Phase 1/2 Study of UI-102 in Selected Advanced Cancers
ConditionAdvanced Cancer
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorUnited Immunity, co., Ltd.
About this trial
This phase 1/2 first-in-human study is designed to assess the safety and efficacy of UI-102, a TLR7/8 agonist encapsulated in a Cholesteryl Pullulan Nanoparticle.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1,
18 Years and Older (adult, older adult),
Histologically confirmed advanced cancer,
Archived or fresh tumor tissue sample that must be confirmed as adequate,
Disqualifiers
central nervous system metastasis,
Ongoing or uncontrolled ascites or pleural effusion,
Significant ongoing toxicity from prior anticancer treatment,
Out-of-range laboratory values,
Trial design
Design model
Sequential
Treatments tested in this trial
UI-102
DrugSpecified dose on specified days
Treatment groups
140 Participants
are divided into 2 treatment groupsGroup A: UI-102 Monotherapy, IV infusionExperimental treatment 1 intervention
Group B: UI-102 Combination Therapy, IV infusionExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Dose Escalation: Percentage of participants with ≥1 dose-limiting toxicity (DLT)
Time frame
Up to 24 months2
Dose Escalation: Percentage of participants with ≥1 adverse event (AE)
Time frame
Up to 24 months3
Dose Escalation: Percentage of participants with ≥1 serious adverse event (SAE)
Time frame
Up to 24 months4
Dose Escalation: Percentage of participants with significant changes in electrocardiogram (ECG) recordings
Time frame
Up to 24 monthsSecondary outcomes
1
Dose Escalation: Best Overall Response (BOR) as Determined by RECIST v1.1 with Monotherapy and in Combination
Time frame
Up to 48 months2
Dose Escalation: Duration of Response (DOR) as Determined by RECIST v1.1 with I Monotherapy and in Combination
Time frame
Up to 48 months3
Dose Escalation: Progression-free survival (PFS) as Determined by RECIST v1.1 with Monotherapy and in Combination
Time frame
Up to 48 months4
Expansion: Duration of Response (DOR) as Determined by RECIST v1.1 with Monotherapy and combination
Time frame
Up to 48 monthsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov