Recruiting NCT06801470
A Study to Assess the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of CD-001 in Patients With Advanced Solid Tumors
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: CD-001.
- Who it may be relevant to
- Registry conditions: Advanced Solid Tumors. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
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
Overview
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
- Drug CD-001
CD-001 administered as an intravenous (IV) infusion.
Primary outcome measures
- Number of Participants with Dose Limiting Toxicities (DLTs) [Time frame: 28 days]
- Incidence of AE and serious adverse events (SAE) [Time frame: Up to 3 Years]
- The recommended dose for expansion (RDE) and/ or maximum tolerated dose (MTD) of CD-001 monotherapy [Time frame: Up to 3 Years]
Secondary outcome measures (9)
- Maximum Observed Plasma Concentration (Cmax) of CD-001 [Time frame: Up to 3 Years]
- Time to Achieve Cmax (Tmax) of CD-001 [Time frame: Up to 3 Years]
- Area Under the Plasma Concentration-time Curve (AUC) of CD-001 [Time frame: Up to 3 Years]
- Objective Response (OR) [Time frame: Up to 3 Years]
- Duration of Response (DOR) [Time frame: Up to 3 Years]
- Progression-Free Survival (PFS) [Time frame: Up to 1 Years]
- Disease Control Rate (DCR) [Time frame: Up to 3 Years]
- Overall Survival (OS) [Time frame: Up to 3 Years]
- Frequency of anti-drug antibody (ADA) to CD-001 [Time frame: Up to 3 Years]
Eligibility criteria
Inclusion criteria
- Age ≥ 18 years , regardless of gender.
- Patients with advanced solid tumors that are histologically or cytological confirmed, lacking standard therapy, progressing after adequate standard therapy, or intolerant of standard therapy.
- ECOG score ≤ 2.
- At least one measurable lesion as defined by RECIST v1.1.
- Expected survival ≥ 3 months.
Exclusion criteria
- Patients with known active central nervous system (CNS) and/or leptomeningeal metastases .
- 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.
- Patients who have previously undergone a major organ transplant, bone marrow transplant, or allogeneic stem-cell transplant.
- 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.
- Patients who have received anti-tumor therapy within 4 weeks or 5 drug half-lives (whichever is shorter) prior to the first dosing.
- At screening as determined by the investigator, the presence of any serious or uncontrollable disease or associated risk.
- 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.
- Patients who have had a pulmonary embolism within 6 months prior to first dosing or have interstitial pneumonia at screening.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Non-randomized
- Model
- Sequential
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
China · 1 center
- Tianjin Medical University Cancer Institute&Hospital — Tianjin
Identifiers
NCT: NCT06801470 · CD-001-CT101