TGRX-1942 Chinese Phase I for Advanced Solid Tumor And/or Relapsed/Refractory Hematologic Malignancies

NCT06484816 | Recruiting Phase 1

• 1 other identifier: TGRX-1942-1001
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

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

Conditions

Non Small Cell Lung Cancer; Advanced Solid Tumor; Hematologic Malignancy

Outcome Measures

Primary Outcomes (2)

• 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

  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.

  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

  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)

  On day 1-6 of the single dosing phase; patient will only be dosed once on Day 1 of this phase

• Maximum Concentration (Cmax)

  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)

  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)

  On day 1-6 of the single dosing phase; patient will only be dosed once on Day 1 of this phase

Study Arms (1)

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

Drug: TGRX-1942

Interventions

TGRX-1942 DRUG

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).

Experimental: TGRX-1942

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify 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 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

Sponsors & Collaborators

• Shenzhen TargetRx, Inc.: lead
• Sir Run Run Shaw Hospital: collaborator

Study Sites (1)

Sir Run Run Shaw Hospital, Zhejiang University School of Medicine

Hangzhou, Zhejiang, 310009, China

RECRUITING

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung; Hematologic Neoplasms

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Hematologic Diseases; Hemic and Lymphatic Diseases

Study Officials

• panhongming@zju.edu.cn Pan, MD

  Zhejiang University School of Medicine Sir Run Run Shaw Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Hongming Pan, MD

CONTACT

86-0571-86006926; panhongming@zju.edu.cn

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 26, 2024
• First Posted: July 3, 2024
• Study Start: July 8, 2024
• Primary Completion (Estimated): February 1, 2027
• Study Completion (Estimated): June 1, 2027
• Last Updated: February 24, 2025

Record last verified: 2025-02

Locations

CN (1)