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Tests treatment safety and results for Advanced Solid Tumor
Official title Safety and Tolerability Study for T-1301 Capsules to Treat Advanced Solid Tumors
ClinicalTrials.gov ID: NCT05156203
What this study is testing
What is T-1301 Capsules?
T-1301 Capsules is an investigational medicine, given as an once-daily pill taken by mouth, being studied as a potential treatment for advanced solid tumor.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- T-1301 is a novel small-molecule inhibitor of multiple kinases being developed as an oral drug for the treatment of advanced solid tumors. The nonclinical study results demonstrate the nonclinical efficacy and safety of T-1301 and support the design of this Phase 1, first-in-human (FIH) clinical trial in subjects with advanced cancer.
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 20 and older
You may be able to join if
- Having signed and dated informed consent form indicating that the subject has been informed of all pertinent aspects of the study.
- people with histologically and cytologically confirmed advanced solid tumors (including lymphoma) that are refractory to standard treatments, or for...
- Solid tumors that are measurable or evaluable per Response Evaluation Criteria in Solid Tumors (RECIST v1.1). Target lesions that have been...
- Have a life expectancy of ≥ 3 months in the Investigator's opinion.
- Females or males ≥ 20 years old.
You likely can't join if
- Major surgery within 4 weeks prior to the first dose of study drug.
- people receiving any of the following anti-cancer therapy:
- Anti-cancer definitive radiation therapy (4,000-6,000 cGy) within 4 weeks prior to the first dose of study drug.
- Palliative radiation (≤ 10 fractions with total dose \< 3,000 cGy) within 2 weeks prior to the first dose of study drug.
- Any systemic cytotoxic chemotherapy within 4 weeks prior to the first dose of study drug.
- Any targeted therapy within 2 weeks or 5 half-lives, whichever is longer, prior to the first dose of study drug.
See the full eligibility criteria
- Having signed and dated informed consent form indicating that the subject has been informed of all pertinent aspects of the study.
- people with histologically and cytologically confirmed advanced solid tumors (including lymphoma) that are refractory to standard treatments, or for whom no standard treatment is available, or who are not amenable or...
- Solid tumors that are measurable or evaluable per Response Evaluation Criteria in Solid Tumors (RECIST v1.1). Target lesions that have been previously irradiated will not be considered measurable (lesion) unless...
- Have a life expectancy of ≥ 3 months in the Investigator's opinion.
- Females or males ≥ 20 years old.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
- Recovered from prior treatment-related toxicity to at least grade 1 with the exception of alopecia.
- Adequate organ function as defined by the following criteria:
- Serum alanine transaminase (ALT) ≤ 3 x upper limit of normal (ULN)
- Total serum bilirubin ≤ 1.5 x ULN
- Absolute neutrophil count (ANC) ≥ 1500/µL
- Platelets ≥ 100,000/µL
- Hemoglobin ≥ 9.0 g/dL
- Creatinine clearance (CrCl) ≥ 50 mL/min CrCl = [(140 - age (year)) x weight (kg)] / (serum creatinine x 72) (x 0.85 for females)
- Willingness and ability to comply with the study scheduled visits, treatment plans, laboratory tests and other procedures.
- Major surgery within 4 weeks prior to the first dose of study drug.
- people receiving any of the following anti-cancer therapy:
- Anti-cancer definitive radiation therapy (4,000-6,000 cGy) within 4 weeks prior to the first dose of study drug.
- Palliative radiation (≤ 10 fractions with total dose \< 3,000 cGy) within 2 weeks prior to the first dose of study drug.
- Any systemic cytotoxic chemotherapy within 4 weeks prior to the first dose of study drug.
- Any targeted therapy within 2 weeks or 5 half-lives, whichever is longer, prior to the first dose of study drug.
- Any immunotherapy within 4 weeks prior to the first dose of study drug.
- Any treatment treatments in another clinical trial following Exclusion Criteria 2c, 2d and 2e.
- people received blood transfusion or biological response modifiers (e.g., G-CSF) within 2 weeks prior to the first dose of study drug.
- Subject who received autologous bone marrow transplant or stem cells rescue within 6 months prior to the first dose of study drug.
- people received strong inhibitors and/or inducers of CYP3A4 within 14 days prior to the first dose of study drug. A list of CYP3A4 modulators is provided in Appendix 3.
- Documented or suspected brain metastases, spinal cord compression, carcinomatous meningitis, or leptomeningeal disease.
- Any of the following within 6 months of the first dose of study drug: myocardial infarction, severe/unstable angina, coronary/peripheral artery bypass graft, congestive heart failure, or cerebrovascular accident...
- Ongoing cardiac dysrhythmias of ≥ NCI CTCAE version 5.0 grade 2, or atrial fibrillation of any grade. Corrected QT interval by Fridericia (QTcF) ≥ 470 msec.
- Hypertension that cannot be controlled by medications (\> 160/100 mm-Hg despite optimal medical therapy).
- AIDS-defining opportunistic infections within the past 12 months.
- Positive test for hepatitis B (HBsAg) or hepatitis C (anti-HCV (anti-hepatitis C virus) antibody), unless the HCV RNA level is below the limit of detection (for people with positive anti-HCV Ab).
- Men and women of childbearing potential who are unwilling to use highly effective contraceptive methods during the study period. Highly effective contraceptive methods include implants, injectables, combined oral...
- If females, patient is pregnant or breast feeding.
- Other severe acute or chronic medical or psychiatric condition or laboratory abnormality that would impart, in the judgement of the investigator and/or sponsor, excess risk associated with study participation or study...
The study team makes the final eligibility decision.
Where it's taking place
- Kaohsiung City, Taiwan
- Taipei, Taiwan
- Taoyuan City, Taiwan
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 20 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Kaohsiung City, Taiwan; Taipei, Taiwan; Taoyuan City, Taiwan. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.