Phase 1/2 Study of UI-102 in Selected Advanced Cancers
1. juni 2026 opdateret af: United Immunity, co., Ltd.
A Phase I/II Open-Label, Dose Escalation, Dose Optimization, and Cohort Expansion Trial to Investigate the Safety, Pharmacokinetics and Pharmacodynamics of UI-102, a Novel Cholesteryl Pullulan (CHP) Nanoparticle-formulated TLR7/8 Agonist in Patients With Selected Locally Advanced and/or Metastatic Solid Tumors
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.
Studieoversigt
Detaljeret beskrivelse
This phase 1/2 , open-labelled, multi-center study is designed to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics, and preliminary clinical activities of UI-102 in patients with advanced solid tumors.
Phase 2 part is designed to assess the efficacy and safety as well as to optimize the dosing amount of UI-102
Undersøgelsestype
Interventionel
Tilmelding (Anslået)
140
Fase
- Fase 2
- Fase 1
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiekontakt
- Navn: K Hashimoto, MD
- Telefonnummer: +81 (0)3-6265-1670
- E-mail: clinical-contact@unitedimmunity.co.jp
Studiesteder
-
-
Texas
-
Dallas, Texas, Forenede Stater, 75039
- Rekruttering
- NEXT Oncology
-
Kontakt:
- Clinical Trial Navigator
- Telefonnummer: 972-893-8800
- E-mail: fakinwale@nextoncology.com
-
Houston, Texas, Forenede Stater, 77054
- Rekruttering
- NEXT Oncology
-
Kontakt:
- Clinical Trial Navigator
- Telefonnummer: 832-384-7912
- E-mail: emorales@nextoncology.com
-
San Antonio, Texas, Forenede Stater, 78229
- Rekruttering
- NEXT Oncology
-
Kontakt:
- Clinical Trial Navigator
- Telefonnummer: 210-580-9521
- E-mail: jgeorg@nextoncology.com
-
-
Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
- Voksen
- Ældre voksen
Tager imod sunde frivillige
Ingen
Beskrivelse
Inclusion Criteria:
- 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,
- Evaluable/Measurable disease per RECIST 1.1,
- Previously received applicable standard treatments,
- Male and female participants of childbearing potential who are sexually active with a non-sterilized partner must agree to use highly effective methods of birth control
Exclusion Criteria:
- central nervous system metastasis,
- Ongoing or uncontrolled ascites or pleural effusion,
- Significant ongoing toxicity from prior anticancer treatment,
- Out-of-range laboratory values,
- Clinically significant lung, heart, or autoimmune disease,
- Ongoing requirement for immunosuppressive treatment,
- Significant secondary malignancy,
- Hypersensitivity to study drug or excipients,
- Pregnant or lactating,
- Ongoing active infection
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Ikke-randomiseret
- Interventionel model: Sekventiel tildeling
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Eksperimentel: UI-102 Monotherapy, IV infusion
UI-102 monotherapy administered intravenously.
This arm includes Phase I dose escalation, backfill cohorts, and cohort expansion in participants with selected locally advanced and/or metastatic solid tumors.
|
Specified dose on specified days
|
|
Eksperimentel: UI-102 Combination Therapy, IV infusion
UI-102 administered intravenously in combination with standard-of-care agents commonly used.
This arm includes dose escalation, dose optimization, and cohort expansion.
|
Specified dose on specified days
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
Dose Escalation: Percentage of participants with ≥1 dose-limiting toxicity (DLT)
Tidsramme: Up to 24 months
|
Up to 24 months
|
|
Dose Escalation: Percentage of participants with ≥1 adverse event (AE)
Tidsramme: Up to 24 months
|
Up to 24 months
|
|
Dose Escalation: Percentage of participants with ≥1 serious adverse event (SAE)
Tidsramme: Up to 24 months
|
Up to 24 months
|
|
Dose Escalation: Percentage of participants with significant changes in electrocardiogram (ECG) recordings
Tidsramme: Up to 24 months
|
Up to 24 months
|
|
Dose Escalation: Percentage of participants with significant changes in vital signs
Tidsramme: Up to 24 months
|
Up to 24 months
|
|
Dose Escalation: Percentage of participants with significant changes in laboratory results
Tidsramme: Up to 24 months
|
Up to 24 months
|
|
Dose Escalation: Percentage of participants with a dose interruption, reduction, or discontinuation
Tidsramme: Up to 24 months
|
Up to 24 months
|
|
Expansion: Best Overall Response (BOR) as Determined by RECIST v1.1
Tidsramme: Up to 48 months
|
Up to 48 months
|
Sekundære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
Dose Escalation: Best Overall Response (BOR) as Determined by RECIST v1.1 with Monotherapy and in Combination
Tidsramme: Up to 48 months
|
Up to 48 months
|
|
Dose Escalation: Duration of Response (DOR) as Determined by RECIST v1.1 with I Monotherapy and in Combination
Tidsramme: Up to 48 months
|
Up to 48 months
|
|
Dose Escalation: Progression-free survival (PFS) as Determined by RECIST v1.1 with Monotherapy and in Combination
Tidsramme: Up to 48 months
|
Up to 48 months
|
|
Expansion: Duration of Response (DOR) as Determined by RECIST v1.1 with Monotherapy and combination
Tidsramme: Up to 48 months
|
Up to 48 months
|
|
Expansion: Progression-free survival (PFS) as Determined by RECIST v1.1 with Monotherapy and combination
Tidsramme: Up to 48 months
|
Up to 48 months
|
|
Plasma Concentration of UI-102
Tidsramme: Up to 48 months
|
Up to 48 months
|
|
Incidence of anti-UI-102 Antibody Formation
Tidsramme: Up to 48 months
|
Up to 48 months
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart (Faktiske)
20. maj 2026
Primær færdiggørelse (Anslået)
31. marts 2030
Studieafslutning (Anslået)
31. marts 2031
Datoer for studieregistrering
Først indsendt
18. maj 2026
Først indsendt, der opfyldte QC-kriterier
18. maj 2026
Først opslået (Faktiske)
26. maj 2026
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
3. juni 2026
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
1. juni 2026
Sidst verificeret
1. juni 2026
Mere information
Begreber relateret til denne undersøgelse
Andre undersøgelses-id-numre
- UI-102-CT01
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
UBESLUTET
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Ja
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Ingen
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