Crescent Biopharma Advances CR-001 Cancer Trial Into First-in-Human Stage

Crescent Biopharma, Inc. (CBIO) announced an update on their ongoing clinical study.

Study Overview

Crescent Biopharma, Inc. has launched a new early-stage cancer trial titled “A Phase 1/2, Multicenter, Open-label, Dose Escalation and Dose Expansion Study to Evaluate the Safety, Pharmacokinetics, Pharmacodynamics, and Antitumor Activity of CR-001 in Adult Participants With Locally Advanced or Metastatic Solid Tumors.” The study aims to find a safe and effective dose of CR-001, a new cancer drug candidate, in patients with advanced solid tumors who have limited treatment options, a step that could open the door to broader development if results are encouraging.

Intervention/Treatment

The trial is testing CR-001, an experimental cancer drug given through intravenous infusion. It is being studied as a stand-alone treatment (monotherapy) in several groups of patients with advanced or metastatic solid tumors. The goal is to understand how the drug behaves in the body, how well patients tolerate it, and whether it shows signs of shrinking or slowing tumors.

Study Design

This is an interventional Phase 1/2 study, meaning participants receive an active experimental treatment rather than standard care alone. Patients are assigned to treatment groups in a non-random way, and dose levels are increased step by step to find the best balance between safety and activity. The study is open-label, so both doctors and patients know they are receiving CR-001. The main purpose at this stage is treatment-focused: identify a safe dose and look for early signs that the drug may work against cancer.

Study Timeline

The study was first submitted on January 8, 2026, marking the formal start of the regulatory process and signaling Crescent’s move into clinical testing of CR-001. The most recent update was posted on January 13, 2026, which shows active preparation and continued set-up for the trial. The study is listed as “Not Yet Recruiting,” so site activation and patient screening still lie ahead. Primary completion and final completion dates are not yet posted, which is typical at this stage and implies data that can move the stock will likely come several quarters, if not years, later.

Market Implications

For investors, this update confirms that Crescent Biopharma is progressing its lead asset into first-in-human testing, a key value inflection point for any small or mid-cap biotech. Positive early safety and dose-finding data can support future capital raises or partnerships, but the “Not Yet Recruiting” status suggests near-term news flow will focus on enrollment and operational milestones rather than efficacy. In a crowded oncology space that includes larger players with more advanced pipelines, CR-001 will need clear early signals to stand out and drive sustained share price gains. Near term, the listing and update on ClinicalTrials.gov may offer a modest sentiment boost as it reduces execution risk around trial initiation, but meaningful re-rating will depend on patient dosing and early readouts once the trial is underway. The study is currently ongoing in its set-up phase, with updated information available on the ClinicalTrials portal.

To learn more about CBIO’s potential, visit the Crescent Biopharma, Inc. drug pipeline page.