The Efficacy and Safety of IBI363 in Solid Tumors

NCT06081907 | Recruiting Phase 1

• 1 other identifier: IBI-363
• Study Type: interventional
• Target: 430
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (2)

• Adverse Event

  Number of participants experiencing clinical and laboratory adverse events (AEs)

  Up to 90 days post last dose

• ORR

  Defined as the proportion of subjects in complete remission (CR) and partial remission (PR) to the total subjects

  1 year

Study Arms (11)

IBI363 DL1

EXPERIMENTAL

IBI363 + IBI325

Drug: IBI363

IBI363 DL2

EXPERIMENTAL

IBI363 + IBI325

Drug: IBI363

IBI363 DL3

EXPERIMENTAL

IBI363 + Lenvatinib

Drug: IBI363

IBI363 DL4

EXPERIMENTAL

IBI363 + Lenvatinib

Drug: IBI363

IBI363 DL5

EXPERIMENTAL

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

Drug: IBI363

IBI363 DL6

EXPERIMENTAL

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

Drug: IBI363

IBI363 DL7

EXPERIMENTAL

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.

Drug: IBI363

IBI363 DL8

EXPERIMENTAL

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.

Drug: IBI363

IBI363 DL9

EXPERIMENTAL

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.

Drug: IBI363

IBI363 DL10

EXPERIMENTAL

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

Drug: IBI363

IBI363 DL11

EXPERIMENTAL

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.

Drug: IBI363

Interventions

IBI363 DRUG

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

Also known as: IBI325

IBI363 DL1

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• \. Known history of seizures, active central nervous system metastasis, spinal cord compression, carcinomatous meningitis, history of meningeal metastasis, and newly diagnosed brain metastasis or meningeal metastasis.
• a) Subjects who have previously received treatment for central nervous system metastases must meet all of the following criteria to be eligible for this study:
• Completed treatment for central nervous system metastases (e.g., whole-brain radiation therapy, stereotactic radiosurgery, or equivalent treatment) at least 14 days before the first dose of the investigational drug.
• Post-treatment repeat imaging confirmed no evidence of new brain metastases or enlargement of existing brain metastatic lesions (with an interval of ≥4 weeks and using the same imaging technique as the pre-treatment head imaging).
• No requirement for steroid treatment and stable symptoms for at least 14 days before the first dose of the investigational drug.
• b) Subjects who have not previously received treatment for central nervous system metastases must meet all of the following criteria to be eligible for this study:
• No symptoms related to central nervous system metastases.
• Investigator assessment that immediate treatment for central nervous system metastases is not required.
• A maximum of three central nervous system metastatic lesions, with each lesion having a maximum diameter of ≤5 mm.
• \. Significant cardiovascular and cerebrovascular diseases, including:
• Requiring medical intervention due to ventricular arrhythmias or other uncontrolled arrhythmias, such as treatment with anti-arrhythmic drugs.
• Severe conduction disturbances (e.g., third-degree atrioventricular block).
• HR-corrected QT interval (QTc interval, calculated using the Fridericia method) ≥480 ms.
• Uncontrolled hypertension (systolic blood pressure \>140 mmHg and/or diastolic blood pressure \>90 mmHg), a history of hypertensive crisis, or hypertensive encephalopathy.
• A history of myocarditis.

Sponsors & Collaborators

• Hunan Province Tumor Hospital: lead
• Xiangya Hospital of Central South University: collaborator

Study Sites (1)

Yongchang Zhang

Changsha, Hunan, 410013, China

RECRUITING

MeSH Terms

Interventions

lenvatinib

Study Officials

• Yongchang Zhang

  Hunan Cancer Hospital

  PRINCIPAL INVESTIGATOR

• Nong Yang

  Hunan Cancer Hospital

  PRINCIPAL INVESTIGATOR

• Xiang Chen

  Xiangya Hospital of Central South University

  PRINCIPAL INVESTIGATOR

• Hong Liu

  Xiangya Hospital of Central South University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yongchang Zhang, MD

CONTACT

+8613873123436; zhangyongchang@csu.edu.cn

Nong Yang, MD

CONTACT

+8613873123436; yangnong0217@163.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, Deputy Director of Thoracic Oncology Department

Study Record Dates

• First Submitted: October 5, 2023
• First Posted: October 13, 2023
• Study Start: December 25, 2023
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): September 1, 2028
• Last Updated: May 30, 2024

Record last verified: 2024-05

Locations

CN (1)