A Study of TXN10128 in Subjects With Solid Tumors
- Conditions
- Locally Advanced (Unresectable) or Metastatic Solid Tumors
- Interventions
- Registration Number
- NCT05978492
- Lead Sponsor
- Txinno Bioscience Inc.
- Brief Summary
This is a phase I clinical trial to primarily evaluate the safety, tolerability, and addtionally assess pharmacokinetics, pharmacodynamics, and antitumor activity of investigational product, TXN10128. The target subjects will be consisted of patients with locally advanced (unresectable) or metastatic soild tumors.
This study includes a dose-escalation part and a dose-expansion part, and a TXN10128 monotherapy part and a TXN10128 + Irinotecan or Paclitaxel combination therapy part.
- Detailed Description
This study includes a dose-escalation part and a dose-expansion part, and a TXN10128 monotherapy part and a TXN10128 + Irinotecan or Paclitaxel combination therapy part. The study includes dose-escalation and dose-expansion parts across three cohorts: TXN10128 monotherapy (Cohorts A) TXN10128 + Irinotecan (Cohorts B) and TXN10128+ Paclitaxel (Cohorts C).
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 96
- Male or female subjects ≥19 years of age at the time of informed consent.
- Histologically and/or cytologically confirmed any progressive, locally advanced (unresectable), or metastatic solid tumors that have relapsed or are refractory following the last line of treatment and for which prior standard therapy has been ineffective, or standard therapy does not exist or is not considered appropriate.
- ECOG performance status of 0 or 1.
- Life expectancy of at least 12 weeks.
- Has leptomeningeal disease.
- Experienced a Grade ≥3 immune-related adverse events (irAE) with prior immunotherapy with the exception of non-clinically significant laboratory abnormalities.
- Prior organ transplantation.
- Known positive human immunodeficiency virus (HIV) infection.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SEQUENTIAL
- Arm && Interventions
Group Intervention Description Cohort B-1 Irinotecan Combination Therapy with TXN10128 and Irinotecan Dose esclation part Cohort C-1 TXN10128 Combination therapy with TXN10128 and Paclitaxel Dose esclation part Cohort C-1 Paclitaxel Combination therapy with TXN10128 and Paclitaxel Dose esclation part Cohort A-1 TXN10128 TXN10128 Monotherapy Dose esclation part Cohort B-1 TXN10128 Combination Therapy with TXN10128 and Irinotecan Dose esclation part
- Primary Outcome Measures
Name Time Method Adverse events (AE) Up to 30 days from end of treatment Adverse events (AE) defined by the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) criteria version 5.0 at each dose level
DLT Day 1 up to Day 21 for Cohort A(TXN10128 mono cohort) and Day 1 up to Day 28 for Cohort B,C(TXN10128 combination with Irinotecan or paclitaxel cohort) in dose escalation period A DLT is defined as any of the following AEs (graded using NCI CTCAE v5.0) whose relationship to TXN10128 cannot be ruled out.
- Secondary Outcome Measures
Name Time Method Cmax Up to 21 days from Day 1 dose The time to reach the maximum observed concentration (time)
AUC inf Up to 21 days from Day 1 dose The area under the concentration-time curve extrapolated to infinity (mass\*time/volume)
AUC last Up to 21 days from Day 1 dose The area under the concentration (AUC) -time curve calculated to the last quantifiable concentration point (mass\* time/volume)
Tmax Up to 21 days from Day 1 dose The time to reach the maximum observed concentration (time)
Progression free survival (PFS) Up to 30 days from end of treatment The survival function will be estimated using the Kaplan-Meier product limit method. Median duration, with a two-sided Brookmeyer-Crowley 90% confidence interval and Kaplan-Meier estimates of survival proportions will be provided at specified time points.
Disease control rate (DCR) Up to 30 days from end of treatment The disease control rate is calculated as the percentage of patients with advanced or metastatic cancer who have achieved complete response, partial response and stable disease
Duration of Response (DOR) Up to 30 days from end of treatment Duration of response is defined as the time from the date of the first documented response (CR or PR), to the date of first documented progression, or death due to study indication. Estimates will use Kaplan-Meier method
Overall response rate (ORR) Up to 30 days from end of treatment Overall response rate will be summarized with accompanying 90% exact binomial confidence interval (CI).
T1/2 Up to 21 days from Day 1 dose Elimination half-life, determined as 0.693/Lambda_z (time)
Vss Up to 21 days from Day 1 dose Volume of distribution during the steady state phase (volume)
Best overall response (BOR) Up to 30 days from end of treatment Best overall response will be summarized
Trial Locations
- Locations (6)
Gachon University Gil Medical Center
🇰🇷Incheon, Korea, Republic of
Chungbuk National University Hospital
🇰🇷Cheonju, Chungcheongbuk-do, Korea, Republic of
Seoul National University Bundang Hospital
🇰🇷Seongnam, Gyeonggi-do, Korea, Republic of
Seoul National Univ. Hospital
🇰🇷Seoul, Korea, Republic of
Asan Medical Center
🇰🇷Seoul, Korea, Republic of
SAMSUNG Medical Center
🇰🇷Seoul, Korea, Republic of