RECRUITING

TT-10 (PORT-6) and TT-4 (PORT-7) As Single Agents and in Combination in Subjects with Advanced Selected 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

The goal of this clinical trial is to evaluate TT-10, TT-4 and TT-10 + TT-4, (Dual Blockade) in participants with advanced selected solid tumors, who have failed or are not eligible for standard of care. The main questions it aims to answer are: 1. To evaluate the safety and tolerability of TT-10, TT-4 and TT-10 + TT-4, (Dual Blockade) 2. To determine the maximum tolerated dose or the recommended phase 2 dose of TT-10, TT-4 and TT-10 + TT-4, (Dual Blockade) 3. To obtain a preliminary estimate of efficacy of TT-10, TT-4 and TT-10 + TT-4, (Dual Blockade) in advanced solid tumors.

Official Title

Phase I/II First-in-Human Study of TT-10 (PORT-6), an Adenosine 2A Receptor Antagonist, and PORT-7, an Adenosine 2B Receptor Antagonist, As Single Agents and in Combination in Participants with Advanced Selected Solid Tumors

Quick Facts

Study Start:2023-06-23
Study Completion:2027-12-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT04969315

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

Desa Rae E Stanton-Pastore, MS
CONTACT
1585-305-3850
desi@portagebiotech.com; drpastore@cyncado.com

Study Locations (Sites)

USC Norris Comprehensive Cancer Center
Los Angeles, California, 90033
United States
Norton Cancer Institute
Louisville, Kentucky, 40241
United States
The University of Texas MD Anderson Cancer Center
Houston, Texas, 77030
United States

Collaborators and Investigators

Sponsor: Portage Biotech

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 Date2023-06-23
Study Completion Date2027-12-31

Study Record Updates

Study Start Date2023-06-23
Study Completion Date2027-12-31

Terms related to this study

Keywords Provided by Researchers

  • Failed or not eligible for standard of care
  • Advanced Selected Solid Tumors
  • TT-10
  • Adenosine
  • Adenosine Antagonist
  • A2A
  • A2AR Inhibitor
  • PORT-6
  • ADPORT-601
  • TT-4
  • PORT-7
  • A2B
  • Dual
  • A2AR
  • A2BR

Additional Relevant MeSH Terms

  • Renal Cell Cancer
  • Castrate Resistant Prostate Cancer
  • Non Small Cell Lung Cancer
  • Head and Neck Squamous Cell Carcinoma
  • Colorectal Cancer (CRC)
  • Endometrial Cancer
  • Ovarian Cancer