An Early Stage Study to Evaluate Oba01 for Injection in P... | NCT06083870

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

NCT06083870

Sponsor

Lu Shun

Status

Recruiting

Last Update Posted

Dec 20, 2023Actual

Enrollment

35Estimated

Phase

Phase 1

Conditions

Non-small Cell Lung Cancer Metastatic

Interventions

Oba01

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2023

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 13, 2023Actual

Primary Completion Date

Jul 2025Estimated

Completion Date

Jul 2026Estimated

First Submitted Date

Oct 9, 2023

First Submission Date that Met QC Criteria

Oct 9, 2023

First Posted Date

Oct 16, 2023Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 14, 2023

Last Update Posted Date

Dec 20, 2023Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

35Estimated

Label	Type	Description	Intervention Names
Oba01	Experimental		Drug: Oba01

Name	Type	Description	Arm Group Labels	Other Names
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

Outcomes Module

Primary Outcomes

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 Outcomes

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)

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

75 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Shun Lu, PhD	Contact	86-21-62821990	15216769608	shunlu@sjtu.edu.cn

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Department of Oncology, Shanghai Lung Cancer Center, Shanghai Chest Hospital, Shanghai Jiao Tong University	Recruiting	Shanghai		200030	China

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided