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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
6
Sigvotatug vedotin is a antibody-drug conjugate (ADC) designed to deliver the cytotoxic agent monomethyl auristatin E (MMAE) to cells expressing integrin beta-6.
Guangdong Provincial People's Hospital
Guangzhou, Guangdong, China
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, China
Jiangsu Province Hospital
Nanjing, Jiangsu, China
Number of participants with adverse events (AEs)
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.
Time frame: Through 30-37 days following last dose of sigvotatug vedotin; up to 3 years
Number of participants with laboratory abnormalities
Time frame: Through 30-37 days following last dose of sigvotatug vedotin; up to 3 years
Number of participants with dose-limiting toxicities (DLTs)
Time frame: Up to 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
Time frame: 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
Time frame: 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: time to maximum concentration (Tmax) after a single dose and multiple doses of SGN-B6A
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: From first dose through up to 37 days following last dose of sigvotatug vedotin
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