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Advanced Solid TumorPhase 1NCT04866641

Safety and Tolerability Study for T-1201 Injection 100 mg Kit in Patients With Advanced Solid Tumors

A Phase 1 study testing T-1201 Injection 100 mg Kit in people with Advanced Solid Tumor, run by Taivex Therapeutics Corporation at 2 sites in Taiwan.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

The goal of this clinical trial is to evaluate the safety, tolerability, pharmacokinetics (PK), and preliminary efficacy of T-1201 injection in subjects with advanced solid tumors refractory to standard therapy, or for whom no standard therapy is available. Read more about this study

Who is it for?
Ages 20 years and older
Conditions the study is for
Advanced Solid Tumor
What is being tested?
T-1201 Injection 100 mg Kit
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
40 participants
Where
2 sitesTaiwan
Study dates
24 Jun 2021to 31 Dec 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 20 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Subjects must meet all of the following criteria to be eligible for enrollment in the study:
  • Signed and dated informed consent form.
  • Histologically and cytologically confirmed advanced malignancies that are refractory to standard therapy or have no accepted standard therapy.
  • Solid tumors that are measurable or evaluable as per Response Evaluation Criteria in Solid Tumors (RECIST v1.1). Target lesions that have been previously irradiated will not be considered measurable (lesion).
  • Female or male, 20 years of age or older.
  • ECOG performance status 0 or 1.
  • QTcF ≤ 470 ms at screening.

Who cannot join

  • Subjects presenting with any of the following will not be included in the study:
  • Clinically significant comorbidity such as unstable angina, congestive heart failure (NYHA Grade III or IV), uncontrolled hypertension (>160/100 mmHg despite optimal medical treatment), chronic obstructive pulmonary disease (COPD) with frequent exacerbations, refractory asthma, inflammatory bowel disease or intestinal obstruction.
  • Acute myocardial infarction or cerebrovascular accident (CVA) within 6 months prior the first dose of study drug.
  • Central nervous system (CNS) metastasis or seizure disorder due to underlying malignancy except those who have been treated and have stable CNS metastases or are asymptomatic.
  • AIDS-defining opportunistic infections within the past 12 months.
  • HBV infection (positive HBsAg) except for carrier of inactive HBV as defined by negative HBeAg with normal ALT and HBV DNA < 2,000 IU/mL or HCV infection (positive anti-HCV antibody) except for those with undetectable HCV RNA.
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  • Inadequate bone marrow reserve, hepatic or renal function as defined by any of the following laboratory values:
  • absolute neutrophil count (ANC) < 1500/µL
  • platelet count < 100 x 10^9 /µL
  • hemoglobin < 9 g/dL
  • total bilirubin > 1.5 x the upper limit of normal (ULN)
  • aspartate aminotransferase (AST) or alanine aminotransferase (ALT) > 3 x ULN if no hepatic metastases are present; > 5 x ULN if hepatic metastases are present
  • Estimated (Cockroft-Gault formula) creatinine clearance (CrCl) < 60 mL/min CrCl = [(140 - age (year)) x weight (kg)] / (serum creatinine x 72) (x 0.85 for females)
  • Toxicities resulting from prior therapy or surgical procedures not yet resolved to ≤ NCI CTCAE v5.0 Grade 1 with the exception of alopecia, skin hyperpigmentation or hypopigmentation.
  • Major surgical procedures (as defined by Investigator) within 4 weeks prior to the first dose of study drug or any ongoing post-operative complications.
  • Receiving any (investigational or approved) anti-cancer therapy (including chemotherapy or targeted therapy) within 28 days or 5 half-lives (whichever is longer) prior to the first dose of study drug.
  • A history of apparent allergic reactions to irinotecan, Tween 80 (dosed with prior treatment with prophylactic drug), and/or ethanol.
  • If female, is pregnant or breastfeeding.
  • If men or women with childbearing potential, unwilling to use effective contraceptive methods during the study and for at least 3 months (men) or 1 month (women) after the last dose of study drug. Effective contraceptive methods include implants, injectables, combined oral contraceptives, intra-uterine devices (IUDs), sexual abstinence, surgical sterilization or a partner who is sterile.
  • Receiving live attenuated vaccine within 28 days prior to the first dose of study drug.
  • Life expectancy < 3 months
  • Other prior or ongoing condition(s) that, in Investigator's opinion, could affect the safety of the subject, compromise the subject's ability to comply with the study requirements or impair the assessment of study results.

Trial locations and contacts

2 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Hsiao-Fang Li, Ph.D contact

+886227486200 ext. 127

hfli@taivex.com

TJ Wu contact

+886227486200 ext. 163

tj_wu@taivex.com

Taiwan2 sites, 2 recruiting

  • Kaohsiung Medical University Chung-Ho Memorial Hospital

    Kaohsiung City

    Hui-Ching Wang, M.D., 886975358630

    Hui-Ching Wang, M.D.

    Recruiting

  • National Cheng Kung University Hospital

    Tainan

    Yu-Min Yeh, M.D., 88662353535 ext. 4626, i5485111@gmail.com

    Yu-Min Yeh, M.D.

