Metastatic MelanomaPhase 1NCT04109456
IN10018 Monotherapy and Combination Therapy for Metastatic Melanoma
A Phase 1 study testing IN10018, Cobimetinib and Atezolizumab in people with Metastatic Melanoma, run by InxMed (Shanghai) Co., Ltd. at 8 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Metastatic Melanoma
- What is being tested?
- IN10018, Cobimetinib and Atezolizumab
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 51 participants
- Where
- 8 sitesin 2 countries
- Study dates
- 16 Mar 2020to 20 Dec 2024
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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:
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- 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.
- Have failed immunotherapy therapy (anti-PD-1 or anti-PD-L1) alone or in combination with other agents for metastatic disease either with no initial response or disease progression after an initial response. (Part 3)
- Received a minimum of two cycles of anti-PD-1/PD-L1 therapy. (Part 3)
- Consent to undergo tumor biopsies of accessible lesions, before and during treatment and at radiographic progression, for biomarker analyses (site dependent).
- At least one measurable lesion can be accurately measured per RECIST 1.1 by investigator.
- ECOG performance status of 0 or 1.
- Life expectancy of at least 3 months as assessed by investigator.
- Availability of fresh tumor tissue and/or archival tumor tissue at Screening if agreed by subjects.
- Must have recovered from all AEs due to previous therapies to ≤ Grade 1 (CTCAE 5.0) or stable status as assessed by investigator.
- Adequate bone marrow, liver, renal, and coagulation function within 5 days prior to first dose of study treatment.
- A male subject must agree to use contraception as detailed in Appendix 4 of this protocol during the treatment period and through 30 days after the last dose of study treatment and must refrain from donating sperm during this period.
- A female subject is eligible to participate if she is not pregnant, not breastfeeding, and at least 1 of the following conditions applies:
- Not a woman of childbearing potential (WOCBP) as defined in Appendix 4. OR
- A WOCBP who agrees to follow the contraceptive guidance in Appendix 4 during the treatment period and through 30 days after the last dose of study treatment.
Who cannot join
- 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.
- 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.
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- 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.
- Prior history of Alport syndrome.
- Recent medical history (with the last 1-year) of acute renal injury, Goodpasture's Syndrome, IgA nephropathy, focal segmental glomerulosclerosis, nephrotic syndrome, parenteral drug abuse, recurrent pyelonephritis, systemic lupus erythematosus, uncontrolled hypertension, vasculitis, and chronic illnesses with potential underlying glomerular renal disease.
- Has contraindications to anti-PD-1 or anti-PD-L1 immunotherapy (Part 3).
- Has received prior treatment with anti-PD-1, anti-PD-L1, or anti-CTLA4 immunotherapy and was discontinued for significant immunotherapy-related adverse events (Part 3).
- Current treatment with anti-viral therapy for HBV (Part 3).
- Prior allogeneic stem cell or solid organ transplantation.
- Active tuberculosis
- Significant cardiovascular disease (such as New York Heart Association Class II or greater cardiac disease, myocardial infarction, or cerebrovascular accident) within 3 months prior to initiation of study treatment, unstable arrhythmia, or unstable angina (Part 3).
- Active or history of autoimmune disease or immune deficiency, including, but not limited to, myasthenia gravis, myositis, autoimmune hepatitis, systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, antiphospholipid antibody syndrome, Wegener granulomatosis, Sjögren's syndrome, Guillain-Barré syndrome, or multiple sclerosis, with the following exceptions: Patients with a history of autoimmune-related hypothyroidism who are on thyroid-replacement hormone are eligible for the study. (Part 3).
- History of idiopathic pulmonary fibrosis, organizing pneumonia, drug-induced pneumonitis, idiopathic pneumonitis, or evidence of active pneumonitis on previous chest computed tomography (CT) scan.
- Has a history of major cardiovascular, cerebrovascular, or thromboembolic diseases (e.g., congestive heart failure, acute myocardial infarction, unstable angina, atrial fibrillation, ventricular tachyarrhythmia, uncontrolled hypertension, stroke, transient ischemic attack, deep vein thrombosis or pulmonary embolism) within 6 months before first dose of study treatment, or has any of the following abnormality:
- QTc interval > 480 msec (Fridericia formula), (patients with right bundle branch block is not required to have QTc if the block is stable and assessed as not clinically significant by the PI),
- Left ventricular ejection fraction (LVEF) < 50%,
- Arrhythmia with clinical significance, or
- Other heart diseases with clinical significance.
