Clinical trial · Interventional
TGRX-1942 Chinese Phase I for Advanced Solid Tumor And/or Relapsed/Refractory Hematologic Malignancies
A Dose Escalation and Expansion Phase I Study Evaluating the Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of TGRX-1942 in Patients with Advanced Solid Tumor And/or Relapsed/Refractory Hematologic Malignancies
NCT06484816CI-TRIAL-00086399recruitingPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Advanced Solid Tumor | Solid Neoplasm | CURATED_BROADER | 0.80 |
| Hematologic Malignancy | Hematopoietic and Lymphoid Cell Neoplasm | ALIAS | 0.90 |
| Non Small Cell Lung Cancer | Lung Non-Small Cell Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| TGRX-1942 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Experimental: TGRX-1942
- description
- Patients will be given one of the doses of 4mg, 10mg, 20mg, 30mg, 40mg, 50mg, or 60mg orally once a day
- interventionNames
- Drug: TGRX-1942
Primary outcomes (2)
- measure
- Adverse events/serious adverse events
- timeFrame
- From screening through completion of the study, an average of 3.5 years.
- description
- to record and analyse the occasions and rates of subjects with adverse events (AEs) and serious adverse events (SAEs) to understand drug safety profile
- measure
- Maximum Tolerated Dose (MTD)
- timeFrame
- From Day 1 of Cycle 1 to Day 28 of Cycle 1 of dose escalation phase (each cycle is 28 days)
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.