    Recruiting

Other trials in Taiwan

About this study

Official title: A Phase I, Open-label, Dose-finding Study to Assess the Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of T-1201 Injection 100 mg Kit in Patients With Advanced Solid Tumors

The goal of this clinical trial is to evaluate the safety, tolerability, pharmacokinetics (PK), and preliminary efficacy of T-1201 injection in subjects with advanced solid tumors refractory to standard therapy, or for whom no standard therapy is available. The main questions it aims to answer are:

  • The Maximum tolerated dose (MTD) of T-1201 on different dosing schedules.
  • The Recommended Phase 2 dose (RP2D) of T-1201 on different dosing schedules.
Read more

Researchers will evaluate the safety, tolerability, pharmacokinetics (PK), and preliminary efficacy of T-1201.

Participants will:

Received T-1201 either once every 4 (Part A)/2 (Part B)/3 (Part C) weeks, depend on they participate in which parts of study.

Visit the clinic once every 2/3 weeks for checkups and tests

Being tested
T-1201 Injection 100 mg Kit

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • T-1201 Injection 100 mg KitDrug

    T-1201 Injection 100 mg Kit contains lyophilized powder with a sterile aqueous solution formulated for intravenous administration.

Study groups in NCT04866641
Study groupRoleWhat they receive
T-1201 Injection 100 mg KitExperimentalT-1201 Injection 100 mg Kit will be administered via intravenous infusion once every 4 weeks (Part A), 2 weeks (Part B) or 3 weeks (Part C). T-1201 Injection 100 mg Kit is required to be reconstituted with its specific Injection Diluent supplied in the kit, then further diluted with 5% Dextrose solution prior to the intravenous infusion in patients.
Receives: Drug: T-1201 Injection 100 mg Kit

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Maximum tolerated dose (MTD)

    MTD is highest dose level in which 6 patients have been treated with at most 1 experiencing dose limiting toxicity (DLT).

    Measured: First treatment cycle (i.e., the first 28 days post the first dose)

  2. Recommended Phase 2 dose (RP2D) dose (RP2D)

    To determine the recommended Phase 2 dose (RP2D)

    Measured: First treatment cycle (i.e., the first 28 days post the first dose)

  3. Frequency, type, severity and relationship to study drug of adverse events (AEs)

    Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]

    Measured: At least 2 months

Secondary outcomes (9)

  1. Pharmacokinetic profiles: Cmax of T-1201 and its metabolite(s) [0060 and SN-38]

    Maximum plasma concentration (Cmax ) of T-1201, 0060, and SN-38 from plasma concentration-time profiles.

    Measured: 340 hours

  2. Pharmacokinetic profiles: Tmax of T-1201 and its metabolite(s) [0060 and SN-38]

    Time to reach maximum concentration (Tmax ) of T-1201, 0060, and SN-38 from plasma concentration-time profiles.

    Measured: 340 hours

  3. Pharmacokinetic profiles: MRT of T-1201 and its metabolite(s) [0060 and SN-38]

    Mean residence time (MRT) of T-1201, 0060, and SN-38 from plasma concentration-time profiles.

    Measured: 340 hours

  4. Pharmacokinetic profiles: AUC of T-1201 and its metabolite(s) [0060 and SN-38]

    The area under the plasma concentration-time curve (AUC) of T-1201, 0060, and SN-38 from plasma concentration-time profiles.

    Measured: 340 hours

  5. Pharmacokinetic profiles: T1/2 of T-1201 and its metabolite(s) [0060 and SN-38]

    Terminal half-life (T1/2 ) of T-1201, 0060, and SN-38 from plasma concentration-time profiles.

    Measured: 340 hours

  6. Assess preliminary anti-tumor activity: ORR of T-1201 according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1

    Objective response rate (ORR)

    Measured: At least 56 days

  7. Assess preliminary anti-tumor activity: CBR of T-1201 according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1

    Clinical benefit rate (CBR)

    Measured: At least 56 days

  8. Assess preliminary anti-tumor activity: DOR of T-1201 according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1

    Duration of response (DOR)

    Measured: At least 56 days

  9. Assess preliminary anti-tumor activity of T-1201 according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1

    Time to tumor progression per RECIST v1.1

    Measured: At least 56 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted30 Apr 2021
  2. Study start24 Jun 2021
  3. Primary completion30 Nov 2026 (estimated)
  4. Study completion31 Dec 2027 (estimated)

Resources

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
Sequential
Masking
None (open label)
Enrolment
40 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04866641
Sponsor's protocol ID
TAI-201
Status last verified
Sep 2026
First submitted
23 Apr 2021
Last updated
2 Oct 2026
Results posted
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing T-1201 Injection 100 mg Kit in people with Advanced Solid Tumor, run by Taivex Therapeutics Corporation at 2 sites in Taiwan.

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 7 inclusion and 22 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 2 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Taiwan. 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 Hsiao-Fang Li, Ph.D (+886227486200 ext. 127, hfli@taivex.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Maximum tolerated dose (MTD) (time frame: First treatment cycle (i.e., the first 28 days post the first dose)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04866641.

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 2 Oct 2026.

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