Phase 1 Study of MST-168 in Participants With Advanced Solid Malignant Tumors
A Phase 1, Multiregional, Open-label Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Efficacy of MST-168, in Participants With Advanced Solid Malignant Tumors
A Phase 1, multiregional, open-label study of MST-168 in participants with target-driven advanced solid tumors.
The goal of this clinical trial is to evaluate the safety, tolerability, pharmacokinetics, immunogenicity, pharmacodynamic effects, and preliminary efficacy of MST-168 in participants with target-driven advanced solid tumors. MST-168 is an investigational ADC.
Studie Overzicht
Studietype
Inschrijving (Geschat)
Fase
- Fase 1
Contacten en locaties
Studiecontact
- Naam: Changlong Liu
- Telefoonnummer: +86-15810213012
- E-mail: changlong.liu@mabsoftbio.com
Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
- Volwassen
- Oudere volwassene
Accepteert gezonde vrijwilligers
Beschrijving
Inclusion Criteria:
- Participants are eligible to be included in the study only if all of the following criteria apply:
I1. Is capable of giving signed informed consent, including compliance with the requirements and restrictions listed in the ICF and in this protocol.
I2. Is at least 18 years of age at the time of signing the ICF.
I3. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
I4. Life expectancy ≥ 12 weeks.
I5. Has adequate organ function.
I6. Pregnancy and Contraception: Female participants agree not to be pregnant or lactating from beginning of the study screening until 6 months after receiving the last treatment. Male participants with partners of childbearing potential and female participants of childbearing potential are willing and able to employ a highly effective method of birth control/contraception to prevent pregnancy from beginning of the study screening until 6 months after receiving the last treatment of MST-168.
I7. Has a pathologically documented advanced/unresectable or metastatic solid tumor that is refractory to or intolerable with standard treatment, or for which no standard treatment is available.
Exclusion Criteria:
- Participants are excluded from the study if any of the following criteria apply:
E1. Has untreated brain or CNS metastases or brain/CNS metastases that have progressed [e.g., evidence of new or enlarging brain metastasis or new neurologic symptoms attributable to brain/CNS metastases]. Participants with previously unstable brain or CNS metastases.
E2. Has a malignancy (except disease under study) that has progressed or required active treatment within the past 24 months except for basal cell or squamous cell carcinomas of the skin or in-situ carcinomas [e.g., breast, cervix, bladder] that have been resected with no evidence of metastatic disease.
E3. Has any history of prior allogenic or autologous bone marrow transplant or other solid organ transplant.
E4. Has known sensitivity to study intervention components or excipients.
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Behandeling
- Toewijzing: Niet-gerandomiseerd
- Interventioneel model: Opdracht voor een enkele groep
- Masker: Geen (open label)
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
|---|---|
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Experimenteel: MST-168 initial dose level treatment Cohort
MST-168 initial dose level
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MST-168 is a proprietary antibody-drug conjugate (ADC) developed by Mabsoft Therapeutics.
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Experimenteel: MST-168 dose level 2 treatment Cohort
MST-168 dose level 2
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MST-168 is a proprietary antibody-drug conjugate (ADC) developed by Mabsoft Therapeutics.
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Experimenteel: MST-168 dose level 3 treatment Cohort
MST-168 dose level 3
|
MST-168 is a proprietary antibody-drug conjugate (ADC) developed by Mabsoft Therapeutics.
|
|
Experimenteel: MST-168 dose level 4 treatment Cohort
MST-168 dose level 4
|
MST-168 is a proprietary antibody-drug conjugate (ADC) developed by Mabsoft Therapeutics.
|
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Experimenteel: MST-168 dose level 5 treatment Cohort
MST-168 dose level 5
|
MST-168 is a proprietary antibody-drug conjugate (ADC) developed by Mabsoft Therapeutics.
|
|
Experimenteel: MST-168 dose level 6 treatment Cohort
MST-168 dose level 6, if needed
|
MST-168 is a proprietary antibody-drug conjugate (ADC) developed by Mabsoft Therapeutics.
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Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Tijdsspanne |
|---|---|
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Incidence of dose-limiting toxicities (DLT)
Tijdsspanne: Day 1 - Day 28
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Day 1 - Day 28
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Incidence and severity of AEs, clinically significant changes from Baseline (pre-dose on D1) through to the EOT in vital signs, laboratory tests, physical examinations, 12-lead ECG, and ECHO/MUGA.
Tijdsspanne: Through study completion, up to 25 months
|
Through study completion, up to 25 months
|
Secundaire uitkomstmaten
Uitkomstmaat |
Tijdsspanne |
|---|---|
|
PK parameters for MST-168, total anti-drug antibody and free payload: Tmax
Tijdsspanne: Day 1 to Day 8
|
Day 1 to Day 8
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PK parameters for MST-168, total anti-drug antibody and free payload: Cmax
Tijdsspanne: Day 1 to Day 8
|
Day 1 to Day 8
|
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PK parameters for MST-168, total anti-drug antibody and free payload: AUC0-t
Tijdsspanne: Day 1 to Day 8
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Day 1 to Day 8
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PK parameters for MST-168, total anti-drug antibody and free payload: AUC0-∞
Tijdsspanne: Day 1 to Day 8
|
Day 1 to Day 8
|
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PK parameters for MST-168, total anti-drug antibody and free payload: t1/2
Tijdsspanne: Day 1 to Day 8
|
Day 1 to Day 8
|
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PK parameters for MST-168, total anti-drug antibody and free payload: CL
Tijdsspanne: Day 1 to Day 8
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Day 1 to Day 8
|
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PK parameters for MST-168, total anti-drug antibody and free payload: Vss
Tijdsspanne: Through study completion, up to 24 months
|
Through study completion, up to 24 months
|
|
PK parameters for MST-168, total anti-drug antibody and free payload: AUCss
Tijdsspanne: Through study completion, up to 24 months
|
Through study completion, up to 24 months
|
|
PK parameters for MST-168, total anti-drug antibody and free payload: Css,max
Tijdsspanne: Through study completion, up to 24 months
|
Through study completion, up to 24 months
|
|
PK parameters for MST-168, total anti-drug antibody and free payload: Css,min
Tijdsspanne: Through study completion, up to 24 months
|
Through study completion, up to 24 months
|
|
Frequencies of ADAs and neutralizing antibodies specific to MST-168.
Tijdsspanne: Through study completion, up to 24 months
|
Through study completion, up to 24 months
|
|
Biomarkers: cytokines/chemokines and immune cell phenotypes
Tijdsspanne: Through study completion, up to 24 months
|
Through study completion, up to 24 months
|
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Objective response rate (ORR) based on RECIST v1.1.
Tijdsspanne: Through study completion, up to 24 months
|
Through study completion, up to 24 months
|
|
Duration of response (DoR) based on RECIST v1.1.
Tijdsspanne: Through study completion, up to 24 months
|
Through study completion, up to 24 months
|
|
Progression-free survival (PFS) based on RECIST v1.1.
Tijdsspanne: Through study completion, up to 24 months
|
Through study completion, up to 24 months
|
|
Disease control rate (DCR) based on RECIST v1.1.
Tijdsspanne: Through study completion, up to 24 months
|
Through study completion, up to 24 months
|
Medewerkers en onderzoekers
Studie record data
Bestudeer belangrijke data
Studie start (Geschat)
Primaire voltooiing (Geschat)
Studie voltooiing (Geschat)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Werkelijk)
Updates van studierecords
Laatste update geplaatst (Werkelijk)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Andere studie-ID-nummers
- MST-168-101
Plan Individuele Deelnemersgegevens (IPD)
Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?
Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct
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