Status:
COMPLETED
A Study of SGN-B6A in Chinese Participants With Advanced Solid Tumors
Lead Sponsor:
Seagen, a wholly owned subsidiary of Pfizer
Conditions:
Carcinoma, Non-Small Cell Lung
Squamous Cell Carcinoma of Head and Neck
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
This trial will look at a drug called sigvotatug vedotin (SGN-B6A) to find out whether it is safe for Chinese participants who have solid tumors. It will study sigvotatug vedotin to find out what its ...
Eligibility Criteria
Inclusion
- Subjects must have histologically or cytologically confirmed metastatic or unresectable locally advanced solid malignancy within one of the tumor types listed below.
- NSCLC
- HNSCC
- ESCC
- GAC
- EAC
- GEJ adenocarcinoma
- Subjects must have disease that is relapsed or refractory, or be intolerant to systemic standard-of-care therapies, and in the judgement of the investigator, should have no appropriate standard-of-care therapeutic option. If a standard-of-care therapy is available that has not been administered, the reason that the therapy is not appropriate must be documented.
- Adequate organ function as defined by the baseline laboratory criteria obtained within 7 days prior to SGN-B6A initiation (Cycle 1 Day 1)
- Measurable or non-measurable disease per RECIST v1.1 at baseline.
- An Eastern Cooperative Oncology Group (ECOG) Performance Status score of 0 or 1.
Exclusion
- History of another malignancy within 3 years before the first dose of study intervention, or any evidence of residual disease from a previously diagnosed malignancy. Exceptions are malignancies with a negligible risk of metastasis or death.
- Participants with any of the following respiratory conditions:
- Evidence of noninfectious interstitial lung disease (ILD) or pneumonitis that:
- \* Was previous diagnosed and required systemic steroids, or
- \* Is currently diagnosed and managed, or
- \* Is suspected on radiologic imaging at screening
- Known diffusing capacity of the lung for carbon monoxide (DLCO) \< 50%
- Any Grade greater than or equal to (≥) 3 pulmonary disease unrelated to underlying malignancy
- Prior radiation therapy to the lung that is \>30 gray (Gy) within 6 months of the first dose of sigvotatug vedotin.
- Pre-existing peripheral neuropathy Grade greater than or equal to (≥) 2
- Uncontrolled diabetes mellitus
- 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 of corticosteroids prescribed for symptoms associated with brain metastases for at least 7 days prior to first dose of study drug.
- Known history or current diagnosis of carcinomatous meningitis
- Previous treatment with an MMAE-containing agent or an agent targeting integrin beta-6
- Prior anticancer therapies:
- Chemotherapy within 21 days prior to first administration of sigvotatug vedotin
- Targeted small molecule agents within 14 days or 5 half-lives (whichever is longer) prior to first administration of sigvotatug vedotin
- Antibody-based anticancer or other investigational antitumor therapy within 28 days prior to first administration of sigvotatug vedotin
- Focal radiotherapy or major surgery that is not completed 14 days prior to the first dose of sigvotatug vedotin
- Traditional or herbal medicines:
- Anti-cancer traditional or herbal medicines within 28 days prior to first administration of sigvotatug vedotin
- Traditional or herbal medicines for other purposes (such as supportive care) within 7 days prior to first administration of sigvotatug vedotin
Key Trial Info
Start Date :
August 21 2024
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 18 2025
Estimated Enrollment :
6 Patients enrolled
Trial Details
Trial ID
NCT06549816
Start Date
August 21 2024
End Date
November 18 2025
Last Update
December 15 2025
Active Locations (3)
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1
Guangdong Provincial People's Hospital
Guangzhou, Guangdong, China, 510080
2
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, China, 430023
3
Jiangsu Province Hospital
Nanjing, Jiangsu, China, 210029