FDA Fast-Tracks Novel ADC in Cervical Cancer
ADRX-0706, a Nectin-4-targeted antibody-drug conjugate, has earned FDA fast track designation in advanced cervical cancer.
- The FDA has granted fast track designation to ADRX-0706 for the treatment of advanced cervical cancer.
US FDA
- ADRX-0706 is a Nectin-4-targeted antibody-drug conjugate (ADC).
- The agent is being evaluated in a phase 1a/b clinical trial (NCT06036121) for the treatment of advanced solid tumors.
The FDA has granted fast track designation to ADRX-0706, a Nectin-4-targeted ADC, for the treatment of patients with advanced cervical cancer.1
Fast track designation is intended to accelerate the development and review of therapies that address unmet medical needs for serious conditions.
“The fast track designation granted by the FDA underscores the significant unmet need in advanced cervical cancer and marks another meaningful milestone for Adcentrx,” said Hui Li, PhD, founder and chief executive officer of Adcentrx, in a press release. “This recognition, together with the early clinical signals observed for ADRX-0706, reinforces the best-in-class potential of our Nectin-4 ADC and provides the opportunity for enhanced regulatory dialogue as we continue advancing this important program through clinical development.”
A phase 1a/b study is assessing ADRX-0706 for the treatment of advanced solid tumors, including cervical cancer. Interim data from the phase 1a dose-escalation portion will be presented at the upcoming 2025 American Society of Clinical Oncology (ASCO) Annual Meeting.
Microscopic, photorealistic image of cervical cancer cells - Generated with Adobe Firefly
In phase 1a, the dose-escalation portion of the trial, patients with histologically confirmed advanced solid tumors, including urothelial carcinoma, head and neck squamous cell carcinoma, breast cancer, cervical cancer, ovarian cancer, non–small cell lung cancer, and pancreatic cancer, were enrolled.2 Patients must have received at least 1 prior systemic therapy and have no other therapy available to provide meaningful clinical benefit in the investigator’s opinion.
Phase 1b, the dose-expansion portion, is enrolling patients with urothelial carcinoma, triple-negative breast cancer, or cervical cancer with disease progression after at least 1 prior systemic therapy. Patients were required to have an ECOG performance status of 0 or 1 and adequate hematologic, liver, and renal function.
The primary end point of the study is to determine the incidence of adverse events. The secondary end points include pharmacokinetics, objective response rate, duration of response, disease control rate, progression-free survival, and overall survival.
Twenty-one sites across the US and China are recruiting patients. The study has a planned primary completion date of September 2025.
Adcentrx is developing additional ADCs, including ADRX-0405, which targets STEAP1 and is in phase 1 development, and ADRX-0134 targeting NaPi2b and ADRX-4721, both of which are in preclinical development.3
