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SLC-3010 + Gemcitabine for Solid Cancers

Phase 1 & 2
Recruiting
Research Sponsored by Selecxine
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Patients must meet all the following inclusion criteria to be eligible for enrollment into the study: 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 life-prolonging therapies are either not available or are not qualified to receive such therapies. Additional general and tumor specific inclusion and exclusion criteria will apply.
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.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 30 days after last dose
Awards & highlights
No Placebo-Only Group

Study Summary

This trial is testing a new cancer drug, SLC-3010, to see if it is safe and works well against various types of solid tumors.

Who is the study for?
Adults over 18 with advanced solid tumors that can't be removed by surgery or have spread, and who've tried standard treatments without success or can't receive them. They must be in good enough health to participate, not pregnant or breastfeeding, use effective birth control, and have a life expectancy of at least 3 months.Check my eligibility
What is being tested?
The trial is testing SLC-3010 alone and combined with gemcitabine to see how safe they are, what side effects they cause, how the body processes them, and their preliminary effectiveness against various advanced solid tumors.See study design
What are the potential side effects?
Possible side effects include reactions related to the immune system due to SLC-3010's properties as an investigational drug. Gemcitabine may cause symptoms like nausea, low blood counts leading to infection risk or bleeding problems, liver issues, and fatigue.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have an advanced solid tumor and have tried or can't use standard treatments.
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I am at least 18 years old and can legally consent to participate.
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I am fully active or restricted in physically strenuous activity but can do light work.
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My organs are functioning well.
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Any side effects from my previous treatments are mild or gone, except for hair loss.
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I agree to use effective birth control during and up to 3-6 months after treatment.
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I am not using any form of birth control that is listed as unacceptable for this study.
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My cancer is advanced, has spread, or come back and cannot be removed by surgery.
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I have had at least one standard treatment for my recurring/metastatic cancer and cannot receive or qualify for standard life-prolonging therapies.
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I am fully active or can carry out light work.
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I am using a birth control method that contains both estrogen and progestin.
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I am using a progestin-only birth control method.
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I have had both of my fallopian tubes surgically closed.
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I am postmenopausal with the required FSH levels.
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I have had a hysterectomy or both ovaries removed.
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My ovaries have stopped working.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~30 days after last dose
This trial's timeline: 3 weeks for screening, Varies for treatment, and 30 days after last dose for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Occurrence of DLTs

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Experimental Treatment
Group I: MonotherapyExperimental Treatment1 Intervention
SLC-3010 Intravenous infusion over 30 minutes on day 1 of each 21-day cycle
Group II: Gemcitabine combinationExperimental Treatment2 Interventions
SLC-3010 Intravenous infusion over 30 minutes on day 1 of each 21-day cycle Gemcitabine 1000 ㎎/㎡ Intravenous infusion over 30 minutes on day 1 and 8 of each 21-day cycle
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Gemcitabine
2017
Completed Phase 3
~2070

Find a Location

Who is running the clinical trial?

SelecxineLead Sponsor
Sunmi Shin, BSNStudy DirectorProject Manager
Yunjeong Jeong, M.S.Study DirectorProject Associate

Media Library

SLC-3010 (Other) Clinical Trial Eligibility Overview. Trial Name: NCT05525247 — Phase 1 & 2
Solid Tumors Research Study Groups: Gemcitabine combination, Monotherapy
Solid Tumors Clinical Trial 2023: SLC-3010 Highlights & Side Effects. Trial Name: NCT05525247 — Phase 1 & 2
SLC-3010 (Other) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05525247 — Phase 1 & 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is this research endeavor in need of participants?

"According to the data shared on clinicaltrials.gov, this medical trial is no longer enrolling participants; the study was first posted in October of 2022 and last updated at the end of August that same year. Despite these unfortunate circumstances, there are a plethora of other trials actively seeking patients right now - 468 in total."

Answered by AI
~261 spots leftby Feb 2026