NCT05978492 A Study of TXN10128 in Subjects With Solid Tumors
| NCT ID | NCT05978492 |
| Status | Recruiting |
| Phase | Phase 1 |
| Sponsor | Txinno Bioscience Inc. |
| Condition | Locally Advanced (Unresectable) or Metastatic Solid Tumors |
| Study Type | INTERVENTIONAL |
| Enrollment | 96 participants |
| Start Date | 2023-07-27 |
| Primary Completion | 2025-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 96 participants in total. It began in 2023-07-27 with a primary completion date of 2025-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
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.
Contact & Investigator
Min-Hee Ryu, M.D., Ph.D.
PRINCIPAL INVESTIGATOR
Asan Medical Center
Frequently Asked Questions
Who can join the NCT05978492 clinical trial?
This trial is open to participants of all sexes, aged 19 Years or older, studying Locally Advanced (Unresectable) or Metastatic Solid Tumors. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT05978492 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT05978492 currently recruiting?
Yes, NCT05978492 is actively recruiting participants. Contact the research team at bella@txinno.com for enrollment information.
Where is the NCT05978492 trial being conducted?
This trial is being conducted at Seongnam-si, South Korea, Cheonju, South Korea, Seoul, South Korea, Seoul, South Korea and 2 additional locations.
Who is sponsoring the NCT05978492 clinical trial?
NCT05978492 is sponsored by Txinno Bioscience Inc.. The principal investigator is Min-Hee Ryu, M.D., Ph.D. at Asan Medical Center. The trial plans to enroll 96 participants.