A Phase I Study of JSKN021 in Advanced Solid Tumors
24. August 2026 aktualisiert von: 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.
Studienübersicht
Status
Rekrutierung
Bedingungen
Intervention / Behandlung
Studientyp
Interventionell
Einschreibung (Geschätzt)
199
Phase
- Phase 1
Kontakte und Standorte
Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.
Studienkontakt
- Name: Jian Zhang, MD
- Telefonnummer: 08602134778299
- E-Mail: syner2000@163.com
Studienorte
-
-
Fujian
-
Fuzhou, Fujian, China, 350014
- Rekrutierung
- Fujian Cancer Hospital
-
-
Guangxi
-
Nanning, Guangxi, China
- Rekrutierung
- Tumor Hospital of Guangxi Medical University
-
-
Heilongjiang
-
Harbin, Heilongjiang, China, 150081
- Rekrutierung
- Harbin Medical University Cancer Hospital
-
-
Hubei
-
Wuhan, Hubei, China
- Rekrutierung
- Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
-
Wuhan, Hubei, China, 430079
- Rekrutierung
- Hubei Cancer Hospital
-
-
Jiangsu
-
Nanjing, Jiangsu, China
- Rekrutierung
- Jiangsu Province Hospital
-
Xuzhou, Jiangsu, China
- Rekrutierung
- Xuzhou Central Hospital
-
-
Shandong
-
Jining, Shandong, China
- Rekrutierung
- Affiliated Hospital of Jining Medical College
-
-
Shanghai Municipality
-
Shanghai, Shanghai Municipality, China
- Rekrutierung
- Fudan University Shanghai Cancer Center
-
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Tianjin Municipality
-
Tianjin, Tianjin Municipality, China, 300060
- Rekrutierung
- Tianjin Medical University Cancer Institute & Hospital
-
-
Teilnahmekriterien
Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.
Zulassungskriterien
Studienberechtigtes Alter
- Erwachsene
- Älterer Erwachsener
Akzeptiert gesunde Freiwillige
Nein
Beschreibung
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.
Studienplan
Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Behandlung
- Zuteilung: Zufällig
- Interventionsmodell: Sequenzielle Zuweisung
- Maskierung: Keine (Offenes Etikett)
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
|---|---|
|
Experimental: Dosis-Eskalations-Kohorte 2
|
JSKN021 administered intravenously at selected dose levels according to protocol
|
|
Experimental: Dosis-Eskalations-Kohorte 3
|
JSKN021 administered intravenously at selected dose levels according to protocol
|
|
Experimental: Dosis-Eskalations-Kohorte 4
|
JSKN021 administered intravenously at selected dose levels according to protocol
|
|
Experimental: Dosis-Eskalations-Kohorte 5
|
JSKN021 administered intravenously at selected dose levels according to protocol
|
|
Experimental: Dosis-Eskalations-Kohorte 6
|
JSKN021 administered intravenously at selected dose levels according to protocol
|
|
Experimental: Dose escalation cohort 1
|
JSKN021 administered intravenously at selected dose levels according to protocol
|
|
Experimental: Dose optimization cohort 1
|
JSKN021 administered intravenously at selected dose levels according to protocol
|
|
Experimental: Dose optimization cohort 2
|
JSKN021 administered intravenously at selected dose levels according to protocol
|
Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Frequency and severity of treatment-emergent adverse events (TEAEs), treatment-related adverse events (TRAEs), serious adverse events (SAEs), etc (Safety and tolerability of JSKN021)
Zeitfenster: 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)
Zeitfenster: 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.
Zeitfenster: Up to 24 months
|
Based on safety and efficacy data.
|
Up to 24 months
|
Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Objective response rate (ORR)
Zeitfenster: 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)
Zeitfenster: Up to 24months
|
Duration of response (DoR) assessed according to RECIST v1.1.
|
Up to 24months
|
|
Disease control rate (DCR)
Zeitfenster: Up to 24months
|
Disease control rate (DCR) assessed according to RECIST v1.1.
|
Up to 24months
|
|
Progression-Free Survival (PFS)
Zeitfenster: 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)
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: Up to 24months
|
Maximum concentration (Cmax) of JSKN021
|
Up to 24months
|
|
Time to maximum concentration (Tmax) of JSKN021
Zeitfenster: Up to 24 months.
|
Time to maximum concentration (Tmax) of JSKN021
|
Up to 24 months.
|
|
Trough concentration (Ctrough) of JSKN021
Zeitfenster: Up to 24 months
|
Trough concentration (Ctrough) of JSKN021
|
Up to 24 months
|
|
Area under the concentration-time curve of JSKN021
Zeitfenster: Up to 24 months
|
Area under the concentration-time curve of JSKN021
|
Up to 24 months
|
|
Volume of distribution (V) of JSKN021
Zeitfenster: Up to 24 months
|
Volume of distribution (V) of JSKN021
|
Up to 24 months
|
|
Elimination half-life (t1/2) of JSKN021
Zeitfenster: Up to 24 months
|
Elimination half-life (t1/2) of JSKN021
|
Up to 24 months
|
|
Clearance (CL) of JSKN021
Zeitfenster: Up to 24 months
|
Clearance (CL) of JSKN021
|
Up to 24 months
|
Mitarbeiter und Ermittler
Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.
Studienaufzeichnungsdaten
Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.
Haupttermine studieren
Studienbeginn (Tatsächlich)
2. Juni 2026
Primärer Abschluss (Geschätzt)
31. Oktober 2028
Studienabschluss (Geschätzt)
31. Mai 2029
Studienanmeldedaten
Zuerst eingereicht
20. Mai 2026
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
29. Mai 2026
Zuerst gepostet (Tatsächlich)
1. Juni 2026
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
26. August 2026
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
24. August 2026
Zuletzt verifiziert
1. August 2026
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Plan für individuelle Teilnehmerdaten (IPD)
Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?
NEIN
Beschreibung des IPD-Plans
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.
Arzneimittel- und Geräteinformationen, Studienunterlagen
Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt
Nein
Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt
Nein
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