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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT05194072




Registration number
NCT05194072
Ethics application status
Date submitted
3/01/2022
Date registered
18/01/2022
Date last updated
1/10/2024

Titles & IDs
Public title
A Study of SGN-B7H4V in Advanced Solid Tumors
Scientific title
A Phase 1 Study of SGN-B7H4V in Advanced Solid Tumors
Secondary ID [1] 0 0
2021-002107-35
Secondary ID [2] 0 0
SGNB7H4V-001
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Ovarian Neoplasms 0 0
Peritoneal Neoplasms 0 0
Fallopian Tube Neoplasms 0 0
Triple Negative Breast Neoplasms 0 0
HER2 Negative Breast Neoplasms 0 0
Hormone Receptor Positive Breast Neoplasms 0 0
Endometrial Neoplasms 0 0
Carcinoma, Non-Small-Cell Lung 0 0
Cholangiocarcinoma 0 0
Gallbladder Carcinoma 0 0
Adenoid Cystic Carcinoma 0 0
Condition category
Condition code
Cancer 0 0 0 0
Non melanoma skin cancer
Cancer 0 0 0 0
Kidney
Cancer 0 0 0 0
Biliary tree (gall bladder and bile duct)
Oral and Gastrointestinal 0 0 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon
Cancer 0 0 0 0
Breast
Cancer 0 0 0 0
Lung - Non small cell
Cancer 0 0 0 0
Ovarian and primary peritoneal
Cancer 0 0 0 0
Womb (Uterine or endometrial cancer)
Cancer 0 0 0 0
Stomach

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - SGN-B7H4V

Experimental: SGN-B7H4V - SGN-B7H4V monotherapy


Treatment: Drugs: SGN-B7H4V
Given into the vein (IV; intravenously)
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Number of participants with adverse events (AEs)
Timepoint [1] 0 0
Through 30 days after last study treatment, up to approximately 3 years
Primary outcome [2] 0 0
Number of participants with laboratory abnormalities
Timepoint [2] 0 0
Through 30-37 days after last study treatment, up to approximately 3 years
Primary outcome [3] 0 0
Number of participants with dose limiting toxicities (DLTs)
Timepoint [3] 0 0
Up to 28 days
Secondary outcome [1] 0 0
Confirmed objective response rate (ORR) by investigator assessment
Timepoint [1] 0 0
Up to approximately 3 years
Secondary outcome [2] 0 0
Complete response rate (CRR)
Timepoint [2] 0 0
Up to approximately 3 years
Secondary outcome [3] 0 0
Duration of response (DOR)
Timepoint [3] 0 0
Up to approximately 3 years
Secondary outcome [4] 0 0
Progression-free survival (PFS)
Timepoint [4] 0 0
Up to approximately 3 years
Secondary outcome [5] 0 0
Overall survival (OS)
Timepoint [5] 0 0
Up to approximately 3 years
Secondary outcome [6] 0 0
Pharmacokinetic (PK) parameter - Area under the curve (AUC)
Timepoint [6] 0 0
Through 30-37 days after last study treatment; up to approximately 3 years
Secondary outcome [7] 0 0
PK parameter - Maximum concentration (Cmax)
Timepoint [7] 0 0
Through 30-37 days after last study treatment, up to approximately 3 years
Secondary outcome [8] 0 0
PK parameter - Time to maximum concentration (Tmax)
Timepoint [8] 0 0
Through 30-37 days after last study treatment, up to approximately 3 years
Secondary outcome [9] 0 0
PK parameter - Apparent terminal half-life (t1/2)
Timepoint [9] 0 0
Through 30-37 days after last study treatment, up to approximately 3 years
Secondary outcome [10] 0 0
PK parameter - Trough concentration (Ctrough)
Timepoint [10] 0 0
Through 30-37 days after last study treatment, up to approximately 3 years
Secondary outcome [11] 0 0
Incidence of antidrug antibodies (ADAs)
Timepoint [11] 0 0
Through 30-37 days after last study treatment, up to approximately 3 years

Eligibility
Key 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
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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

Study design
Purpose of the study
Treatment
Allocation to intervention
Not applicable
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
12/01/2022
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
31/01/2027
Actual
Sample size
Target
430
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Colorado
Country [2] 0 0
United States of America
State/province [2] 0 0
Florida
Country [3] 0 0
United States of America
State/province [3] 0 0
Illinois
Country [4] 0 0
United States of America
State/province [4] 0 0
Indiana
Country [5] 0 0
United States of America
State/province [5] 0 0
Michigan
Country [6] 0 0
United States of America
State/province [6] 0 0
Tennessee
Country [7] 0 0
United States of America
State/province [7] 0 0
Texas
Country [8] 0 0
United States of America
State/province [8] 0 0
Utah
Country [9] 0 0
Canada
State/province [9] 0 0
Ontario
Country [10] 0 0
Canada
State/province [10] 0 0
Quebec
Country [11] 0 0
Germany
State/province [11] 0 0
Other
Country [12] 0 0
Italy
State/province [12] 0 0
Other
Country [13] 0 0
Spain
State/province [13] 0 0
Other
Country [14] 0 0
United Kingdom
State/province [14] 0 0
Other

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Seagen Inc.
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Medical Monitor
Address 0 0
Seagen Inc.
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Seagen Trial Information Support
Address 0 0
Country 0 0
Phone 0 0
866-333-7436
Fax 0 0
Email 0 0
clinicaltrials@seagen.com
Contact person for scientific queries

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results not provided in https://clinicaltrials.gov/study/NCT05194072