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CompletedNCT06549816Updated Dec 15, 2025

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

A Phase 1 interventional study of sigvotatug vedotin in Carcinoma, Non-Small Cell Lung, Squamous Cell Carcinoma of Head and Neck and Esophageal Squamous Cell Carcinoma, sponsored by Seagen, a wholly owned subsidiary of Pfizer. Completed at 3 sites in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-12-15.

Sponsored by Seagen, a wholly owned subsidiary of Pfizer · Phase 1, Interventional, and Treatment

Phase
Phase 1
Study type
Interventional
Enrollment
6
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study 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.

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Conditions studied

  • Carcinoma, Non-Small Cell Lung
  • Squamous Cell Carcinoma of Head and Neck
  • Esophageal Squamous Cell Carcinoma
  • Gastric Adenocarcinoma
  • Esophageal Adenocarcinoma
  • Gastroesophageal Junction Adenocarcinoma

Keywords

  • NSCL
  • Lung Neoplasm
  • Cancer of Ovary
  • Ovarian Cancer
  • Colorectal Cancer
  • Colorectal Tumors
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In context

Carcinoma, Non-Small-Cell Lung

6,488 studies on the registry are indexed under Carcinoma, Non-Small-Cell Lung; 1,632 are open to participants now.

This study's enrollment of 6 is below the median of 62 across 5,213 interventional studies indexed under Carcinoma, Non-Small-Cell Lung.

Browse Carcinoma, Non-Small-Cell Lung studies →

Lead sponsor

Seagen, a wholly owned subsidiary of Pfizer is the lead sponsor of 30 studies on the registry; 5 are open to participants now.

Of its 11 completed or terminated interventional studies of FDA-regulated products, 3 (27%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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.
  • An Eastern Cooperative Oncology Group (ECOG) Performance Status score of 0 or 1.

Exclusion 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
  • 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
05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
6 participants (actual)

Study arms

  • Experimental
    sigvotatug vedotin

    sigvotatug vedotin monotherapy 1.8 mg/kg adjusted ideal body weight intravenous administration on Days 1 and 15 of a 28-day cycle.

    Drug: sigvotatug vedotin

Interventions

  • Drugsigvotatug vedotin

    Sigvotatug vedotin is a antibody-drug conjugate (ADC) designed to deliver the cytotoxic agent monomethyl auristatin E (MMAE) to cells expressing integrin beta-6.

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What researchers measure

Primary outcomes

  1. Number of participants with adverse events (AEs)

    An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention.

    Time frame: Through 30-37 days following last dose of sigvotatug vedotin; up to 3 years

  2. Number of participants with laboratory abnormalities

    Time frame: Through 30-37 days following last dose of sigvotatug vedotin; up to 3 years

  3. Number of participants with dose-limiting toxicities (DLTs)

    Time frame: Up to 28 days

Secondary outcomes

  1. Pharmacokinetics (PK) of antibody-conjugated monomethyl auristatin E (ac-MMAE) in plasma: Area under the curve (AUC) after a single dose and multiple doses of SGN-B6A

    Time frame: Single dose: Cycle 1 Day 1 through predose Cycle 1 Day 15; Multiple dose: Cycle 2 Day 1 through predose Cycle 2 Day 15 (Each Cycle is 28 days)

  2. PK of ac-MMAE in plasma: maximum concentration (Cmax) after a single dose and multiple doses of SGN-B6A

    Time frame: Single dose: Cycle 1 Day 1 (predose, end of infusion [EOI], and 2 hour and 4 hour post-dose); Multiple dose: Cycle 2 Day 1 (predose, EOI, and 2 hour and 4 hour post-dose) (Each Cycle is 28 days)

  3. PK of ac-MMAE in plasma: time to maximum concentration (Tmax) after a single dose and multiple doses of SGN-B6A

    Time frame: Single dose: Cycle 1 Day 1 (predose, End of Infusion (EOI), and 2 hour and 4 hour post-dose); Multiple dose: Cycle 2 Day 1 (predose, EOI, and 2 hour and 4 hour post-dose) (Each Cycle is 28 days)

  4. PK of ac-MMAE in plasma: apparent half-life (t1/2) after a single dose and multiple doses of SGN-B6A

    Time frame: Single dose: Cycle 1 Day 1 through predose Cycle 1 Day 15; Multiple dose: Cycle 2 Day 1 through predose Cycle 2 Day 15 (Each Cycle is 28 days)

  5. PK of ac-MMAE in plasma: trough concentration (Ctrough) after a single dose and multiple doses of SGN-B6A

    Time frame: Single dose: Cycle 1 Day 15 predose; Multiple dose: Cycle 2 Day 15 predose (Each Cycle is 28 days)

  6. PK of monomethyl auristatin E (MMAE) in plasma - AUC after a single dose and multiple doses of SGN-B6A

    Time frame: Single dose: Cycle 1 Day 1 through predose Cycle 1 Day 15; Multiple dose: Cycle 2 Day 1 through predose Cycle 2 Day 15 (Each Cycle is 28 days)

  7. PK of MMAE in plasma: maximum concentration (Cmax) after a single dose and multiple doses of SGN-B6A

    Time frame: Single dose: Cycle 1 Day 1 (predose, end of infusion [EOI], and 2 hour and 4 hour post-dose); Multiple dose: Cycle 2 Day 1 (predose, EOI, and 2 hour and 4 hour post-dose) (Each Cycle is 28 days)

  8. PK of MMAE in plasma: time to maximum concentration (Tmax) after a single dose and multiple doses of SGN-B6A

    Time frame: Single dose: Cycle 1 Day 1 (predose, EOI, and 2 hour and 4 hour post-dose); Multiple dose: Cycle 2 Day 1 (predose, EOI, and 2 hour and 4 hour post-dose) (Each Cycle is 28 days)

  9. PK of MMAE in plasma: apparent half-life (t1/2) after a single dose and multiple doses of SGN-B6A

    Time frame: Single dose: Cycle 1 Day 1 through predose Cycle 1 Day 15; Multiple dose: Cycle 2 Day 1 through predose Cycle 2 Day 15 (Each Cycle is 28 days)

  10. PK of MMAE in plasma: trough concentration (Ctrough) after a single dose and multiple doses of SGN-B6A

    Time frame: Single dose: Cycle 1 Day 15 predose; Multiple dose: Cycle 2 Day 15 predose (Each Cycle is 28 days)

  11. Number of participants with antidrug antibodies

    Time frame: From first dose through up to 37 days following last dose of sigvotatug vedotin

07

Study locations

3 sites
  • Guangdong Provincial People's Hospital
    Guangzhou, Guangdong 510080, China
  • Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
    Wuhan, Hubei 430023, China
  • Jiangsu Province Hospital
    Nanjing, Jiangsu 210029, China
08

References and documents

Individual participant data

Plan to share: No — Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical\_trials/trial\_data\_and\_results/data\_requests.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 15, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06549816
Lead sponsor
Seagen, a wholly owned subsidiary of Pfizer
Responsible party
Sponsor
First posted
Aug 12, 2024
Start date
Aug 21, 2024
Primary completion
Nov 18, 2025
Completion
Nov 18, 2025
Last update
Dec 15, 2025

Study contacts

Pfizer CT.gov Call Center
study director · Pfizer

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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