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

Shanghai Junshi Biosciences

Status and phase: Active, not recruiting; Phase 1

Conditions: Advanced Malignant Tumor

Treatments: Drug: JS207

Study type: Interventional

Funder types: Other

Identifiers

NCT06022250

JS207-001-I

Details and patient eligibility

About

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.

Enrollment: 98 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

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；

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Sequential Assignment

Masking: None (Open label)

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98 participants in 1 patient group

JS207

Experimental group

Treatment:

Drug: JS207