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

Breast Cancer

Other or Multiple Cancer Types

Felmetatug vedotin (PF-08046048 | SGN-B7H4V)

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 Not-enrolling

Locations

United States, Canada, Germany, Italy, Spain, United Kingdom

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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: SGN-B7H4V (Parts A, B, and C)

SGN-B7H4V monotherapy

Intervention/Treatment

DRUG: SGN-B7H4V

Given into the vein (IV; intravenously)

Participant Group/Arm

EXPERIMENTAL: SGN-B7H4V and Pembrolizumab (Parts D and E)

SGN-B7H4V in combination with Pembrolizumab.

Intervention/Treatment

DRUG: SGN-B7H4V

Given into the vein (IV; intravenously)

DRUG: Pembrolizumab

400 mg every 6 weeks, given by IV

Study design table for Clinical Trial

Key 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.
Cohort E1: Participants must have histologically or cytologically confirmed locally advanced unresectable or metastatic TNBC and must have CPS≥10 by local testing
Cohort E2: Participants must have histologically or cytologically confirmed locally advanced unresectable or metastatic TNBC and must have CPS\<10 by local testing
Cohort E3: Participants must have triple negative breast cancer with residual disease following neoadjuvant therapy and definitive surgery
- 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.
- Part D and E1/E2: Participants must have had no prior treatment for locally advanced unresectable or metastatic TNBC
- Part E3: Participants must have completed at least 6 cycles of neoadjuvant therapy for locally advanced unresectable or metastatic TNBC
- 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 (not applicable for E3 participants).
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

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 Study Completion Date

November 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 5 years

Outcome Measure

Number of participants with laboratory abnormalities

Measure Description

Time Frame

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

Outcome Measure

Number of participants with dose limiting toxicities (DLTs)

Measure Description

Time Frame

Up to 28 days

Outcome Measure

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

Measure Description

Time Frame

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

Primary Outcome Measures table for Clinical Trial

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 5 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 5 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 5 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 5 years

Outcome Measure

Invasive disease-free survival (iDFS)

Measure Description

The time from the start of any study treatment until the date of first occurrence of one of the following events: ipsilateral invasive breast tumor (local) recurrence, regional invasive breast cancer recurrence (axilla, regional lymph nodes, chest wall, and skin of ipsilateral breast), or distant (metastatic) recurrence; contralateral invasive breast cancer; second primary non-breast invasive cancer (other than squamous of basal cell skin cancer); or death from any cause.

Time Frame

Up to approximately 5 years