NCT06484816 TGRX-1942 Chinese Phase I for Advanced Solid Tumor And/or Relapsed/Refractory Hematologic Malignancies
| NCT ID | NCT06484816 |
| Status | Recruiting |
| Phase | Phase 1 |
| Sponsor | Shenzhen TargetRx Co., Ltd. |
| Condition | Non Small Cell Lung Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 90 participants |
| Start Date | 2024-07-08 |
| Primary Completion | 2027-02 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 90 participants in total. It began in 2024-07-08 with a primary completion date of 2027-02.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 Criteria
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
Contact & Investigator
panhongming@zju.edu.cn Pan, MD
PRINCIPAL INVESTIGATOR
Zhejiang University School of Medicine Sir Run Run Shaw Hospital
Frequently Asked Questions
Who can join the NCT06484816 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Non Small Cell Lung Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06484816 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT06484816 currently recruiting?
Yes, NCT06484816 is actively recruiting participants. Contact the research team at panhongming@zju.edu.cn for enrollment information.
Where is the NCT06484816 trial being conducted?
This trial is being conducted at Hangzhou, China.
Who is sponsoring the NCT06484816 clinical trial?
NCT06484816 is sponsored by Shenzhen TargetRx Co., Ltd.. The principal investigator is panhongming@zju.edu.cn Pan, MD at Zhejiang University School of Medicine Sir Run Run Shaw Hospital. The trial plans to enroll 90 participants.
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