RecruitingPhase 1NCT06484816

TGRX-1942 Chinese Phase I for Advanced Solid Tumor And/or Relapsed/Refractory Hematologic Malignancies

A Dose Escalation and Expansion Phase I Study Evaluating the Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of TGRX-1942 in Patients with Advanced Solid Tumor And/or Relapsed/Refractory Hematologic Malignancies

Sponsor

Shenzhen TargetRx Co., Ltd.

Enrollment

90 participants

Start Date

Jul 8, 2024

Study Type

INTERVENTIONAL

Conditions

Advanced Solid Tumor Non-small Cell Lung Cancer Hematologic Malignancy

Summary

A phase I study to evaluate the safety, tolerability, pharmacokinetics and preliminary efficacy of TGRX-1942 in patients with advanced solid tumor and/or relapsed or refractory hematological malignancies

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This early-phase trial is testing a new cancer drug called TGRX-1942 in patients in China with advanced solid tumors or blood cancers that have stopped responding to standard treatments. The study is primarily focused on finding the right dose and assessing safety. **You may be eligible if...** - You have an advanced or metastatic solid tumor, or a relapsed or treatment-resistant blood cancer - Your cancer has failed standard therapies and no effective treatments remain - You have a good performance score (ECOG 0-1) - You have a life expectancy of at least 3 months - Your organs (blood, liver, kidneys) are functioning adequately - You are willing to provide tumor samples and blood for testing **You may NOT be eligible if...** - You have an allergy to any ingredient in TGRX-1942 - You have had another type of cancer - You have unresolved toxic effects from prior treatments - You are pregnant or not willing to use contraception Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGTGRX-1942

At dose escalation phase, TGRX-1942 will be given orally to patient once a day under a 7-dose sequence of 4mg, 10mg, 20mg, 30mg, 40mg, 50mg, and 60mg. The dose level a particular patient will be assigned depends on the progression of the study and PI evaluation on the safety of previous dose group(s).

Locations(1)

Sir Run Run Shaw Hospital, Zhejiang University School of Medicine

Hangzhou, Zhejiang, China

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NCT06484816

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