Assessing a new treatment for advanced solid tumors

A Phase I, Multicenter, Open-Label, First-In-Human Study to Assess the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of CD 001 in Patients With Advanced Solid Tumors

This study is testing a new drug called CD-001 to see if it can help people with advanced solid tumors who haven't had success with other treatments.

Quick facts

• Phase: Phase 1
• Study type: Interventional
• Enrollment: 137 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: CD (Suzhou) Biopharma Co., Ltd. (Academic / other)
• Locations: 1 site (Tianjin)
• Trial ID: NCT06801470 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older with advanced solid tumors that have progressed after standard therapies.

Not a fit: Patients with active central nervous system metastases or those requiring major surgery during the study may not benefit from this treatment.

Why it matters

Potential benefit: If successful, this treatment could provide a new therapeutic option for patients with advanced solid tumors who have limited alternatives.

How similar studies have performed: Other studies have shown promise with similar investigational drugs in treating advanced solid tumors, indicating potential for success.

Eligibility criteria

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 this trial is running

Tianjin

• Tianjin Medical University Cancer Institute&Hospital — Tianjin, China (Recruiting)

Study contacts

• Study coordinator: Daqing Tang

Conditions Advanced Solid Tumors