A Study of ADRX-0706 in Select Advanced Solid Tumors

Launched by ADCENTRX THERAPEUTICS · Sep 12, 2023

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment called ADRX-0706 for patients with certain types of advanced solid tumors, such as bladder cancer, head and neck cancer, breast cancer, cervical cancer, ovarian cancer, lung cancer, and pancreatic cancer. The main goal is to find out how safe this treatment is, how well it is tolerated, and to determine the best dose for patients. The trial is currently looking for participants who are between 65 and 74 years old, and it is open to all genders.

To be eligible for this trial, participants need to have a confirmed diagnosis of one of the targeted cancers and must have already received at least one previous treatment. They should have measurable disease, which means their cancer can be seen and measured, and they should be in relatively good health, with a performance status score of 0 or 1 (indicating they are fully active or only slightly limited in their daily activities). Participants can expect to receive the new treatment and will be closely monitored for any side effects or reactions. It’s important to note that individuals with active brain metastases, serious heart conditions, or those who have had other cancers in the last three years are not eligible.

Gender

ALL

Eligibility 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