RecruitingPhase 1Phase 2NCT06359860

A Study of ST-1898 for Unresectable or Metastatic Melanoma

A Phase Ib/II Study to Evaluate the Efficacy and Safety of ST-1898 in Subjects With Unresectable or Metastatic Melanoma

Sponsor

Beijing Scitech-Mq Pharmaceuticals Limited

Enrollment

64 participants

Start Date

Nov 7, 2023

Study Type

INTERVENTIONAL

Conditions

Unresectable or Metastatic Melanoma

Summary

ST-1898 is a receptor tyrosine kinase (RTK) inhibitor for multi-targets, especially for VEGFR2, c-MET, AXL, PDGFRA, RET, KIT etc. This trial is to evaluate its safety, tolerability, pharmacokinetic, and efficacy in subjects with unresectable or metastatic melanoma. In phase Ib, the primary objectives are to assess the safety and tolerability, and to determine Recommended Phase 2 dose (RP2D) of ST-1898 tablets in subjects with unresectable or metastatic melanoma. Secondary objectives are to assess the plasma concentration of ST-1898 and to evaluate the efficacy. In phase II, the primary objective is to assess the anti-tumor activities of ST-1898 tablets in subjects with unresectable or metastatic melanoma. The secondary objective is to evaluate the safety of ST-1898 tablets.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This trial is testing an experimental drug called ST-1898 in patients with advanced acral melanoma — a rare form of skin cancer that develops on the palms, soles, or under fingernails and toenails — that has already progressed despite standard treatments. **You may be eligible if...** - You are 18 or older - You have been confirmed by biopsy to have unresectable (cannot be removed by surgery) or metastatic acral melanoma at Stage III or IV - Your cancer has worsened despite previous standard therapy - You have at least one measurable lesion - You are in good general health (ECOG performance status 0 or 1) **You may NOT be eligible if...** - Your melanoma is not acral (e.g., it is cutaneous/skin melanoma or mucosal melanoma) - You have active brain metastases causing symptoms - You have significant heart, liver, or kidney problems - You have active autoimmune disease or are on immune-suppressing drugs - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGST-1898 tablets

Supplied as 5 mg and 40 mg tablets

Locations(1)

Peking University Cancer Hospital & Institute

Beijing, China

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NCT06359860