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Phase Ia/Ib study for Saftey, Tolerability, Pharmacokinetics, pharmacodynamics and efficacy of recombinant human anti-VEGFR-2 antibody(JY025) in patients with advanced, recurrent or metastatic solid tumor

Phase Ia/Ib study for Saftey, Tolerability, Pharmacokinetics, pharmacodynamics and efficacy of recombinant human anti-VEGFR-2 antibody(JY025) in patients with advanced, recurrent or metastatic solid tumor

Status
Recruiting
Phases
Phase 1
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR1900022387
Enrollment
Unknown
Registered
2019-04-09
Start date
2019-02-12
Completion date
Unknown
Last updated
2019-04-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Advanced Solid Tumor

Interventions

Group 1:JY025, 4mg/kg, intravenous infusion
Group 2:JY025, 8mg/kg, intravenous infusion
Group 3:JY025,12mg/kg, intravenous infusion
Group 4:JY025,16mg/kg, intravenous infusion
Group 5:JY025,20mg/kg, intravenous infusion
Group 6:JY025,24mg/kg, intravenous infusion
Group 7:JY025, paclitaxel, intravenous infusion
Group 8:JY025, Irinotecan, 5-Fluorouracil, Folinic Acid, intravenous infusion
Group 9:JY025, intravenous infusion, best supportive care

Sponsors

307th Hospital of Chinese People's Liberation Army
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 70 Years

Inclusion criteria

Inclusion criteria: 1. The patient or his legal representative signs a written informed consent; 2. Aged 18-70 years; 3. Participants with histopathologically or cytologically diagnosed advanced solid tumors; 4. The ECOG score is 0-1; 5. The estimated survival time is greater than 12 weeks.

Exclusion criteria

Exclusion criteria: 1. Patients with other malignant tumors, excluding non-melanoma skin cancer, cervical carcinoma in situ, other noninvasive carcinoma, precancerous lesions in situ or non-recurrent early stage malignant tumors in the past 5 years 2. Has elective or planned surgery to be conducted during the trial; 3. LVEF is less than 50%; 4. Has a serious or non healing wound, ulcer, gastrointestinal perforation or bone fracture; 5. Has a known allergy to monoclonal antibodyor any other ingredient in JY025 Injection; 6. Pregnant or lactating women; 7. Has known alcohol or drug dependency; 8. Is not considered to be suitable for this study, in the opinion of the investigator.

Design outcomes

Primary

MeasureTime frame
MTD;Safety Evaluation;

Secondary

MeasureTime frame
Pharmacokinetic characterization;Disease Control Rate;

Countries

China

Contacts

Public ContactJianming Xu

307th Hospital of Chinese People's Liberation Army

Jmxu2003@yahoo.com+86 010-66947176

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026