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

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

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

Conditions5

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