A Study of SGN-B6A in Chinese Participants With Advanced Solid Tumors
- Registration Number
- NCT06549816
- Lead Sponsor
- Seagen Inc.
- 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...
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 12
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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
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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.
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Adequate organ function as defined by the baseline laboratory criteria obtained within 7 days prior to SGN-B6A initiation (Cycle 1 Day 1)
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Measurable or non-measurable disease per RECIST v1.1 at baseline.
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An Eastern Cooperative Oncology Group (ECOG) Performance Status score of 0 or 1.
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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.
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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 (β₯) 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.
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Pre-existing peripheral neuropathy Grade greater than or equal to (β₯) 2
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Uncontrolled diabetes mellitus
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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.
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Known history or current diagnosis of carcinomatous meningitis
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Previous treatment with an MMAE-containing agent or an agent targeting integrin beta-6
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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
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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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description sigvotatug vedotin sigvotatug vedotin sigvotatug vedotin monotherapy 1.8 mg/kg adjusted ideal body weight intravenous administration on Days 1 and 15 of a 28-day cycle.
- Primary Outcome Measures
Name Time Method Number of participants with adverse events (AEs) Through 30-37 days following last dose of sigvotatug vedotin; up to 3 years 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.
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 Outcome Measures
Name Time Method 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) 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: 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) PK of monomethyl auristatin E (MMAE) in plasma - 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 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 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, 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 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 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) Number of participants with antidrug antibodies From first dose through up to 37 days following last dose of sigvotatug vedotin
Trial Locations
- Locations (3)
Guangdong Provincial People's Hospital
π¨π³Guangzhou, China
Jiangsu Province Hospital
π¨π³Nanjing, China
Union Hospital, Tongji Medical College of Huazhong University of Science & Technology
π¨π³Wuhan, China