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

NCT ID: NCT06549816

Last Updated: 2025-12-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 6 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-08-21
• Study Completion Date: 2025-11-18

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 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.

Conditions

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

sigvotatug vedotin

Intervention Type: DRUG

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

Interventions

sigvotatug 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.

Intervention Type: DRUG

Eligibility Criteria

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

• 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Seagen, a wholly owned subsidiary of Pfizer

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Pfizer CT.gov Call Center

Role: STUDY_DIRECTOR

Pfizer

Locations

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

Countries

China

Related Links

https://pmiform.com/clinical-trial-info-request?StudyID=SGNB6A-003

To obtain contact information for a study center near you, click here.

Other Identifiers

C5751004

Identifier Type: OTHER

Identifier Source: secondary_id

SGNB6A-003

Identifier Type: -

Identifier Source: org_study_id