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

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).

Study Overview

• Status: Recruiting
• Conditions: Advanced Solid Tumors
• Intervention / Treatment: Drug: CD-001

• Study Type: Interventional
• Enrollment (Estimated): 137
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Daqing Tang; Phone Number: +86-0512-68765766; Email: daqing.tang@cdbiopharma.com

Study Locations

• China
  • Tianjin, China
    • Recruiting
    • Tianjin Medical University Cancer Institute&Hospital
    • Contact: Jihui Hao
    • Contact: Jun Yu
    • Contact: jun yu; Phone Number: +86-022-23340123; Email: yujun@tjmuch.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Sequential Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Dose Escalation Phase; Determine the recommended dose for expansion (RDE) and/ maximum tolerated dose (MTD) of CD-001 monotherapy.	Drug: CD-001; CD-001 administered as an intravenous (IV) infusion.
Experimental: Dose Expansion Phase; Further evaluate the safety tolerability and the preliminary efficacy of CD-001 monotherapy	Drug: CD-001; CD-001 administered as an intravenous (IV) infusion.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants with Dose Limiting Toxicities (DLTs)		28 days
Incidence of AE and serious adverse events (SAE)	According to National Cancer Institute Common Terminology Criteria for Adverse Events [NCI CTCAE] v5.0)	Up to 3 Years
The recommended dose for expansion (RDE) and/ or maximum tolerated dose (MTD) of CD-001 monotherapy		Up to 3 Years

Secondary Outcome Measures

Outcome Measure	Time Frame
Maximum Observed Plasma Concentration (Cmax) of CD-001	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
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

Collaborators and Investigators

• Sponsor: CD (Suzhou) Biopharma Co., Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): January 8, 2025
• Primary Completion (Estimated): January 1, 2028
• Study Completion (Estimated): June 1, 2028

Study Registration Dates

• First Submitted: January 21, 2025
• First Submitted That Met QC Criteria: January 24, 2025
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: February 5, 2025
• Last Verified: January 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms
• Other Study ID Numbers: CD-001-CT101

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No