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The IIT Study of Evaluation of P-IL-2 Single Agent and With Anti-PD-1

NCT05829057 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 10

Last updated 2024-02-13

No results posted yet for this study

Summary

Phase Ia: single-dose escalation study: accelerated titration combined with traditional "3+3" dose. Sample size is correlated with the DLT occurring in each dose group. 4 dose groups are expected; the first dose group is the accelerated titration group, which includes only 1 subject; subsequent dose groups are in traditional "3+3" dose increments, with 3-6 subjects in each group; a total of 10-19 subjects are expected in all dose groups. If the DLT is still not present in the highest dose ,the safety monitoring committee(SMC) to determine if it is necessary to continue incrementally to a higher dose.

Conditions

Interventions

BIOLOGICAL

Intravenous injection of P-IL-2

Ia :Single dose intravenous injection of P-IL-2；

BIOLOGICAL

P-IL-2 plus Anti-PD-1 Monoclonal Antibody

Ib：P-IL-2 plus Anti-PD-1 Monoclonal Antibody；

Sponsors & Collaborators

  • Zcapsule Pharmaceuticals (Shaoxing) Co., Ltd

    collaborator INDUSTRY

  • Zhejiang University

    lead OTHER

Principal Investigators

  • weijia weijia · stem cell and somatic cell clinical study committee

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-05-23
Primary Completion
2024-12-31
Completion
2025-06-21

Countries

  • China

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05829057 on ClinicalTrials.gov