IN10018 Monotherapy and Combination Therapy for Metastatic Melanoma (NCT04109456) | Clinical Trial Compass
CompletedPhase 1
IN10018 Monotherapy and Combination Therapy for Metastatic Melanoma
United States51 participantsStarted 2020-03-16
Plain-language summary
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.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Ability to understand and willingness to sign informed consent(s).
✓. Male or female subjects ≥ 18 years at the time of signing informed consent.
✓. Histologically or cytologically confirmed metastatic melanoma with subtypes limited to:
✓. Metastatic uveal melanoma, or
✓. Metastatic NRAS-mutant melanoma harboring an NRAS activating mutations of Q61, G12, or G13 mutation per local laboratory (including local reference laboratory) results.
✓. Requirements for previous therapy:
✓. Uveal melanoma: Either be treatment naïve or have failed the most recent therapy for metastatic disease, or
✓. NRAS-mutant melanoma: Either be ineligible for standard of care due to the presence of various comorbidities or have failed the most recent therapy such as immunotherapy for metastatic disease.
Exclusion criteria
✕. Has had major surgery or significant traumatic injury within 28 days prior to first dose of study treatment, or anticipation of the need for major surgery during study treatment.
✕. Has received prior systemic, intrahepatic, or sphere anticancer therapy including investigational agents within 14 days or less than 5 half-lives (whichever is shorter) of chemotherapy or targeted therapy, or within 28 days of immunotherapy, prior to first dose of study treatment.
✕
What they're measuring
1
Safety and tolerability of IN10018 monotherapy
Timeframe: The first 21-day cycle
2
Safety and tolerability of IN10018 in combination with cobimetinib
Timeframe: The first 28-day cycle
3
Safety and tolerability of IN10018 in combination with cobimetinib and atezolizumab
. Has received prior radiotherapy or radioactive chemotherapy within 14 days prior to first dose of study treatment.
✕. Has received prior treatment of any FAK inhibitor (Parts 1, 2 and 3), or prior treatment of any MEK inhibitor (Parts 2 and 3 only).
✕. Has a known previous or concurrent cancer that is distinct in primary site or histology from current melanoma within 3 years prior to first dose of study treatment, except for curatively treated cancers such as cervical carcinoma in situ and indolent cancers with very low likelihood of relapse or progress per investigator judgement.
✕. Has known active central nervous system (CNS) metastases and/or carcinomatous meningitis.
✕. Diabetes mellitus, insulin dependent and non-insulin dependent with HBA1C \> 6.5%, microalbuminuria \> 150 mg (24-h collection), and CrCL of \< 45ml/min with an adequate 24-hour urine collection.