- History of or evidence of retinal pathology on ophthalmologic examination that is considered a risk factor for neurosensory retinal detachment/ central serous chorioretinopathy (CSCR), retinal vein occlusion (RVO), neovascular macular degeneration, or uncontrolled glaucoma with intra-ocular pressures >21 mmHg in the eye(s) unaffected by melanoma. (Parts 2 and 3)
- Has known uncontrollable pleural effusion, pericardial effusion, or ascites requiring repeated drainage prior to the first dose of study treatment.
- Has malabsorption syndrome or inability to take oral drugs.
- Has clinically significant gastrointestinal abnormalities including uncontrolled gastrointestinal inflammatory lesions (Crohn's disease, or ulcerative colitis in active or uncontrolled gastrointestinal bleeding).
- Known allergy or hypersensitivity to IN10018 cobimetinib and/or atezolizumab, or their ingredients.
- Has had an active infection requiring systemic therapy within 14 days prior to the first dose of study treatment.
- Has known human immunodeficiency virus (HIV) infection.
- Has known active Hepatitis B or Hepatitis C virus infection.
- Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the study, interfere with the subject's participation for the full duration of the study, or is not in the best interest of the subject to participate, in the opinion of the treating investigator.
- Has a known psychiatric or substance abuse disorder that would interfere with the subject's ability to cooperate with the requirements of the study.
- Has had used below CYP3A inhibitors/inducers and P-gp inhibitors within 14 days prior to first dose of study treatment, or anticipation of the need to use them during study treatment:
- Part 1: Strong CYP3A inhibitors/inducers and P-gp inhibitors are prohibited at least 14 days prior to initiation of and during study treatment.
- Parts 2 and 3: Moderate and Strong CYP3A inhibitors/inducers and P-gp inhibitors are prohibited at least 14 days prior to initiation of and during study treatment.
Trial locations and contacts
8 sites in 2 countries.
8 sites in 2 countries
United States5 sites
Massachusetts General Hospital
Boston, Massachusetts, 02114
Dana-Farber Cancer Institute
Boston, Massachusetts, 02215
MD Anderson
Houston, Texas, 77030
Sylvester Comprehensive Cancer Center.
Miami, Florida, 33136
Columbia University Medical Center
New York, New York, 10032
Australia3 sites
The Alfred Hospital
Melbourne, Victoria
Linear Clinical Research
Nedlands, Western Australia
St Vincent Hospital Sydney
Sydney, New South Wales
About this study
Official title: 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
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.
Read the 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
- Being tested
- IN10018, Cobimetinib, Atezolizumab
- Keywords
- uveal, NRAS
- Medical subject headings
- Melanoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IN10018Drug
Also called BI 853520
100 mg or 50mg, orally once daily continuously;
CobimetinibDrug
Also called Cotellic
60mg , orally once daily from day 1 to day 21 in a 28-day cycle
AtezolizumabBiological
biweekly 840 mg dose will be used in this study starting from Cycle 2.
| Study group | Role | What they receive |
|---|---|---|
| Part 1, Monotherapy Arm | Experimental | The safety and tolerability of IN10018 monotherapy will be assessed. Other dose levels may be explored if necessary. Receives: Drug: IN10018 |
| Part 2, Combination Arm | Experimental | 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. Receives: Drug: IN10018; Drug: Cobimetinib |
| Part 3, Combination Arm | Experimental | The safety and tolerability of IN10018 in combination with Cobimetinib and Atezolizumab will be assessed. Receives: Drug: IN10018; Drug: Cobimetinib; Biological: Atezolizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety and tolerability of IN10018 monotherapy
Number of Participants With Abnormal Laboratory Values and/or Adverse Events That Are Related to Treatment
Measured: 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
Measured: 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
Measured: All treatment period
Secondary outcomes (11)
Pharmacokinetics (PK) : Cmax
Peak Plasma Concentration (Cmax)
Measured: Cycle 1 and Cycle 3
Pharmacokinetics (PK) : AUC
Area under the plasma concentration versus time curve (AUC)
Measured: Cycle 1 and Cycle 3
Pharmacokinetics (PK) : tmax
Time to Cmax (tmax)
Measured: Cycle 1 and Cycle 3
Pharmacokinetics (PK) : t1/2
Elimination half-life (t1/2)
Measured: Cycle 1 and Cycle 3
Pharmacokinetics (PK) : CL/F
apparent clearance (CL/F)
Measured: Cycle 1 and Cycle 3
Pharmacokinetics (PK) : Vd
Apparent volume of distribution(Vd)
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Sep 2019
- Study start16 Mar 2020
- Primary completion20 Dec 2024
- Study completion20 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metastatic MelanomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Model description
- The safety and tolerability of IN10018 monotherapy (Part 1) will be assessed firstly. Other dose levels may be explored if necessary. and then the safety and tolerability of IN10018 in combination with Cobimetinib (Part 2) will be evaluated. the safety and tolerability of IN10018 in combination with Cobimetinib and Atezolizumab (Part 3) will be evaluated .
