NCT07812805
SKL35501 With SKL35502 Imaging in Adults With NTSR1 Positive Advanced Solid Tumors
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Record History
All 1 version: 1 with changes below.
- Study First Submitted
Endpoints
Primary
Number of Participants With Treatment-Emergent Adverse Events Following SKL35502 Administration
Timeframe: From the first administration of SKL35502 until initiation of SKL35501, 15 days after the last administration of SKL35502, or initiation of a new antitumor therapy, whichever occurs first.
Absorbed Radiation Dose to Prespecified Normal Organs Following SKL35502 Administration
Timeframe: From SKL35502 administration through 7 days after administration.
Absorbed Radiation Dose to Evaluable Tumor Lesions Following SKL35502 Administration
Timeframe: From SKL35502 administration through 7 days after administration.
Whole-Body Radiation Dose Following SKL35502 Administration
Timeframe: From SKL35502 administration through 7 days after administration.
Number of Participants With Dose-Limiting Toxicities During Cycle 1 Following the First Dose of SKL35501
Timeframe: From the first administration of SKL35501 through the end of Cycle 1, a period of 6 weeks.
Lower SKL35501 Administered Activity Selected for the Biologically Active Dose Range for Part B
Timeframe: At completion of Part A dose escalation and backfill, after all Part A participants have completed at least one 6-week treatment cycle.
Upper SKL35501 Administered Activity Selected for the Biologically Active Dose Range for Part B
Timeframe: At completion of Part A dose escalation and backfill, after all Part A participants have completed at least one 6-week treatment cycle.
Tumor-to-Background Ratio of SKL35502 Uptake in RECIST Version 1.1 Measurable Tumor Lesions
Timeframe: From SKL35502 administration through 144 hours after administration.
Number of Participants With at Least One SKL35502-Positive RECIST Version 1.1 Measurable Tumor Lesion
Timeframe: From SKL35502 administration through 144 hours after administration.
SKL35502 Imaging Time Point Selected for Tumor Eligibility Assessment
Timeframe: At completion of the Part A SKL35502 imaging review following collection of imaging data through 144 hours after administration.
Percentage of Participants With Complete Response, Partial Response, or Stable Disease Lasting at Least 4 Months Following SKL35501 Treatment
Timeframe: Tumor assessments will be performed every 8 weeks during the first 6 months and every 12 weeks thereafter, up to 12 months after the last participant's first SKL35501 dose.
Objective Response Rate Following SKL35501 Treatment
Timeframe: Tumor assessments will be performed every 8 weeks during the first 6 months and every 12 weeks thereafter, up to 12 months after the last participant's first SKL35501 dose.
Clinical Benefit Rate Following SKL35501 Treatment
Timeframe: Tumor assessments will be performed every 8 weeks during the first 6 months and every 12 weeks thereafter, up to 12 months after the last participant's first SKL35501 dose.
Progression-Free Survival Following SKL35501 Treatment
Timeframe: From the first SKL35501 dose until documented disease progression, death, or completion of protocol-defined efficacy follow-up, up to 12 months after the last participant's first SKL35501 dose.
Time to Disease Progression Following SKL35501 Treatment
Timeframe: From the first SKL35501 dose until documented disease progression or completion of protocol-defined efficacy follow-up, up to 12 months after the last participant's first SKL35501 dose.
Overall Survival Following SKL35501 Treatment
Timeframe: From the first SKL35501 dose until death, loss to follow-up, withdrawal of consent, or completion of protocol-defined survival follow-up, up to 12 months after the last participant's first SKL35501 dose.
Secondary (27)
Number of Participants With Grade 3 or Higher Treatment-Emergent Adverse Events Following SKL35502 Administration
Number of Participants With Serious Adverse Events Following SKL35502 Administration
Number of Participants With Adverse Events of Special Interest Following SKL35502 Administration
Number of Participants With Clinically Significant 12-Lead Electrocardiogram Abnormalities Following SKL35502 Administration
Number of Participants With Clinically Significant Vital-Sign Abnormalities Following SKL35502 Administration
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Number of Participants With Clinically Significant Physical Examination Findings Following SKL35502 Administration
Number of Participants With Clinically Significant Safety Laboratory Abnormalities Following SKL35502 Administration
Total Radioactivity Concentration in Whole Blood Following SKL35502 Administration
Total Radioactivity Concentration in Plasma Following SKL35502 Administration
Total Radioactivity Concentration in Urine Following SKL35502 Administration
Correlation Coefficient Between SKL35502 Tumor-to-Background Ratio and Tumor NTSR1 Expression
Number of Participants With Treatment-Emergent Adverse Events Following SKL35501 Administration
Number of Participants With Grade 3 or Higher Treatment-Emergent Adverse Events Following SKL35501 Administration
Number of Participants With Serious Adverse Events Following SKL35501 Administration
Number of Participants With Adverse Events of Special Interest Following SKL35501 Administration
Number of Participants With Clinically Significant 12-Lead Electrocardiogram Abnormalities Following SKL35501 Administration
Number of Participants With Clinically Significant Vital-Sign Abnormalities Following SKL35501 Administration
Number of Participants With Clinically Significant Physical Examination Findings Following SKL35501 Administration
Number of Participants With Clinically Significant Safety Laboratory Abnormalities Following SKL35501 Administration
Total Radioactivity Concentration in Whole Blood Following SKL35501 Administration
Total Radioactivity Concentration in Plasma Following SKL35501 Administration
Total Radioactivity Concentration in Urine Following SKL35501 Administration
Duration of Response Following SKL35501 Treatment
Absorbed Radiation Dose to Prespecified Normal Organs Following SKL35501 Administration
Absorbed Radiation Dose to Evaluable Tumor Lesions Following SKL35501 Administration
Cumulative Absorbed Radiation Dose to Prespecified Normal Organs Across SKL35501 Treatment Cycles
Maximum Absorbed Radiation Dose Among Prespecified Normal Organs Following SKL35501 Administration
Arms and interventions
SKL35501 Low DoseExperimental
Description: For dose optimization, one cohort with 2 groups (Low Dose SKL35501 group and High Dose SKL35501 group) will be initiated in part B of the study
SKL35501 High DoseExperimental
Description: For dose optimization, one cohort with 2 groups (Low Dose SKL35501 group and High Dose SKL35501 group) will be initiated in part B of the study
Drugs: SKL35501
Diagnostic tests: SKL35502
Sites
5 sites in 2 countries
South Korea 3, United States 2