Actively Recruiting
TGRX-1942 Chinese Phase I for Advanced Solid Tumor And/or Relapsed/Refractory Hematologic Malignancies
Led by Shenzhen TargetRx Co., Ltd. · Updated on 2025-02-24
90
Participants Needed
1
Research Sites
151 weeks
Total Duration
On this page
Sponsors
S
Shenzhen TargetRx Co., Ltd.
Lead Sponsor
S
Sir Run Run Shaw Hospital
Collaborating Sponsor
AI-Summary
What this Trial Is 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
CONDITIONS
Official Title
TGRX-1942 Chinese Phase I for Advanced Solid Tumor And/or Relapsed/Refractory Hematologic Malignancies
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosed with advanced/metastatic solid tumor who failed standard therapies or relapsed from prior treatments (for dose escalation phase)
- ECOG score equal to or lower than 1
- Life expectancy of at least 3 months
- Adequate hematologic, liver, and kidney functions
- Willing to provide tumor biopsy samples or reports, or willing to undergo tumor biopsy examination
- Willing to provide whole blood samples for evaluations
- Female of child-bearing potential must have negative plasma pregnancy test 28 days before first dose
- Male and female of child-bearing potential must agree to use effective contraception during treatment and for 2 months after
- Understand and willing to sign informed consent
- Willing and able to complete visit schedule and study tasks
You will not qualify if you...
- Allergy to any ingredient of the investigational drug
- History of other primary cancers
- Unrecovered adverse or toxic effects from prior treatment above Grade 1 (CTCAE 5.0)
- Received other anti-tumor treatments within 28 days before first dose, or radiation therapy within 14 days
- Used drugs affecting P450 metabolism within 2 weeks before first dose
- Participated in other clinical trials using investigational agents within 28 days before first dose
- Major surgeries or traumatic injuries within 28 days before first dose
- Need to use drugs causing QTc elongation or Torsades de Pointes
- Presence or history of HIV, HBV, HCV infection; anticoagulation treatment; coagulation dysfunction; major cardiovascular disease; pneumonia; significant gastrointestinal issues affecting drug absorption; uncontrolled hypertension; ulcers; uncontrolled seizures or CNS diseases; poorly managed diabetes; long QT syndrome; uncontrolled infections; uncontrolled pericardial or abdominal effusion; adrenal malfunction; thyroid dysfunction; severe unhealed wounds, ulcers, or bone fractures; toxic epidermal necrolysis; Stevens-Johnson syndrome
- Symptomatic or uncontrolled CNS tumors or leptomeningeal tumors, or untreated spinal cord compression diseases
- Female patients who are pregnant or breastfeeding
- Any condition or history affecting study results or participation as judged by investigator
- Use of immunosuppressant drugs within 14 days before first dose
- Vaccine injection within 30 days before Cycle 1 Day 1
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Sir Run Run Shaw Hospital, Zhejiang University School of Medicine
Hangzhou, Zhejiang, China, 310009
Actively Recruiting
Research Team
H
Hongming Pan, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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