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

NCT04830501 | Completed Phase 1

• 1 other identifier: TT00434CN01
• Study Type: interventional
• Target: 11
• Locations: 1 country
• Sites: 3

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.

Conditions

Advanced Solid Tumors

Outcome Measures

Primary Outcomes (2)

• Dose Limiting Toxicity (DLT)

  Safety and tolerability

  At the end of Cycle 1 (each cycle is 28 days)

• Incidence of AEs

  Safety and tolerability

  up to 30 days from study discontinuation

Secondary Outcomes (8)

• Peak Plasma Concentration (Cmax)

  At the end of Cycle 1 (each cycle is 28 days)

• Area under the plasma concentration versus time curve (AUC)

  At the end of Cycle 1 (each cycle is 28 days)

• Time of first Occurance of Cmax（tmax)

  At the end of Cycle 1 (each cycle is 28 days)

• Serum phosphate levels

  up to 30 days from study discontinuation

• Objective response rate (ORR)

  through study completion, an average of 1 year

Study Arms (1)

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.

Drug: TT-00434

Interventions

TT-00434 DRUG

Once daily \[QD\], 28 days/cycle.

Dose Escalation

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• TransThera Sciences (Nanjing), Inc.: lead

Study Sites (3)

National Cheng Kung University Hospital

Tainan, Taiwan

Location

Taipei Medical University Hospital

Taipei, Taiwan

Location

Tri-Service General Hospital

Taipei, Taiwan

Location

Study Officials

• Huey En Tzeng

  Taipei Medical University Hospital

  PRINCIPAL INVESTIGATOR

• Chia Jui Yen

  National Cheng-Kung University Hospital

  PRINCIPAL INVESTIGATOR

• Ching Liang Ho

  Tri-Service General Hospital

  PRINCIPAL INVESTIGATOR

• Ming Che Liu

  Taipei Medical University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 28, 2021
• First Posted: April 5, 2021
• Study Start: July 12, 2021
• Primary Completion: October 18, 2023
• Study Completion: October 18, 2023
• Last Updated: November 21, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

TW (3)