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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
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.
Trial website
https://clinicaltrials.gov/study/NCT05194072
Trial related presentations / publications
Public notes
This record is viewable in the ANZCTR as it had previously listed Australia and/or New Zealand as a recruitment site, however these sites have since been removed

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
[email protected]
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT05194072