Non Small Cell Lung CancerPhase 1NCT06484816
TGRX-1942 Chinese Phase I for Advanced Solid Tumor And/or Relapsed/Refractory Hematologic Malignancies
A Phase 1 study testing TGRX-1942 in people with Non Small Cell Lung Cancer and Advanced Solid Tumor, run by Shenzhen TargetRx Co., Ltd. at 1 site in China.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non Small Cell Lung Cancer, Advanced Solid Tumor, Hematologic Malignancy
- What is being tested?
- TGRX-1942
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteChina
- Study dates
- 8 Jul 2024to Jun 2027
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 14Show fewer
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Sir Run Run Shaw Hospital, Zhejiang University School of Medicine
Hangzhou, Zhejiang, 310009
Hongming Pan, MD, 86-0571-86006926, panhongming@zju.edu.cn
About this study
Official title: 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
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
Read the detailed 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.
- Being tested
- TGRX-1942
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung, Hematologic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TGRX-1942Drug
At dose escalation phase, TGRX-1942 will be given orally to patient once a day under a 7-dose sequence of 4mg, 10mg, 20mg, 30mg, 40mg, 50mg, and 60mg. The dose level a particular patient will be assigned depends on the progression of the study and PI evaluation on the safety of previous dose group(s).
| Study group | Role | What they receive |
|---|---|---|
| Experimental: TGRX-1942 | Experimental | Patients will be given one of the doses of 4mg, 10mg, 20mg, 30mg, 40mg, 50mg, or 60mg orally once a day Receives: Drug: TGRX-1942 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse events/serious adverse events
to record and analyse the occasions and rates of subjects with adverse events (AEs) and serious adverse events (SAEs) to understand drug safety profile
Measured: From screening through completion of the study, an average of 3.5 years.
Maximum Tolerated Dose (MTD)
MTD is defined as the dose level with dose-limiting toxicity (DLT) rate of greater than 0.322 as calculated using the BOIN design at dose escalation phase.
Measured: From Day 1 of Cycle 1 to Day 28 of Cycle 1 of dose escalation phase (each cycle is 28 days)
Secondary outcomes (11)
Preliminary efficacy
For patients with advanced solid tumors, efficacy is evaluated based on RECIST 1.1 criteria which evaluates tumor size changes. Preliminary efficacy is evaluated by Principal investigator.
Measured: From screening, every 3 cycles during treatment period (each cycle is 28 days) and at end of study, an average of 3.5 years.
Time to Maximum Concentration (Tmax)
To measure the time to reach maximum plasma drug concentration from dosing
Measured: On day 1-6 of the single dosing phase; patient will only be dosed once on Day 1 of this phase
Maximum Concentration (Cmax)
To measure the maximum plasma drug concentration from dosing
Measured: On day 1-6 of the single dosing phase; patient will only be dosed once on Day 1 of this phase
Area Under Curve (AUC0-t)
To calculate area under curve of drug plasma concentration from dosing to last measurable time point
Measured: On day 1-6 of the single dosing phase; patient will only be dosed once on Day 1 of this phase
Half life (T1/2)
to measure the time needed to reach half maximal concentration from dosing
Measured: On day 1-6 of the single dosing phase; patient will only be dosed once on Day 1 of this phase
Apparent Clearance (CL/F)
To calculate the rate of clearance of the drug after first dosing
Measured: On day 1-6 of the single dosing phase; patient will only be dosed once on Day 1 of this phase
Apparent Volume of Distribution (Vz/F)
To calculate the volume of distribution of the drug after first dosing
Measured: On day 1-6 of the single dosing phase; patient will only be dosed once on Day 1 of this phase
Steady State Time to Maximal Concentration (Tmax,ss)
Under once daily dosing schedule, to measure the time to reach maximum plasma drug concentration between two dosing timepoints
Measured: On day 1 of Cycle 1 of dose escalation phase (each cycle is 28 days)
Steady State Maximal Concentration (Cmax,ss)
Under once daily dosing schedule, to measure the maximal plasma drug concentration from first dosing
Measured: On Day 1, 8, 15 and 22 of Cycle 1 and Day 1 of every 3 cycles (each cycle is 28 days). Average duration of the treatment period is 3 years.
Steady State Trough Concentration (Ctrough,ss)
Under once daily dosing schedule, to measure the minimal plasma drug concentration from first dosing
Measured: On Day 1, 8, 15 and 22 of Cycle 1 and Day 1 of every 3 cycles (each cycle is 28 days). Average duration of the treatment period is 3 years.
