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Active, not recruitingNCT06022250Updated Jul 2, 2026

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

A Phase 1 interventional study of JS207 in Advanced Malignant Tumor, sponsored by Shanghai Junshi Bioscience Co., Ltd.. Active, not recruiting at 1 site in China. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2026-07-02.

Sponsored by Shanghai Junshi Bioscience Co., Ltd. · Phase 1, Interventional, and Treatment

Phase
Phase 1
Study type
Interventional
Enrollment
98
Allocation
Not applicable
Ages
18 Years to 80 Years
Sex
All
01

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.

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Conditions studied

  • Advanced Malignant Tumor
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In context

Lead sponsor

Shanghai Junshi Bioscience Co., Ltd. is the lead sponsor of 98 studies on the registry; 19 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  1. Patients with advanced malignant tumor confirmed by histology or pathology, failed by 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 criteria

Exclusion Criteria:

  1. central nervous system metastasis；
  2. There is a pleural, abdominal or pericardial effusion that is clinically symptomatic or requires repeated management (puncture or drainage, etc.)；
  3. 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；
  4. The presence of severe, unhealed or open wounds, active ulcers, or untreated fractures；
  5. A history of significant bleeding tendency or severe coagulopathy；
  6. The presence of poorly controlled hypertension；
05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Sequential assignment
Masking
None (open label)
Enrollment
98 participants (actual)

Study arms

  • Experimental
    JS207

    Drug: JS207

Interventions

  • DrugJS207

    Patients will receive specific dose of JS207 via intravenous infusion.

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What researchers measure

Primary outcomes

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

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

    Time frame: 2 Years

  2. Maximum tolerated dose (MTD),RP2D

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

    Time frame: 2 Years

Secondary outcomes

  1. Peak concentration（Cmax）

    The highest plasma drug concentration that can be achieved after medication

    Time frame: 2 years

  2. Time to peak（Tmax）

    After a single dose, the time of peak blood concentration

    Time frame: 2 years

  3. Elimination half life（t1/2）

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

    Time frame: 2 years

  4. Progression free survival(PFS)

    The time from first dose to Disease progression or death

    Time frame: 2 years

  5. Overall survival (OS)

    The time from first dose to death from any cause

    Time frame: 2 years

  6. Immunogenicity

    Incidence of Anti-Drug Antibody (ADA)

    Time frame: 2 years

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

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

    Time frame: 2 years

07

Study locations

1 site
  • Affiliated Cancer Hospital of Shandong First Medical University
    Jinan, Shandong 250117, China
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References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 2, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT06022250
Lead sponsor
Shanghai Junshi Bioscience Co., Ltd.
Collaborators
Sponsor GmbH
Responsible party
Sponsor
First posted
Sep 1, 2023
Start date
Sep 26, 2023
Primary completion
Apr 8, 2026
Completion
Dec 30, 2026 (estimated)
Last update
Jul 2, 2026

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is active, not recruiting, as verified in Jul 2026. You cannot join it, but the record below documents what was studied.

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