Clinical Trials/NCT05194072

NCT05194072

Terminated

Phase 1

A Phase 1 Study of Felmetatug Vedotin/SGN-B7H4V in Advanced Solid Tumors

Seagen, a wholly owned subsidiary of Pfizer27 sites in 5 countries250 target enrollmentJanuary 12, 2022

ConditionsOvarian Neoplasms Peritoneal Neoplasms Fallopian Tube Neoplasms Triple Negative Breast Neoplasms HER2 Negative Breast Neoplasms Hormone Receptor Positive Breast Neoplasms Endometrial Neoplasms Carcinoma, Non-Small-Cell Lung Cholangiocarcinoma Gallbladder Carcinoma Adenoid Cystic Carcinoma

InterventionsFelmetatug Vedotin Pembrolizumab

Overview

Phase: Phase 1
Intervention: Felmetatug Vedotin
Conditions: Ovarian Neoplasms
Sponsor: Seagen, a wholly owned subsidiary of Pfizer
Enrollment: 250
Locations: 27
Primary Endpoint: Number of participants with adverse events (AEs)
Status: Terminated
Last Updated: 3 months ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

The purpose of the study is to test the safety of the medicine called Felmetatug Vedotin alone and with pembrolizumab in participants with solid tumors. It will also look at the side effects of this medicine. A side effect is anything a medicine does to the body besides treating the disease.

This study is seeking for participants who either have cancer:

that has spread in the body near where it started (locally advanced) and cannot be removed (unresectable),
has spread through the body (metastatic), or have some cancer left over after surgery.

This study will have five parts.

Parts A and B of the study will find out how much Felmetatug Vedotin should be given to participants.
Part C will use the amount found in Parts A and B to find out how safe Felmetatug Vedotin is and if it works to treat solid tumor cancers.
Part D will find out if and how much Felmetatug Vedotin can be given with pembrolizumab.
Part E will use the amount found in Part D to find out how safe Felmetatug Vedotin with pembrolizumab is and if it works to treat triple negative breast cancer.

Registry

clinicaltrials.gov

Start Date

January 12, 2022

End Date

May 14, 2025

Last Updated

3 months ago

Study Type

Interventional

Study Design

Sequential

Sex

All

Investigators

Sponsor

Seagen, a wholly owned subsidiary of Pfizer

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•For Parts A, B, and C:
•Participants must have one of the following histologically or cytologically confirmed locally advanced unresectable or metastatic solid tumor types:
•High-grade serous epithelial ovarian cancer, primary peritoneal cancer, or fallopian tube cancer
•HER2-negative, HR positive breast cancer
•Triple-negative breast cancer (TNBC)
•Endometrial carcinoma
•Non-small cell lung cancer (Squamous cell carcinoma \[SqCC\], Adenocarcinoma \[AC\])
•Cholangiocarcinoma or gallbladder carcinoma
•Adenoid cystic carcinoma (ACC) For Part D: Participants must have histologically or cytologically confirmed locally advanced unresectable or metastatic TNBC.
•For Part E:

Exclusion Criteria

•History of another malignancy within 3 years before the first dose of study drug. 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. Participants with previously treated brain metastases may participate provided they:
•are clinically stable for at least 4 weeks prior to study entry after brain metastasis treatment
•have no new or enlarging brain metastases
•and are off corticosteroids prescribed for symptoms associated with brain metastases for at least 7 days prior to the first dose of study treatment.
•Carcinomatous meningitis
•Previous receipt of an MMAE-containing agent or an agent targeting B7-H4
•Pre-existing neuropathy ≥ Grade 2 per National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0
•Corneal disease or injury requiring treatment or active monitoring

Arms & Interventions

Felmetatug Vedotin (Parts A, B, and C)

Felmetatug Vedotin monotherapy

Intervention: Felmetatug Vedotin

Felmetatug Vedotin and Pembrolizumab (Parts D and E)

Felmetatug Vedotin in combination with Pembrolizumab.

Intervention: Felmetatug Vedotin

Felmetatug Vedotin and Pembrolizumab (Parts D and E)

Felmetatug Vedotin in combination with Pembrolizumab.

Intervention: Pembrolizumab

Outcomes

Primary Outcomes

Number of participants with adverse events (AEs)

Time Frame: Through 30 days after last study treatment, up to approximately 5 years

Any untoward medical occurrence in a clinical investigational participant administered a medicinal product and which does not necessarily have a causal relationship with this treatment.

Number of participants with laboratory abnormalities

Time Frame: Through 30-37 days after last study treatment, up to approximately 5 years

Number of participants with dose limiting toxicities (DLTs)

Time Frame: Up to 28 days

Number of participants with dose limiting toxicities (DLTs) and overall safety by dose level

Time Frame: Through 30-37 days after last study treatment; up to approximately 5 years

Secondary Outcomes

Confirmed objective response rate (ORR) by investigator assessment(Up to approximately 5 years)
Complete response rate (CRR)(Up to approximately 5 years)
Duration of response (DOR)(Up to approximately 5 years)
Progression-free survival (PFS)(Up to approximately 5 years)
Invasive disease-free survival (iDFS)(Up to approximately 5 years)
Pharmacokinetic (PK) parameter - Area under the curve (AUC)(Through 30-37 days after last study treatment; up to approximately 3 years)
PK parameter - Maximum concentration (Cmax)(Through 30-37 days after last study treatment, up to approximately 3 years)
PK parameter - Time to maximum concentration (Tmax)(Through 30-37 days after last study treatment, up to approximately 3 years)
PK parameter - Apparent terminal half-life (t1/2)(Through 30-37 days after last study treatment, up to approximately 3 years)
PK parameter - Trough concentration (Ctrough)(Through 30-37 days after last study treatment, up to approximately 3 years)
Incidence of antidrug antibodies (ADAs)(Through 30-37 days after last study treatment, up to approximately 3 years)