Actively Recruiting

Phase 1
Phase 2
Age: 18Years +
All Genders
NCT07253116

A Phase I/II Clinical Study of WJ22096 Tablets in Patients With Advanced Tumors

Led by Nanjing Jingao biomidical technology Co. Ltd. · Updated on 2026-01-14

20

Participants Needed

1

Research Sites

158 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

This is a Phase I/II, open-label, preliminary study of safety, tolerability, pharmacokinetics, and efficacy. The study comprises three parts: a Dose Escalation cohort, a Dose Expansion cohort, and an Efficacy Expansion cohort. Dose Escalation cohort aims to evaluate the safety, tolerability, pharmacokinetic (PK) characteristics, and preliminary efficacy of WJ22096 Tablets in patients with advanced solid tumors for whom standard therapies have failed, are not tolerated, or for whom no standard therapy exists. Dose Expansion cohort Based on an evaluation of preliminary data, the Sponsor and the Safety Monitoring Committee (SMC) will select 1-2 dose levels to further evaluate preliminary efficacy, safety, tolerability, and PK characteristics, and to confirm the Recommended Phase 2 Dose (RP2D). Each dose cohort will enroll approximately 9-12 subjects with advanced solid tumors (for whom standard therapies have failed, are not tolerated, or for whom no standard therapy exists), predominantly comprising patients with Non-Small Cell Lung Cancer (NSCLC), Colorectal Cancer (CRC), and Pancreatic Cancer. Efficacy Expansion cohort aims to evaluate the efficacy, safety, tolerability, and PK characteristics at the selected dose in patients with specific tumor types, such as NSCLC, CRC, and Pancreatic Cancer. The dosing regimen will be the RP2D determined during the Dose Escalation and Dose Expansion cohorts. It is initially planned to expand 2-3 cohorts using Simon's two-stage minimax design, with approximately 20-40 subjects planned for enrollment in each cohort. (The specific tumor types for expansion, sample size, and number of cohorts will be adjusted by the Principal Investigator (PI) and the Sponsor based on results from the preceding stages of the trial).

CONDITIONS

Official Title

A Phase I/II Clinical Study of WJ22096 Tablets in Patients With Advanced Tumors

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age 18 years or older
  • Signed informed consent form
  • Histologically or cytologically confirmed advanced solid tumors with failed, intolerant, or no standard therapy
  • ECOG performance status of 0 or 1
  • Estimated life expectancy greater than 12 weeks
  • Adequate blood counts and organ function within 7 days prior to first dose
  • Resolved acute toxicities from prior therapies to baseline or Grade 1 or less
  • Negative pregnancy test for women of childbearing potential and agreement to use contraception during and 3 months after treatment
  • At least one measurable tumor lesion (for dose and efficacy expansion cohorts)
  • NSCLC patients with G12C mutations prioritized (for efficacy expansion cohort)
  • Pancreatic cancer patients must have received at least 2 prior therapy lines (for dose and efficacy expansion cohorts)
Not Eligible

You will not qualify if you...

  • Pregnant or lactating women
  • Known allergy or contraindication to study drug components
  • History of drug or alcohol abuse
  • Difficulty with intravenous blood collection
  • Prior or current treatment with FAK inhibitors
  • Recent systemic anti-tumor therapy, radiotherapy, or immunotherapy within specified washout periods before first dose
  • Use of Chinese herbal medicines with anti-tumor effects within 2 weeks prior to first dose
  • Concomitant use of CYP3A or P-gp modulators not discontinued for required washout
  • History of organ or stem cell transplant
  • Major surgery within 4 weeks prior to first dose or planned surgery during study
  • Radiotherapy within 21 days prior to dosing (with exceptions)
  • Active gastrointestinal issues affecting oral medication intake or drug absorption
  • Uncontrolled third-space fluid accumulation
  • Active brain metastases unless stable and meeting specified conditions
  • Poorly controlled hypertension
  • Uncontrolled diabetes mellitus
  • Significant bleeding symptoms within 4 weeks prior to first dose
  • Active HBV, HCV, HIV infections or positive serology
  • History of syphilis with positive antibodies
  • Other malignancies within 5 years except certain treated or localized cancers
  • Recent significant cardiovascular or cerebrovascular events
  • Clinically significant arrhythmias or prolonged QTc interval
  • Severe active infections requiring IV therapy
  • Refractory or recurrent urinary tract infections
  • Any condition affecting study participation or results as judged by the investigator

AI-Screening

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Trial Site Locations

Total: 1 location

1

Peking Union Medical College Hospital

Beijing, Beijing Municipality, China, 100730

Actively Recruiting

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Research Team

T

Tong FANG

CONTACT

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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