A Study of SGN-MesoC2 in Advanced Solid Tumors

NCT06466187Active, Not RecruitingPHASE1INTERVENTIONAL

Summary

Key Facts

Lead Sponsor

Seagen, a wholly owned subsidiary of Pfizer

Enrollment

19

Start Date

2024-08-02

Completion Date

2028-05-01

Study Type

INTERVENTIONAL

Official Title

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

Interventions

PF-08052666

Conditions

CarcinomaNon-Small-Cell LungOvarian NeoplasmsPancreatic AdenocarcinomaColorectal NeoplasmsMesotheliomaOther Solid TumorsEndometrial

Eligibility

Age Range

18 Years+

Sex

ALL

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

Outcome Measures

Primary Outcomes

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.

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

Number of participants with laboratory abnormalities

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

Number of participants with dose modifications

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

Time frame: Up to 4 months

Number of participants with dose-limiting toxicities (DLTs)

Incidence of dose-limiting toxicities (DLTs)

Time frame: Cycle 1 (21 days)

Secondary Outcomes

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.

Time frame: Approximately 1 year 4 months

Best response

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

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.

Time frame: Approximately 1 year 4 months

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.

Time frame: Approximately 1 year 4 months

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.

Time frame: Approximately 1 year 4 months

Overall survival (OS)

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

Time frame: Approximately 1 year 4 months

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

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

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

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

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

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

Pharmacokinetic (PK) parameter - Half-life

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

Number of participants with antidrug antibodies

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

Locations

University of Alabama at Birmingham, Birmingham, United States

The University of Alabama at Birmingham, Birmingham, United States

University of Alabama at Birmingham, Birmingham, United States

The Board of Trustees of the University of Alabama for the University of Alabama at Birmingham, Birmingham, United States

The University of Kansas Clinical Research Center, Fairway, United States

The University of Kansas Hospital Cambridge North Tower A, Kansas City, United States

The University of Kansas Hospital, Kansas City, United States

The University of Kansas Medical Center Medical Office Building, Kansas City, United States

The University of Kansas Cancer Center - Indian Creek Campus, Overland Park, United States

The University of Kansas Cancer Center - Westwood, Westwood, United States

The University of Kansas Cancer Center, Investigational Drug Services, Westwood, United States

Atrium Health Wake Forest Baptist, Winston-Salem, United States

Sarah Cannon Research Institute - Pharmacy, Nashville, United States

SCRI Oncology Partners, Nashville, United States

START San Antonio, LLC, San Antonio, United States

START Mountain Region, LLC, Salt Lake City, United States

START Mountain Region, West Valley City, United States

University Health Network, Toronto, Canada

University Health Network, Princess Margaret Cancer Centre, Toronto, Canada

The Research Institute of the McGill University Health Centre, Montreal, Canada

McGill University Health Centre, Montreal, Canada

A Study of SGN-MesoC2 in Advanced Solid Tumors