Advanced Solid TumorsPhase 1NCT04830501
Study of the of the Safety and Tolerability of TT-00434 in Patients With Advanced Solid Tumors
A Phase 1 study testing TT-00434 in people with Advanced Solid Tumors, run by TransThera Sciences (Nanjing), Inc. at 3 sites in Taiwan.
Trial summary
This is a phase I study of the safety, tolerability, pharmacokinetics profile, and preliminary efficacy of TT-00434 in patients with advanced solid tumors. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Advanced Solid Tumors
- What is being tested?
- TT-00434
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 11 participants
- Where
- 3 sitesTaiwan
- Study dates
- 12 Jul 2021to 18 Oct 2023
- Phase
- Phase 1
- Are there results?
- None posted in the registry
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
- Age ≥ 20 years.
- Patients must have a histological or cytologically confirmed diagnosis of advanced or recurrent malignant solid tumors.
- Patients have received all currently available standard treatments (unless the therapy is contraindicated, intolerable or unavailable due to any reasons).
- Patients must have measurable or evaluable disease (according to RECIST 1.1)
- Eastern Cooperative Oncology Group (ECOG) Performance Status ≤ 2
- Must agree to take sufficient contraceptive methods to avoid pregnancy during the study and until at least 6 months after ceasing study treatment
- Patients must have fully understood and voluntarily signed informed consent form (ICF) for this study.
Who cannot join
- Patients who received other investigational products or devices in other clinical trials within 4 weeks before the first dose.
- Patients who received anti-tumor therapy within 4 weeks, or within 5-half-lives (which is longer) before the first dose, including but not limited to chemotherapy, radiotherapy (palliative radiotherapy is completed at least 2 weeks before the first dose can enrol), targeted therapy or immunotherapy.
- Patients who have previous toxicity of anti-tumor therapy that has not recovered to Grade 1. (except for ≤ Grade 2 alopecia, chemotherapy-induced peripheral neurotoxicity, and ototoxicity).
- Patients who have gastrointestinal disorders that will affect oral administration or the Investigator judges that the absorption of TT-00434 will be interfered.
- Patients underwent major surgery (except biopsy) within 4 weeks, or the surgical incision has not completely healed prior to the first dose.
- Patients who have active bacterial or fungal infections (CTCAE, Grade ≥ 2) that required systemic treatment within 2 weeks prior to the first dose.
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- Patients who have active HBV infection (HBV DNA copies ≥ ULN) and/or HCV infection (HCV RNA copies ≥ ULN)
- Patients who test positive for human immunodeficiency virus (HIV) or known acquired immunodeficiency syndrome.
- Has received a live-virus vaccination within 30 days of planned first dose NOTE: Seasonal flu vaccines are permitted.
- Known or suspected drug hypersensitivity to any ingredients of TT-00434 tablets.
- Female patients in pregnancy or lactation. Male patients or female patients at reproductive ages who are unwilling to receive effective contraceptive measures.
- Patients who are judged by the Investigator to be unsuitable for this study.
Trial locations and contacts
3 sites in 1 country.
Taiwan3 sites
National Cheng Kung University Hospital
Tainan
Taipei Medical University Hospital
Taipei
Tri-Service General Hospital
Taipei
About this study
Official title: A Phase I Study of the Safety, Tolerability, Pharmacokinetics Profile, and Preliminary Efficacy of TT-00434 in Patients With Advanced Solid Tumors
This is a phase I study of the safety, tolerability, pharmacokinetics profile, and preliminary efficacy of TT-00434 in patients with advanced solid tumors.
Read the detailed description
This is a phase I, First-in-Human (FIH), open-label, dose escalation clinical study in patients who have a histological or cytologically confirmed diagnosis of advanced or recurrent tumors that all standard treatments have been used or are not feasible. It aims to determine the maximum tolerated dose (MTD) and/or the recommended phase 2 dose (RP2D) for study, evaluate the safety, tolerability, pharmacokinetic (PK) and pharmacodynamic (PD) characteristics and the preliminary anti-tumor activity of TT-00434, and explore the relationship between the anti-tumor activity of TT-00434 and the tumor FGFR alterations.
- Conditions
- Advanced Solid Tumors
- Being tested
- TT-00434
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TT-00434Drug
Once daily [QD], 28 days/cycle.
