A Phase I Study of JSKN021 in Advanced Solid Tumors
24. august 2026 oppdatert av: Jiangsu Alphamab Biopharmaceuticals Co., Ltd
A Phase I Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Antitumor Activity of JSKN021 in Advanced Malignant Solid Tumors
This is a Phase I, open-label, multi-center, first-in-human (FIH) clinical trial designed to evaluate the safety, tolerability, pharmacokinetic (PK) profiles, and the preliminary antitumor activity of JSKN021 in advanced malignant solid tumors.
Studieoversikt
Status
Rekruttering
Intervensjon / Behandling
Studietype
Intervensjonell
Registrering (Antatt)
199
Fase
- Fase 1
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiekontakt
- Navn: Jian Zhang, MD
- Telefonnummer: 08602134778299
- E-post: syner2000@163.com
Studiesteder
-
-
Fujian
-
Fuzhou, Fujian, Kina, 350014
- Rekruttering
- Fujian Cancer Hospital
-
-
Guangxi
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Nanning, Guangxi, Kina
- Rekruttering
- Tumor Hospital of Guangxi Medical University
-
-
Heilongjiang
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Harbin, Heilongjiang, Kina, 150081
- Rekruttering
- Harbin Medical University Cancer Hospital
-
-
Hubei
-
Wuhan, Hubei, Kina
- Rekruttering
- Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
-
Wuhan, Hubei, Kina, 430079
- Rekruttering
- Hubei Cancer Hospital
-
-
Jiangsu
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Nanjing, Jiangsu, Kina
- Rekruttering
- Jiangsu Province Hospital
-
Xuzhou, Jiangsu, Kina
- Rekruttering
- Xuzhou Central Hospital
-
-
Shandong
-
Jining, Shandong, Kina
- Rekruttering
- Affiliated Hospital of Jining Medical College
-
-
Shanghai Municipality
-
Shanghai, Shanghai Municipality, Kina
- Rekruttering
- Fudan University Shanghai Cancer Center
-
-
Tianjin Municipality
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Tianjin, Tianjin Municipality, Kina, 300060
- Rekruttering
- Tianjin Medical University Cancer Institute & Hospital
-
-
Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Voksen
- Eldre voksen
Tar imot friske frivillige
Nei
Beskrivelse
Inclusion Criteria:
- Voluntarily participate and sign the informed consent form.
- Age ≥ 18 years old, male or female.
- Eastern Cooperative Oncology Group performance status (ECOG PS) score of 0 or 1.
- Expected survival ≥ 3 months.
- Histologically or cytologically confirmed malignant solid tumors confirmed by histology and/or cytology, who have failed previous standard treatment (disease progression), are intolerant to standard treatment, or have no access to standard treatment.
- At least one measurable lesion at baseline according to RECIST 1.1 criteria.
- Adequate organ function.
- Female subjects of childbearing potential or male subjects whose partners are of childbearing potential agree to use effective contraceptive measures.
- Female subjects of childbearing potential must have a negative serum/urine pregnancy test within 7 days before the first dose.
- Be able and willing to comply with the visits, treatment plans, laboratory tests, and other study-related procedures specified in the study protocol.
- Adequate washout period of previous therapy before the first dose.
Exclusion Criteria:
- Complicated with other malignant tumors within 3 years before the first dose.
- History of brainstem, meningeal metastasis, spinal cord metastasis or compression, or carcinomatous meningitis; presence of active brain metastasis.
- Screening imaging shows tumor invasion, compression, or occurrence in surrounding important organs or risk of esophagotracheal fistula or esophagopleural fistula.
- Presence of clinically severe respiratory impairment caused by pulmonary disease complications.
- Presence of the risk factors related to interstitial lung disease (ILD) or non-infectious pneumonia:
- Presence of cardiovascular and cerebrovascular diseases or cardiovascular and cerebrovascular risk factors.
- Uncontrolled infection.
- Received live vaccines within 28 days before the first dose, or plan to receive live vaccines during the study period.
- Toxicity of previous anti-tumor treatment has not fully or partially recovered.
- Known allergy to any component of the study drug, or history of severe allergic reactions to other antibody drugs.
- Pregnant and/or lactating women, or planning to become pregnant during the study period.
- Known history of mental illness, substance abuse, alcoholism, etc., or other situations that the investigator deems may affect the safety or compliance of the study drug treatment.
