An Early Stage Study to Evaluate Oba01 for Injection in Patients With DR5 Positive LA/mNSCLC

Phase 1

Recruiting

• Conditions: Non-small Cell Lung Cancer Metastatic
• Interventions: Drug: Oba01

• Registration Number: NCT06083870
• Lead Sponsor: Lu Shun

Brief Summary

This study will evaluate the safety, tolerability, pharmacokinetics and efficacy of Oba01 for injection in patients with DR5 positive LA/mNSCLC.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-10-09
• Study First Submitted QC: 2023-10-09
• Study First Posted: 2023-10-16
• Status Verified: 2023-12
• Study Start: 2023-12-13
• Last Update Submitted: 2023-12-14
• Last Update Posted: 2023-12-20
• Primary Completion: 2025-07
• Study Completion: 2026-07

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 35

Inclusion Criteria

• Voluntary agreement to provide written informed consent.
• Man or woman ≥ 18 years and ≤75 years of age at the time of enrollment.
• Histologically and/or cytologically-confirmed locally advanced or metastatic NSCLC.
• Measurable lesion according to RECIST 1.1.
• Progression after systemic treatment for advanced NSCLC.
• Available archived paraffin-embedded or fresh tumor tissue from the primary tumor or metastasis for submission to the central laboratory.
• Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
• Measurable and/or non-measurable disease as per RECIST 1.1 criteria.
• Adequate organ function as assessed by laboratory tests.
• Male or female subjects of child-producing potential must agree to use avoidance of pregnancy measures during the study and for 6 months after the last day of treatment.

Exclusion Criteria

• Patient has received previous treatment with DR5 targeted regimen or antibody-MMAE conjugate.
• Brain metastases unless asymptomatic, stable and not requiring steroids for at least 7 days prior to start of study treatment.
• Subject with positive HCV-Ab, Anti-HIV or positive HBS-Ag with copies of HBV DNA > ULN.
• Pregnancy, lactation, or breastfeeding.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Oba01	Oba01	-

Primary Outcome Measures

Name	Time	Method
maximal tolerance dose (MTD) of Oba01	DLT will be evaluated on 21 days of observation period	Maximum-tolerated dose (MTD) was defined as the highest dose level at which no more than one of six patients experienced DLT during the DLT assessment window.

Secondary Outcome Measures

Name	Time	Method
Overall response rate(ORR)	Up to approximately 2 years	The objective response rate will be mainly analyzed by investigators according to the RECIST 1.1 standard tumor evaluation.
Disease control rate (DCR)	Up to approximately 2 years	Disease control rate (DCR) is defined as cases where objective remission (assessed as complete remission or partial remission according to RECIST 1.1 standard) or stable disease during the study.
Duration of response (DOR)	Up to approximately 2 years	DOR is defined as the time from the first documented objective response (CR or PR) to the first documented disease progression or death.
Overall survival (OS)	Up to approximately 2 years	Overall survival (OS) refers to the time from the date of first dose to death.
Progression-free survival (PFS)	Up to approximately 2 years	Progression-free survival (PFS) refers to the time from the date of first dose to the first researcher's evaluation of disease progression or death.

Trial Locations

Locations (1)

Department of Oncology, Shanghai Lung Cancer Center, Shanghai Chest Hospital, Shanghai Jiao Tong University; 🇨🇳 Shanghai, China