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

Seagen

Status and phase: Enrolling; Phase 1

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

Treatments: Drug: sigvotatug vedotin

Study type: Interventional

Funder types: Industry

Identifiers

NCT06549816

C5751004 (Other Identifier)

SGNB6A-003

Details and patient eligibility

About

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.

Enrollment: 12 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No 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.

• 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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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12 participants in 1 patient group

sigvotatug vedotin

Experimental group

Description:

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

Treatment:

Drug: sigvotatug vedotin