investigational drugs will be excluded:
    • Any systemic anticancer therapy or focal radiotherapy within 4 weeks prior to first dose of PF-08052666or within 2 weeks prior to the first dose of PF-08052666if the underlying disease has progressed on treatment.
    • For Part C, prior anti-Mesothelin (MSLN) antibody (mAb or BsAb), MSLN- directed AD
  • Major surgery (excluding placement of vascular access) within 4 weeks, or minor surgery within 7 days, prior to first dose of study intervention. Participants must have recovered adequately from the toxicity or complications from the surgery prior to starting PF-08052666. Participants who have planned major surgery during the treatment period must be excluded from the study.
  • History of another malignancy within 3 years before the first dose of study intervention, or any evidence of residual disease from a previously diagnosed malignancy. Exceptions are malignancies with a negligible risk of metastasis or death.
  • Known to be positive for human immunodeficiency virus (HIV). Participants with severe or uncontrolled systemic diseases, including uncontrolled hypertension, uncontrolled diabetes mellitus, or active bleeding diatheses.
  • Participants with medical history of clinically significant lung diseases (eg, interstitial pneumonia, pneumonitis, pulmonary fibrosis, and severe radiation pneumonitis) or who are suspected to have these diseases by imaging at screening period.
  • Previously untreated brain metastases. Participants who have received radiation or surgery for brain metastases are eligible if therapy was completed at least 4 weeks prior to initiation of study treatment, there is no evidence of central nervous system (CNS) disease progression, and there is no requirement for chronic corticosteroid therapy. Leptomeningeal metastases or spinal cord compression due to disease.
    • Key dates
    Study start date
    • August 2024
    Estimated Study Completion Date
    • November 2028
    Key endpoints
    Primary Outcome Measures
    Outcome Measure

    Number of participants with adverse events (AEs)

    Measure Description

    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.

    Time Frame

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

    Outcome Measure

    Number of participants with laboratory abnormalities

    Measure Description

    Time Frame

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

    Outcome Measure

    Number of participants with dose modifications

    Measure Description

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

    Time Frame

    Up to 4 months

    Outcome Measure

    Number of participants with dose-limiting toxicities (DLTs)

    Measure Description

    Incidence of dose-limiting toxicities (DLTs)

    Time Frame

    Cycle 1 (21 days)

    Primary Outcome Measures table for Clinical Trial
    Secondary Outcome Measures:
    Outcome Measure

    Objective response rate (ORR)

    Measure Description

    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.

    Time Frame

    Approximately 1 year 4 months

    Outcome Measure

    Best response

    Measure Description

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

    Time Frame

    Approximately 1 year 4 months

    Outcome Measure

    Duration of response (DOR)

    Measure Description

    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.

    Time Frame

    Approximately 1 year 4 months

    Outcome Measure

    Disease control rate (DCR)

    Measure Description

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

    Time Frame

    Approximately 1 year 4 months

    Outcome Measure

    Progression-free survival (PFS)

    Measure Description

    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.

    Time Frame

    Approximately 1 year 4 months

    Outcome Measure

    Overall survival (OS)

    Measure Description

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

    Time Frame

    Approximately 1 year 4 months

    Outcome Measure

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

    Measure Description

    Time Frame

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

    Outcome Measure

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

    Measure Description

    Time Frame

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

    Outcome Measure

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

    Measure Description

    Time Frame

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

    Outcome Measure

    Pharmacokinetic (PK) parameter - Half-life

    Measure Description

    Time Frame

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

    Outcome Measure

    Number of participants with antidrug antibodies

    Measure Description

    Time Frame

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

    Secondary Outcome Measures table for Clinical Trial
    Number of participants

    365

    Collaborators and investigators

    Sponsor: Seagen Inc.

    Collaborator: None

    This information is current as of November 22nd 2024.

    Contact Us
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    For more information, call or email the Pfizer Clinical Trial Contact Center:

    1-800-887-7002 Email us

    When calling, please reference this study number:

    More Information Close NCT# stands for National Clinical Trial number. This is a unique identification code given to each clinical trial registered on ClinicalTrials.gov. The format is "NCT" followed by an 8-digit number (for example, NCT00000419). Also called the ClinicalTrials.gov identifier. NCT06466187