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.
Tutkimuksen yleiskatsaus
Opintotyyppi
Ilmoittautuminen (Arvioitu)
Vaihe
- Vaihe 1
Yhteystiedot ja paikat
Opiskeluyhteys
- Nimi: Changlong Liu
- Puhelinnumero: +86-15810213012
- Sähköposti: changlong.liu@mabsoftbio.com
Osallistumiskriteerit
Kelpoisuusvaatimukset
Opintokelpoiset iät
- Aikuinen
- Vanhempi Aikuinen
Hyväksyy terveitä vapaaehtoisia
Kuvaus
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.
Opintosuunnitelma
Miten tutkimus on suunniteltu?
Suunnittelun yksityiskohdat
- Ensisijainen käyttötarkoitus: Hoito
- Jako: Ei satunnaistettu
- Inventiomalli: Yksittäinen ryhmätehtävä
- Naamiointi: Ei mitään (avoin tarra)
Aseet ja interventiot
Osallistujaryhmä / Arm |
Interventio / Hoito |
|---|---|
|
Kokeellinen: MST-168 initial dose level treatment Cohort
MST-168 initial dose level
|
MST-168 is a proprietary antibody-drug conjugate (ADC) developed by Mabsoft Therapeutics.
|
|
Kokeellinen: MST-168 dose level 2 treatment Cohort
MST-168 dose level 2
|
MST-168 is a proprietary antibody-drug conjugate (ADC) developed by Mabsoft Therapeutics.
|
|
Kokeellinen: 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.
|
|
Kokeellinen: 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.
|
|
Kokeellinen: 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.
|
|
Kokeellinen: 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.
|
Mitä tutkimuksessa mitataan?
Ensisijaiset tulostoimenpiteet
Tulosmittaus |
Aikaikkuna |
|---|---|
|
Incidence of dose-limiting toxicities (DLT)
Aikaikkuna: Day 1 - Day 28
|
Day 1 - Day 28
|
|
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.
Aikaikkuna: Through study completion, up to 25 months
|
Through study completion, up to 25 months
|
Toissijaiset tulostoimenpiteet
Tulosmittaus |
Aikaikkuna |
|---|---|
|
PK parameters for MST-168, total anti-drug antibody and free payload: Tmax
Aikaikkuna: Day 1 to Day 8
|
Day 1 to Day 8
|
|
PK parameters for MST-168, total anti-drug antibody and free payload: Cmax
Aikaikkuna: Day 1 to Day 8
|
Day 1 to Day 8
|
|
PK parameters for MST-168, total anti-drug antibody and free payload: AUC0-t
Aikaikkuna: Day 1 to Day 8
|
Day 1 to Day 8
|
|
PK parameters for MST-168, total anti-drug antibody and free payload: AUC0-∞
Aikaikkuna: Day 1 to Day 8
|
Day 1 to Day 8
|
|
PK parameters for MST-168, total anti-drug antibody and free payload: t1/2
Aikaikkuna: Day 1 to Day 8
|
Day 1 to Day 8
|
|
PK parameters for MST-168, total anti-drug antibody and free payload: CL
Aikaikkuna: Day 1 to Day 8
|
Day 1 to Day 8
|
|
PK parameters for MST-168, total anti-drug antibody and free payload: Vss
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: Through study completion, up to 24 months
|
Through study completion, up to 24 months
|
|
Frequencies of ADAs and neutralizing antibodies specific to MST-168.
Aikaikkuna: Through study completion, up to 24 months
|
Through study completion, up to 24 months
|
|
Biomarkers: cytokines/chemokines and immune cell phenotypes
Aikaikkuna: Through study completion, up to 24 months
|
Through study completion, up to 24 months
|
|
Objective response rate (ORR) based on RECIST v1.1.
Aikaikkuna: Through study completion, up to 24 months
|
Through study completion, up to 24 months
|
|
Duration of response (DoR) based on RECIST v1.1.
Aikaikkuna: Through study completion, up to 24 months
|
Through study completion, up to 24 months
|
|
Progression-free survival (PFS) based on RECIST v1.1.
Aikaikkuna: Through study completion, up to 24 months
|
Through study completion, up to 24 months
|
|
Disease control rate (DCR) based on RECIST v1.1.
Aikaikkuna: Through study completion, up to 24 months
|
Through study completion, up to 24 months
|
Yhteistyökumppanit ja tutkijat
Opintojen ennätyspäivät
Opi tärkeimmät päivämäärät
Opiskelun aloitus (Arvioitu)
Ensisijainen valmistuminen (Arvioitu)
Opintojen valmistuminen (Arvioitu)
Opintoihin ilmoittautumispäivät
Ensimmäinen lähetetty
Ensimmäinen toimitettu, joka täytti QC-kriteerit
Ensimmäinen Lähetetty (Todellinen)
Tutkimustietojen päivitykset
Viimeisin päivitys julkaistu (Todellinen)
Viimeisin lähetetty päivitys, joka täytti QC-kriteerit
Viimeksi vahvistettu
Lisää tietoa
Tähän tutkimukseen liittyvät termit
Avainsanat
Muut tutkimustunnusnumerot
- MST-168-101
Yksittäisten osallistujien tietojen suunnitelma (IPD)
Aiotko jakaa yksittäisten osallistujien tietoja (IPD)?
Lääke- ja laitetiedot, tutkimusasiakirjat
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Tutkii yhdysvaltalaista FDA sääntelemää laitetuotetta
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