FDA Clears IND of ADRX-0405, Next-Gen ADC, in Solid Tumors

Tumor cell being attacked - Generated with Google Gemini AI

• The FDA has cleared the investigational new drug (IND) application of ADRX-0405 for the treatment of advanced solid tumors.
• ADRX-0405 is a next-generation antibody-drug conjugate (ADC) that targets six-transmembrane epithelial antigen of the prostate 1 (STEAP1).
• A planned phase 1a/b trial will investigate the agent.

The IND application for ADRX-0405, a next-generation ADC for the treatment of advanced solid tumors, has been cleared by the FDA.¹

“The FDA’s clearance of our second IND marks another major advancement for Adcentrx,” said Hui Li, PhD, president and chief executive officer of Adcentrx Therapeutics, in a press release. “We are excited about the first-in-class potential for ADRX-0405 and the opportunity to make a meaningful difference for patients battling advanced cancers, including patients with metastatic castration resistant prostate cancer, who have a significant need for new targeted therapies.”

With this clearance, a phase 1a/b study will commence. The open-label, multicenter, non-randomized, dose-escalation and dose-expansion study plans to enroll patients with advanced solid tumors, including those with metastatic castration-resistant prostate cancer. The primary end points will be safety and tolerability as well as determining the optimal dose.

Adcentrx anticipates enrolling the first patient in Q4 of this year.

About ADRX-0405

ADRX-0405 is an ADC targeting STEAP1, a cell surface protein upregulated in certain cancers, including prostate cancer, but with limited expression in healthy tissue. The agent has a topoisomerase inhibitor payload conjugated at a drug-to-antibody ratio of 8.

In preclinical studies, ADRX-0405 has demonstrated promising pharmacokinetics, safety, and efficacy in multiple tumor models.

ADRX-0405 is the second ADC developed with Adcentrx’s proprietary i-Conjugation technology. ADRX-0706, is an ADC targeting Nectin-4 and is currently being investigated in a phase 1a/b study (NCT06036121). Patients with histologically confirmed advanced solid tumors, including urothelial carcinoma, head and neck squamous cell carcinoma, breast cancer, cervical cancer, non–small cell lung cancer, and pancreatic cancer are eligible for enrollment in this study.²

REFERENCES:

1. Adcentrx Therapeutics announces FDA clearance of investigational new drug application for ADRX-0405, a potential first-in-class ADC targeting STEAP1 for the treatment of advanced solid tumors. News release. Adcentrx Therapeutics. October 21, 2024. Accessed October 22, 2024. https://tinyurl.com/3632a293

2. A study of ADRX-0706 in select advanced solid tumors. ClinicalTrials.gov. Updated August 6, 2024. Accessed October 22, 2024. https://www.clinicaltrials.gov/study/NCT06036121