A Study of ADRX-0706 in Select Advanced Solid Tumors

Last updated: December 13, 2024
Sponsor: Adcentrx Therapeutics
Overall Status: Active - Recruiting

Phase

1

Condition

Cervical Cancer

Solid Tumors

Neoplasms

Treatment

ADRX-0706

Clinical Study ID

NCT06036121
ADRX-0706-001
  • Ages > 18
  • All Genders

Study Summary

The primary purpose of this study is to assess the safety, tolerability, and pharmacokinetics, and to identify the optimal dose of ADRX-0706 in patients with select advanced solid tumors.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Phase 1a Dose Escalation: Subjects with histologically confirmed select advancedsolid tumors, including urothelial carcinoma (UC), head and neck squamous cellcarcinoma (HNSCC), breast cancer, cervical cancer, ovarian cancer, non-small celllung cancer (NSCLC), and pancreatic cancer. Subjects must have received at least oneprior systemic regimen and have no other therapy available known to providemeaningful clinical benefit in the opinion of the investigator.

  • Phase 1b Dose Expansion: Subjects with urothelial cancer, triple negative breastcancer or cervical cancer with disease progression after at least one prior systemicregimen and no standard treatment options available and considered appropriate inthe opinion of the investigator, unless subject refuses standard therapy.

  • Measurable disease according to RECIST version 1.1

  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1

  • Adequate hematologic, liver, and renal function

Exclusion

Exclusion Criteria:

  • Active and uncontrolled central nervous system metastases

  • Significant cardiovascular disease

  • History of another malignancy other than the one for which the subject is beingtreated on this study within 3 years

  • Receipt of any anticancer or investigational therapy within 5 elimination half-livesor 14 days (whichever is less)

  • Any P-gp inducers/inhibitors or strong CYP3A inhibitors received within 14 daysprior to the first dose of study drug

  • Receiving systemic antimicrobial treatment for active infection; routineantimicrobial prophylaxis is permitted

Study Design

Total Participants: 144
Treatment Group(s): 1
Primary Treatment: ADRX-0706
Phase: 1
Study Start date:
September 26, 2023
Estimated Completion Date:
December 31, 2026

Study Description

This is a 2 part study. The Phase 1a will consist of a dose escalation of ADRX-0706 to evaluate initial safety and tolerability in patients with select advanced solid tumors, and to identify the recommended dose to be used in the Phase 1b. The Phase 1b will further evaluate the safety and tolerability, as well as preliminary efficacy, and identify the optimal dose of ADRX-0706 in patients with urothelial cancer, triple negative breast cancer, and cervical cancer.

Connect with a study center

  • Beijing University Third Hospital

    Beijing,
    China

    Active - Recruiting

  • Fujian Cancer Hospital

    Fujian,
    China

    Active - Recruiting

  • Sun Yat-sen University Cancer Center

    Guangzhou,
    China

    Active - Recruiting

  • Hunan Cancer hospital

    Hunan,
    China

    Active - Recruiting

  • Shandong Cancer Hospital

    Jinan,
    China

    Active - Recruiting

  • Shanghai East Hospital

    Shanghai,
    China

    Active - Recruiting

  • Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

    Wuhan,
    China

    Active - Recruiting

  • Wuhan Union Hospital

    Wuhan,
    China

    Active - Recruiting

  • UCLA

    Los Angeles, California 90404
    United States

    Active - Recruiting

  • USC Norris Comprehensive Cancer Center

    Los Angeles, California 90033
    United States

    Active - Recruiting

  • Comprehensive Hematology Oncology

    Saint Petersburg, Florida 33709
    United States

    Active - Recruiting

  • Moffitt Cancer Center

    Tampa, Florida 33610
    United States

    Active - Recruiting

  • Henry Ford Cancer

    Detroit, Michigan 48202
    United States

    Active - Recruiting

  • Karmanos Cancer Institute

    Detroit, Michigan 48201
    United States

    Active - Recruiting

  • START Midwest

    Grand Rapids, Michigan 49546
    United States

    Active - Recruiting

  • The Ohio State University Wexner Medical Center

    Hillard, Ohio 43026
    United States

    Active - Recruiting

  • Stephenson Cancer Center

    Oklahoma City, Oklahoma 73104
    United States

    Active - Recruiting

  • Sarah Cannon Cancer Network

    Nashville, Tennessee 37203
    United States

    Active - Recruiting

  • University of Texas MD Anderson Cancer Center

    Houston, Texas 77030
    United States

    Active - Recruiting

  • START San Antonio

    San Antonio, Texas 78229
    United States

    Active - Recruiting

  • START Mountain Region

    West Valley City, Utah 84119
    United States

    Active - Recruiting

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