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Sekvensiell tildeling
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Eksperimentell: Doseeskaleringskohort 2
|
JSKN021 administered intravenously at selected dose levels according to protocol
|
|
Eksperimentell: Doseeskaleringskohort 3
|
JSKN021 administered intravenously at selected dose levels according to protocol
|
|
Eksperimentell: Doseeskaleringskohort 4
|
JSKN021 administered intravenously at selected dose levels according to protocol
|
|
Eksperimentell: Doseøkningskohort 5
|
JSKN021 administered intravenously at selected dose levels according to protocol
|
|
Eksperimentell: Doseøkningskohort 6
|
JSKN021 administered intravenously at selected dose levels according to protocol
|
|
Eksperimentell: Dose escalation cohort 1
|
JSKN021 administered intravenously at selected dose levels according to protocol
|
|
Eksperimentell: Dose optimization cohort 1
|
JSKN021 administered intravenously at selected dose levels according to protocol
|
|
Eksperimentell: Dose optimization cohort 2
|
JSKN021 administered intravenously at selected dose levels according to protocol
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Frequency and severity of treatment-emergent adverse events (TEAEs), treatment-related adverse events (TRAEs), serious adverse events (SAEs), etc (Safety and tolerability of JSKN021)
Tidsramme: From the first dose to 30 days after the last dose or until initiation of new anti-tumor treatment, whichever comes first.
|
Frequency and severity of treatment-emergent adverse events (TEAEs), treatment-related adverse events (TRAEs), serious adverse events (SAEs), etc.; abnormalities in physical examinations, laboratory tests, electrocardiograms, and other safety measures.
|
From the first dose to 30 days after the last dose or until initiation of new anti-tumor treatment, whichever comes first.
|
|
Dose-limiting toxicity (DLT)
Tidsramme: 21 days from the first dose
|
Incidence of dose-limiting toxicity (DLT) in each dose group.
|
21 days from the first dose
|
|
Optimal biological dose (OBD) and/or recommended Phase Ⅱ dose (RP2D) of JSKN021.
Tidsramme: Up to 24 months
|
Based on safety and efficacy data.
|
Up to 24 months
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Objective response rate (ORR)
Tidsramme: Up to 24months
|
Objective response rate (ORR) was defined as the proportion of participants who achieve either complete response [CR] or partial response [PR] per Response Evaluation Criteria in Solid Tumors (RECIST v1.1）
|
Up to 24months
|
|
Duration of response (DoR)
Tidsramme: Up to 24months
|
Duration of response (DoR) assessed according to RECIST v1.1.
|
Up to 24months
|
|
Disease control rate (DCR)
Tidsramme: Up to 24months
|
Disease control rate (DCR) assessed according to RECIST v1.1.
|
Up to 24months
|
|
Progression-Free Survival (PFS)
Tidsramme: Up to 24months
|
Progression-free survival (PFS) is defined as the time from the date of initial administration till the first documentation of disease progression or death due to any cause (whichever occurs first).
|
Up to 24months
|
|
Overall survival(OS)
Tidsramme: Up to 24months
|
Overall Survival (OS) is defined as the time from the date of initial administration till death due to any cause.
|
Up to 24months
|
|
Immunogenicity
Tidsramme: Up to 24months
|
Incidence and titer changes of anti-drug antibodies (ADAs) and neutralizing antibodies (Nabs, if applicable)
|
Up to 24months
|
|
Maximum concentration (Cmax) of JSKN021
Tidsramme: Up to 24months
|
Maximum concentration (Cmax) of JSKN021
|
Up to 24months
|
|
Time to maximum concentration (Tmax) of JSKN021
Tidsramme: Up to 24 months.
|
Time to maximum concentration (Tmax) of JSKN021
|
Up to 24 months.
|
|
Trough concentration (Ctrough) of JSKN021
Tidsramme: Up to 24 months
|
Trough concentration (Ctrough) of JSKN021
|
Up to 24 months
|
|
Area under the concentration-time curve of JSKN021
Tidsramme: Up to 24 months
|
Area under the concentration-time curve of JSKN021
|
Up to 24 months
|
|
Volume of distribution (V) of JSKN021
Tidsramme: Up to 24 months
|
Volume of distribution (V) of JSKN021
|
Up to 24 months
|
|
Elimination half-life (t1/2) of JSKN021
Tidsramme: Up to 24 months
|
Elimination half-life (t1/2) of JSKN021
|
Up to 24 months
|
|
Clearance (CL) of JSKN021
Tidsramme: Up to 24 months
|
Clearance (CL) of JSKN021
|
Up to 24 months
|
Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart (Faktiske)
2. juni 2026
Primær fullføring (Antatt)
31. oktober 2028
Studiet fullført (Antatt)
31. mai 2029
Datoer for studieregistrering
Først innsendt
20. mai 2026
Først innsendt som oppfylte QC-kriteriene
29. mai 2026
Først lagt ut (Faktiske)
1. juni 2026
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
26. august 2026
Siste oppdatering sendt inn som oppfylte QC-kriteriene
24. august 2026
Sist bekreftet
1. august 2026
Mer informasjon
Begreper knyttet til denne studien
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
NEI
IPD-planbeskrivelse
No individual participant data will be shared.
The informed consent form does not include provisions for sharing de-identified participant-level data with researchers outside the study team.
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
Nei
Studerer et amerikansk FDA-regulert enhetsprodukt
Nei
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