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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

Must not have

Has known active central nervous system (CNS) metastases and/or carcinomatous meningitis

Has had used below CYP3A inhibitors/inducers and P-gp inhibitors within 14 days prior to first dose of study treatment, or anticipation of the need to use them during study treatment: Part 1: Strong CYP3A inhibitors/inducers and P-gp inhibitors are prohibited at least 14 days prior to initiation of and during study treatment. Parts 2 and 3: Moderate and Strong CYP3A inhibitors/inducers and P-gp inhibitors are prohibited at least 14 days prior to initiation of and during study treatment

Timeline

Screening 3 weeks

Treatment Varies

Follow Up through study completion, an average of 5 year

Awards & highlights

No Placebo-Only Group

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.

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.

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 below

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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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have cancer that has spread to my brain or spinal cord.

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I haven't used strong or moderate CYP3A or P-gp inhibitors in the last 14 days.

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I stopped immunotherapy due to severe side effects.

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I have had serious heart or blood clot issues in the last 6 months.

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I have fluid buildup that needs frequent draining.

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I haven't had major heart issues or strokes in the last 3 months.

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I haven't had an infection needing treatment in the last 14 days.

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I do not have active or uncontrolled gastrointestinal issues like Crohn's or ulcerative colitis.

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I have eye conditions that could risk further damage.

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I am currently on anti-viral medication for hepatitis B.

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In the past year, I haven't had severe kidney issues or certain chronic diseases.

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I am HIV positive.

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I have a history of specific lung conditions or signs of lung inflammation on a past CT scan.

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I cannot receive certain immune therapies due to health reasons.

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I am allergic to IN10018, cobimetinib, atezolizumab, or their ingredients.

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I haven't had cancer treatment or experimental drugs within the required time before starting the study.

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I haven't had major surgery or significant injury in the last 28 days and don't expect to need major surgery soon.

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I cannot absorb nutrients properly or take pills by mouth.

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I have active tuberculosis.

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I have had a stem cell or organ transplant in the past.

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I have diabetes with an HBA1C over 6.5%, kidney issues, and reduced kidney function.

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

This trial's timeline: 3 weeks for screening, Varies for treatment, and through study completion, an average of 5 year for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

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 study objectives

Disease Control Rate using RECiST1.1 criteria

Overall Response Rates using RECiST1.1 criteria

Pharmacokinetics (PK) : AUC

+8 more

Other study objectives

To explore potential predictive biomarkers

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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