IN10018 Monotherapy and Combination Therapy for Metastatic Melanoma

Part of paid clinical trials in Miami, Florida.

Sponsor
InxMed (Shanghai) Co., Ltd.
Study ID
NCT04109456
Phase
PHASE1
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

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

Study Details

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.

Key Dates

Start date
Mar 16, 2020
Status verified
Jan 2026
Primary completion
Dec 20, 2024
Completion
Dec 20, 2024

Study Design

Enrollment
51 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Part 1, Monotherapy Arm
    The safety and tolerability of IN10018 monotherapy will be assessed. Other dose levels may be explored if necessary.
  • Experimental: Part 2, Combination Arm
    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.
  • Experimental: Part 3, Combination Arm
    The safety and tolerability of IN10018 in combination with Cobimetinib and Atezolizumab will be assessed.

Primary Outcome Measure

Safety and tolerability of IN10018 monotherapy [ Time Frame: The first 21-day cycle ]

Locations (5)

FacilityCityStateZIPSite coordinators
Sylvester Comprehensive Cancer Center.MiamiFlorida33136-
Dana-Farber Cancer InstituteBostonMassachusetts02215-
Massachusetts General HospitalBostonMassachusetts02114-
Columbia University Medical CenterNew YorkNew York10032-
MD AndersonHoustonTexas77030-

Find similar trials in Miami, FL

By condition
Melanoma
By specialty
OncologySkin cancerDermatology
By research site
Sylvester Comprehensive Cancer Center.· Miami, FLDana-Farber Cancer Institute· Boston, MAMassachusetts General Hospital· Boston, MAColumbia University Medical Center· New York, NYMD Anderson· Houston, TX

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