Trial record 1 of 1 for:
SGNB7H4V-001
A Study of SGN-B7H4V in Advanced Solid Tumors
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| ClinicalTrials.gov Identifier: NCT05194072 |
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Recruitment Status :
Recruiting
First Posted : January 18, 2022
Last Update Posted : April 16, 2024
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Sponsor:
Seagen Inc.
Information provided by (Responsible Party):
Seagen Inc.
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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.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| 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 | Drug: SGN-B7H4V | Phase 1 |
| Study Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 430 participants |
| Allocation: | N/A |
| Intervention Model: | Single Group Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Treatment |
| Official Title: | A Phase 1 Study of SGN-B7H4V in Advanced Solid Tumors |
| Actual Study Start Date : | January 12, 2022 |
| Estimated Primary Completion Date : | June 30, 2025 |
| Estimated Study Completion Date : | January 31, 2027 |
Resource links provided by the National Library of Medicine
MedlinePlus Genetics related topics:
Breast cancer
| Arm | Intervention/treatment |
|---|---|
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Experimental: SGN-B7H4V
SGN-B7H4V monotherapy
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Drug: SGN-B7H4V
Given into the vein (IV; intravenously) |
Primary Outcome Measures :
- 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 ]
Secondary Outcome Measures :
- 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.
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| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
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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.
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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
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05194072
Contacts
| Contact: Seagen Trial Information Support | 866-333-7436 | clinicaltrials@seagen.com |
Locations
Show 18 study locations
Sponsors and Collaborators
Seagen Inc.
Investigators
| Study Director: | JoAl Mayor, PharmD, BCOP | Seagen Inc. |
| Responsible Party: | Seagen Inc. |
| ClinicalTrials.gov Identifier: | NCT05194072 |
| Other Study ID Numbers: |
SGNB7H4V-001 2021-002107-35 ( EudraCT Number ) |
| First Posted: | January 18, 2022 Key Record Dates |
| Last Update Posted: | April 16, 2024 |
| Last Verified: | April 2024 |
| Studies a U.S. FDA-regulated Drug Product: | Yes |
| Studies a U.S. FDA-regulated Device Product: | No |
Keywords provided by Seagen Inc.:
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High-grade serous epithelial ovarian cancer Primary peritoneal cancer Fallopian tube cancer HER2-negative breast cancer HR positive breast cancer Triple-negative breast cancer TNBC |
Endometrial carcinoma Non-small cell lung cancer NSCLC SqCC AC ACC Seattle Genetics |
Additional relevant MeSH terms:
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Carcinoma Neoplasms Cholangiocarcinoma Breast Neoplasms Carcinoma, Non-Small-Cell Lung Carcinoma, Adenoid Cystic Ovarian Neoplasms Endometrial Neoplasms Peritoneal Neoplasms Triple Negative Breast Neoplasms Fallopian Tube Neoplasms Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Adenocarcinoma Neoplasms by Site |
Breast Diseases Skin Diseases Carcinoma, Bronchogenic Bronchial Neoplasms Lung Neoplasms Respiratory Tract Neoplasms Thoracic Neoplasms Lung Diseases Respiratory Tract Diseases Endocrine Gland Neoplasms Ovarian Diseases Adnexal Diseases Genital Diseases, Female Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications |