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Clinical Trials in China / NCT06801470
Recruiting Phase 1

A Study to Assess the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of CD-001 in Patients With Advanced Solid Tumors

NCT06801470 · tracked via the Priya Life Science China tracker
Sponsor
CD (Suzhou) Biopharma Co., Ltd.
Phase
Phase 1
Started
2025-01-08
Last updated
2025-02-07

Condition(s) studied

Advanced Solid Tumors

Investigational drug(s) / intervention(s)

CD-001

CD-001: CD-001 administered as an intravenous (IV) infusion.

Study summary

To assess the safety, tolerability, PK and preliminary efficacy of CD-001 in patients with advanced solid tumors. and to determine the maximum tolerated dose (MTD) and/or recommended phase 2 dose (RP2D).

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: 1. Age ≥ 18 years , regardless of gender. 2. Patients with advanced solid tumors that are histologically or cytological confirmed, lacking standard therapy, progressing after adequate standard therapy, or intolerant of standard therapy. 3. ECOG score ≤ 2. 4. At least one measurable lesion as defined by RECIST v1.1. 5. Expected survival ≥ 3 months. Exclusion Criteria: 1. Patients with known active central nervous system (CNS) and/or leptomeningeal metastases . 2. Patients who have undergone major organ surgery within 4 weeks prior to the first dosing, or who are expected to require major surgery during this study, or who have severe unhealed wounds, trauma, ulcers, etc. 3. Patients who have previously undergone a major organ transplant, bone marrow transplant, or allogeneic stem-cell transplant. 4. Patients who have a past or current history of active or chronic autoimmune disease and who have required systemic therapy within the past 2 years or is receiving systemic therapy for an autoimmune or inflammatory disease. 5. Patients who have received anti-tumor therapy within 4 weeks or 5 drug half-lives (whichever is shorter) prior to the first dosing. 6. At screening as determined by the investigator, the presence of any serious or uncontrollable disease or associated risk. 7. Patients with a history of ≥ Grade 3 (CTCAE) immune-related adverse events (irAEs) during prior anti-tumor therapy or permanent drug discontinuation due to irAEs. 8. Patients who have had a pulmonary embolism within 6 months prior to first dosing or have interstitial pneumonia at screening.

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
Tianjin Medical University Cancer Institute&Hospital Tianjin China Recruiting

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06801470 on ClinicalTrials.gov ↗ ← All trials in China