This trial will look at a drug called sigvotatug vedotin (SGN-B6A) alone and with pembrolizumab, with or without chemotherapy, to find out whether it is safe for people 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 whether sigvotatug vedotin works to treat solid tumors. The study will have four parts. * Part A of the study will find out how much sigvotatug vedotin should be given to participants. * Part B will use the dose found in Part A to find out how safe sigvotatug vedotin is and if it works to treat solid tumors. * Part C of the study will find out how safe sigvotatug vedotin is in combination with these other drugs. * Part D will include people who have not received treatment. This part of the study will find out how safe sigvotatug vedotin is in combination with these other drugs and if these combinations work to treat solid tumors. * In Parts C and D, participants will receive sigvotatug vedotin with either: * Pembrolizumab or, * Pembrolizumab and carboplatin, or * Pembrolizumab and cisplatin.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
1,006
Administered into the vein (IV; intravenously)
200mg every 3 weeks or 400mg every 6 weeks, given by IV
75 mg/m2 every 3 weeks, given by IV
AUC 5 mg/mL per min every 3 weeks, given by IV
Alaska Oncology and Hematology
Anchorage, Alaska, United States
NOT_YET_RECRUITINGHighlands Oncology Group
Fayetteville, Arkansas, United States
RECRUITINGHighlands Oncology Group
Rogers, Arkansas, United States
RECRUITINGHighlands Oncology Group
Springdale, Arkansas, United States
Number of participants with adverse events (AEs)
Any untoward medical occurrence in a clinical investigational participant administered a medicinal product and which does not necessarily have a causal relationship with this treatment.
Time frame: Through 30-37 days following last dose of sigvotatug vedotin. For participants receiving pembrolizumab up to 90 days after last dose of pembrolizumab; up to 3 years
Number of patients 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: Through 30-37 days following last dose of sigvotatug vedotin; up to 3 years
Confirmed objective response rate (ORR) per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 by investigator assessment
The proportion of participants with complete response (CR) or partial response (PR) which is subsequently confirmed as assessed according to RECIST v1.1.
Time frame: Up to approximately 3 years
Duration of objective response (DOR) per RECIST v1.1 by investigator assessment
The time from the first documentation of objective response (CR or PR that is subsequently confirmed) to the first documentation of progressive disease (PD) or to death due to any cause
Time frame: Up to approximately 3 years
Progression-free survival (PFS) per RECIST v1.1 by investigator assessment
The time from the start of any study treatment to the first documentation of PD, or death due to any cause
Time frame: Up to approximately 3 years
Overall survival (OS)
The time from the start of any study treatment to the date of death due to any cause
Time frame: Up to approximately 3 years
Area under the concentration-time curve (AUC)
Pharmacokinetic (PK) endpoint
Time frame: Through 30-37 days following last dose of sigvotatug vedotin; up to 3 years
Concentration at the end of infusion (Ceoi)
PK endpoint
Time frame: Through 30-37 days following last dose of sigvotatug vedotin; up to 3 years
Maximum observed concentration (Cmax)
PK endpoint
Time frame: Through 30-37 days following last dose of sigvotatug vedotin; up to 3 years
Time to maximum observed concentration (Tmax)
PK endpoint
Time frame: Through 30-37 days following last dose of sigvotatug vedotin; up to 3 years
Trough concentration (Ctrough)
PK endpoint
Time frame: Through 30-37 days following last dose of sigvotatug vedotin; up to 3 years
Apparent terminal elimination half-life (t1/2)
PK endpoint
Time frame: Through 30-37 days following last dose of sigvotatug vedotin; up to 3 years
Number of participants with antidrug antibodies (ADAs)
Time frame: Through 30-37 days following last dose of sigvotatug vedotin; up to 3 years
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Providence Medical Foundation
Anaheim, California, United States
RECRUITINGProvidence Medical Foundation
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RECRUITINGProvidence St. Jude Medical Center Virginia K Crosson and Infusion Center
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RECRUITINGCancer and Blood Research Center, LLC
Los Alamitos, California, United States
NOT_YET_RECRUITINGCancer and Blood Specialty Clinic
Los Alamitos, California, United States
NOT_YET_RECRUITINGRonald Reagan UCLA Medical Center
Los Angeles, California, United States
RECRUITING...and 140 more locations