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

NCT06549816 | Completed Phase 1 DMC

• 2 other identifiers: SGNB6A-003C5751004
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 3

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

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

Keywords

NSCL; Lung Neoplasm; Cancer of Ovary; Ovarian Cancer; Colorectal Cancer; Colorectal Tumors

Outcome Measures

Primary Outcomes (3)

• 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.

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

• Number of participants with laboratory abnormalities

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

• Number of participants with dose-limiting toxicities (DLTs)

  Up to 28 days

Secondary Outcomes (11)

• 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

  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)

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

  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)

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

  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)

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

  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)

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

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

Study Arms (1)

sigvotatug vedotin

EXPERIMENTAL

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

sigvotatug vedotin 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.

sigvotatug vedotin

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Seagen, a wholly owned subsidiary of Pfizer: lead

Study Sites (3)

Guangdong Provincial People's Hospital

Guangzhou, Guangdong, 510080, China

Location

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

Wuhan, Hubei, 430023, China

Location

Jiangsu Province Hospital

Nanjing, Jiangsu, 210029, China

Location

Related Links

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

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung; Squamous Cell Carcinoma of Head and Neck; Esophageal Squamous Cell Carcinoma; Adenocarcinoma Of Esophagus; Lung Neoplasms; Ovarian Neoplasms; Colorectal Neoplasms

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Carcinoma, Squamous Cell; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Head and Neck Neoplasms; Neoplasms, Squamous Cell; Esophageal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Esophageal Diseases; Gastrointestinal Diseases; Endocrine Gland Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Neoplasms, Female; Urogenital Neoplasms; Genital Diseases; Endocrine System Diseases; Gonadal Disorders; Intestinal Neoplasms; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 22, 2024
• First Posted: August 12, 2024
• Study Start: August 21, 2024
• Primary Completion: November 18, 2025
• Study Completion: November 18, 2025
• Last Updated: December 15, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

CN (3)