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Recruiting Phase 1 NCT06246071

A Study of TYK-00540 in Adult Patients With Solid Tumors

Trial Parameters

Condition Locally Advanced or Metastatic Solid Tumors
Sponsor TYK Medicines, Inc
Study Type INTERVENTIONAL
Phase Phase 1
Enrollment 156
Sex ALL
Min Age 18 Years
Max Age N/A
Start Date 2024-01-02
Completion 2026-12-05
Interventions
TYK-00540

Brief Summary

The primary objective of this study is to evaluate the safety and tolerability of TYK-00540, with dose-escalation stage and dose-expansion stage.

Eligibility Criteria

Inclusion Criteria: 1. Age ≥18 years. 2. In the Single-agent escalation phase, subjects should fulfill the following criterion at Screening: Histologically or cytologically confirmed locally advanced/metastatic solid tumors that do not have, failed or intolerated standard of care (SOC).In the single-agent expansion phase, subjects should fulfill the following criteria at Screening: Cohort 1: Histologically or cytologically confirmed platinum-resistant HGSOC (Platinum-resistant: responds at first to treatment with drugs that contain platinum, but then comes back within 6 months period; only female subjects will be enrolled). Cohort 2: Histologically or cytologically confirmed locally advanced/metastatic TNBC who have received two lines of standard of care (SOC) regimens, including: 1. Any prior treatment can be considered as one of the SOC regimens if executed on patients with the receptor status of triple-negative no matter the previous pathological type; 2. For patients whose treatmen

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