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The Efficacy and Safety of IBI363 in Solid Tumors

NCT06081907 · Status: RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 430

Last updated 2024-05-30

No results posted yet for this study

Summary

The study is a prospective multi-cohort clinical study. The study is divided into two phases, Phase Ia and Phase Ib. In Phase Ia, a dose escalation portion was conducted using a 3+3 dose-escalation design, with a preference for enrolling subjects with advanced non-small cell lung cancer and melanoma. Phase Ib represents the cohort expansion phase, comprising seven cohorts.

Conditions

  • Advanced Solid Tumor

Interventions

DRUG

IBI363

IBI363 is based on the "3+3" model with a dose of 1 mg/kg Q3W. IBI325, 20 mg/kg Q3W.

DRUG

IBI363

IBI363 is based on the "3+3" model with a dose of 1.5 mg/kg Q3W. IBI325, 20 mg/kg Q3W.

DRUG

IBI363

IBI363 is based on the "3+3" model with a dose of 600 μg/kg Q2W. Lenvatinib, 8mg QD.

DRUG

IBI363

IBI363 is based on the "3+3" model with a dose of 1000 μg/kg Q2W. Lenvatinib, 8mg QD.

DRUG

IBI363

The recommended dosages for IBI363, IBI325, and Lenvatinib in Phase Ib will be determined based on a comprehensive assessment of safety, efficacy, and other data obtained from the safety introduction portions of both Phase Ia (Part A) and Phase Ib (Part B).

Sponsors & Collaborators

  • Xiangya Hospital of Central South University

    collaborator OTHER

  • Hunan Province Tumor Hospital

    lead OTHER

Principal Investigators

  • Yongchang Zhang · Hunan Cancer Hospital

  • Nong Yang · Hunan Cancer Hospital

  • Xiang Chen · Xiangya Hospital of Central South University

  • Hong Liu · Xiangya Hospital of Central South University

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2023-12-25
Primary Completion
2026-12-01
Completion
2028-09-01

Countries

  • China

Study Locations

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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 NCT06081907 on ClinicalTrials.gov