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

Shenzhen TargetRx

Status and phase

Enrolling

Phase 1

Conditions

Hematologic Malignancy

Advanced Solid Tumor

Non Small Cell Lung Cancer

Treatments

Drug: TGRX-1942

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT06484816

TGRX-1942-1001

Details and patient eligibility

About

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

Full description

This study is designed as a three-part study, with dose escalation, dose expansion and indication expansion phases. Patients with advanced solid tumors will be initially enrolled to the study. Other indications including solid tumors with specific gene mutations, or other hematological malignancies with be considered for expansion phases, with appropriate doses as evaluated at the end of dose escalation phase.

Enrollment

90 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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