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

NCT06083870 | Recruiting Phase 1

• 1 other identifier: RC248-C001
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Non-small Cell Lung Cancer Metastatic

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Overall response rate(ORR)

  Up to approximately 2 years

• Disease control rate (DCR)

  Up to approximately 2 years

• Duration of response (DOR)

  Up to approximately 2 years

• Progression-free survival (PFS)

  Up to approximately 2 years

• Overall survival (OS)

  Up to approximately 2 years

Study Arms (1)

Oba01

EXPERIMENTAL

Drug: Oba01

Interventions

Oba01 DRUG

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

Oba01

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Lu Shun: lead

Study Sites (1)

Department of Oncology, Shanghai Lung Cancer Center, Shanghai Chest Hospital, Shanghai Jiao Tong University

Shanghai, 200030, China

RECRUITING

Central Study Contacts

Shun Lu, PhD

CONTACT

86-21-62821990; shunlu@sjtu.edu.cn

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Prof.

Study Record Dates

• First Submitted: October 9, 2023
• First Posted: October 16, 2023
• Study Start: December 13, 2023
• Primary Completion: July 1, 2025
• Study Completion (Estimated): July 1, 2026
• Last Updated: December 20, 2023

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)