A Study to Assess the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of CD-001 in Patients with Advanced Solid Tumors

Phase 1

Recruiting

• Conditions: Advanced Solid Tumors
• Interventions: Drug: CD-001

• Registration Number: NCT06801470
• Lead Sponsor: CD (Suzhou) Biopharma Co., Ltd.

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).

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-01
• Study Start: 2025-01-08
• Study First Submitted: 2025-01-21
• Study First Submitted QC: 2025-01-24
• Study First Posted: 2025-01-30
• Last Update Submitted: 2025-02-05
• Last Update Posted: 2025-02-07
• Primary Completion: 2028-01
• Study Completion: 2028-06

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 137

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
Dose Escalation Phase	CD-001	Determine the recommended dose for expansion (RDE) and/ maximum tolerated dose (MTD) of CD-001 monotherapy.
Dose Expansion Phase	CD-001	Further evaluate the safety tolerability and the preliminary efficacy of CD-001 monotherapy

Primary Outcome Measures

Name	Time	Method
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
Number of Participants with Dose Limiting Toxicities (DLTs)	28 days

Secondary Outcome Measures

Name	Time	Method
Maximum Observed Plasma Concentration (Cmax) of CD-001	Up to 3 Years
Area Under the Plasma Concentration-time Curve (AUC) of CD-001	Up to 3 Years
Time to Achieve Cmax (Tmax) of CD-001	Up to 3 Years
Objective Response (OR)	Up to 3 Years
Duration of Response (DOR)	Up to 3 Years
Progression-Free Survival (PFS)	Up to 1 Years
Disease Control Rate (DCR)	Up to 3 Years
Overall Survival (OS)	Up to 3 Years
Frequency of anti-drug antibody (ADA) to CD-001	Up to 3 Years

Trial Locations

Locations (1)

Tianjin Medical University Cancer Institute&Hospital; 🇨🇳 Tianjin, China