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A Study of SGN-B6A in Chinese Participants With Advanced Solid Tumors | Clinical Trials | Clareo Health

COMPLETEDPHASE1

A Study of SGN-B6A in Chinese Participants With Advanced Solid Tumors

An Open-label, Phase 1 Study to Investigate the Safety and Pharmacokinetics of SGN-B6A in Chinese Subjects With Advanced Solid Tumors

NCT06549816•Seagen, a wholly owned subsidiary of Pfizer

View on ClinicalTrials.gov

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 side effects are. A side effect is anything the drug does besides treating cancer. It will also study how do Chinese participants' body interact with sigvotatug vedotin.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•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.
+1 more criteria

Exclusion Criteria

•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
+15 more criteria

Locations (3)

Guangdong Provincial People's Hospital

Guangzhou, Guangdong, China

Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

Wuhan, Hubei, China

Jiangsu Province Hospital

Nanjing, Jiangsu, China

Key Dates

Start Date

August 21, 2024

Primary Completion Date

November 18, 2025

Completion Date

November 18, 2025

Last Updated

December 15, 2025

Enrollment

ACTUAL participants

Conditions

Carcinoma, Non-Small Cell LungSquamous Cell Carcinoma of Head and NeckEsophageal Squamous Cell CarcinomaGastric AdenocarcinomaEsophageal AdenocarcinomaGastroesophageal Junction Adenocarcinoma

Interventions

sigvotatug vedotin

DRUG

Vebrekotuzumab ± Anti-PD-1 in Pretreated Advanced ESCC

NCT07403136

Esophageal Squamous Cell Carcinoma

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RECRUITINGPHASE1/PHASE2

A Study of Amivantamab Alone or in Addition to Other Treatment Agents in Participants With Head and Neck Cancer

NCT06385080

Squamous Cell Carcinoma of Head and Neck

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RECRUITINGNA

HN-BIO 02: A Phase II Randomized Study of the Effects of Delayed Elective Radiotherapy on Head and Neck MRI and Immune Response Biomarkers

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: December 15, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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A Study of SGN-B6A in Chinese Participants With Advanced Solid Tumors

Inclusion Criteria

Exclusion Criteria

Vebrekotuzumab ± Anti-PD-1 in Pretreated Advanced ESCC

A Study of Amivantamab Alone or in Addition to Other Treatment Agents in Participants With Head and Neck Cancer

HN-BIO 02: A Phase II Randomized Study of the Effects of Delayed Elective Radiotherapy on Head and Neck MRI and Immune Response Biomarkers

Neoadjuvant Adebrelimab Plus Chemotherapy for Esophageal Cancer: A Clinical Study

A Study of MGC026 in Participants With Advanced Solid Tumors

Registry Platform Gastric/Esophageal Cancer (SAPHIR)