Clinical trial · Interventional
A Study of SGN-B6A in Chinese Participants With Advanced Solid Tumors
An Open-label, Phase 1 Study to Investigate the Safety and Pharmacokinetics of SGN-B6A in Chinese Subjects With Advanced Solid Tumors
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (6)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Carcinoma, Non-Small Cell Lung | Lung Non-Small Cell Carcinoma | ALIAS | 0.90 |
| Esophageal Adenocarcinoma | Esophageal Adenocarcinoma | ONTOLOGY_EXACT | 0.98 |
| Esophageal Squamous Cell Carcinoma | Esophageal Squamous Cell Carcinoma | ONTOLOGY_EXACT | 0.98 |
| Gastric Adenocarcinoma | Gastric Adenocarcinoma | ONTOLOGY_EXACT | 0.98 |
| Gastroesophageal Junction Adenocarcinoma | Gastroesophageal Junction Adenocarcinoma | ONTOLOGY_EXACT | 0.98 |
| Squamous Cell Carcinoma of Head and Neck | Head and Neck Squamous Cell Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| sigvotatug vedotin | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- sigvotatug vedotin
- description
- sigvotatug vedotin monotherapy 1.8 mg/kg adjusted ideal body weight intravenous administration on Days 1 and 15 of a 28-day cycle.
- interventionNames
- Drug: sigvotatug vedotin
Primary outcomes (3)
- measure
- Number of participants with adverse events (AEs)
- timeFrame
- Through 30-37 days following last dose of sigvotatug vedotin; up to 3 years
- description
- 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.
- measure
- Number of participants with laboratory abnormalities
- timeFrame
- Through 30-37 days following last dose of sigvotatug vedotin; up to 3 years
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available