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IN10018 Monotherapy and Combination Therapy for Metastatic Melanoma

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

Summary

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.

Description

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

Conditions

Metastatic Melanoma

Intervention

IN10018, Binimetinib

Status

Not yet recruiting

Source

InxMed (Shanghai) Co., Ltd.

Results (where available)

View Results

Links

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

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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.

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