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New treatment option for Non Small Cell Lung Cancer
Official title TGRX-1942 Chinese Phase I for Advanced Solid Tumor And/or Relapsed/Refractory Hematologic Malignancies
ClinicalTrials.gov ID: NCT06484816
What this study is testing
What is TGRX-1942?
TGRX-1942 is an investigational medicine, given as an once-daily pill taken by mouth, being studied as a potential treatment for non small cell lung cancer.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- For dose escalation phase, patient is diagnosed with advanced/metastatic solid tumor who had failed standard therapies and does not have available...
- 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...
You likely can't join if
- 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...
- 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
See the full eligibility 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
- 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...
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Hangzhou, Zhejiang, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Hangzhou, Zhejiang, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.