Evaluating ADRX-0706 for advanced solid tumors
A Phase 1a/b Study of ADRX-0706 in Subjects with Select Advanced Solid Tumors
PHASE1 · Adcentrx Therapeutics · NCT06036121
This study is testing a new treatment called ADRX-0706 to see if it is safe and effective for people with advanced solid tumors like triple negative breast cancer, urothelial cancer, and cervical cancer who have run out of other treatment options.
Quick facts
| Phase | PHASE1 |
|---|---|
| Study type | Interventional |
| Enrollment | 144 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Adcentrx Therapeutics (industry) |
| Locations | 21 sites (Los Angeles, California and 20 other locations) |
| Trial ID | NCT06036121 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to assess the safety, tolerability, and pharmacokinetics of ADRX-0706 in patients with select advanced solid tumors, including triple negative breast cancer, urothelial cancer, and cervical cancer. The study is divided into two parts: Phase 1a focuses on dose escalation to determine the recommended dose, while Phase 1b will further evaluate safety, tolerability, and preliminary efficacy at the identified optimal dose. Participants must have previously received systemic treatment and have no available standard therapy options.
Who should consider this trial
Good fit: Ideal candidates include patients with advanced solid tumors, specifically urothelial cancer, triple negative breast cancer, or cervical cancer, who have experienced disease progression after prior treatments.
Not a fit: Patients with early-stage tumors or those who have not received prior systemic therapy may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a new treatment option for patients with advanced solid tumors who have limited therapeutic alternatives.
How similar studies have performed: Other studies have shown promise with similar approaches in targeting advanced solid tumors, indicating potential for success in this trial.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Los Angeles, California and 20 other locations
- USC Norris Comprehensive Cancer Center — Los Angeles, California, United States (RECRUITING)
- UCLA — Los Angeles, California, United States (RECRUITING)
- Comprehensive Hematology Oncology — Saint Petersburg, Florida, United States (RECRUITING)
- Moffitt Cancer Center — Tampa, Florida, United States (RECRUITING)
- Karmanos Cancer Institute — Detroit, Michigan, United States (RECRUITING)
- Henry Ford Cancer — Detroit, Michigan, United States (RECRUITING)
- START Midwest — Grand Rapids, Michigan, United States (RECRUITING)
- The Ohio State University Wexner Medical Center — Hillard, Ohio, United States (RECRUITING)
- Stephenson Cancer Center — Oklahoma City, Oklahoma, United States (RECRUITING)
- Sarah Cannon Cancer Network — Nashville, Tennessee, United States (RECRUITING)
- University of Texas MD Anderson Cancer Center — Houston, Texas, United States (RECRUITING)
- START San Antonio — San Antonio, Texas, United States (RECRUITING)
- START Mountain Region — West Valley City, Utah, United States (RECRUITING)
- Beijing University Third Hospital — Beijing, China (RECRUITING)
- Fujian Cancer Hospital — Fujian, China (RECRUITING)
- Sun Yat-sen University Cancer Center — Guangzhou, China (RECRUITING)
- Hunan Cancer hospital — Hunan, China (RECRUITING)
- Shandong Cancer Hospital — Jinan, China (RECRUITING)
- Shanghai East Hospital — Shanghai, China (RECRUITING)
- Union Hospital, Tongji Medical College, Huazhong University of Science and Technology — Wuhan, China (RECRUITING)
- Wuhan Union Hospital — Wuhan, China (RECRUITING)
Study contacts
- Study coordinator: Adcentrx Therapeutics
- Email: clinicaltrials@adcentrx.com
- Phone: 858-428-9502
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Solid Tumors, Triple Negative Breast Cancer, Urothelial Cancer, Cervical Cancer, urothelial cancer, triple negative breast cancer, cervical cancer, ADC