A Study of TXN10128 in Subjects With Solid Tumors
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age19+
SponsorTxinno Bioscience Inc.
About this trial
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
Qualifiers
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.
Disqualifiers
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.
Trial design
Treatments tested in this trial
- TXN10128
- Irinotecan
- Paclitaxel
Treatment groups
96 Participants
are divided into 3 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov