A Study of SGN-B7H4V in Advanced Solid Tumors

• ClinicalTrials.gov Identifier: NCT05194072
• Recruitment Status: Recruiting
• First Posted: January 18, 2022
• Last Update Posted: April 16, 2024
• Sponsor: Seagen Inc.
• Information provided by (Responsible Party): Seagen Inc.

Tracking Information

• First Submitted Date: January 3, 2022
• First Posted Date: January 18, 2022
• Last Update Posted Date: April 16, 2024
• Actual Study Start Date: January 12, 2022
• Estimated Primary Completion Date: June 30, 2025 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: January 3, 2022)

• Number of participants with adverse events (AEs) [ Time Frame: Through 30 days after last study treatment, up to approximately 3 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 3 years ]
• Number of participants with dose limiting toxicities (DLTs) [ Time Frame: Up to 28 days ]

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: December 7, 2023)

• Confirmed objective response rate (ORR) by investigator assessment [ Time Frame: Up to approximately 3 years ]
  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.
• Complete response rate (CRR) [ Time Frame: Up to approximately 3 years ]
  The proportion of participants achieving a CR as determined by the investigator per RECIST Version 1.1.
• Duration of response (DOR) [ Time Frame: Up to approximately 3 years ]
  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.
• Progression-free survival (PFS) [ Time Frame: Up to approximately 3 years ]
  The time from the start of any study treatment to first documentation of disease progression or to death due to any cause.
• Overall survival (OS) [ Time Frame: Up to approximately 3 years ]
  The time from the start of any study treatment to the date of death due to any cause.
• Pharmacokinetic (PK) parameter - Area under the curve (AUC) [ Time Frame: Through 30-37 days after last study treatment; up to approximately 3 years ]
  To be summarized using descriptive statistics.
• PK parameter - Maximum concentration (Cmax) [ Time Frame: Through 30-37 days after last study treatment, up to approximately 3 years ]
  To be summarized using descriptive statistics.
• PK parameter - Time to maximum concentration (Tmax) [ Time Frame: Through 30-37 days after last study treatment, up to approximately 3 years ]
  To be summarized using descriptive statistics.
• PK parameter - Apparent terminal half-life (t1/2) [ Time Frame: Through 30-37 days after last study treatment, up to approximately 3 years ]
  To be summarized using descriptive statistics.
• PK parameter - Trough concentration (Ctrough) [ Time Frame: Through 30-37 days after last study treatment, up to approximately 3 years ]
  To be summarized using descriptive statistics.
• Incidence of antidrug antibodies (ADAs) [ Time Frame: Through 30-37 days after last study treatment, up to approximately 3 years ]
  To be summarized using descriptive statistics.

Original Secondary Outcome Measures (submitted: January 3, 2022)

• Objective response rate (ORR) [ Time Frame: Up to approximately 3 years ]
  The proportion of subjects achieving a partial response (PR), or complete response (CR) as assessed by the investigator per RECIST Version 1.1.
• Complete response rate (CRR) [ Time Frame: Up to approximately 3 years ]
  The proportion of subjects achieving a CR as determined by the investigator per RECIST Version 1.1.
• Duration of response (DOR) [ Time Frame: Up to approximately 3 years ]
  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.
• Progression-free survival (PFS) [ Time Frame: Up to approximately 3 years ]
  The time from the start of any study treatment to first documentation of disease progression or to death due to any cause.
• Overall survival (OS) [ Time Frame: Up to approximately 3 years ]
  The time from the start of any study treatment to the date of death due to any cause.
• Pharmacokinetic (PK) parameter - Area under the curve (AUC) [ Time Frame: Through 30-37 days after last study treatment; up to approximately 3 years ]
  To be summarized using descriptive statistics.
• PK parameter - Maximum concentration (Cmax) [ Time Frame: Through 30-37 days after last study treatment, up to approximately 3 years ]
  To be summarized using descriptive statistics.
• PK parameter - Time to maximum concentration (Tmax) [ Time Frame: Through 30-37 days after last study treatment, up to approximately 3 years ]
  To be summarized using descriptive statistics.
• PK parameter - Apparent terminal half-life (t1/2) [ Time Frame: Through 30-37 days after last study treatment, up to approximately 3 years ]
  To be summarized using descriptive statistics.
• PK parameter - Trough concentration (Ctrough) [ Time Frame: Through 30-37 days after last study treatment, up to approximately 3 years ]
  To be summarized using descriptive statistics.
• Incidence of antidrug antibodies (ADAs) [ Time Frame: Through 30-37 days after last study treatment, up to approximately 3 years ]
  To be summarized using descriptive statistics.

• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: A Study of SGN-B7H4V in Advanced Solid Tumors
• Official Title: A Phase 1 Study of SGN-B7H4V in Advanced Solid Tumors

Brief Summary

This study will test the safety of a drug called SGN-B7H4V in participants with solid tumors. It will also study the side effects of this drug. A side effect is anything a drug does to the body besides treating the disease.

Participants will have cancer that has spread in the body near where it started (locally advanced) and cannot be removed (unresectable) or has spread through the body (metastatic).

This study will have three parts. Parts A and B of the study will find out how much SGN-B7H4V should be given to participants. Part C will use the dose found in Parts A and B to find out how safe SGN-B7H4V is and if it works to treat solid tumor cancers.

• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Phase 1
• Study Design: Allocation: N/A; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Treatment

Condition

• Ovarian 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

Intervention

Drug: SGN-B7H4V

Given into the vein (IV; intravenously)

Study Arms

Experimental: SGN-B7H4V

SGN-B7H4V monotherapy

Intervention: Drug: SGN-B7H4V

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Recruiting
• Estimated Enrollment (submitted: December 7, 2023): 430
• Original Estimated Enrollment (submitted: January 3, 2022): 355
• Estimated Study Completion Date: January 31, 2027
• Estimated Primary Completion Date: June 30, 2025 (Final data collection date for primary outcome measure)

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 (ACC)
• 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 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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Contacts

Contact: Seagen Trial Information Support; 866-333-7436; clinicaltrials@seagen.com

• Listed Location Countries: Canada, Germany, Italy, Spain, United Kingdom, United States

Administrative Information

• NCT Number: NCT05194072
• Other Study ID Numbers: SGNB7H4V-001; 2021-002107-35 ( EudraCT Number )
• Has Data Monitoring Committee: No

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No

• IPD Sharing Statement: Not Provided
• Current Responsible Party: Seagen Inc.
• Original Responsible Party: Same as current
• Current Study Sponsor: Seagen Inc.
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• Study Director: JoAl Mayor, PharmD, BCOP; Seagen Inc.

• PRS Account: Seagen Inc.
• Verification Date: April 2024