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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
- Bilateral tubal occlusion/ligation
- Have medically confirmed ovarian failure
Must not have
Major surgery within 2 weeks prior to study drug administration; patients must have recovered adequately from toxicity and/ or complications per investigator discretion
For women only: pregnant or breastfeeding
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 30 days after last dose
Awards & highlights

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 had both of my fallopian tubes surgically closed.
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My ovaries have stopped working.
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I have had a hysterectomy or both ovaries removed.
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I am postmenopausal with the required FSH levels.
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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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My cancer is advanced, has spread, or come back and cannot be removed by surgery.
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I am fully active or restricted in physically strenuous activity but can do 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 an advanced solid tumor and have tried or can't use standard treatments.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have not had major surgery in the last 2 weeks or have fully recovered from one.
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I am not pregnant or breastfeeding.
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I have been treated with an IL-2 based drug before.
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I haven't needed systemic treatment for an autoimmune disease in the last 2 years.
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I haven't had radiation in the last 2 weeks and have no ongoing issues from past radiation.
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I am currently being treated for an infection.
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I need extra oxygen or have severe breathing problems.
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I have or had severe heart failure.
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I have had severe side effects from previous immunotherapy.
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I haven't had a heart attack or heart surgery in the last 6 months.

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

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
~204 spots leftby Feb 2026