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

Korábbi kezelés

• 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

Más betegség

• 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

Egyéb

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

• 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.