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

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Molecule overview Clinical trials

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 SGN-MesoC2 in Subjects With Advanced Solid Tumors

Phase 1

NCT06466187

Active enrolling

Locations

United States, Canada

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Study design Key eligibility criteria Key dates Key endpoints Number of participants Collaborators and investigators

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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

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).

Exclusion criteria

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

Key dates

Study start date

August 2024

Estimated Study Completion Date

February 2029

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