This study will test the safety of a drug called SGN-ALPV in participants with solid tumors. It will also study the side effects of this drug. A side effect is anything a drug does to your body besides treating your disease. Participants will have solid tumor cancer that has spread through the body (metastatic) or cannot be removed with surgery (unresectable). This study will have three parts. Parts A and B of the study will find out how much SGN-ALPV should be given to participants. Part C will use the dose and schedule found in Parts A and B to find out how safe SGN-ALPV is and if it works to treat solid tumor cancers.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
43
Given into the vein (IV; intravenously)
Women's Cancer Care
Fresno, California, United States
Yale Cancer Center
New Haven, Connecticut, United States
Florida Cancer Specialists - Lake Nona
Wellington, Florida, United States
START Midwest
Grand Rapids, Michigan, United States
Oklahoma University at Stephenson Cancer Center
Oklahoma City, Oklahoma, United States
START Mountain Region
West Valley City, Utah, United States
Virginia Cancer Specialists
Fairfax, Virginia, United States
Ottawa Hospital Cancer Centre
Ottawa, Ontario, Canada
University Health Network, Princess Margaret Hospital
Toronto, Ontario, Canada
START Madrid-CIOCC_Hospital HM Sanchinarro
Madrid, Other, Spain
...and 3 more locations
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 after last study treatment, approximately 6 months
Number of participants with laboratory abnormalities
Time frame: Through 30-37 days after last study treatment, approximately 6 months
Number of participants with dose-limiting toxicities (DLTs)
Time frame: Up to 28 days
Number of participants with DLTs by dose level
Time frame: Up to 28 days
Incidence of antidrug antibodies (ADAs)
Time frame: Through 30-37 days after last study treatment, approximately 6 months
Area under the concentration-time curve (AUC)
PK parameter
Time frame: Through 14 days after last study treatment, approximately 6 months
Maximum concentration (Cmax)
PK parameter
Time frame: Through 14 days after last study treatment, approximately 6 months
Time to Cmax (Tmax)
PK parameter
Time frame: Through 14 days after last study treatment, approximately 6 months
Apparent terminal half-life (t1/2)
PK parameter
Time frame: Through 14 days after last study treatment, approximately 6 months
Trough concentration (Ctrough)
PK parameter
Time frame: Through 14 days after last study treatment, approximately 6 months
Objective response rate (ORR) per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1)
The proportion of participants with an objective response (OR) per investigator. A participant is determined to have an OR if, based on RECIST v1.1, the subject achieves a complete response (CR) or a partial response (PR) after initiation of treatment and at or prior to the end of treatment (EOT) disease assessment.
Time frame: Approximately 2 years
Duration of objective response (DOR)
The time from start of the first documentation of objective tumor response (CR or PR) to the first documentation of disease progression (based on radiographic assessments per RECIST v1.1) or death due to any cause.
Time frame: Approximately 2 years
Progression-free survival (PFS)
The time from start of study treatment to first documentation of disease progression or death due to any cause
Time frame: Approximately 2 years
Overall survival (OS)
The time from start of study treatment to death due to any cause
Time frame: Approximately 2 years
CA-125 response rate according to Gynecological Cancer Intergroup (GCIG) criteria (subjects with ovarian cancer only)
The proportion of participants with ovarian cancer who have at least a 50% reduction in CA-125 value from baseline according to GCIG CA-125 criteria
Time frame: Approximately 2 years
Combined RECIST/CA-125 overall response rate according to GCIG (subjects with ovarian cancer only)
The proportion of participants with ovarian cancer whose best response is a CR or PR according to the GCIG combined RECIST and CA-125 criteria
Time frame: Approximately 2 years
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