IN10018 Monotherapy and Combination Therapy for Metastatic Melanoma

• Status: Recruiting
• Trial end date: 2022-12-30
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: InxMed (Shanghai) Co., Ltd.

Criteria

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.