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
Breast Cancer
Other or Multiple Cancer Types
Felmetatug vedotin (B7-H4-directed Antibody Drug Conjugate)
Felmetatug vedotin is an investigational compound. Its safety and efficacy have not been established.
A Phase 1 Study of SGN-B7H4V in Advanced Solid Tumors
Phase 1
NCT05194072
Active enrolling
Locations
United States, Canada, Germany, Italy, Spain, United Kingdom
Study design
Participant Group/Arm
EXPERIMENTAL: SGN-B7H4V
SGN-B7H4V monotherapy
Intervention/Treatment
DRUG: SGN-B7H4V
Given into the vein (IV; intravenously)
Key eligibility criteria
Inclusion criteria
- 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 (AC
- Parts A and B: Participants must have disease that is relapsed or refractory or be intolerant to SOC therapies, and, in the judgement of the investigator, should have no appropriate SOC therapeutic option
- Part C: Participants must have disease that is relapsed or refractory or be intolerant to SOC therapies, unless contraindicated
- Tumor tissue is required for enrollment.
- Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1
- Measurable disease per RECIST version 1.1 at baseline
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 treatmen
- 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
Key dates
Study start date
- January 2022
Estimated primary completion date
- January 2027
Key endpoints
Primary Outcome Measures
Outcome Measure
Number of participants with adverse events (AEs)
Measure Description
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.
Time Frame
Through 30 days after last study treatment, up to approximately 3 years
Outcome Measure
Number of participants with laboratory abnormalities
Time Frame
Through 30-37 days after last study treatment, up to approximately 3 years
Outcome Measure
Number of participants with dose limiting toxicities (DLTs)
Time Frame
Up to 28 days
Secondary Outcome Measures:
Outcome Measure
Confirmed objective response rate (ORR) by investigator assessment
Measure Description
The proportion of participants with complete response (CR) or partial response (PR) which is subsequently confirmed as assessed according to Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 by investigator.
Time Frame
Up to approximately 3 years
Outcome Measure
Complete response rate (CRR)
Measure Description
The proportion of participants achieving a CR as determined by the investigator per RECIST Version 1.1.
Time Frame
Up to approximately 3 years
Outcome Measure
Duration of response (DOR)
Measure Description
The time from start of the first documentation of objective tumor response (CR or PR) to the first documentation of tumor progression or to death due to any cause.
Time Frame
Up to approximately 3 years
Outcome Measure
Progression-free survival (PFS)
Measure Description
The time from the start of any study treatment to first documentation of disease progression or to death due to any cause.
Time Frame
Up to approximately 3 years
Outcome Measure
Overall survival (OS)
Measure Description
The time from the start of any study treatment to the date of death due to any cause.
Time Frame
Up to approximately 3 years
Outcome Measure
Pharmacokinetic (PK) parameter - Area under the curve (AUC)
Measure Description
To be summarized using descriptive statistics.
Time Frame
Through 30-37 days after last study treatment; up to approximately 3 years
Outcome Measure
PK parameter - Maximum concentration (Cmax)
Measure Description
To be summarized using descriptive statistics.
Time Frame
Through 30-37 days after last study treatment, up to approximately 3 years
Outcome Measure
PK parameter - Time to maximum concentration (Tmax)
Measure Description
To be summarized using descriptive statistics.
Time Frame
Through 30-37 days after last study treatment, up to approximately 3 years
Outcome Measure
PK parameter - Apparent terminal half-life (t1/2)
Measure Description
To be summarized using descriptive statistics.
Time Frame
Through 30-37 days after last study treatment, up to approximately 3 years
Outcome Measure
PK parameter - Trough concentration (Ctrough)
Measure Description
To be summarized using descriptive statistics.
Time Frame
Through 30-37 days after last study treatment, up to approximately 3 years
Outcome Measure
Incidence of antidrug antibodies (ADAs)
Measure Description
To be summarized using descriptive statistics.
Time Frame
Through 30-37 days after last study treatment, up to approximately 3 years
Number of participants
430
Collaborators and investigators
Sponsor: Seagen Inc.
Collaborator: None