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Clinical Trials in China / NCT06484816
Recruiting Phase 1

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

NCT06484816 · tracked via the Priya Life Science China tracker
Sponsor
Shenzhen TargetRx Co., Ltd.
Phase
Phase 1
Started
2024-07-08
Last updated
2025-02-24

Condition(s) studied

Non Small Cell Lung CancerAdvanced Solid TumorHematologic Malignancy

Investigational drug(s) / intervention(s)

TGRX-1942

TGRX-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).

Study 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

Sex
ALL
Min age
18 Years
Max age
Healthy volunteers
No
Inclusion Criteria: * For dose escalation phase, patient is diagnosed with advanced/metastatic solid tumor who had failed standard therapies and does not have available effective treatment, or who relapsed from prior treatments * ECOG score of equals to or lower than 1 * Life expectancy of at least 3 months * Adequate systemic and organ functions, including hematologic, hepatic and kidney functions * Willing to provide available tumor biopsy sample or reports, or willing to undergo tumor biopsy examination, and willing to partake whole blood sampling for evaluations * For female of child-bearing potential, willing to undergo plasma pregnancy test 28 days before first dose and have negative results * Male and Female of child-bearing potential must agree to take effective contraceptive measures during the entire treatment period and for 2 months after the end of treatment * Understand and willing to sign informed concent; willing and able to complete the visiting schedule and other tasks as required for the study Exclusion Criteria: * Allergic to any of the ingredient of the investigational drug * History of other primary malignancies * Have adverse/toxic effects from previous treatment that has not recovered to CTCAE 5.0 \<= Grade 1 * Received other anti-tumor treatments (i.e., chemotherapy, biologics, immunotherapy, targeted therapy, etc.) 28 days before first dose, or radiation therapy 14 days before first dose * Used drugs known to significantly affect P450 metabolism 2 weeks before first dose * Participated in other clinical trials and used other investigational agents 28 days before first dose * Received major surgeries or had traumatic injuries 28 days before first dose * Need to use concomitant drugs that could cause QTc elongation or induce Torsades de Pointes * History or presence of other medical conditions, such as HIV/HBV/HCV positive; received anticoagulation treatment; coagulation dysfunction; major or clinically significant cardiovascular disease; pneumonia; clinically significant gastrointestinal abnormalities that could affect drug absorption; uncontrollable hypertension; ulcer in abdomen, intestine, stomach, trachea or esophagus; uncontrolled seizure or have other central nervous system diseases, poorly managed diabetes; long QT syndrome; uncontrolled active infections; uncontrolled pericardial or abdominal effusion; adrenaline malfunction; thyroid dysfunction; severe unhealed wound, ulcer or bone fractures; Toxic epidermal necrolysis; Stevens-Johnson syndrome * Have symptomatic or uncontrolled primary or metastatic central nervous system tumor or Leptomeninges tumor, or untreated diseases that cause compressions to spinal cords * For female patients: in pregnancy or breast-feeding periods * Presence of any condition or history that could affect study results or participation to the study in the judgement of the investigator * Used immunosuppressant drugs within14 days before first dose * Received vaccine injection within 30 days of Cycle 1 Day 1

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
Sir Run Run Shaw Hospital, Zhejiang University School of Medicine Hangzhou Zhejiang Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06484816 on ClinicalTrials.gov ↗ ← All trials in China