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NextCure’s Phase I Study of SIM0505: A Potential Breakthrough in Cancer Treatment

NextCure’s Phase I Study of SIM0505: A Potential Breakthrough in Cancer Treatment

Nextcure ((NXTC)) announced an update on their ongoing clinical study.

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NextCure, Inc. is conducting a Phase I clinical study titled ‘A Phase I First-in-human, Open-label, Multicenter Study to Investigate the Safety, Tolerability, Pharmacokinetics and Preliminary Antitumor Activity of SIM0505 in Adult Participants With Advanced Solid Tumors.’ The study aims to evaluate the safety and preliminary antitumor activity of SIM0505, a potential treatment for advanced solid tumors. This research is significant as it explores a new therapeutic option for patients with limited treatment choices.

The study is testing SIM0505, a drug administered via injection, designed to assess its maximum tolerated dose and recommended dose across various cancer types, including ovarian, renal, uterine, and lung cancers. The drug is being evaluated for its safety and potential antitumor effects.

This interventional study uses a randomized, sequential intervention model without masking, focusing primarily on treatment. The study’s design allows for exploring different dose levels to determine the most effective and safe dosage for patients.

The study began on January 13, 2025, with its primary completion and estimated completion dates yet to be announced. The latest update was submitted on September 29, 2025, indicating ongoing recruitment and progress in the study.

This update from NextCure could positively influence its stock performance by demonstrating progress in its pipeline, potentially increasing investor confidence. The study’s success could position NextCure favorably against competitors in the oncology sector, highlighting its commitment to innovative cancer treatments.

The study is ongoing, with further details available on the ClinicalTrials portal.

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