A Study of ADRX-0706 in Select Advanced Solid Tumors

A Phase 1a/b Study of ADRX-0706 in Subjects With Select Advanced Solid Tumors

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Cervical Cancer; Solid Tumors; Urothelial Cancer; Triple Negative Breast Cancer (TNBC)
• Intervention / Treatment: Drug: ADRX-0706

Detailed 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.

• Study Type: Interventional
• Enrollment (Estimated): 144
• Phase: Phase 1

Contacts and Locations

Study Locations

• China
  • Beijing, China
    • Beijing University Third Hospital
  • Fujian, China
    • Fujian Cancer Hospital
  • Guangzhou, China
    • Sun Yat-Sen University Cancer Center
  • Hunan, China
    • Hunan Cancer Hospital
  • Jinan, China
    • Shandong Cancer Hospital
  • Shanghai, China
    • Shanghai East Hospital
  • Wuhan, China
    • Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
  • Wuhan, China
    • Wuhan Union Hospital
• United States
  • California
    • Los Angeles, California, United States, 90033
      • Usc Norris Comprehensive Cancer Center
    • Los Angeles, California, United States, 90404
      • UCLA
  • Florida
    • Saint Petersburg, Florida, United States, 33709
      • Comprehensive Hematology Oncology
    • Tampa, Florida, United States, 33610
      • Moffitt Cancer Center
  • Michigan
    • Detroit, Michigan, United States, 48201
      • Karmanos Cancer Institute
    • Detroit, Michigan, United States, 48202
      • Henry Ford Cancer
    • Grand Rapids, Michigan, United States, 49546
      • START Midwest
  • Ohio
    • Hilliard, Ohio, United States, 43026
      • The Ohio State University Wexner Medical Center
  • Oklahoma
    • Oklahoma City, Oklahoma, United States, 73104
      • Stephenson Cancer Center
  • Tennessee
    • Nashville, Tennessee, United States, 37203
      • Sarah Cannon Cancer Network
  • Texas
    • Houston, Texas, United States, 77030
      • University of Texas MD Anderson Cancer Center
    • San Antonio, Texas, United States, 78229
      • START San Antonio
  • Utah
    • West Valley City, Utah, United States, 84119
      • START Mountain Region

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Phase 1a Dose Escalation: Subjects with histologically confirmed select advanced solid tumors, including urothelial carcinoma (UC), head and neck squamous cell carcinoma (HNSCC), breast cancer, cervical cancer, ovarian cancer, non-small cell lung cancer (NSCLC), and pancreatic cancer. Subjects must have received at least one prior systemic regimen and have no other therapy available known to provide meaningful clinical benefit in the opinion of the investigator.
• Phase 1b Dose Expansion: Subjects with urothelial cancer, triple negative breast cancer or cervical cancer with disease progression after at least one prior systemic regimen and no standard treatment options available and considered appropriate in the 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 Criteria:

• Active and uncontrolled central nervous system metastases
• Significant cardiovascular disease
• History of another malignancy other than the one for which the subject is being treated on this study within 3 years
• Receipt of any anticancer or investigational therapy within 5 elimination half-lives or 14 days (whichever is less)
• Any P-gp inducers/inhibitors or strong CYP3A inhibitors received within 14 days prior to the first dose of study drug
• Receiving systemic antimicrobial treatment for active infection; routine antimicrobial prophylaxis is permitted

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Sequential Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Phase 1a Dose Escalation; Increasing doses of ADRX-0706 will be administered to identify the maximum tolerated dose (MTD) and the recommended dose to be used in the Phase 1b part.	Drug: ADRX-0706; Antibody drug conjugate targeting Nectin-4
Experimental: Phase 1b Dose Expansion; ADRX-0706 will be initially administered to patients at the dose recommended from the Phase 1a part in 3 disease-specific cohorts: urothelial cancer, triple negative breast cancer, and cervical cancer.	Drug: ADRX-0706; Antibody drug conjugate targeting Nectin-4

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Incidence of adverse events	Until study completion (estimated 3 years)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Measurement of maximum plasma concentration (Cmax) of ADRX-0706	Measured from pharmacokinetic (PK) blood samples	Until study completion (estimated 3 years)
Measurement of trough concentration (Ctrough) of ADRX-0706	Measured from PK blood samples	Until study completion (estimated 3 years)
Measurement of area under the serum concentration-time curve (AUC) of ADRX-0706	Measured from PK blood samples	Until study completion (estimated 3 years)
Measurement of terminal half-life (t1/2) of ADRX-0706	Measured from PK blood samples	Until study completion (estimated 3 years)
Measurement of systemic clearance (CL) of ADRX-0706	Measured from PK blood samples	Until study completion (estimated 3 years)
Measurement of volume of distribution at steady state (Vss) of ADRX-0706	Measured from PK blood samples	Until study completion (estimated 3 years)
Incidence of anti-drug antibodies (ADA)	Measured from ADA blood samples	Until study completion (estimated 3 years)
Measurement of objective response rate (ORR) per RECIST 1.1	Percentage of subjects achieving complete response (CR) or partial response (PR)	Until study completion (estimated 3 years)
Measurement of duration of response (DOR)	Time from first response until first evidence of disease progression (PD) or death from any cause	Until study completion (estimated 3 years)
Measurement of disease control rate (DCR)	Percentage of subjects achieving CR, PR or stable disease (SD)	Until study completion (estimated 3 years)
Measurement of progression free survival (PFS)	Time from the start of study drug until first evidence of PD or death from any cause	Until study completion (estimated 3 years)
Measurement of overall survival (OS)	Time from the start of study drug until death from any cause	Until study completion (estimated 3 years)

Collaborators and Investigators

• Sponsor: Adcentrx Therapeutics

Study record dates

Study Major Dates

• Study Start (Actual): September 26, 2023
• Primary Completion (Estimated): September 1, 2025
• Study Completion (Estimated): December 1, 2026

Study Registration Dates

• First Submitted: September 6, 2023
• First Submitted That Met QC Criteria: September 12, 2023
• First Posted (Actual): September 13, 2023

Study Record Updates

• Last Update Posted (Actual): August 17, 2025
• Last Update Submitted That Met QC Criteria: August 13, 2025
• Last Verified: August 1, 2025

More Information

Terms related to this study

• Keywords: urothelial cancer; cervical cancer; ADC; triple negative breast cancer
• Additional Relevant MeSH Terms: Urogenital Diseases; Genital Diseases; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Uterine Diseases; Genital Diseases, Female; Genital Neoplasms, Female; Skin Diseases; Breast Diseases; Uterine Cervical Diseases; Uterine Neoplasms; Breast Neoplasms; Uterine Cervical Neoplasms; Triple Negative Breast Neoplasms
• Other Study ID Numbers: ADRX-0706-001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No