Clinical trial NCT05978492: A Study of TXN10128 in Subjects With Solid Tumors
Official title: A Multicenter, Open-label, Phase 1 Dose Escalation and Expansion Study of TXN10128, an Inhibitor of ENPP1 as Monotherapy and Combination Therapy With Irinotecan or Paclitaxel in Locally Advanced or Metastatic Solid Tumors
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
Conditions: Locally Advanced (Unresectable) or Metastatic Solid Tumors
Keywords: ENPP1
ENPP1 inhibitor
TXN10128
TxinnoBio
Txinno Bioscience
Innate immune
STING pathway
Lead sponsor: Txinno Bioscience Inc.
Sponsor class: INDUSTRY
First posted: 2023-08-07
Enrollment: 96
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Intervention model description: Bayesian optimal interval (BOIN) design will be employed to find the MTD. The target DLT rate for determining the MTD is 30% for this study.
Primary purpose: TREATMENT

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).

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.

Primary outcomes:
measure: DLT
timeFrame: 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
measure: Adverse events (AE)
timeFrame: Up to 30 days from end of treatment
Secondary outcomes:
measure: Cmax
timeFrame: Up to 21 days from Day 1 dose
measure: AUC inf
timeFrame: Up to 21 days from Day 1 dose
measure: AUC last
timeFrame: Up to 21 days from Day 1 dose
measure: Tmax
timeFrame: Up to 21 days from Day 1 dose
measure: T1/2
timeFrame: Up to 21 days from Day 1 dose
measure: Vss
timeFrame: Up to 21 days from Day 1 dose
measure: Best overall response (BOR)
timeFrame: Up to 30 days from end of treatment
measure: Progression free survival (PFS)
timeFrame: Up to 30 days from end of treatment
measure: Disease control rate (DCR)
timeFrame: Up to 30 days from end of treatment
measure: Duration of Response (DOR)
timeFrame: Up to 30 days from end of treatment
measure: Overall response rate (ORR)
timeFrame: Up to 30 days from end of treatment
Other outcomes:
Locations:
city: Cheonju
country: Korea, Republic of
facility: Chungbuk National University Hospital
state: Chungcheongbuk-do
city: Seongnam
country: Korea, Republic of
facility: Seoul National University Bundang Hospital
state: Gyeonggi-do
city: Incheon
country: Korea, Republic of
facility: Gachon University Gil Medical Center
city: Seoul
country: Korea, Republic of
facility: Seoul National Univ. Hospital
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center
city: Seoul
country: Korea, Republic of
facility: SAMSUNG Medical Center
Study officials:
affiliation: Asan Medical Center
name: Min-Hee Ryu, M.D., Ph.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Seoul National University Hospital
name: Do-Youn Oh, M.D., Ph.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Samsung Medical Center
name: Jin Seok Ahn, M.D., Ph.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Seoul National University Bundang Hospital
name: SeHyun Kim, M.D., Ph.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Chungbuk National University Hospital
name: Ki-hyeong Lee, M.D., Ph.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: eoul National University Hospital
name: Joo-Hwan Park, M.D., Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: