This is a Phase 1/1b Study to Evaluate the Safety and Preliminary Antitumor Activity of LTZ-232 in Participants With Advanced/Metastatic Colorectal Cancer and Other Solid Tumors
A Phase 1/1b, Muticenter Study to Evaluate the Safety and Preliminary Antitumor Activity of LTZ-232 in Participants With Advanced/Metastatic Colorectal Cancer and Other Solid Tumors
This is a first-in-human, Phase 1, multi-center, open-label study to characterize the safety, pharmacokinetics, pharmacodynamics, and preliminary anti tumor activity of LTZ-232 as monotherapy in adult participants with unresectable or metastatic colorectal cancer and other solid tumors failing standard therapies.
Studieoversigt
Status
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
LTZ-232 is an engineered anti-EPCAM bispecific antibody designed to activate tumor-associated macrophages to phagocytose and kill tumor cells.
Undersøgelsestype
Tilmelding (Anslået)
Fase
- Fase 1
Kontakter og lokationer
Studiekontakt
- Navn: Sherry Unabia
- Telefonnummer: 669-207-0084
- E-mail: sherry.unabia@ltztherapeutics.com
Studiesteder
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Arizona
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Scottsdale, Arizona, Forenede Stater, 85258
- Rekruttering
- HonorHealth Research Institute
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Ledende efterforsker:
- Sunil Sharma, MD
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Kontakt:
- Stephanie Stanford
- Telefonnummer: 480-323-1350
- E-mail: stsanford@honorhealth.com
-
-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
Inclusion Criteria:
- Advanced /metastatic colorectal tumors that have failed standard treatments
- Measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST v1.1)
- Eastern Cooperative Oncology Group performance status (ECOG PS) ≤ 1
- Adequate organ function based on laboratory testing
Exclusion Criteria:
- Active infection with hepatitis B or C
- Uncontrolled CNS metastases
- Active autoimmune disease
- Clinically significant cardiovascular disease not adequately controlled with medication or impaired function
- Previous treatment with EpCAM targeting agent
- Pregnant or breast feeding
- Non-colorectal active malignancy within 3 years that could interfere with study interpretation
Studieplan
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: Dose Escalation in metastatic colorectal cancer
Participants in this arm will participate in one (1) of up to eight (8) escalating defined dose level cohorts. Participants may receive LTZ-232 intravenously up to 24 months unless treatment discontinuation criteria are met. |
LTZ-232 will be administered intravenously every two weeks for up to 24 months unless treatment discontinuation criteria are met. |
|
Eksperimentel: Safety/PK/Pharmacodynamic Cohorts
Participants may be dosed with LTZ-232 intravenously at levels previously declared safe to further explore safety and clinical activity at particular dose levels. |
LTZ-232 will be administered intravenously every two weeks for up to 24 months unless treatment discontinuation criteria are met. |
|
Eksperimentel: Dose Expansion in metastatic colorectal cancer and other solid tumor types
Participants with unresectable or metastatic colorectal cancer and other specific solid tumor types at a LTZ-232 dosing regimen(s) identified from dose escalation. |
LTZ-232 will be administered intravenously every two weeks for up to 24 months unless treatment discontinuation criteria are met. |
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Characterize the Safety and Tolerability of LTZ-232 in metastatic colorectal cancer and other solid tumors using the incidence, severity, and type of adverse events according to CTCAE v5.0.
Tidsramme: Up to 24 months
|
To determine the incidence, severity, and type of adverse events according to NCI and CTCAE v5.0 and assessment of protocol defined dose limiting toxicity criteria. |
Up to 24 months
|
Samarbejdspartnere og efterforskere
Sponsor
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Primær færdiggørelse (Anslået)
Studieafslutning (Anslået)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
- Patologiske processer
- Neoplasmer efter sted
- Neoplasmer
- Tarmsygdomme
- Gastrointestinale neoplasmer
- Neoplasmer i fordøjelsessystemet
- Sygdomme i fordøjelsessystemet
- Gastrointestinale sygdomme
- Intestinale neoplasmer
- Endetarmssygdomme
- Tyktarmssygdomme
- Neoplastiske processer
- Patologiske tilstande, tegn og symptomer
- Kolorektale neoplasmer
- Colon neoplasmer
- Neoplasma Metastase
Andre undersøgelses-id-numre
- LTZ-232-001
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
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