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

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

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

Study Overview

• Status: Recruiting
• Conditions: Non-small Cell Lung Cancer Metastatic
• Intervention / Treatment: Drug: Oba01

• Study Type: Interventional
• Enrollment (Estimated): 35
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Shun Lu, PhD; Phone Number: 15216769608 86-21-62821990; Email: shunlu@sjtu.edu.cn

Study Locations

• China
  • Shanghai, China, 200030
    • Recruiting
    • Department of Oncology, Shanghai Lung Cancer Center, Shanghai Chest Hospital, Shanghai Jiao Tong University
    • Contact: Shun Lu; Phone Number: 86-21-22200000; Email: shunlu@sjtu.edu.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Oba01	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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
Overall survival (OS)	Overall survival (OS) refers to the time from the date of first dose to death.	Up to approximately 2 years

Collaborators and Investigators

• Sponsor: Lu Shun

Study record dates

Study Major Dates

• Study Start (Actual): December 13, 2023
• Primary Completion (Estimated): July 1, 2025
• Study Completion (Estimated): July 1, 2026

Study Registration Dates

• First Submitted: October 9, 2023
• First Submitted That Met QC Criteria: October 9, 2023
• First Posted (Actual): October 16, 2023

Study Record Updates

• Last Update Posted (Actual): December 20, 2023
• Last Update Submitted That Met QC Criteria: December 14, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Neoplasms; Lung Diseases; Neoplasms by Site; Respiratory Tract Neoplasms; Thoracic Neoplasms; Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Carcinoma, Non-Small-Cell Lung
• Other Study ID Numbers: RC248-C001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No