A Prospective, Multi-cohort Study on Efficacy and Safety of IBI363 for Advanced Solid Tumors

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 1/Phase 2
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 75
Healthy Volunteers: f
View:

• Sign written informed consent before implementing any trial-related procedures

• Age ≥18 years old and ≤75 years old;

• No limit on the gender;

• Phase Ia: Enrollment priority is given to subjects with advanced non-small cell lung cancer and melanoma.

• Phase Ib: This study comprises seven cohorts, including:

• Cohort A: Patients with histopathologically confirmed advanced melanoma, who have failed PD-1/PD-L1 treatment and CD73 ≥++ confirmed by IHC.

• Cohort B: Patients with histopathologically confirmed advanced NSCLC, who have failed PD-1/PD-L1 treatment and CD73 ≥++ confirmed by IHC.

• Cohort C: Patients with histopathologically confirmed advanced NSCLC, who have failed PD-1/PD-L1 treatment, and whose best response during PD-1/PD-L1 treatment was disease stabilization for less than 6 months or disease progression.

• Cohort D: Patients with histopathologically confirmed advanced NSCLC, who have failed PD-1/PD-L1 treatment, and whose best response during PD-1/PD-L1 treatment was partial response or complete response lasting more than 6 months.

• Cohort E: Patients with histologically confirmed advanced NSCLC, who have undergone NGS testing confirming the presence of an ALK fusion mutation and have previously failed standard treatment.

• Cohort F: Patients with histological or cytological confirmation of advanced NSCLC who harboring EGFR mutation and failed standard treatment.

• Cohort G: Patients with histological or cytological confirmation of advanced NSCLC and failed standard treatment with rare mutations, including but not limited to ROS1, BRAF V600E, METex14 skipping, HER2, NTRK, and RET fusion.

• Tumor assessment according to RECIST v1.1, at least one measurable lesion.

• Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1

Locations
Other Locations
China
Yongchang Zhang
RECRUITING
Changsha
Contact Information
Primary
Yongchang Zhang, MD
zhangyongchang@csu.edu.cn
+8613873123436
Backup
Nong Yang, MD
yangnong0217@163.com
+8613873123436
Time Frame
Start Date: 2023-12-25
Estimated Completion Date: 2028-09-01
Participants
Target number of participants: 430
Treatments
Experimental: IBI363 DL1
IBI363 + IBI325
Experimental: IBI363 DL2
IBI363 + IBI325
Experimental: IBI363 DL3
IBI363 + Lenvatinib
Experimental: IBI363 DL4
IBI363 + Lenvatinib
Experimental: IBI363 DL5
Patients with histopathologically confirmed advanced melanoma, who have failed PD-1/PD-L1 treatment and CD73 ≥++ confirmed by IHC.
Experimental: IBI363 DL6
Patients with histopathologically confirmed advanced NSCLC, who have failed PD-1/PD-L1 treatment and CD73 ≥++ confirmed by IHC.
Experimental: IBI363 DL7
Patients with histopathologically confirmed advanced NSCLC, who have failed PD-1/PD-L1 treatment, and whose best response during PD-1/PD-L1 treatment was disease stabilization for less than 6 months or disease progression.
Experimental: IBI363 DL8
Patients with histopathologically confirmed advanced NSCLC, who have failed PD-1/PD-L1 treatment, and whose best response during PD-1/PD-L1 treatment was partial response or complete response lasting more than 6 months.
Experimental: IBI363 DL9
Patients with histologically confirmed advanced NSCLC, who have undergone NGS testing confirming the presence of an ALK fusion mutation and have previously failed standard treatment.
Experimental: IBI363 DL10
Patients with histological or cytological confirmation of advanced NSCLC who harboring EGFR mutation and failed standard treatment.
Experimental: IBI363 DL11
Patients with histological or cytological confirmation of advanced NSCLC and failed standard treatment with rare mutations, including but not limited to ROS1, BRAF V600E, METex14 skipping, HER2, NTRK, and RET fusion.
Sponsors
Leads: Hunan Province Tumor Hospital
Collaborators: Xiangya Hospital of Central South University

This content was sourced from clinicaltrials.gov

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