IN10018 Monotherapy/Combination for Metastatic Melanoma

Recruiting in Palo Alto (17 mi)

+7 other locations

Age: 18+

Sex: Any

Travel: May be covered

Time Reimbursement: Varies

Trial Phase: Phase 1

Waitlist Available

Sponsor: InxMed (Shanghai) Co., Ltd.

No Placebo Group

Breakthrough Therapy

Trial Summary

What is the purpose of this trial?This is a phase Ib, open label clinical study to evaluate the safety, tolerability, PK and antitumor activities of IN10018 as monotherapy and in combination with cobimetinib in subjects with metastatic uveal melanoma and NRAS-mutant metastatic melanoma.

Eligibility Criteria

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.

Inclusion Criteria

I am 18 years old or older.

I agree to use contraception and not donate sperm during and for 30 days after treatment.

My cancer did not respond or got worse after immunotherapy.

I am fully active or restricted in physically strenuous activity but can do light work.

My melanoma is metastatic, either uveal or with an NRAS mutation.

I have completed at least two cycles of anti-PD-1/PD-L1 therapy.

Exclusion Criteria

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

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

I stopped immunotherapy due to severe side effects.

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 am currently on anti-viral medication for hepatitis B.

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

I am HIV positive.

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

I cannot receive certain immune therapies due to health reasons.

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.

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

I cannot absorb nutrients properly or take pills by mouth.

I have active tuberculosis.

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

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

Participant Groups

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.

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.

Atezolizumab is already approved in United States, European Union for the following indications:

🇺🇸 Approved in United States as Tecentriq for: