A Phase 1/2, Open-label, Multicenter, Dose Escalation and Expansion Study of SLC-3010 Monotherapy… (NCT05525247) | Clinical Trial Compass
TerminatedPhase 1/2
A Phase 1/2, Open-label, Multicenter, Dose Escalation and Expansion Study of SLC-3010 Monotherapy and in Combination
Stopped: Business decision
United States, Australia, South Korea27 participantsStarted 2022-12-21
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Histologically or cytologically-documented solid tumors that are inoperable locally advanced, metastatic, or recurrent:
Exclusion criteria
. Patients who have at least one measurable lesion, as defined by RECIST v1.1.
. Adult male or female patients ≥18 years of age on day of signing the informed consent form (ICF) or follow local regulatory requirement if the legal age for consenting for study participation is more than 18 years.
. Patients who are able and willing to provide written informed consent and are willing and able to comply with all study procedures.
. Patients with life expectancy of ≥3 months.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
. Patients with Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1.
. Patients who demonstrate adequate organ function as defined.
. Resolution of any clinically significant toxic effects of prior therapy to Grade 0 or 1 according to the NCI CTCAE v5.0 (exception of alopecia and other AEs that are acceptable in the opinion of the Investigator and after discussion with the Medical Monitor)
. Willingness of male and female patients of reproductive potential to observe conventional and effective birth control methods with failure rates of \<1% for the duration of treatment and for 3 months (6 months for female patients administering gemcitabine) following the last dose of study treatment. This must include barrier methods such as condom or diaphragm with spermicidal gel. Women of childbearing potential (WOCBP) are defined as following menarche and who are not postmenopausal (and 2 years of nontherapy-induced amenorrhea or surgically sterile). For male patients with a nonpregnant female partner of childbearing potential and a WOCBP, 1 of the following highly effective birth control methods, with a failure rate of less than 1% per year when used consistently and correctly, is recommended: