A Phase 1/2, Open-label, Multicenter, Dose Escalation and Expansion Study of SLC-3010 Monotherapy and in Combination With Various Anticancer Therapies in Patients With Advanced Solid Tumors
Selecxine
Summary
This is a Phase 1/2, open-label, multicenter, dose escalation and expansion study, evaluating the safety, tolerability, pharmacokinetic, preliminary anti-tumor activity, and effects on pharmacodynamic markers following administration of SLC-3010 as monotherapy and in combination with gemcitabine, in patients with various advanced solid tumors.
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: Patients must meet all the following inclusion criteria to be eligible for enrollment into the study: 1. Histologically or cytologically-documented solid tumors that are inoperable locally advanced, metastatic, or recurrent: * Part 1 Dose Escalation: Patients with any solid tumor who have progressed on or are intolerant to standard therapy, for which no standard therapy is available, or who decline standard therapy. * Part 2: Dose Expansion: Patients must have received at least one prior line of standard therapy in recurrent/metastatic setting and for whom standard…
Interventions
- DrugSLC-3010
Intravenous (IV) infusion over 30 minutes on day 1 of each 21-day cycle
- Combination ProductGemcitabine
1000 ㎎/㎡ IV infusion over 30 minutes on day 1 and 8 of each 21-day cycle
Locations (9)
- Selecxine Investigator siteSarasota, Florida
- Selecxine Investigator siteDetroit, Michigan
- Selecxine Investigator siteOklahoma City, Oklahoma
- Selecxine Investigator siteWaratah, New South Wales
- Selecxine Investigator siteBrentwood, Perth
- Selecxine Investigator siteSeoul, Jongno-gu