| Study group | Role | What they receive |
|---|---|---|
| Dose Escalation | Experimental | This study adopts an accelerated titration design (ATD) and utilizes an accelerated dose escalation phase in order to minimize suboptimal drug exposures, followed by a conventional 3+3 dose escalation phase to achieve MTD. Receives: Drug: TT-00434 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dose Limiting Toxicity (DLT)
Safety and tolerability
Measured: At the end of Cycle 1 (each cycle is 28 days)
Incidence of AEs
Safety and tolerability
Measured: up to 30 days from study discontinuation
Secondary outcomes (8)
Peak Plasma Concentration (Cmax)
PK evaluation
Measured: At the end of Cycle 1 (each cycle is 28 days)
Area under the plasma concentration versus time curve (AUC)
PK evaluation
Measured: At the end of Cycle 1 (each cycle is 28 days)
Time of first Occurance of Cmax（tmax)
PK evaluation
Measured: At the end of Cycle 1 (each cycle is 28 days)
Serum phosphate levels
PD biomarker
Measured: up to 30 days from study discontinuation
Objective response rate (ORR)
Assess anti-tumor activity
Measured: through study completion, an average of 1 year
Disease control rate (DCR)
Assess anti-tumor activity
Measured: through study completion, an average of 1 year
Progression Free Survival (PFS)
Assess anti-tumor activity
Measured: through study completion, an average of 1 year
Overall Survival (OS)
Assess anti-tumor activity
Measured: through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Apr 2021
- Study start12 Jul 2021
- Primary completion18 Oct 2023
- Study completion18 Oct 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced Solid TumorsStudies 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
- 11 participants (actual)
Sponsor and investigators
- Lead sponsor
- TransThera Sciences (Nanjing), Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Huey En Tzeng, Principal investigator, Taipei Medical University HospitalChia Jui Yen, Principal investigator, National Cheng-Kung University HospitalChing Liang Ho, Principal investigator, Tri-Service General Hospital (TSGH)Ming Che Liu, Principal investigator, Taipei Medical University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04830501
- Sponsor's protocol ID
- TT00434CN01
- Status last verified
- Nov 2023
- First submitted
- 28 Mar 2021
- Last updated
- 21 Nov 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Study of the Safety, Tolerability, Pharmacokinetics Profile, and Preliminary Efficacy of TT-00434 in Patients With Advanced Solid Tumors
- ClinicalTrials.gov ID
- NCT04830501
- Acronym / sponsor ID
- TT00434CN01
- Conditions
- Advanced Solid Tumors
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 11 participants (actual)
- Lead sponsor
- TransThera Sciences (Nanjing), Inc.Industry (pharma, biotech, devices)
- Study start
- 12 Jul 2021 (actual)
- Primary completion
- 18 Oct 2023 (actual)
- Study completion
- 18 Oct 2023 (actual)
- First posted
- 5 Apr 2021 (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.
This is a phase I study of the safety, tolerability, pharmacokinetics profile, and preliminary efficacy of TT-00434 in patients with advanced solid tumors.
Detailed description
This is a phase I, First-in-Human (FIH), open-label, dose escalation clinical study in patients who have a histological or cytologically confirmed diagnosis of advanced or recurrent tumors that all standard treatments have been used or are not feasible. It aims to determine the maximum tolerated dose (MTD) and/or the recommended phase 2 dose (RP2D) for study, evaluate the safety, tolerability, pharmacokinetic (PK) and pharmacodynamic (PD) characteristics and the preliminary anti-tumor activity of TT-00434, and explore the relationship between the anti-tumor activity of TT-00434 and the tumor FGFR alterations.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Dose Escalation | Experimental | Drug: TT-00434This study adopts an accelerated titration design (ATD) and utilizes an accelerated dose escalation phase in order to minimize suboptimal drug exposures, followed by a conventional 3+3 dose escalation phase to achieve MTD. |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Age ≥ 20 years.
- Patients must have a histological or cytologically confirmed diagnosis of advanced or recurrent malignant solid tumors.
- Patients have received all currently available standard treatments (unless the therapy is contraindicated, intolerable or unavailable due to any reasons).
- Patients must have measurable or evaluable disease (according to RECIST 1.1)
- Eastern Cooperative Oncology Group (ECOG) Performance Status ≤ 2
Key exclusion criteria (12 listed)
- Patients who received other investigational products or devices in other clinical trials within 4 weeks before the first dose.
- Patients who received anti-tumor therapy within 4 weeks, or within 5-half-lives (which is longer) before the first dose, including but not limited to chemotherapy, radiotherapy (palliative radiotherapy is completed at least 2 weeks before the first dose can enrol), targeted therapy or immunotherapy.
- Patients who have previous toxicity of anti-tumor therapy that has not recovered to Grade 1. (except for ≤ Grade 2 alopecia, chemotherapy-induced peripheral neurotoxicity, and ototoxicity).
- Patients who have gastrointestinal disorders that will affect oral administration or the Investigator judges that the absorption of TT-00434 will be interfered.
- Patients underwent major surgery (except biopsy) within 4 weeks, or the surgical incision has not completely healed prior to the 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 |
|---|---|---|
| TT-00434Once daily [QD], 28 days/cycle. | Drug | Dose Escalation |
Primary outcome
Dose Limiting Toxicity (DLT)
Time frame: At the end of Cycle 1 (each cycle is 28 days)
Safety and tolerability
Incidence of AEs
Time frame: up to 30 days from study discontinuation
Safety and tolerability
8 secondary outcomes
Peak Plasma Concentration (Cmax)
Time frame: At the end of Cycle 1 (each cycle is 28 days)
Area under the plasma concentration versus time curve (AUC)
Time frame: At the end of Cycle 1 (each cycle is 28 days)
Time of first Occurance of Cmax（tmax)
Time frame: At the end of Cycle 1 (each cycle is 28 days)
Serum phosphate levels
Time frame: up to 30 days from study discontinuation
Objective response rate (ORR)
Time frame: through study completion, an average of 1 year
Disease control rate (DCR)
Time frame: through study completion, an average of 1 year
Progression Free Survival (PFS)
Time frame: through study completion, an average of 1 year
Overall Survival (OS)
Time frame: through study completion, an average of 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Nov 2023.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Huey En Tzeng principal investigator
Taipei Medical University Hospital
Chia Jui Yen principal investigator
National Cheng-Kung University Hospital
Ching Liang Ho principal investigator
Tri-Service General Hospital (TSGH)
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing TT-00434 in people with Advanced Solid Tumors, run by TransThera Sciences (Nanjing), Inc. at 3 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 12 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: finished, as of the sponsor's last update on 21 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dose Limiting Toxicity (DLT) (time frame: At the end of Cycle 1 (each cycle is 28 days)). 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 21 Nov 2023.