Actively Recruiting

Phase 1
Age: 18Years +
All Genders
NCT05866692

A Study of TY-2699a in Patients With Locally Advanced or Metastatic Solid Tumors

Led by TYK Medicines, Inc · Updated on 2023-11-07

156

Participants Needed

2

Research Sites

163 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

This is a phase I, multicenter, open-label study. The study will investigate the safety, tolerability, PK, and preliminary efficacy of TY-2699a on locally advanced or metastatic solid tumors.

CONDITIONS

Official Title

A Study of TY-2699a in Patients With Locally Advanced or Metastatic Solid Tumors

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Able to provide written informed consent approved by institutional review board or ethics committee
  • Age 18 years or older
  • For escalation stage: Locally advanced or metastatic solid tumors including TNBC, ER+HER2- breast cancer, ovarian cancer, small cell lung cancer, castrate-resistant prostate cancer, or pancreatic cancer with KRAS mutation; or other solid tumors with deregulated RB-pathway confirmed by molecular tests
  • For escalation stage: Patients progressed on or intolerant to standard anti-cancer therapies, or deemed ineligible for such therapies
  • For expansion stage: TNBC patients progressed on at least 2 previous therapy lines and/or other solid tumors
  • ECOG performance status of 0 or 1 and life expectancy greater than 3 months
  • Ability to swallow intact capsules
  • At least one measurable target lesion per RECIST v1.1
  • Recovery from acute toxic effects of prior therapy to grade 1 or less (excluding alopecia and prior neuropathy)
  • Adequate baseline lab results including neutrophils, platelets, hemoglobin, creatinine clearance, bilirubin, and liver enzymes
  • No blood transfusions or hematopoietic factors within 14 days prior to first dose
  • Negative pregnancy test within 7 days prior to treatment start for females of childbearing potential
  • Use of two highly effective contraception methods during and after study as specified
  • Willing and able to comply with all study requirements
Not Eligible

You will not qualify if you...

  • Participation in another interventional clinical trial unless in long-term follow-up
  • Major surgery within 4 weeks prior to first dose
  • Bone marrow or extensive radiation therapy within 28 days prior to first dose; local radiation within 7 days prior to first dose
  • Use of CYP3A, CYP2C8 strong inducers/inhibitors or p-gp inhibitors within 14 days prior to first dose
  • Use of proton pump inhibitors within 4 days or histamine H2 blockers within 2 days prior to first dose
  • Prior exposure to transcriptional kinase family CDK inhibitors except CDK4/6 inhibitors
  • History of other cancers requiring therapy within past 5 years except certain skin or in situ carcinomas
  • Unstable brain metastases or CNS complications needing urgent treatment
  • Epilepsy needing treatment or history of substance abuse or mental disorders without abstinence
  • Long-term systemic immunosuppressant therapy except low-dose corticosteroids
  • Certain cardiac abnormalities or clinically significant cardiovascular disease
  • Uncontrolled systemic diseases including high blood pressure, diabetes, active bleeding, severe eye disease, psychosis, nerve, vascular, or respiratory disease
  • Active infections including uncontrolled HIV, hepatitis B or C except asymptomatic carriers
  • Interstitial lung disease or conditions causing pulmonary toxicity
  • Active gastrointestinal disease impacting drug absorption
  • Allergy to TY-2699a or its components
  • Pregnant or breastfeeding women
  • Investigator judgment of unsuitability for study participation

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 2 locations

1

National Cancer Center/Cancer Hospital, Chinese Academy of Medical Science and Peking Union Medical College

Beijing, Beijing Municipality, China, 100021

Actively Recruiting

2

Shandong Cancer Hospital

Jinan, Shandong, China, 250117

Actively Recruiting

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How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SEQUENTIAL

Primary Purpose

TREATMENT

Number of Arms

1

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A Study of TY-2699a in Patients With Locally Advanced or Metastatic Solid Tumors | DecenTrialz