FDA Clears IND for Phase 1 Trial of ADCE-T02 in Solid Tumors

• The FDA cleared the investigational new drug (IND) application for a phase 1 trial of ADCE-T02 for the treatment of patients with advanced solid tumors.
• ADCE-T02 is a promising first-in-class antibody-drug conjugate (ADC) that utilizes a Topoisomerase I inhibitor and targets tissue factor (TF).
• The study, Tiffany-01 (NCT06597721), plans to evaluate the safety, preliminary efficacy, and pharmacokinetics (PK) of ADCE-T02 as a monotherapy in patients with advanced solid tumors.

The FDA has granted clearance to an IND application for a phase 1 trial evaluating ADCE-T02, a potential first-in-class ADC, in advanced solid tumor treatment.¹

ADCE-T02 is a distinct anti-TF ADC and the first to feature a Topoisomerase I inhibitor–based linker/payload. The agent is being developed in Australia and the US.

Its specialized antibody design reduces effects on the coagulation pathway, while the T1000-exatecan linker-payload technology enhances the bystander effect, improves linker stability, and may help overcome resistance mechanisms.

"Tissue factor is a validated ADC target with overexpression in many high unmet need solid tumor indications, however, the currently approved TF targeting ADC has severe limitations due to a suboptimal side effect profile and a limited therapeutic window. The highly differentiated profile of ADCE-T02, based on the use of an improved monoclonal antibody and a next generation Topoisomerase I inhibitor linker/payload technology, could overcome those limitations and offer an enhanced therapeutic window and improved side effect profile, which may lead to better clinical outcomes for patients," said Lone Ottesen, MD, PhD, chief medical officer of Adcendo, in a press release.

Tumor cell being attacked - Generated with Google Gemini AI

"The US IND clearance of ADCE-T02 is an important milestone for our program and our company, and we look forward to initiating patient enrollment in the US and working closely with all of our investigators to evaluate the therapeutic utility of this drug in multiple advanced solid tumor indications," added Ottesen.

The phase 1 Tiffany-01 trial is an ongoing, first-in-human, multicenter, open-label, dose-escalation study of ADCE-T02 given as a monotherapy for the potential treatment of patients with advanced solid tumors.

Enrollment is open to patients who have pathologically confirmed unresectable advanced solid tumors who have undergone 1 or more systemic therapy and have progressive disease. Patients are required to have at least 1 measurable lesion as per RECIST version 1.1, an ECOG performance status of 0 or 1, a life expectancy of 3 months or more, and adequate organ function as indicated by laboratory values.

The study plans to establish the maximum tolerated dose, the recommended dose, and the safety and tolerability of ADCE-T02 when given as a single therapy over multiple dose levels.

Secondary end points of the study include overall response rate, disease control rate, progression-free survival, concentration of anti-drug antibodies, maximum observed concentration, area under the curve, terminal half-life, and time to maximum concentration.

A total of 66 patients are expected to be enrolled in the study, and recruitment in the trial is currently ongoing in Australia. Patients are anticipated to begin being recruited in the next few months within the US.

"ADCs have in the past years shown highly encouraging results and have already become standard of care in quite a number of solid tumor indications. ADCE-T02 represents an attractive new option to explore in advanced solid tumors with high unmet need,” Vinod Ganju, MBBS, FRACP, managing director of Peninsula and Southeast Oncology, Melbourne, Australia and principal investigator of Tiffany-01, said in the press release.¹

REFERENCES:

1. Adcendo ApS announces U.S. FDA clearance of IND application for phase I Tiffany-01 trial of ADCE-T02. News release. February 26, 2025. Accessed February 27, 2025. https://tinyurl.com/33x5n44w

2. ADCE-T02, a tissue factor targeted antibody-drug conjugate, in patients with selected advanced solid tumours. ClinicalTrials.gov. Updated February 10, 2025. Accessed February 27, 2025. https://clinicaltrials.gov/study/NCT06597721?tab=table