- Masking
- None (open label)
- Enrolment
- 51 participants (actual)
Sponsor and investigators
- Lead sponsor
- InxMed (Shanghai) Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Eddie Xing, Dr., Study director, InxMed Shanghai
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04109456
- Sponsor's protocol ID
- IN10018-004-01
- Status last verified
- Jan 2026
- First submitted
- 26 Sep 2019
- Last updated
- 15 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT04109456
- Acronym / sponsor ID
- IN10018-004-01
- Conditions
- Metastatic Melanoma
- Keywords
- uveal, NRAS
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 51 participants (actual)
- Lead sponsor
- InxMed (Shanghai) Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 16 Mar 2020 (actual)
- Primary completion
- 20 Dec 2024 (actual)
- Study completion
- 20 Dec 2024 (actual)
- First posted
- 30 Sep 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- The safety and tolerability of IN10018 monotherapy (Part 1) will be assessed firstly. Other dose levels may be explored if necessary. and then the safety and tolerability of IN10018 in combination with Cobimetinib (Part 2) will be evaluated. the safety and tolerability of IN10018 in combination with Cobimetinib and Atezolizumab (Part 3) will be evaluated .
| Arm | Type | Receives |
|---|---|---|
| Part 1, Monotherapy Arm | Experimental | Drug: IN10018The safety and tolerability of IN10018 monotherapy will be assessed. Other dose levels may be explored if necessary. |
| Part 2, Combination Arm | Experimental | Drug: IN10018, Drug: CobimetinibThe 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. |
| Part 3, Combination Arm | Experimental | Drug: IN10018, Drug: Cobimetinib, Biological: AtezolizumabThe safety and tolerability of IN10018 in combination with Cobimetinib and Atezolizumab will be assessed. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (21 listed)
- 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:
- Requirements for previous therapy:
- Consent to undergo tumor biopsies of accessible lesions, before and during treatment and at radiographic progression, for biomarker analyses (site dependent).
Key exclusion criteria (35 listed)
- 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.
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| IN10018Also: BI 853520100 mg or 50mg, orally once daily continuously; | Drug | Part 1, Monotherapy Arm, Part 2, Combination Arm, Part 3, Combination Arm |
| CobimetinibAlso: Cotellic60mg , orally once daily from day 1 to day 21 in a 28-day cycle | Drug | Part 2, Combination Arm, Part 3, Combination Arm |
| Atezolizumabbiweekly 840 mg dose will be used in this study starting from Cycle 2. | Biological | Part 3, Combination Arm |
Primary outcome
Safety and tolerability of IN10018 monotherapy
Time frame: The first 21-day cycle
Number of Participants With Abnormal Laboratory Values and/or Adverse Events That Are Related to Treatment
Safety and tolerability of IN10018 in combination with cobimetinib
Time frame: The first 28-day cycle
Number of Participants With Abnormal Laboratory Values and/or Adverse Events That Are Related to Treatment
Safety and tolerability of IN10018 in combination with cobimetinib and atezolizumab
Time frame: All treatment period
Number of Participants With Abnormal Laboratory Values and/or Adverse Events That Are Related to Treatment
11 secondary outcomes
Pharmacokinetics (PK) : Cmax
Time frame: Cycle 1 and Cycle 3
Pharmacokinetics (PK) : AUC
Time frame: Cycle 1 and Cycle 3
Pharmacokinetics (PK) : tmax
Time frame: Cycle 1 and Cycle 3
Pharmacokinetics (PK) : t1/2
Time frame: Cycle 1 and Cycle 3
Pharmacokinetics (PK) : CL/F
Time frame: Cycle 1 and Cycle 3
Pharmacokinetics (PK) : Vd
Time frame: Cycle 1 and Cycle 3
Overall Response Rates using RECiST1.1 criteria
Time frame: 1 year
Disease Control Rate using RECiST1.1 criteria
Time frame: 1 year
duration of response (DOR)
Time frame: 1 year
progression free survival (PFS)
Time frame: 1 year
overall survival (OS)
Time frame: 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jan 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Eddie Xing, Dr. study director
InxMed Shanghai
8 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing IN10018, Cobimetinib and Atezolizumab in people with Metastatic Melanoma, run by InxMed (Shanghai) Co., Ltd. at 8 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 21 inclusion and 35 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in United States, Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety and tolerability of IN10018 monotherapy (time frame: The first 21-day cycle). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jan 2026.