RECRUITING

Study of DF6215 in Patients with Advanced Solid Tumors

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

A Phase I/Ib, First-In-Human, Multi-Part, Open-Label Study to Investigate the Safety, Tolerability, Pharmacokinetics, Biological and Clinical Activity of DF6215 Monotherapy and in Combination Therapy in Patients with Advanced (Unresectable, Recurrent, or Metastatic) Solid Tumors; is designed to assess the safety, tolerability, and preliminary efficacy of DF6215 alone or in combination with pembrolizumab in patients with advanced solid tumors. The study is open-label, meaning both participants and investigators are aware of the treatment being administered.

Official Title

A Phase I/Ib, First-In-Human, Multi-Part, Open-Label Study to Investigate the Safety, Tolerability, Pharmacokinetics, Biological and Clinical Activity of DF6215 Monotherapy and in Combination Therapy in Patients with Advanced (Unresectable, Recurrent, or Metastatic) Solid Tumors

Quick Facts

Study Start:2023-11-28
Study Completion:2027-12
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06108479

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. Age 18 years or older
  2. Willing and able to provide informed consent
  3. Able to understand and follow study procedures
  4. Stable medical condition
  1. Pregnancy or breastfeeding
  2. Severe psychiatric disorders
  3. Active substance abuse
  4. Unstable medical conditions
  5. Inability to comply with study requirements

Contacts and Locations

Study Contact

Clinical Trials
CONTACT
617-588-0086
clinicaltrials@dragonflytx.com

Study Locations (Sites)

The Angeles Clinic and Research Institute - West Los Angeles Office
Los Angeles, California, 90025
United States
University of California Irvine Medical Center
Orange, California, 92868
United States
University of California San Diego Moores Cancer Center
San Diego, California, 92093
United States
Sarcoma Oncology Center
Santa Monica, California, 90403
United States
Tampa General Hospital
Tampa, Florida, 33606
United States
Moffitt Cancer Center
Tampa, Florida, 33612
United States
NYU Langone Health
New York, New York, 10016
United States
Lifespan - Rhode Island Hospital
Providence, Rhode Island, 02903
United States
SCRI Oncology Partners
Nashville, Tennessee, 37203
United States

Collaborators and Investigators

Sponsor: Dragonfly Therapeutics

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-11-28
Study Completion Date2027-12

Study Record Updates

Study Start Date2023-11-28
Study Completion Date2027-12

Terms related to this study

Keywords Provided by Researchers

  • DF6215-001
  • DF6215
  • Melanoma
  • HPV-Positive Advanced Malignancies
  • Ovarian Cancer
  • Head and Neck Cancer
  • Non-Small Cell Lung Cancer
  • Renal Cell Carcinoma
  • Advanced or Metastatic Solid Tumors
  • Antineoplastic Agents
  • Antineoplastic Agents, Immunological
  • Molecular Mechanisms of Pharmacological Action
  • Neoplasms
  • Solid Tumor
  • Dose Escalation
  • oncology
  • pembrolizumab
  • KEYTRUDA®

Additional Relevant MeSH Terms

  • Solid Tumor, Adult
  • Solid Tumor Cancer