IN10018 Monotherapy and Combination Therapy for Metastatic Melanoma
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT04109456 |
Recruitment Status :
Recruiting
First Posted : September 30, 2019
Last Update Posted : March 31, 2022
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Metastatic Melanoma | Drug: IN10018 Drug: Cobimetinib | Phase 1 |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 52 participants |
Allocation: | Non-Randomized |
Intervention Model: | Sequential Assignment |
Intervention Model Description: | The safety and tolerability of IN10018 monotherapy will be assessed firstly. Other dose levels may be explored if necessary. And then the safety and tolerability of IN10018 in combination with Cobimetinib will be evaluated. |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
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 |
Actual Study Start Date : | March 16, 2020 |
Estimated Primary Completion Date : | December 30, 2022 |
Estimated Study Completion Date : | June 30, 2023 |

Arm | Intervention/treatment |
---|---|
Experimental: Part 1, Monotherapy Arm
The safety and tolerability of IN10018 monotherapy will be assessed. Other dose levels may be explored if necessary.
|
Drug: IN10018
100 mg, orally once daily continuously
Other Name: BI 853520 |
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. |
Drug: IN10018
100 mg, orally once daily continuously
Other Name: BI 853520 Drug: Cobimetinib 60mg , orally once daily from day 1 to day 21 in a 28-day cycle
Other Name: Cotellic |
- 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
- Pharmacokinetics (PK) : Cmax [ Time Frame: Cycle 1 and Cycle 3 ]Peak Plasma Concentration (Cmax)
- Pharmacokinetics (PK) : AUC [ Time Frame: Cycle 1 and Cycle 3 ]Area under the plasma concentration versus time curve (AUC)
- Pharmacokinetics (PK) : tmax [ Time Frame: Cycle 1 and Cycle 3 ]Time to Cmax (tmax)
- Pharmacokinetics (PK) : t1/2 [ Time Frame: Cycle 1 and Cycle 3 ]Elimination half-life (t1/2)
- Pharmacokinetics (PK) : CL/F [ Time Frame: Cycle 1 and Cycle 3 ]apparent clearance (CL/F)
- Pharmacokinetics (PK) : Vd [ Time Frame: Cycle 1 and Cycle 3 ]Apparent volume of distribution(Vd)
- Overall Response Rates using RECiST1.1 criteria [ Time Frame: 1 year ]Proportion of participants with (complete response, partial response, stable disease, progressive disease)
- Disease Control Rate using RECiST1.1 criteria [ Time Frame: 1 year ]Proportion of subjects who have disease control (CR, PR or stable disease (SD))
- duration of response (DOR) [ Time Frame: 1 year ]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.
- progression free survival (PFS) [ Time Frame: 1 year ]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.
- overall survival (OS) [ Time Frame: 1 year ]OS is defined as the time from the first day of study treatment to death due to any cause.
- To explore potential predictive biomarkers [ Time Frame: through study completion, an average of 1 year ]the level of Phospho-FAK [Tyr 397]

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Key Inclusion Criteria:
- Written informed consent provided.
- Histologically or cytologically confirmed metastatic uveal melanoma or Metastatic NRAS-mutant melanoma .
- At least one measurable lesion can be accurately measured per RECIST 1.1 by investigator.
- ECOG performance status of 0 or 1.
- Adequate organ system functions as defined in the protocol
- A male subject must agree to use contraception as detailed in 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.
Key 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 anticancer therapy including investigational agents, such as 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 within 14 days prior to first dose of study treatment.
- Has received prior treatment of any FAK inhibitor (Part 1&2), or prior treatment of any MEK inhibitor (Part 2 only).
- Has a known previous or concurrent cancer that is distinct in primary site or histology from current uveal melanoma within 3 years prior to first dose of study treatment, except for curatively treated cancers such as cervical carcinoma in situ).
- Has known active central nervous system (CNS) metastases and/or carcinomatous meningitis.
- Has a history of major cardiovascular, cerebrovascular or thromboembolic diseases within 6 months before first dose of study treatment, or has any of the abnormality defined in protocol:
- Part 2 only: Has history or current evidence of retinal pigmented epithelial detachment, central serous retinopathy, or retinal vein occlusion in the unaffected eye; or intraocular pressure > 21 mmHg or uncontrolled glaucoma (irrespective of intraocular pressure) in the unaffected eye.
- 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 or Has clinically significant gastrointestinal abnormalities.
- Known allergy or hypersensitivity to IN10018 and/or cobimetinib, or their ingredients.
- Has an active infection requiring systemic therapy within 14 days prior to the first dose of study treatment.
- Has known HIV/ active HBV/ active HCV infection.
- subject is not suitable for participating this study based on the investigator's judgement.
- has used Strong CYP3A inhibitors/inducers or P-gp inhibitors within 14 days prior to first dose of study treatment and during study treatment.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04109456
Contact: Eddie Xing, Dr. | 9495200786 | eddie.xing@inxmed.com |
United States, Florida | |
Sylvester Comprehensive Cancer Center. | Recruiting |
Miami, Florida, United States, 33136 | |
Contact: Lynn Feun, Dr. 305-243-4981 lfeun@miami.edu | |
United States, Massachusetts | |
Massachusetts General Hospital | Recruiting |
Boston, Massachusetts, United States, 02114 | |
Contact: Ryan Sullivan, MD 617-724-4000 RSULLIVAN7@PARTNERS.ORG | |
Dana-Farber Cancer Institute | Recruiting |
Boston, Massachusetts, United States, 02215 | |
Contact: Rizwan Haq, PhD. 617-632-5055 Rizwan_haq@dfci.harvard.edu | |
United States, New York | |
Columbia University Medical Center | Recruiting |
New York, New York, United States, 10032 | |
Contact: Rachard Carvajal, Dr. rdc2150@cumc.columbia.edu | |
United States, Texas | |
MD Anderson | Recruiting |
Houston, Texas, United States, 77030 | |
Contact: Sapna Patel 713-792-2921 melanoma@mdanderson.org.org | |
Principal Investigator: Sapna Patel |
Study Director: | Eddie Xing, Dr. | InxMed Shanghai |
Responsible Party: | InxMed (Shanghai) Co., Ltd. |
ClinicalTrials.gov Identifier: | NCT04109456 |
Other Study ID Numbers: |
IN10018-004-01 |
First Posted: | September 30, 2019 Key Record Dates |
Last Update Posted: | March 31, 2022 |
Last Verified: | March 2022 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Studies a U.S. FDA-regulated Drug Product: | Yes |
Studies a U.S. FDA-regulated Device Product: | No |
uveal NRAS |
Melanoma Neuroendocrine Tumors Neuroectodermal Tumors Neoplasms, Germ Cell and Embryonal |
Neoplasms by Histologic Type Neoplasms Neoplasms, Nerve Tissue Nevi and Melanomas |