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A Study of TY-2136b in Patients With Advanced Solid Tumors Harboring ALK, ROS1 or NTRK1-3 Alterations

NCT05769075 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 282

Last updated 2023-04-24

No results posted yet for this study

Summary

The primary objective of this study is to evaluate the safety and tolerability of TY-2136b and to determine the recommended phase 2 dose (RP2D), with dose-escalation stage and dose-expansion stage.

Conditions

  • Locally Advanced Solid Tumor
  • Metastatic Solid Tumor

Interventions

DRUG

TY-2136b

Drug: TY-2136b PO, QD or BID Escalation stage: 7 increased dose cohorts from low dose to MTD (from 40mg QD to 420mg QD)

DRUG

TY-2136b

Expansion stage: 4 distinct cohorts The dose for the Expansion stage will be determined based on results from the Escalation stage

Sponsors & Collaborators

  • TYK Medicines, Inc

    lead INDUSTRY

Principal Investigators

  • TYK Medicines, Inc · TYK Medicines, Inc

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-04-20
Primary Completion
2025-01-31
Completion
2025-10-31
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05769075 on ClinicalTrials.gov