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NCT Number: NCT06022250

The Safety, Tolerability, Pharmacokinetics And Pharmacodynamics Of JS207 in Patients With Advanced Malignant Tumor

This is a Phase I open-label, multicenter study to evaluate the safety, tolerability, pharmacokinetics (PK),Pharmacodynamic characteristics, immunogenicity and antitumor activity of JS207 in patients with advanced malignant tumor. The Recommended dose for phase II trial (RP2D) will be determined based on the safety, tolerability, pharmacokinetics.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Affiliated Cancer Hospital of Shandong First Medical University

Jinan, Shandong, 250117, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients with advanced malignant tumor confirmed by histology or pathology, failed by standard treatment, no standard treatment or no standard treatment is applicable;
  • Eastern Cooperative Oncology Group (ECOG) 0 or 1;
  • Life expectancy ≥ 12 weeks;
  • At least one measurable lesion according to RECIST 1.1;
  • Adequate organ function;

Exclusion criteria

  • central nervous system metastasis;
  • There is a pleural, abdominal or pericardial effusion that is clinically symptomatic or requires repeated management (puncture or drainage, etc.);
  • Images in screening showed that the tumor surrounded important blood vessels or had obvious necrosis and voids, and the investigators believed that it might cause bleeding risk;
  • The presence of severe, unhealed or open wounds, active ulcers, or untreated fractures;
  • A history of significant bleeding tendency or severe coagulopathy;
  • The presence of poorly controlled hypertension;

Treatment and study plan

JS207

Drug

Patients will receive specific dose of JS207 via intravenous infusion.

Primary outcomes

  1. Dose-limiting toxicity (DLT)、adverse event(AE)

    Time frame: 2 Years

    Incidence and severity of DLT, adverse events (AE), Abnormal changes in laboratory and other tests with clinical significance

  2. Maximum tolerated dose (MTD),RP2D

    Time frame: 2 Years

    Maximum tolerated dose (MTD), Recommended dose for phase II trial

Secondary outcomes

  1. Peak concentration(Cmax)

    Time frame: 2 years

    The highest plasma drug concentration that can be achieved after medication

  2. Time to peak(Tmax)

    Time frame: 2 years

    After a single dose, the time of peak blood concentration

  3. Elimination half life(t1/2)

    Time frame: 2 years

    The time it takes the blood to reduce the concentration of the drug to half

  4. Progression free survival(PFS)

    Time frame: 2 years

    The time from first dose to Disease progression or death

  5. Overall survival (OS)

    Time frame: 2 years

    The time from first dose to death from any cause

  6. Immunogenicity

    Time frame: 2 years

    Incidence of Anti-Drug Antibody (ADA)

  7. Objective response rate (ORR) based on Response Evaluation Criteria In Solid Tumors 1.1 (RECIST1.1)

    Time frame: 2 years

    Defined as the proportion of subjects who achieved partial response (PR) or complete response (CR)

Sponsors and collaborators

Lead sponsor

Shanghai Junshi Bioscience Co., Ltd.

Other

Collaborators

  • Sponsor GmbH

Registry information

Official study title

A Phase I Study to Evaluate The Safety, Tolerability, Pharmacokinetics And Pharmacodynamics Of JS207 in Patients With Advanced Malignant Tumor

Important dates

Study start
2023
Primary completion
2026
Study completion
2026
First posted
Sep 1, 2023
Registry last updated
Jul 2, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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