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

Last updated: February 27, 2025
Sponsor: Shanghai Junshi Bioscience Co., Ltd.
Overall Status: Active - Recruiting

Phase

1

Condition

Neoplasms

Treatment

JS207

Clinical Study ID

NCT06022250
JS207-001-I
  • Ages 18-80
  • All Genders

Study Summary

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Patients with advanced malignant tumor confirmed by histology or pathology, failedby standard treatment, no standard treatment or no standard treatment is applicable;

  2. Eastern Cooperative Oncology Group (ECOG) 0 or 1;

  3. Life expectancy ≥ 12 weeks;

  4. At least one measurable lesion according to RECIST 1.1;

  5. Adequate organ function;

Exclusion

Exclusion Criteria:

  1. central nervous system metastasis;

  2. There is a pleural, abdominal or pericardial effusion that is clinically symptomaticor requires repeated management (puncture or drainage, etc.);

  3. Images in screening showed that the tumor surrounded important blood vessels or hadobvious necrosis and voids, and the investigators believed that it might causebleeding risk;

  4. The presence of severe, unhealed or open wounds, active ulcers, or untreatedfractures;

  5. A history of significant bleeding tendency or severe coagulopathy;

  6. The presence of poorly controlled hypertension;

Study Design

Total Participants: 192
Treatment Group(s): 1
Primary Treatment: JS207
Phase: 1
Study Start date:
September 26, 2023
Estimated Completion Date:
June 30, 2026

Connect with a study center

  • Affiliated Cancer Hospital of Shandong First Medical University

    Jinan, Shandong 250117
    China

    Active - Recruiting

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