A Study of ADRX-0706 in Select Advanced Solid Tumors
- Conditions
- Solid TumorsTriple Negative Breast Cancer (TNBC)Urothelial CancerCervical Cancer
- Interventions
- Registration Number
- NCT06036121
- Lead Sponsor
- Adcentrx Therapeutics
- Brief 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.
- 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 144
- 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
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SEQUENTIAL
- Arm && Interventions
Group Intervention Description Phase 1b Dose Expansion ADRX-0706 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. Phase 1a Dose Escalation ADRX-0706 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.
- Primary Outcome Measures
Name Time Method Incidence of adverse events Until study completion (estimated 3 years)
- Secondary Outcome Measures
Name Time Method Measurement of trough concentration (Ctrough) of ADRX-0706 Until study completion (estimated 3 years) Measured from PK blood samples
Measurement of systemic clearance (CL) of ADRX-0706 Until study completion (estimated 3 years) Measured from PK blood samples
Measurement of overall survival (OS) Until study completion (estimated 3 years) Time from the start of study drug until death from any cause
Measurement of disease control rate (DCR) Until study completion (estimated 3 years) Percentage of subjects achieving CR, PR or stable disease (SD)
Measurement of area under the serum concentration-time curve (AUC) of ADRX-0706 Until study completion (estimated 3 years) Measured from PK blood samples
Measurement of volume of distribution at steady state (Vss) of ADRX-0706 Until study completion (estimated 3 years) Measured from PK blood samples
Incidence of anti-drug antibodies (ADA) Until study completion (estimated 3 years) Measured from ADA blood samples
Measurement of objective response rate (ORR) per RECIST 1.1 Until study completion (estimated 3 years) Percentage of subjects achieving complete response (CR) or partial response (PR)
Measurement of duration of response (DOR) Until study completion (estimated 3 years) Time from first response until first evidence of disease progression (PD) or death from any cause
Measurement of progression free survival (PFS) Until study completion (estimated 3 years) Time from the start of study drug until first evidence of PD or death from any cause
Measurement of terminal half-life (t1/2) of ADRX-0706 Until study completion (estimated 3 years) Measured from PK blood samples
Measurement of maximum plasma concentration (Cmax) of ADRX-0706 Until study completion (estimated 3 years) Measured from pharmacokinetic (PK) blood samples
Trial Locations
- Locations (17)
USC Norris Comprehensive Cancer Center
🇺🇸Los Angeles, California, United States
UCLA
🇺🇸Los Angeles, California, United States
Comprehensive Hematology Oncology
🇺🇸Saint Petersburg, Florida, United States
Sarah Cannon Cancer Network
🇺🇸Nashville, Tennessee, United States
START Midwest
🇺🇸Grand Rapids, Michigan, United States
START Mountain Region
🇺🇸West Valley City, Utah, United States
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
🇨🇳Wuhan, China
Shanghai East Hospital
🇨🇳Shanghai, China
University of Texas MD Anderson Cancer Center
🇺🇸Houston, Texas, United States
START San Antonio
🇺🇸San Antonio, Texas, United States
Fujian Cancer Hospital
🇨🇳Fujian, China
Moffitt Cancer Center
🇺🇸Tampa, Florida, United States
Karmanos Cancer Institute
🇺🇸Detroit, Michigan, United States
Henry Ford Cancer
🇺🇸Detroit, Michigan, United States
The Ohio State University Wexner Medical Center
🇺🇸Hillard, Ohio, United States
Stephenson Cancer Center
🇺🇸Oklahoma City, Oklahoma, United States
Beijing University Third Hospital
🇨🇳Beijing, China