Menu
Recruiting NCT07617727

A Phase I Study of JSKN021 in Advanced Solid Tumors

Phase I Interventional Advanced Malignant Solid Tumors

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: JSKN021.
Who it may be relevant to
Registry conditions: Advanced Malignant Solid Tumors. Basic parameters: 18 years — 75 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

A Phase I Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Antitumor Activity of JSKN021 in Advanced Malignant Solid Tumors

Overview

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.

Interventions

  • Drug JSKN021
    JSKN021 administered intravenously at selected dose levels according to protocol

Primary outcome measures

  • Frequency and severity of treatment-emergent adverse events (TEAEs), treatment-related adverse events (TRAEs), serious adverse events (SAEs), etc (Safety and tolerability of JSKN021) [Time frame: 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) [Time frame: 21 days from the first dose]
  • Optimal biological dose (OBD) and/or recommended Phase Ⅱ dose (RP2D) of JSKN021. [Time frame: Up to 24 months]
Secondary outcome measures (12)
  • Objective response rate (ORR) [Time frame: Up to 24months]
  • Duration of response (DoR) [Time frame: Up to 24months]
  • Disease control rate (DCR) [Time frame: Up to 24months]
  • Progression-Free Survival (PFS) [Time frame: Up to 24months]
  • Overall survival(OS) [Time frame: Up to 24months]
  • Immunogenicity [Time frame: Up to 24months]
  • Maximum concentration (Cmax) of JSKN021 [Time frame: Up to 24months]
  • Time to maximum concentration (Tmax) of JSKN021 [Time frame: Up to 24 months.]
  • Trough concentration (Ctrough) of JSKN021 [Time frame: Up to 24 months]
  • Area under the concentration-time curve of JSKN021 [Time frame: Up to 24 months]
  • Volume of distribution (V) of JSKN021 [Time frame: Up to 24 months]
  • Elimination half-life (t1/2) of JSKN021 [Time frame: Up to 24 months]

Eligibility criteria

Inclusion criteria

  • Voluntarily participate and sign the informed consent form.
  • Age ≥ 18 and ≤ 75 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Sequential
Masking
Open label
Primary purpose
Treatment

Study locations

China · 6 centers
  • Tumor Hospital of Guangxi Medical University — Nanning
  • Union Hospital, Tongji Medical College, Huazhong University of Science and Technology — Wuhan
  • Jiangsu Province Hospital — Nanjing
  • Xuzhou Central Hospital — Xuzhou
  • Affiliated Hospital of Jining Medical College — Jining
  • Fudan University Shanghai Cancer Center — Shanghai

Identifiers

NCT: NCT07617727 · JSKN021-101

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