Can a new oral drug curb Hard-to-Treat cancers?
NCT ID NCT05156203
First seen Oct 05, 2026 · Last updated Oct 06, 2026 · Updated 1 time
Summary
Researchers are testing an experimental oral drug called T-1301 in people with advanced solid tumors or lymphoma that have not responded to standard treatments. The Phase I trial aims to find the highest dose participants can tolerate and the dose best suited for later studies. About 30 participants will receive T-1301 capsules in escalating doses over 28-day cycles, and researchers will track side effects and how the body processes the drug.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- T-1301, an experimental oral multi-kinase inhibitor
- What this could lead to
- If it works, this could point toward a new oral treatment option for advanced solid tumors and lymphoma that resist standard therapy.
- What could go wrong
- This is a first-in-human Phase I trial with about 30 participants, so its main goal is to find a safe dose, not to prove the drug works. Many experimental cancer drugs fail at this stage, and side effects are a key concern.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
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About 30 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Dec 2021
- Expected to finish
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Dec 2027
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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20 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. Having signed and dated informed consent form indicating that the subject has been informed of all pertinent aspects of the study. 2. Subjects 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 unwilling to receive standard treatments. 3. 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 increase in size is observed following completion of radiation therapy. 4. Have a life expectancy of ≥ 3 months in the Investigator's opinion. 5. Females or males ≥ 20 years old. 6. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1. 7. Recovered from prior treatment-related toxicity to at least grade 1 with the exception of alopecia. 8. Adequate organ function as defined by the following criteria: 1. Serum alanine transaminase (ALT) ≤ 3 x upper limit of normal (ULN) 2. Total serum bilirubin ≤ 1.5 x ULN 3. Absolute neutrophil count (ANC) ≥ 1500/µL 4. Platelets ≥ 100,000/µL 5. Hemoglobin ≥ 9.0 g/dL 6. Creatinine clearance (CrCl) ≥ 50 mL/min CrCl = \[(140 - age (year)) x weight (kg)\] / (serum creatinine x 72) (x 0.85 for females) 9. Willingness and ability to comply with the study scheduled visits, treatment plans, laboratory tests and other procedures. Exclusion Criteria: 1. Major surgery within 4 weeks prior to the first dose of study drug. 2. Subjects receiving any of the following anti-cancer therapy: 1. Anti-cancer definitive radiation therapy (4,000-6,000 cGy) within 4 weeks prior to the first dose of study drug. 2. Palliative radiation (≤ 10 fractions with total dose \< 3,000 cGy) within 2 weeks prior to the first dose of study drug. 3. Any systemic cytotoxic chemotherapy within 4 weeks prior to the first dose of study drug. 4. Any targeted therapy within 2 weeks or 5 half-lives, whichever is longer, prior to the first dose of study drug. 5. Any immunotherapy within 4 weeks prior to the first dose of study drug. 3. Any interventional treatments in another clinical trial following Exclusion Criteria 2c, 2d and 2e. 4. Subjects received blood transfusion or biological response modifiers (e.g., G-CSF) within 2 weeks prior to the first dose of study drug. 5. Subject who received autologous bone marrow transplant or stem cells rescue within 6 months prior to the first dose of study drug. 6. Subjects 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. 7. Documented or suspected brain metastases, spinal cord compression, carcinomatous meningitis, or leptomeningeal disease. 8. 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 including transient ischemic attack. 9. 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. 10. Hypertension that cannot be controlled by medications (\> 160/100 mm-Hg despite optimal medical therapy). 11. AIDS-defining opportunistic infections within the past 12 months. 12. Positive test for hepatitis B (HBsAg) or hepatitis C (anti-hepatitis C virus (anti-HCV) antibody), unless the HCV RNA level is below the limit of detection (for subjects with positive anti-HCV Ab). 13. 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 contraceptives, intra-uterine devices (IUDs), sexual abstinence, surgical sterilization or a partner who is sterile. 14. If females, patient is pregnant or breast feeding. 15. 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 drug administration.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
3 sites. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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ChangGung Memorial Hospital, Linkou
RECRUITINGTaoyuan City, Taiwan
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Kaohsiung Medical University Chung-Ho Memorial Hospital
RECRUITINGKaohsiung City, Taiwan
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Taipei Veterans General Hospital
RECRUITINGTaipei, Taiwan
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Experimental drug ZG005 put to the test against advanced solid tumors
- Radioactive antibody aims to seek and destroy CEA-Positive tumors
- Can a new antibody pair unlock the immune system against Hard-to-Treat tumors?
- New pill tested against Hard-to-Treat cancers
- Pairing two Immune-Boosting antibodies: a new strategy against solid tumors?
- Engineered immune cells target a notorious cancer mutation