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

NCT ID: NCT06801470

Last Updated: 2025-02-07

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE1
• Total Enrollment: 137 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-01-08
• Study Completion Date: 2028-06-30

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

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Dose Escalation Phase

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

Group Type: EXPERIMENTAL

CD-001

Intervention Type: DRUG

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

Dose Expansion Phase

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

Group Type: EXPERIMENTAL

CD-001

Intervention Type: DRUG

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

Interventions

CD-001

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

Intervention Type: DRUG

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

CD (Suzhou) Biopharma Co., Ltd.

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Tianjin Medical University Cancer Institute&Hospital

Tianjin, , China

Site Status: RECRUITING

Countries

China

Central Contacts

Daqing Tang

Role: CONTACT

daqing.tang@cdbiopharma.com

+86-0512-68765766

Facility Contacts

jun yu

Role: primary

yujun@tjmuch.com

+86-022-23340123

Other Identifiers

CD-001-CT101

Identifier Type: -

Identifier Source: org_study_id