A Study of SGN-B6A in Chinese Participants With Advanced Solid Tumors (NCT06549816) | Clinical Trial Compass
CompletedPhase 1
A Study of SGN-B6A in Chinese Participants With Advanced Solid Tumors
China6 participantsStarted 2024-08-21
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
* K…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Number of participants with adverse events (AEs)
Timeframe: Through 30-37 days following last dose of sigvotatug vedotin; up to 3 years
2
Number of participants with laboratory abnormalities
Timeframe: Through 30-37 days following last dose of sigvotatug vedotin; up to 3 years
3
Number of participants with dose-limiting toxicities (DLTs)
Timeframe: Up to 28 days
Trial details
NCT IDNCT06549816
SponsorSeagen, a wholly owned subsidiary of Pfizer