NCT04109456

IN10018 Monotherapy and Combination Therapy for Metastatic Melanoma

A Phase Ib, Open-label Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Antitumor Activities of IN10018 as Monotherapy and Combination Therapy in Subjects With Metastatic Melanoma

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 51 (actual)
• Sponsor: InxMed (Shanghai) Co., Ltd. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Subjects with metastatic uveal melanoma (UM) or with NRAS-mutant metastatic melanoma will be enrolled. IN10018 will be assessed firstly as monotherapy（Part 1）, then in combination with cobimetinib (Part 2) and in combination with cobimetinib and Atezolizumab (Part 3).

Conditions

• Metastatic Melanoma

Interventions

Type	Name	Description
DRUG	IN10018	100 mg or 50mg, orally once daily continuously;
DRUG	Cobimetinib	60mg , orally once daily from day 1 to day 21 in a 28-day cycle
BIOLOGICAL	Atezolizumab	biweekly 840 mg dose will be used in this study starting from Cycle 2.

Timeline

• Start date: 2020-03-16
• Primary completion: 2024-12-20
• Completion: 2024-12-20
• First posted: 2019-09-30
• Last updated: 2026-01-15

Locations

8 sites across 2 countries: United States, Australia

Regulatory

• FDA-regulated drug study