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Study of the of the Safety and Tolerability of TT-00434 in Patients With Advanced Solid Tumors

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ClinicalTrials.gov Identifier: NCT04830501
Recruitment Status : Not yet recruiting
First Posted : April 5, 2021
Last Update Posted : April 6, 2021
Sponsor:
Information provided by (Responsible Party):
TransThera Biosciences Co., Ltd

Brief 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.

Condition or disease Intervention/treatment Phase
Advanced Solid Tumors Drug: TT-00434 Phase 1

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase I Study of the Safety, Tolerability, Pharmacokinetics Profile, and Preliminary Efficacy of TT-00434 in Patients With Advanced Solid Tumors
Estimated Study Start Date : April 23, 2021
Estimated Primary Completion Date : April 9, 2023
Estimated Study Completion Date : August 9, 2023

Arm Intervention/treatment
Experimental: Dose Escalation
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.
Drug: TT-00434
Once daily [QD], 28 days/cycle.




Primary Outcome Measures :
  1. Dose Limiting Toxicity (DLT) [ Time Frame: At the end of Cycle 1 (each cycle is 28 days) ]
    Safety and tolerability

  2. Incidence of AEs [ Time Frame: up to 30 days from study discontinuation ]
    Safety and tolerability


Secondary Outcome Measures :
  1. Peak Plasma Concentration (Cmax) [ Time Frame: At the end of Cycle 1 (each cycle is 28 days) ]
    PK evaluation

  2. Area under the plasma concentration versus time curve (AUC) [ Time Frame: At the end of Cycle 1 (each cycle is 28 days) ]
    PK evaluation

  3. Time of first Occurance of Cmax(tmax) [ Time Frame: At the end of Cycle 1 (each cycle is 28 days) ]
    PK evaluation

  4. Serum phosphate levels [ Time Frame: up to 30 days from study discontinuation ]
    PD biomarker

  5. Objective response rate (ORR) [ Time Frame: through study completion, an average of 1 year ]
    Assess anti-tumor activity

  6. Disease control rate (DCR) [ Time Frame: through study completion, an average of 1 year ]
    Assess anti-tumor activity

  7. Progression Free Survival (PFS) [ Time Frame: through study completion, an average of 1 year ]
    Assess anti-tumor activity

  8. Overall Survival (OS) [ Time Frame: through study completion, an average of 1 year ]
    Assess anti-tumor activity



Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.
  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04830501


Contacts
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Contact: Jia Wang 8602558216298 wangjia@transtherabio.com

Locations
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Taiwan
Taipei Medical University Hospital
Taipei, Taiwan
Sponsors and Collaborators
TransThera Biosciences Co., Ltd
Investigators
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Principal Investigator: Huey En Tzeng Taipei Medical University Hospital
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Responsible Party: TransThera Biosciences Co., Ltd
ClinicalTrials.gov Identifier: NCT04830501    
Other Study ID Numbers: TT00434CN01
First Posted: April 5, 2021    Key Record Dates
Last Update Posted: April 6, 2021
Last Verified: April 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Neoplasms