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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 30 days after last dose
Awards & highlights
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 belowSelect...
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 not using any form of birth control that is listed as unacceptable for this study.
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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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I agree to use effective birth control during and up to 3-6 months after treatment.
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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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Any side effects from my previous treatments are mild or gone, except for hair loss.
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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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My organs are functioning well.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 30 days after last dose
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~30 days after last dose
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
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am not using any form of birth control that is listed as unacceptable for this study.I have had both of my fallopian tubes surgically closed.I am at least 18 years old and can legally consent to participate.My ovaries have stopped working.I have had a hysterectomy or both ovaries removed.I have no other cancers except for cured ones, skin cancers, or completely removed in-situ cancers.I am fully active or can carry out light work.My organs are functioning well.I am postmenopausal with the required FSH levels.I agree to use effective birth control during and up to 3-6 months after treatment.I have had at least one standard treatment for my recurring/metastatic cancer and cannot receive or qualify for standard life-prolonging therapies.I do not have active hepatitis B or C, or my viral load is low and under treatment.Any side effects from my previous treatments are mild or gone, except for hair loss.I have not had major surgery in the last 2 weeks or have fully recovered from one.I am not pregnant or breastfeeding.I haven't received a non-live COVID-19 vaccine in the week before my safety assessment.I have been treated with an IL-2 based drug before.My cancer is advanced, has spread, or come back and cannot be removed by surgery.I am fully active or restricted in physically strenuous activity but can do light work.I have a solid tumor and cannot tolerate or have no standard treatment options left.I have not received any live vaccines in the last 4 weeks.My brain metastases are treated and stable for 4 weeks, and I haven't taken corticosteroids for 2 weeks.I haven't needed systemic treatment for an autoimmune disease in the last 2 years.I haven't had radiation in the last 2 weeks and have no ongoing issues from past radiation.I am currently being treated for an infection.I need extra oxygen or have severe breathing problems.I have or had severe heart failure.I am using a birth control method that contains both estrogen and progestin.I am using a progestin-only birth control method.I have had severe side effects from previous immunotherapy.I haven't had a heart attack or heart surgery in the last 6 months.Any side effects from my previous treatments are mild or gone, except for hair loss.I have an immune system disorder or have been on strong immune-weakening medicines recently.I have an advanced solid tumor and have tried or can't use standard treatments.I do not have serious heart problems.I haven't taken any cancer treatment or experimental drugs within the last 3 weeks.I am at least 18 years old and can legally consent to participate.My organs are functioning well.I agree to use effective birth control during and after treatment.
Research Study Groups:
This trial has the following groups:- Group 1: Gemcitabine combination
- Group 2: Monotherapy
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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."
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