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

Non-small Cell Lung Cancer Metastatic Clinical Trial

Official title:

A Phase 1 Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Efficacy of Oba01 for Injection in Patients With DR5 Positive LA/mNSCLC

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06083870
• Other study ID #: RC248-C001
• Status: Recruiting
• Phase: Phase 1
• Start date: December 13, 2023
• Est. completion date: July 2026

Study information

• Verified date: December 2023
• Source: Shanghai Chest Hospital
• Contact: Shun Lu, PhD
• Phone: 86-21-62821990
• Email: shunlu[@]sjtu.edu.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 35
• Est. completion date: July 2026
• Est. primary completion date: July 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Non-small Cell Lung Cancer Metastatic

Intervention

Drug:
• Oba01
Oba01 0.15, 0.5, 0.75, 1.0 mg/kg by intravenous (IV) infusion, given on Day 1 of each 21-day cycle

Locations

Country	Name	City	State
China	Department of Oncology, Shanghai Lung Cancer Center, Shanghai Chest Hospital, Shanghai Jiao Tong University	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Lu Shun

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	maximal tolerance dose (MTD) of Oba01	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.	DLT will be evaluated on 21 days of observation period
Secondary	Overall response rate(ORR)	The objective response rate will be mainly analyzed by investigators according to the RECIST 1.1 standard tumor evaluation.	Up to approximately 2 years
Secondary	Disease control rate (DCR)	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.	Up to approximately 2 years
Secondary	Duration of response (DOR)	DOR is defined as the time from the first documented objective response (CR or PR) to the first documented disease progression or death.	Up to approximately 2 years
Secondary	Progression-free survival (PFS)	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.	Up to approximately 2 years
Secondary	Overall survival (OS)	Overall survival (OS) refers to the time from the date of first dose to death.	Up to approximately 2 years