Advanced Solid Tumors
Conditions
Brief 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).
Interventions
DRUGCD-001
CD-001 administered as an intravenous (IV) infusion.
Sponsors
CD (Suzhou) Biopharma Co., Ltd.
Study design
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants with Dose Limiting Toxicities (DLTs) | 28 days | — |
| Incidence of AE and serious adverse events (SAE) | Up to 3 Years | According to National Cancer Institute Common Terminology Criteria for Adverse Events \[NCI CTCAE\] v5.0) |
| The recommended dose for expansion (RDE) and/ or maximum tolerated dose (MTD) of CD-001 monotherapy | Up to 3 Years | — |
Secondary
| Measure | Time frame |
|---|---|
| Objective Response (OR) | Up to 3 Years |
| Duration of Response (DOR) | Up to 3 Years |
| Progression-Free Survival (PFS) | Up to 1 Years |
| Maximum Observed Plasma Concentration (Cmax) of CD-001 | Up to 3 Years |
| Overall Survival (OS) | Up to 3 Years |
| Frequency of anti-drug antibody (ADA) to CD-001 | Up to 3 Years |
| Disease Control Rate (DCR) | Up to 3 Years |
| Time to Achieve Cmax (Tmax) of CD-001 | Up to 3 Years |
| Area Under the Plasma Concentration-time Curve (AUC) of CD-001 | Up to 3 Years |
Countries
China
Contacts
Primary ContactDaqing Tang
Outcome results
None listed