Phase 1/2 trial launches of molecular glue degrader for ccRCC

The first patient has been dosed in a phase 1/2 trial (NCT07300241) of NEO-811, an investigational molecular glue degrader, in patients with locally advanced or metastatic non-resectable clear cell renal cell carcinoma (ccRCC).¹

“We are pleased to have the first patient dosed in the phase 1/2 study of NEO-811,” said Toni K. Choueiri, MD, director of the Lank Center for Genitourinary Oncology at Dana-Farber Cancer Institute, professor of medicine at Harvard Medical School, and chair of the study steering committee, in a news release from Neomorph.¹ “NEO-811 is a novel, potent, cereblon-dependent, and selective molecular glue degrader designed to fully block a key signaling pathway in clear cell renal cell cancer. The unique mechanism of action of NEO-811 is quite promising and could offer a new treatment option for patients.”

The open-label, first-in-human study is designed to assess the safety, tolerability, pharmacokinetics, and preliminary anti-tumor activity of NEO-811 in this patient population.² The study will consist of a single-agent dose-escalation phase followed by a dose-expansion phase.

In total, the trial plans to enroll up to 30 patients with locally advanced or metastatic nonresectable ccRCC whose disease progressed on standard therapies. The study is enrolling patients through clinical trial sites across the US.

To be eligible for enrollment, patients need to have measurable disease per RECIST v1.1; an ECOG performance status of 0 or 1; adequate hematologic, hepatic, and renal function; and newly obtained or archival formalin-fixed paraffin-embedded tumor tissue. Patients are not eligible if they have non-clear cell predominant RCC histologic subtypes, leptomeningeal disease or symptomatic active central nervous system (CNS) metastases (with an exception for asymptomatic treated CNS metastases per protocol), or a history of hepatitis B virus, hepatitis C virus, or HIV infection.

The primary outcome measures for phase 1 of the study are the frequency and severity of treatment-emergent adverse events as well as the determination of a maximum tolerated dose and/or recommended phase 2 dose of NEO-811 monotherapy. The study will also assess preliminary tumor responses as well as other pharmacokinetic measures.

Primary completion of the study is expected in January 2027, with final completion slated for September 2027.

“Dosing the first patient in our phase 1/2 trial of NEO-811 in renal cell carcinoma marks a pivotal inflection point for Neomorph, representing the first clinical evaluation of an asset from our internally developed pipeline,” concluded Phil Chamberlain, DPhil, Co-Founder, President, and CEO of Neomorph, in the news release.¹ “As we advance in the clinic, we look forward to generating data that will inform the continued development of NEO-811 and further validate the potential of our platform to deliver differentiated medicines for patients with significant unmet need.”

REFERENCES

1. Neomorph announces first patient dosed in phase 1/2 trial evaluating NEO-811 for the treatment of locally advanced or metastatic non-resectable clear cell renal cell carcinoma. News release. Neomorph, Inc. February 3, 2026. Accessed February 5, 2026. https://www.globenewswire.com/news-release/2026/02/03/3231475/0/en/Neomorph-Announces-First-Patient-Dosed-in-Phase-1-2-Trial-Evaluating-NEO-811-For-the-Treatment-of-Locally-Advanced-or-Metastatic-Non-Resectable-Clear-Cell-Renal-Cell-Carcinoma.html

2. Open-label phase 1/​2 study of NEO-811 in subjects with locally advanced or metastatic non-resectable clear cell renal cell carcinoma. ClinicalTrials.gov. Last updated January 14, 2026. Accessed February 5, 2026. https://clinicaltrials.gov/study/NCT07300241