Advanced Solid TumorsPhase 1NCT06801470
A Study to Assess the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of CD-001 in Patients With Advanced Solid Tumors
A Phase 1 study testing CD-001 in people with Advanced Solid Tumors, run by CD (Suzhou) Biopharma Co., Ltd. at 1 site in China.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Advanced Solid Tumors
- What is being tested?
- CD-001
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 137 participants
- Where
- 1 siteChina
- Study dates
- 8 Jan 2025to Jun 2028
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Tianjin Medical University Cancer Institute&Hospital
Tianjin
jun yu, +86-022-23340123, yujun@tjmuch.com
Jihui Hao
About this study
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
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
- Being tested
- CD-001
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CD-001Drug
CD-001 administered as an intravenous (IV) infusion.
| Study group | Role | What they receive |
|---|---|---|
| Dose Escalation Phase | Experimental | Determine the recommended dose for expansion (RDE) and/ maximum tolerated dose (MTD) of CD-001 monotherapy. Receives: Drug: CD-001 |
| Dose Expansion Phase | Experimental | Further evaluate the safety tolerability and the preliminary efficacy of CD-001 monotherapy Receives: Drug: CD-001 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants with Dose Limiting Toxicities (DLTs)
Measured: 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)
Measured: Up to 3 Years
The recommended dose for expansion (RDE) and/ or maximum tolerated dose (MTD) of CD-001 monotherapy
Measured: Up to 3 Years
Secondary outcomes (9)
Maximum Observed Plasma Concentration (Cmax) of CD-001
Measured: Up to 3 Years
Time to Achieve Cmax (Tmax) of CD-001
Measured: Up to 3 Years
Area Under the Plasma Concentration-time Curve (AUC) of CD-001
Measured: Up to 3 Years
Objective Response (OR)
Measured: Up to 3 Years
Duration of Response (DOR)
Measured: Up to 3 Years
Progression-Free Survival (PFS)
Measured: Up to 1 Years
Disease Control Rate (DCR)
Measured: Up to 3 Years
Overall Survival (OS)
Measured: Up to 3 Years
Frequency of anti-drug antibody (ADA) to CD-001
Measured: Up to 3 Years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2025
- Study start8 Jan 2025
- Primary completionJan 2028 (estimated)
- Study completionJun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced Solid TumorsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 137 participants (estimated)
Sponsor and investigators
- Lead sponsor
- CD (Suzhou) Biopharma Co., Ltd.
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06801470
- Sponsor's protocol ID
- CD-001-CT101
- Status last verified
- Jan 2025
- First submitted
- 21 Jan 2025
- Last updated
- 7 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06801470
- Acronym / sponsor ID
- CD-001-CT101
- Conditions
- Advanced Solid Tumors
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 137 participants (estimated)
- Lead sponsor
- CD (Suzhou) Biopharma Co., Ltd.University, hospital or other
- Study start
- 8 Jan 2025 (actual)
- Primary completion
- Jan 2028 (estimated)
- