Study of TYK-01054 Capsules in Patients With Advanced Solid Tumors

NCT07282873 | Not Yet Recruiting Phase 1 DMC

• 1 other identifier: TYKM1408101
• Study Type: interventional
• Target: 219
• Locations: 1 country
• Sites: 1

Brief Summary

This study is to evaluate the safety, tolerability, pharmacokinetics, and antitumor activity of the TEAD inhibitor TYK-01054 capsules in patients with locally advanced or metastatic advanced solid tumors

Conditions

Solid Tumor Malignancies; Malignant Mesothelioma (MM)

Outcome Measures

Primary Outcomes (5)

• Dose Limiting Toxicity

  Numbers of participants experiencing AEs which are defined as DLTs classfied by CTCAE v6.0

  Up to approximately 28 days

• Maximum tolerated dose（MTD）

  The maximum dose when DLT% ≤ 33% during the DLT observation period

  Through the Dose Escalation phase, approximately 12 months

• Number of participants who experience one or more adverse events (AEs)

  An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention.

  From Baseline up to 28 days after the end of the treatment

• Recommended Dose for Expansion(RDE)

  Recommended Dose for Expansion

  Through the Dose Escalation Phase, approximately 24 months

• Recommended Phase 2 Dose（RP2D）

  The RP2D is defined as the dose level chosen for the dose expansion arms, based on safety, tolerability, efficacy, pharmacokinetics (PK), and pharmacodynamic (PD) data collected during the dose escalation portion of the study.

  Within 28 days of the last patient dosed in the Dose Optimization stage

Secondary Outcomes (2)

• Evaluate the pharmacokinetics of TYK-01054

  Through the Dose Escalation stage and Dose Optimization stage, approximately 24 month

• Evaluate the effectiveness of TYK-01054

  Approximately 36 months

Study Arms (1)

TKY-01054

EXPERIMENTAL

TKY-01054，orally administered daily

Drug: TYK-01054

Interventions

TYK-01054 DRUG

TKY-01054 will be administered orally at a starting dose of 25 mg in 21-day cycles. If well tolerated, dose expansion will proceed in the recommended dose for expansion (RDE) and RDE-1 until the recommended Phase II dose (RP2D) is determined.

TKY-01054

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female subjects ≥18 years old
• Advanced solid tumors must have progressed after receiving at least one standard first-line anti-tumor therapy, OR demonstrate intolerance to standard therapy, OR Lack of standard treatment.
• Patients should have at least 1 measurable lesion as per RECIST v1.1 or mRECIST v1.1.
• Adequate organ function, including hepatic, renal, cardiovascular, astrointestinal,respiratory, and hematopoietic systems.
• ECOG 0-1，
• Life expectancy of \>3 months.
• Willing and able to comply with all aspects of the protocol.

You may not qualify if:

• History of other malignancy, except for:
• Non-melanoma skin cancer (basal cell carcinoma or squamous cell carcinoma) that is non-invasive and has been effectively controlled with no recurrence or metastasis for 5 years, Papillary thyroid carcinoma, Carcinoma in situ of the cervix, Ductal carcinoma in situ of the breast.
• Unstable brain metastases,such as:
• Patients requiring urgent neurosurgical intervention for CNS complications, Presence of symptomatic spinal cord compression due to tumor, Presence of leptomeningeal disease (carcinomatous meningitis).
• Presence of pleural effusion, pericardial effusion, or ascites that, in the investigator's judgment, cannot be stably controlled by repeated drainage or other methods.
• Clinically significant renal disease.
• Clinically significant cardiovascular disease, including but not limited to myocardial infarction, unstable angina, congestive heart failure (NYHA Class ≥ II), or uncontrolled arrhythmias.
• Patients with uncontrolled infectious diseases, such as immunodeficiency disorders (e.g., HIV) or active hepatitis B or C infection; chronic hepatitis B or C carriers without symptoms are excluded from this criterion.
• Known or suspected hypersensitivity to TYK-01054 or any of its excipients, or to compounds of similar chemical class.
• Patients who have previously received a TEAD inhibitor.
• Women who are pregnant or breastfeeding.

Sponsors & Collaborators

• TYK Medicines, Inc: lead

Study Sites (1)

Shanghai Chest Hospital

Shanghai, Shanghai Municipality, 200030, China

Location

MeSH Terms

Conditions

Mesothelioma, Malignant

Condition Hierarchy (Ancestors)

Mesothelioma; Adenoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Mesothelial; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Pleural Neoplasms; Lung Diseases; Respiratory Tract Diseases

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 18, 2025
• First Posted: December 15, 2025
• Study Start: January 1, 2026
• Primary Completion (Estimated): January 1, 2028
• Study Completion (Estimated): June 1, 2029
• Last Updated: December 22, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)