Steady State Area Under Curve (AUC0-t,ss)
Under once daily dosing schedule, to calculate area under curve of drug plasma concentration between two dosing timepoints
Measured: On Day 1, 8, 15 and 22 of Cycle 1 and Day 1 of every 3 cycles (each cycle is 28 days). Average duration of the treatment period is 3 years.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jul 2024
- Study start8 Jul 2024
- Primary completionFeb 2027 (estimated)
- Study completionJun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non Small Cell Lung CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shenzhen TargetRx Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Sir Run Run Shaw Hospital
- Responsible party
- Sponsor
- Investigators
- panhongming@zju.edu.cn Pan, MD, Principal investigator, Zhejiang University School of Medicine Sir Run Run Shaw Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06484816
- Sponsor's protocol ID
- TGRX-1942-1001
- Status last verified
- Feb 2025
- First submitted
- 26 Jun 2024
- Last updated
- 24 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT06484816
- Acronym / sponsor ID
- TGRX-1942-1001
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Shenzhen TargetRx Co., Ltd.Industry (pharma, biotech, devices)
- Collaborators
- Sir Run Run Shaw Hospital
- Study start
- 8 Jul 2024 (actual)
- Primary completion
- Feb 2027 (estimated)
- Study completion
- Jun 2027 (estimated)
- First posted
- 3 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Detailed 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Experimental: TGRX-1942 | Experimental | Drug: TGRX-1942Patients will be given one of the doses of 4mg, 10mg, 20mg, 30mg, 40mg, 50mg, or 60mg orally once a day |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (14 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TGRX-1942At dose escalation phase, TGRX-1942 will be given orally to patient once a day under a 7-dose sequence of 4mg, 10mg, 20mg, 30mg, 40mg, 50mg, and 60mg. The dose level a particular patient will be assigned depends on the progression of the study and PI evaluation on the safety of previous dose group(s). | Drug | Experimental: TGRX-1942 |
Primary outcome
Adverse events/serious adverse events
Time frame: From screening through completion of the study, an average of 3.5 years.
to record and analyse the occasions and rates of subjects with adverse events (AEs) and serious adverse events (SAEs) to understand drug safety profile
Maximum Tolerated Dose (MTD)
Time frame: From Day 1 of Cycle 1 to Day 28 of Cycle 1 of dose escalation phase (each cycle is 28 days)
MTD is defined as the dose level with dose-limiting toxicity (DLT) rate of greater than 0.322 as calculated using the BOIN design at dose escalation phase.
11 secondary outcomes
Preliminary efficacy
Time frame: From screening, every 3 cycles during treatment period (each cycle is 28 days) and at end of study, an average of 3.5 years.
Time to Maximum Concentration (Tmax)
Time frame: On day 1-6 of the single dosing phase; patient will only be dosed once on Day 1 of this phase
Maximum Concentration (Cmax)
Time frame: On day 1-6 of the single dosing phase; patient will only be dosed once on Day 1 of this phase
Area Under Curve (AUC0-t)
Time frame: On day 1-6 of the single dosing phase; patient will only be dosed once on Day 1 of this phase
Half life (T1/2)
Time frame: On day 1-6 of the single dosing phase; patient will only be dosed once on Day 1 of this phase
Apparent Clearance (CL/F)
Time frame: On day 1-6 of the single dosing phase; patient will only be dosed once on Day 1 of this phase
Apparent Volume of Distribution (Vz/F)
Time frame: On day 1-6 of the single dosing phase; patient will only be dosed once on Day 1 of this phase
Steady State Time to Maximal Concentration (Tmax,ss)
Time frame: On day 1 of Cycle 1 of dose escalation phase (each cycle is 28 days)
Steady State Maximal Concentration (Cmax,ss)
Time frame: On Day 1, 8, 15 and 22 of Cycle 1 and Day 1 of every 3 cycles (each cycle is 28 days). Average duration of the treatment period is 3 years.
Steady State Trough Concentration (Ctrough,ss)
Time frame: On Day 1, 8, 15 and 22 of Cycle 1 and Day 1 of every 3 cycles (each cycle is 28 days). Average duration of the treatment period is 3 years.
Steady State Area Under Curve (AUC0-t,ss)
Time frame: On Day 1, 8, 15 and 22 of Cycle 1 and Day 1 of every 3 cycles (each cycle is 28 days). Average duration of the treatment period is 3 years.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Feb 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
panhongming@zju.edu.cn Pan, MD principal investigator
Zhejiang University School of Medicine Sir Run Run Shaw Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing TGRX-1942 in people with Non Small Cell Lung Cancer and Advanced Solid Tumor, run by Shenzhen TargetRx Co., Ltd. at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 24 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Hongming Pan, MD (86-0571-86006926, panhongming@zju.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adverse events/serious adverse events (time frame: From screening through completion of the study, an average of 3.5 years.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Feb 2025.