Assessing a new treatment for advanced solid tumors

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study evaluates the safety, tolerability, pharmacokinetics, and preliminary efficacy of a new drug called CD-001 in patients with advanced solid tumors. It aims to determine the maximum tolerated dose and the recommended dose for further phases of testing. Participants will be closely monitored for any adverse effects and the drug's effectiveness in treating their condition. The study is designed for patients who have not responded to standard therapies or have no available treatment options.

Why it matters

Who can join: the full rules

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.

Where it's running

• Tianjin Medical University Cancer Institute&Hospital
  Tianjin, China Recruiting

Study contacts

• Study coordinator: Daqing Tang
• Email: daqing.tang@cdbiopharma.com
• Phone: +86-0512-68765766

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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• MK-2010 with Sac-TMT in advanced solid tumors

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.