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NCT06549816CompletedPhase 1

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

Source: ClinicalTrials.gov · Last updated 15 Dec 2025

Brief summary (registry, in English)

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.

Status (registry)
Completed
Phase (registry)
Phase 1
Study type
Interventional
Enrollment
6 (actual)
First submitted
22 Jul 2024
Start date
21 Aug 2024
Primary completion date
18 Nov 2025
Lead sponsor
Seagen, a wholly owned subsidiary of Pfizer
NCT number
NCT06549816

What you commit to

  • Study type: Interventional · Phase 1
  • Participants enrolled: 6
  • From 21 Aug 2024 to the primary completion date, 18 Nov 2025
  • 3 sites in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • 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.
  • 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.
  • 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

Other illness

  • 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.
  • Uncontrolled diabetes mellitus

Other

  • Pre-existing peripheral neuropathy Grade greater than or equal to (≥) 2
  • Known history or current diagnosis of carcinomatous meningitis

Who the study is looking for

  • 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.

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (3)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Guangdong Provincial People's Hospital
Coordinator of this site? Confirm its status
GuangzhouChinaUnknown status
Jiangsu Province Hospital
Coordinator of this site? Confirm its status
NanjingChinaUnknown status
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Coordinator of this site? Confirm its status
WuhanChinaUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.