Clinical trial NCT06801470: A Study to Assess the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of CD-001 in Patients With Advanced Solid Tumors
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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
Conditions: Advanced Solid Tumors
Lead sponsor: CD (Suzhou) Biopharma Co., Ltd.
Sponsor class: OTHER
First posted: 2025-01-30
Enrollment: 137
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

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).


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.

Primary outcomes:
measure: Number of Participants with Dose Limiting Toxicities (DLTs)
timeFrame: 28 days
measure: Incidence of AE and serious adverse events (SAE)
timeFrame: Up to 3 Years
measure: The recommended dose for expansion (RDE) and/ or maximum tolerated dose (MTD) of CD-001 monotherapy
timeFrame: Up to 3 Years
Secondary outcomes:
measure: Maximum Observed Plasma Concentration (Cmax) of CD-001
timeFrame: Up to 3 Years
measure: Time to Achieve Cmax (Tmax) of CD-001
timeFrame: Up to 3 Years
measure: Area Under the Plasma Concentration-time Curve (AUC) of CD-001
timeFrame: Up to 3 Years
measure: Objective Response (OR)
timeFrame: Up to 3 Years
measure: Duration of Response (DOR)
timeFrame: Up to 3 Years
measure: Progression-Free Survival (PFS)
timeFrame: Up to 1 Years
measure: Disease Control Rate (DCR)
timeFrame: Up to 3 Years
measure: Overall Survival (OS)
timeFrame: Up to 3 Years
measure: Frequency of anti-drug antibody (ADA) to CD-001
timeFrame: Up to 3 Years
Other outcomes:
Locations:
city: Tianjin
country: China
facility: Tianjin Medical University Cancer Institute&Hospital
Study officials:
References: