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

NCT06801470 | Recruiting Phase 1 FDA Drug

• 1 other identifier: CD-001-CT101
• Study Type: interventional
• Target: 137
• Locations: 1 country
• Sites: 1

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).

Conditions

Advanced Solid Tumors

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (9)

• 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

Study Arms (2)

Dose Escalation Phase

EXPERIMENTAL

Determine the recommended dose for expansion (RDE) and/ maximum tolerated dose (MTD) of CD-001 monotherapy.

Drug: CD-001

Dose Expansion Phase

EXPERIMENTAL

Further evaluate the safety tolerability and the preliminary efficacy of CD-001 monotherapy

Drug: CD-001

Interventions

CD-001 DRUG

CD-001 administered as an intravenous (IV) infusion.

Dose Escalation Phase; Dose Expansion Phase

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

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

Study Sites (1)

Tianjin Medical University Cancer Institute&Hospital

Tianjin, China

RECRUITING

Central Study Contacts

Daqing Tang

CONTACT

+86-0512-68765766; daqing.tang@cdbiopharma.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 21, 2025
• First Posted: January 30, 2025
• Study Start: January 8, 2025
• Primary Completion (Estimated): January 1, 2028
• Study Completion (Estimated): June 1, 2028
• Last Updated: February 7, 2025

Record last verified: 2025-01

Locations

CN (1)