IN10018 Monotherapy and Combination Therapy for Metastatic Melanoma

2019-10-04 08:31:38 | BioPortfolio


This is a phase Ib, open label clinical study to evaluate the safety, tolerability, PK and antitumor activities of IN10018 as monotherapy and combination therapy in subjects with metastatic uveal melanoma.


Initially only subjects with metastatic uveal melanoma (UM) will be enrolled. Additional tumor types and cohorts such as mucosal melanoma with GNAQ/GNA11 mutations and melanoma with NRAS mutations may be added to explore further anti-tumor activities based on emerging data.

This study has 2 parts to enroll up to approximately 52 subjects. IN10018 will be assessed firstly as monotherapy in Part 1, and then in combination with binimetinib in Part 2. The recommended phase II dose (RP2D) of monotherapy or combination therapy will be determined during first component of Part 1 (Stage A) and Part 2 (Stage C), and then to be extended to further evaluate the antitumor activities of IN10018 monotherapy or combination therapy during second component of Part 1 (Stage B) and Part 2 (Stage D).

Study Design


Metastatic Melanoma


IN10018, Binimetinib


Not yet recruiting


InxMed (Shanghai) Co., Ltd.

Results (where available)

View Results


Published on BioPortfolio: 2019-10-04T08:31:38-0400

Clinical Trials [1573 Associated Clinical Trials listed on BioPortfolio]

Study of the Combination of Binimetinib and Encorafenib in Adolescent Patients With Unresectable or Metastatic BRAF V600-mutant Melanoma

This is a multicenter Phase 1b, open-label study to evaluate the pharmacokinetic, safety and efficacy of binimetinib and encorafenib co-administered to adolescent patients with BRAF V600-m...

Binimetinib Plus Encorafenib Real Life Investigation of Next Generation Melanoma Treatment

BERING-MELANOMA - designed as a prospective, longitudinal, non-interventional study - will investigate real-world effectiveness, quality of life, safety and tolerability of encorafenib plu...

Encorafenib and Binimetinib Before Local Treatment in Patients With BRAF Mutant Melanoma Metastatic to the Brain

Phase II clinical trial, with two cohorts of patients included in parallel, all with melanoma BRAF mutated and brain metastases without previous local treatment in the brain. Cohort 1 will...

Immunotherapy With Ipilimumab and Nivolumab Preceded or Not by a Targeted Therapy With Encorafenib and Binimetinib

This is a multicenter, 2-arm open-label, randomized comparative phase II study. The objective of this trial is to prospectively evaluate whether a sequential approach with an induction per...

Stereotactic Radiosurgery Added to Binimetinib and Encorafenib in Patients With BRAFV600 Melanoma With Brain Metastasis

This study evaluates the addition of stereotactic radiosurgery (SRS) to the combination of binimetinib plus encorafenib in the treatment of BRAFV600 mutation-positive Melanoma with brain m...

PubMed Articles [2295 Associated PubMed Articles listed on BioPortfolio]

Adverse events associated with encorafenib plus binimetinib in the COLUMBUS study: incidence, course and management.

Dual inhibition of the mitogen-activated protein kinase pathway with BRAF/MEK inhibitor (BRAFi/MEKi) therapy is a standard treatment for BRAFV600-mutant metastatic melanoma and has historically been a...

Jejunojejunal intussusception secondary to metastatic uveal melanoma after 11 years of remission.

Malignant cutaneous melanoma frequently metastasises to gastrointestinal tract, small bowel being the most common site likely due to its rich vascular supply. However, most common sites for metastatic...

Intracranial antitumor activity with encorafenib plus binimetinib in patients with melanoma brain metastases: A case series.

Sixty percent of patients with stage IV melanoma may develop brain metastases, which result in significantly increased morbidity and a poor overall prognosis. Phase 3 studies of melanoma usually exclu...

Pembrolizumab as first-line treatment for metastatic uveal melanoma.

No standard treatment has been defined for metastatic uveal melanoma (mUM). Although clinical trials testing Nivolumab/Pembrolizumab for cutaneous melanoma did not include mUM, anti PD-1 agents are co...

Immune-checkpoint inhibitors for the treatment of metastatic melanoma: a model of cancer immunotherapy.

Melanoma has always been described as an immunogenic tumor. Despite that, until 2011 the standard of care in metastatic melanoma was chemotherapy, with low response rates and no clear impact on overal...

Medical and Biotech [MESH] Definitions

An unpigmented malignant melanoma. It is an anaplastic melanoma consisting of cells derived from melanoblasts but not forming melanin. (Dorland, 27th ed; Stedman, 25th ed)

An anti-CTLA-4 ANTIGEN monoclonal antibody initially indicated for the treatment of certain types of metastatic MELANOMA. Its mode of actions may include blocking of CTLA-4 mediated inhibition of CYTOTOXIC T LYMPHOCYTES, allowing for more efficient destruction of target tumor cells.

Experimentally induced tumor that produces MELANIN in animals to provide a model for studying human MELANOMA.

A cellular subtype of malignant melanoma. It is a pigmented lesion composed of melanocytes occurring on sun-exposed skin, usually the face and neck. The melanocytes are commonly multinucleated with a "starburst" appearance. It is considered by many to be the in situ phase of lentigo maligna melanoma.

Found in large amounts in the plasma and urine of patients with malignant melanoma. It is therefore used in the diagnosis of melanoma and for the detection of postoperative metastases. Cysteinyldopa is believed to be formed by the rapid enzymatic hydrolysis of 5-S-glutathionedopa found in melanin-producing cells.

More From BioPortfolio on "IN10018 Monotherapy and Combination Therapy for Metastatic Melanoma"

Quick Search

Relevant Topics

Melanoma is a highly malignant tumor of melanin-forming cells (melanocytes) There are most commonly found in the skin (resulting from sunlight exposure), but also in the eyes and mucous membranes. Metastasis to other regions of the body is also common....

  Bladder Cancer Brain Cancer Breast Cancer Cancer Cervical Cancer Colorectal Head & Neck Cancers Hodgkin Lymphoma Leukemia Lung Cancer Melanoma Myeloma Ovarian Cancer Pancreatic Cancer ...

Skin cancers
There are three main types of skin cancer: basal cell carcinoma, squamous cell carcinoma and malignant melanoma. Basal cell carcinoma Basal cell carcinoma, or BCC, is a cancer of the basal cells at the bottom of the epidermis. It’s very common ...

Searches Linking to this Trial