Availability of Dibotatug (DR-01) Outside Clinical Trials... | NCT07647627

Studies
Availability of Dibotatug (DR-01) Outside Clinical Trials Via Expanded Access for Eligible Participants

NCT07647627

Sponsor

Dren Bio

Status

Available

Last Update Posted

Jun 15, 2026Actual

Enrollment

Not provided

Phase

Not provided

Conditions

Not provided

Interventions

Dibotatug

Countries

Not provided

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

Jun 2026

Overall Recruitment Status or Expanded Access Status

Available

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Not provided

Primary Completion Date

Not provided

Completion Date

Not provided

First Submitted Date

Jun 9, 2026

First Submission Date that Met QC Criteria

Jun 9, 2026

First Posted Date

Jun 15, 2026Actual

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

Jun 9, 2026

Last Update Posted Date

Jun 15, 2026Actual

Description Module

Brief Summary

This is an expanded access program (EAP) for eligible participants designed to provide access to Dibotatug (DR-01). Physician-requested expanded access will generally only be considered for patients not otherwise eligible for an ongoing clinical study sponsored by Dren Bio and provided that other program eligibility criteria are also met.

Detailed Description

Not provided

Design Module

Study Type

Expanded Access

Number of References to an Expanded Access Study

Expanded Access Types

Individual Patients

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

No data available

No data is available for this block.

Biospecimen

No data available

No data is available for this block.

Enrollment

Not provided

Name	Type	Description	Arm Group Labels	Other Names
Dibotatug	Drug			DR-01

Eligibility Module

Eligibility Criteria

Not provided

Accepts Healthy Volunteers

Not provided

Sex

Not provided

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Expanded Access Central Contact	Contact	415-737-5277		expanded.access.inquiry@drenbio.com

Overall Officials

Not provided

Locations

Not provided