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Monoclonal Antibodies
IN10018 Monotherapy/Combination for Metastatic Melanoma
Phase 1
Recruiting
Research Sponsored by InxMed (Shanghai) Co., Ltd.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Male or female subjects ≥ 18 years at the time of signing informed consent
A male subject must agree to use contraception as detailed in Appendix 4 of this protocol during the treatment period and through 30 days after the last dose of study treatment and must refrain from donating sperm during this period
Timeline
Screening 3 weeks
Treatment Varies
Follow Up through study completion, an average of 5 year
Awards & highlights
Study Summary
This trial is looking at a new drug, IN10018, to treat metastatic uveal melanoma (a type of skin cancer) and NRAS-mutant metastatic melanoma. The goal is to see if it is safe and works well.
Who is the study for?
Adults with metastatic uveal melanoma or NRAS-mutant metastatic melanoma, who have either not been treated before, are ineligible for standard care, or whose previous treatments failed. Participants must be willing to provide consent and tissue samples, have a life expectancy of at least 3 months, and meet certain health criteria including organ function. Women must agree to contraception guidelines if applicable.Check my eligibility
What is being tested?
The trial is testing the safety and effectiveness of IN10018 alone and combined with cobimetinib in treating advanced melanoma. It's an early-phase study (phase Ib) where all participants know what treatment they're getting (open label). The goal is to see how well these drugs work against specific types of melanoma.See study design
What are the potential side effects?
Possible side effects include reactions related to the immune system affecting organs, infusion-related reactions from the drug entering the body, tiredness, stomach issues like nausea or diarrhea, changes in blood counts which can affect overall health and increase infection risk.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am 18 years old or older.
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I agree to use contraception and not donate sperm during and for 30 days after treatment.
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My cancer did not respond or got worse after immunotherapy.
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I am fully active or restricted in physically strenuous activity but can do light work.
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My melanoma is metastatic, either uveal or with an NRAS mutation.
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I have completed at least two cycles of anti-PD-1/PD-L1 therapy.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ through study completion, an average of 5 year
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~through study completion, an average of 5 year
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Safety and tolerability of IN10018 in combination with cobimetinib
Safety and tolerability of IN10018 in combination with cobimetinib and atezolizumab
Safety and tolerability of IN10018 monotherapy
Secondary outcome measures
Disease Control Rate using RECiST1.1 criteria
Overall Response Rates using RECiST1.1 criteria
Pharmacokinetics (PK) : AUC
+8 moreOther outcome measures
To explore potential predictive biomarkers
Trial Design
3Treatment groups
Experimental Treatment
Group I: Part 3, Combination ArmExperimental Treatment3 Interventions
The safety and tolerability of IN10018 in combination with Cobimetinib and Atezolizumab will be assessed.
Group II: Part 2, Combination ArmExperimental Treatment2 Interventions
The safety and tolerability of IN10018 in combination with Cobimetinib will be assessed. Other dose levels may be explored if necessary.
A modified 3+3 design will be used.
Group III: Part 1, Monotherapy ArmExperimental Treatment1 Intervention
The safety and tolerability of IN10018 monotherapy will be assessed. Other dose levels may be explored if necessary.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
IN10018
2020
Completed Phase 1
~40
Cobimetinib
2017
Completed Phase 3
~2660
Atezolizumab
2017
Completed Phase 3
~5860
Find a Location
Who is running the clinical trial?
InxMed (Shanghai) Co., Ltd.Lead Sponsor
10 Previous Clinical Trials
1,195 Total Patients Enrolled
Eddie Xing, Dr.Study DirectorInxMed Shanghai
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have cancer that has spread to my brain or spinal cord.I am 18 years old or older.I stopped immunotherapy due to severe side effects.In the past year, I haven't had severe kidney issues or certain chronic diseases.I agree to use contraception and not donate sperm during and for 30 days after treatment.You need to have a recent or stored sample of your tumor tissue available for testing during the screening process.I have had serious heart or blood clot issues in the last 6 months.I have fluid buildup that needs frequent draining.I haven't had major heart issues or strokes in the last 3 months.I haven't had an infection needing treatment in the last 14 days.I do not have active or uncontrolled gastrointestinal issues like Crohn's or ulcerative colitis.I have eye conditions that could risk further damage.I have had another type of cancer besides melanoma in the last 3 years, but it was either treated completely or is very slow-growing.My cancer did not respond or got worse after immunotherapy.I am currently on anti-viral medication for hepatitis B.I have previously been treated with FAK or MEK inhibitors.I am HIV positive.I have a history of specific lung conditions or signs of lung inflammation on a past CT scan.I have recovered from side effects of previous treatments to a mild level or they are stable.I can understand and am willing to sign the consent forms.I haven't used strong or moderate CYP3A or P-gp inhibitors in the last 14 days.I am not pregnant or breastfeeding and either cannot become pregnant or will follow the study's birth control advice.I am fully active or restricted in physically strenuous activity but can do light work.I have an autoimmune disease but it's under control or I only have thyroid issues treated with hormones.I cannot receive certain immune therapies due to health reasons.My melanoma is metastatic, either uveal or with an NRAS mutation.You have a current infection with Hepatitis B or Hepatitis C virus.I have not had radiotherapy or radioactive chemotherapy in the last 14 days.I am allergic to IN10018, cobimetinib, atezolizumab, or their ingredients.I haven't had cancer treatment or experimental drugs within the required time before starting the study.The doctor can measure at least one specific area of the body to see if the treatment is working.I haven't had major surgery or significant injury in the last 28 days and don't expect to need major surgery soon.You have had Alport syndrome in the past.I cannot absorb nutrients properly or take pills by mouth.I have uveal melanoma without prior treatment or it didn't respond to the last treatment. Or, I have NRAS-mutant melanoma and can't receive standard care or it didn't respond to the last treatment.I have active tuberculosis.I have had a stem cell or organ transplant in the past.I agree to have tumor biopsies for research before, during, and if my cancer progresses.I have completed at least two cycles of anti-PD-1/PD-L1 therapy.My blood, liver, kidney, and clotting tests are normal.I have diabetes with an HBA1C over 6.5%, kidney issues, and reduced kidney function.
Research Study Groups:
This trial has the following groups:- Group 1: Part 1, Monotherapy Arm
- Group 2: Part 2, Combination Arm
- Group 3: Part 3, Combination Arm
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.
How many venues are administering this experiment?
"This clinical trial is available at 5 distinct medical facilities, the most prominent of which include Dana-Farber Cancer Institute in Boston, Sylvester Comprehensive Cancer Center. in Miami, and MD Anderson in Houston. Additionally, there are two other locations that allow partipation."
Answered by AI
Is this trial a pioneering endeavor?
"Cobimetinib has been studied since 2013, when the first trial sponsored by Bristol-Myers Squibb was completed. Since then, it has gained approval for Phases 1 & 2 and is now being tested in 54 active trials across 352 cities and 48 countries."
Answered by AI
How many individuals are receiving treatment as part of this trial?
"Affirmative, the information hosted on clinicaltrials.gov attests to this medical study's active recruitment phase. Initially posted in March of 2020, it was most recently edited November 17th 2022 and is looking for 120 patients from 5 distinct locations."
Answered by AI
Have there been any prior investigations conducted on Cobimetinib?
"Currently, 54 medical trials are investigating the usage of Cobimetinib with 3 in their final stages. Portland stands as the epicentre for this research; however, there are 1451 other sites running clinical studies related to Cobimetinib."
Answered by AI
What is the aim of this trial?
"The main target of this experiment, which will be monitored throughout the entirety of treatment, is to evaluate IN10018's safety and tolerability. Other metrics that are also taken into account as secondary outcomes comprise pharmacokinetics (AUC), duration of response (DOR) and disease control rate using RECiST1.1 criteria ."
Answered by AI
To what extent can Cobimetinib potentially be detrimental to patients?
"The limited data available on Cobimetinib's safety and efficacy led our team to assign it a score of 1."
Answered by AI
Is enrollment in this trial available to the public currently?
"Confirmative. The clinical trial is currently recruiting, as detailed on the website, having been initially posted on March 16th 2020 and last updated November 17th 2022. This research venture is searching for 120 participants from 5 different sites."
Answered by AI
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