Recruiting
Phase 2

Halneuron

Sponsor:

Dogwood Therapeutics Inc.

Code:

NCT06848348

Conditions

Chemotherapy Induced Neuropathic Pain

Chemotherapy Induced Pain Neuropathy

Chemotherapy Induced Pain

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Halneuron

Placebo

Halneuron (Open Label Extension)

Study Details

Brief summary:

A randomized study to determine safety and efficacy of a series of subcutaneous (SC) injections of HAL in patients with CINP, compared to matching placebo injections. After that, subjects may have the option to enter an Open Label extension phase, where available, in which all subjects will receive Halneuron.

Conditions

Chemotherapy Induced Neuropathic Pain

Chemotherapy Induced Pain Neuropathy

Chemotherapy Induced Pain

Study ID

NCT06848348

Start date

Feb 21, 2025

Status verified date

May, 2026

Completion date

Aug, 2026

Anticipated

Primary completion date

Jul, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Male or female patients aged ≥18 years.
  • Neuropathic pain has been present and is attributed to platinum and/or taxane chemotherapy.
  • Patient has received a cancer chemotherapy regimen that included taxanes and/or platinum and has no active or discernible disease progression.

Exclusion Criteria:

  • Current neuropathic pain with symptoms similar to CINP but attributed to causes other than platinum or taxane chemotherapy.
  • Patients who have received HAL at any time prior to screening.

Study Design

Enrollment

240 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

placebo comparator: Placebo

Placebo

experimental: Halneuron

Halneuron

active comparator: Open Label Extension

Subjects may choose to continue in an Open Label Extension (OLE) phase if they complete the randomized phase. All subjects regardless of treatment assignment in the randomized phase will receive Halneuron, during the OLE phase of the study, if offered by the clinical site.

Interventions

Halneuron

Halneuron for Subcutaneous Injection

Placebo

Placebo for Subcutaneous Injection

Halneuron (Open Label Extension)

Halneuron for Subcutaneous Injection

Primary outcome measure

  • NRS Pain [ Time Frame: From enrollment to end of study at 4 weeks ]
  • Safety Assessments [ Time Frame: From enrollment to end of study at 4 weeks ]

Central Contacts and Locations

Central contacts

Dogwood Therapeutics

866-620-9255Mehran@dwtx.com

Locations

Central Recruiting Site

Recruiting

Sheffield, Alabama, United States, 35660

Central Recruiting Site

Recruiting

Glendale, Arizona, United States, 85308

Central Recruiting Site

Recruiting

Phoenix, Arizona, United States, 85022

Central Recruiting Site

Recruiting

Fair Oaks, California, United States, 95628

Central Recruiting Site

Recruiting

Fountain Valley, California, United States, 92708

Central Recruiting Site

Recruiting

Los Angeles, California, United States, 91307

Central Recruiting Site

Recruiting

Santa Rosa, California, United States, 95403

Central Recruiting Site

Recruiting

Wheat Ridge, Colorado, United States, 80033

Central Recruiting Site

Recruiting

Jacksonville, Florida, United States, 32205

Central Recruiting Site

Recruiting

Jacksonville, Florida, United States, 32256

Central Recruiting Site

Recruiting

Lakeland, Florida, United States, 33812

Central Recruiting Site

Recruiting

Orlando, Florida, United States, 32832

Central Recruiting Site

Recruiting

Port Charlotte, Florida, United States, 33952

Central Recruiting Site

Recruiting

Tampa, Florida, United States, 33613

Central Recruiting Site

Recruiting

Gurnee, Illinois, United States, 60031

Central Recruiting Site

Recruiting

Lake Charles, Louisiana, United States, 70605

Central Recruiting Site

Recruiting

Fenton, Missouri, United States, 63026

Central Recruiting Site

Recruiting

Las Vegas, Nevada, United States, 89109

Central Recruiting Site

Recruiting

Garden City, New York, United States, 11530

Central Recruiting Site

Recruiting

Williamsville, New York, United States, 14221

Central Recruiting Site

Recruiting

Winston-Salem, North Carolina, United States, 27103

Central Recruiting Site

Recruiting

Houston, Texas, United States, 77346

Central Recruiting Site

Recruiting

McAllen, Texas, United States, 78504

Central Recruiting Site

Recruiting

Salt Lake City, Utah, United States, 84107

Central Recruiting Site

Recruiting

Madison, Wisconsin, United States, 53715

More Information

Sponsor

Dogwood Therapeutics Inc.

Last update posted

May 29, 2026

Last verified

May, 2026

Keywords

  • Chemotherapy
  • Pain
  • Neuropathy
  • Cancer
  • CIPN
  • CINP
  • Chemotherapy Induced
  • Neuropathic Pain
  • Breast Cancer
  • Colorectal Cancer
  • Cancer Pain
  • Peripheral Neuropathy

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Dogwood Therapeutics Inc. on 2026-05-29.