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Study SL-801-0115 is a dose-escalation study evaluating multiple doses and schedules of orally administered SL-801 in patients with Advanced Solid Tumors
Full description
Study SL-801-0115 is a first-in-human, dose-escalation study in patients with advanced (i.e., metastatic or locally advanced and unresectable) solid tumors that are resistant to or relapsed following available standard systemic therapy or for which there is no standard systemic therapy and additional radiation therapy or other loco-regional therapies are not considered feasible. Eligible patients will be enrolled and receive treatment with SL-801 in a 28-day cycle. SL-801 will be administered orally and the dose regimen will depend on the cohort in which the patient is enrolled.
The study plans to enroll approximately 70 adult patients at multiple study centers in the US.
Enrollment
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Inclusion criteria
The patient must have histologic or cytologic evidence of a malignant solid tumor and must have disease that is resistant to or relapsed following available standard systemic therapy, or for which there is no standard systemic therapy or reasonable therapy likely to result in clinical benefit.
The patient must have advanced disease, defined as cancer that is either metastatic, OR locally advanced and unresectable (and for which additional radiation therapy or other locoregional therapies are not considered feasible).
The patient must have disease that is measurable by standard imaging techniques, per the Response Evaluation Criteria in Solid Tumors, version 1.1 (RECIST 1.1), or evaluable per RECIST 1.1. (For patients with prior radiation therapy, measurable lesions must be outside of any prior radiation field[s], unless disease progression has been documented at that disease site subsequent to radiation.)
The patient is ≥18 years old.
The patient has an ECOG PS of 0-2.
The patient has adequate baseline organ function, as demonstrated by the following:
The patient has adequate baseline hematologic function, as demonstrated by the following:
If the patient is a woman of child bearing potential (WOCBP), she has had a negative serum or urine pregnancy test within 1 week prior to treatment.
The patient (male and female) agrees to use acceptable contraceptive methods for the duration of time on the study, and continue to use acceptable contraceptive methods for 1 month after the last dose of SL-801.
The patient has signed informed consent prior to initiation of any study-specific procedures or treatment.
The patient is able to adhere to the study visit schedule and other protocol requirements, including follow-up for survival assessment.
Exclusion criteria
Primary purpose
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72 participants in 1 patient group
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Data sourced from clinicaltrials.gov
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