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IN10018 Monotherapy and Combination Therapy for Metastatic Melanoma
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.
Study details:
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).
Eligibility criteria
Researchers look for people who fit a certain description, called eligibility criteria. See if you qualify.
Inclusion criteria
Exclusion criteria
Eligibility
Age eligible for study : 18 and older
Healthy volunteers accepted : No
Gender eligible for study: All
Things to know
Study dates
Study start: 2020-03-16
Primary completion: 2024-06-30
Study completion finish: 2024-09-30
Study type
TREATMENT
Phase
PHASE1
Trial ID
NCT04109456
Intervention or treatment
DRUG: IN10018
DRUG: Cobimetinib
BIOLOGICAL: Atezolizumab
Conditions
- • Metastatic Melanoma
Find a site
Closest Location:
The Alfred Hospital
Research sites nearby
Select from list below to view details:
The Alfred Hospital
Melbourne, Victoria, Australia
Linear Clinical Research
Nedlands, Western Australia, Australia
St Vincent Hospital Sydney
Sydney, New South Wales, Australia
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Participant Group/Arm | Intervention/Treatment |
---|---|
EXPERIMENTAL: Part 1, Monotherapy Arm
| DRUG: IN10018
|
EXPERIMENTAL: Part 2, Combination Arm
| DRUG: IN10018
|
EXPERIMENTAL: Part 3, Combination Arm
| DRUG: IN10018
|
What is the study measuring?
Primary outcome
Primary Outcome Measure | Primary Outcome Description | Primary Outcome Time Frame |
---|---|---|
Safety and tolerability of IN10018 monotherapy | Number of Participants With Abnormal Laboratory Values and/or Adverse Events That Are Related to Treatment | The first 21-day cycle |
Safety and tolerability of IN10018 in combination with cobimetinib | Number of Participants With Abnormal Laboratory Values and/or Adverse Events That Are Related to Treatment | The first 28-day cycle |
Safety and tolerability of IN10018 in combination with cobimetinib and atezolizumab | Number of Participants With Abnormal Laboratory Values and/or Adverse Events That Are Related to Treatment | All treatment period |
Secondary outcome
Secondary Outcome Measure | Secondary Outcome Description | Secondary Outcome Time Frame |
---|---|---|
Pharmacokinetics (PK) : Cmax | Peak Plasma Concentration (Cmax) | Cycle 1 and Cycle 3 |
Pharmacokinetics (PK) : AUC | Area under the plasma concentration versus time curve (AUC) | Cycle 1 and Cycle 3 |
Pharmacokinetics (PK) : tmax | Time to Cmax (tmax) | Cycle 1 and Cycle 3 |
Pharmacokinetics (PK) : t1/2 | Elimination half-life (t1/2) | Cycle 1 and Cycle 3 |
Pharmacokinetics (PK) : CL/F | apparent clearance (CL/F) | Cycle 1 and Cycle 3 |
Pharmacokinetics (PK) : Vd | Apparent volume of distribution(Vd) | Cycle 1 and Cycle 3 |
Overall Response Rates using RECiST1.1 criteria | Proportion of participants with (complete response, partial response, stable disease, progressive disease) in all 3 parts | 1 year |
Disease Control Rate using RECiST1.1 criteria | Proportion of subjects who have disease control (CR, PR or stable disease (SD)) in all 3 parts | 1 year |
duration of response (DOR) | For subjects who demonstrate CR or PR, DOR is defined as the time from first evidence of CR or PR until PD or death due to any cause, whichever occurs first in all 3 parts | 1 year |
progression free survival (PFS) | PFS is defined as the time from the first day of study treatment to the first disease progression or death due to any cause, whichever occurs first in all 3 parts | 1 year |
overall survival (OS) | OS is defined as the time from the first day of study treatment to death due to any cause in all 3 parts | 1 year |
Frequently Asked Questions
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