- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT04504708
Dose-Escalation and Dose-Expansion Study of ZX-101A in Patients With Relapsed/Resistant or Refractory Advanced Hematologic Malignancies
A Phase 1/2a, Dose-Escalation and Dose-Expansion Study of ZX-101A in Patients With Relapsed/Resistant or Refractory Advanced Hematologic Malignancies
Studieoversikt
Status
Intervensjon / Behandling
Detaljert beskrivelse
The ZX-101A-101 study will consist of 2 parts:
- Part 1: ZX-101A Dose Escalation
- Part 2: ZX-101A Dose Expansion
The Part 1 (dose escalation) of the study is designed to determine the safety and tolerability of ZX-101A administered orally once daily in 28-day cycles. The Part 2 (dose expansion) of the study is designed to further investigate the safety, tolerability, pharmacokinetics and pharmacodynamic and clinical activities of ZX-101A administered orally once daily in 28-day cycles at the selected recommended Phase 2 dose (RP2D).
Results of clinical findings in patients in the dose-escalation portion of the study will be reviewed to identify conditions (or genetic characteristics) most likely to respond to ZX-101A. These select types of hematologic malignancies will be enrolled in cohorts in the dose-expansion part of the study.
Male or female patients who are 18 years of age or older with relapsed/resistant or refractory advanced hematologic malignancies (CLL/SLL, iNHL, and other NHL subtypes) will be included in the study provided that all inclusion and exclusion criteria are satisfied.
Up to three cohorts are planned in Part 2 - Dose Expansion of the study: 1) relapsed/resistant or refractory Chronic Lymphocytic Leukemia (CLL)/Small Lymphocytic Lymphoma (SLL), 2) relapsed/resistant or refractory indolent Non- Hodgkin's Lymphoma (iNHL), and based on emerging data from Part 1-Dose Expansion, a third cohort consisting of other types of NHL may be included.
Studietype
Registrering (Faktiske)
Fase
- Fase 2
- Fase 1
Kontakter og plasseringer
Studiesteder
-
-
Arizona
-
Gilbert, Arizona, Forente stater, 85234
- Banner MD Anderson Cancer Center
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Tucson, Arizona, Forente stater, 85715
- Acrc/Arizona Clinical Research Center, Inc.
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-
California
-
Long Beach, California, Forente stater, 90804
- Innovative Clinical Research Institute
-
-
New Jersey
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Brick, New Jersey, Forente stater, 08724
- New Jersey Center for Cancer Research
-
-
Ohio
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Toledo, Ohio, Forente stater, 43614
- University of Toledo Precision Oncology Research
-
-
Washington
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Seattle, Washington, Forente stater, 98109
- Seattle Cancer Care Alliance
-
-
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Beskrivelse
Inclusion Criteria:
- Males and females who are ≥ 18 years old
- Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1 or 2.
- Failed at least 2 prior systemic standard therapies.
- Histopathological confirmed diagnosis of CLL/SLL, indolent NHL,and other NHL subtypes.
- Documented active disease that is relapsed/resistant or refractory requiring treatment after established therapy shown to have clinical benefit.
- Acceptable bone marrow, kidney, and liver function.
- No transfusion or cytokine support for ≥ 2 weeks before initiating study treatment.
- Ability to swallow and retain oral medications (see exclusion criteria #20 below).
- Negative serum pregnancy test in women of childbearing potential at Screening.
- Women of childbearing potential and men who partner with a woman of childbearing potential must agree to use effective contraceptive methods.
- Men must agree to no sperm donations during the study and for 3 months after the last dose of ZX-101A.
- Understands the requirements of the study (e.g. periodic imaging studies, periodic blood sampling, bone marrow studies), is willing to comply with all study procedures and signed the Institutional Review Board (IRB)-approved informed consent.
Exclusion Criteria:
- Received investigational study drug within 28 days (or 5 half-lives, whichever is longer).
- Concurrent participation in another therapeutic treatment trial.
- Received approved anti-cancer drugs within 21 days (42 days for nitrosoureas) or 5 half-lives, whichever is longer.
- Ongoing immunosuppression for chronic conditions.
- Known active hepatitis B virus (HBV), hepatitis C virus (HCV), or HIV infection.
- Any concurrent uncontrolled illness.
- Has not recovered from adverse events from prior anti-cancer treatment (with exception of alopecia).
- Pregnant or breast-feeding or planning to conceive or father children within the projected duration of the study.
- Major surgery within 4 weeks prior to first dose of study treatment.
- Radiation treatment within 2 weeks prior to first dose of study treatment.
- Gastrointestinal dysfunction, including motility or malabsorption syndromes or inflammatory bowel disease which could limit absorption of study drug.
- Active or prior pneumonitis or interstitial lung disease.
Other inclusion and exclusion criteria may apply.
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Ikke-randomisert
- Intervensjonsmodell: Sekvensiell tildeling
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
---|---|
Eksperimentell: ZX-101A Dose Level 1
Starting dose (SD) of ZX-101A administered orally once daily in a 28-day cycle
|
Once daily, oral dosing of ZX-101A at the assigned dose level for 28 consecutive days in a 28-day cycle
|
Eksperimentell: ZX-101A Dose Level 2
2-times the SD of ZX-101A administered orally once daily in a 28-day cycle
|
Once daily, oral dosing of ZX-101A at the assigned dose level for 28 consecutive days in a 28-day cycle
|
Eksperimentell: ZX-101A Dose Level 3
3-times the SD of ZX-101A administered orally once daily in a 28-day cycle
|
Once daily, oral dosing of ZX-101A at the assigned dose level for 28 consecutive days in a 28-day cycle
|
Eksperimentell: ZX-101A Dose Level 4
4-times the SD of ZX-101A administered orally once daily in a 28-day cycle
|
Once daily, oral dosing of ZX-101A at the assigned dose level for 28 consecutive days in a 28-day cycle
|
Eksperimentell: ZX-101A Dose Level 5
5-times the SD of ZX-101A administered orally once daily in a 28-day cycle
|
Once daily, oral dosing of ZX-101A at the assigned dose level for 28 consecutive days in a 28-day cycle
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
---|---|---|
Defining the recommended Phase 2 dose (RP2D) of ZX-101A.
Tidsramme: From Day 1 of Cycle 1 through the end of the DLT evaluation period (28 days for the first two Dose Levels and 84 days for Dose Levels 3, 4 and 5); each cycle is 28 days.
|
To assess number of patients experiencing dose-limiting toxicities (DLTs) in Part 1.
|
From Day 1 of Cycle 1 through the end of the DLT evaluation period (28 days for the first two Dose Levels and 84 days for Dose Levels 3, 4 and 5); each cycle is 28 days.
|
Safety and tolerability of ZX-101A
Tidsramme: From first dose of ZX-101A through 28 days after the last ZX-101A treatment (up to 2 years); each cycle is 28 days.
|
To examine the incidence of clinical and laboratory adverse events after multiple doses of ZX-101A in Parts 1 and 2
|
From first dose of ZX-101A through 28 days after the last ZX-101A treatment (up to 2 years); each cycle is 28 days.
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
---|---|---|
Peak Plasma Concentration of ZX-101A
Tidsramme: Days 1, 2, 15 and 16 of Cycle 1 (each cycle is 28 days), and Day 1 of Cycle 3 and Cycle 5
|
To evaluate the maximum observed concentration (Cmax) after single and repeated oral, once daily doses of ZX-101A
|
Days 1, 2, 15 and 16 of Cycle 1 (each cycle is 28 days), and Day 1 of Cycle 3 and Cycle 5
|
Area under the plasma concentration of ZX-101A
Tidsramme: Days 1, 2, 15 and 16 of Cycle 1 (each cycle is 28 days), and Day 1 of Cycle 3 and Cycle 5
|
To evaluate the area under the curve (AUC) plasma-concentration after single and repeated oral, once daily doses of ZX-101A
|
Days 1, 2, 15 and 16 of Cycle 1 (each cycle is 28 days), and Day 1 of Cycle 3 and Cycle 5
|
Half-life of ZX-101A
Tidsramme: Days 1, 2, 15 and 16 of Cycle 1 (each cycle is 28 days), and Day 1 of Cycle 3 and Cycle 5
|
To evaluate the half-life of ZX-101A after single and repeated oral, once daily doses of ZX-101A
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Days 1, 2, 15 and 16 of Cycle 1 (each cycle is 28 days), and Day 1 of Cycle 3 and Cycle 5
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Phospho-AKT (p-AKT) levels in whole blood
Tidsramme: Days 1 and 2 of Cycle 1 (each cycle is 28 days)
|
To evaluate the differences phospho-AKT (p-AKT) levels in whole blood before and after single oral dose of ZX-101A.
|
Days 1 and 2 of Cycle 1 (each cycle is 28 days)
|
Objektiv responsrate (ORR)
Tidsramme: Inntil 2 år
|
For å evaluere den objektive responsraten (ORR) som bestemt av de spesifikke sykdomsresponskriteriene
|
Inntil 2 år
|
Varighet av respons (DoR)
Tidsramme: Inntil 2 år
|
For å undersøke varigheten av respons (DoR), definert som tiden fra datoen for første dokumentasjon av respons til datoen for første dokumentasjon av progressiv sykdom (PD), eller død på grunn av en hvilken som helst årsak
|
Inntil 2 år
|
Progresjonsfri overlevelse (PFS)
Tidsramme: Inntil 2 år
|
For å undersøke progresjonsfri overlevelse (PFS), definert som tiden fra datoen for første dose av studiebehandlingen til den første datoen for dokumentasjon av PD, eller død på grunn av en hvilken som helst årsak
|
Inntil 2 år
|
Total overlevelse (OS)
Tidsramme: Inntil 2 år
|
For å undersøke total overlevelse (OS), definert som tiden fra datoen for første dose av studiebehandlingen til døden på grunn av en hvilken som helst årsak
|
Inntil 2 år
|
Samarbeidspartnere og etterforskere
Etterforskere
- Studieleder: Xiaolin Qin, PhD, Zenshine Pharmaceutical, Inc.
Studierekorddatoer
Studer hoveddatoer
Studiestart (Faktiske)
Primær fullføring (Faktiske)
Studiet fullført (Faktiske)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
- Sykdommer i immunsystemet
- Neoplasmer etter histologisk type
- Neoplasmer
- Lymfoproliferative lidelser
- Lymfesykdommer
- Immunproliferative lidelser
- Neoplasmer etter nettsted
- Hematologiske sykdommer
- Leukemi, lymfoid
- Leukemi
- Leukemi, B-celle
- Lymfom
- Hematologiske neoplasmer
- Leukemi, lymfatisk, kronisk, B-celle
Andre studie-ID-numre
- ZX-101A-101
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
Studerer et amerikansk FDA-regulert enhetsprodukt
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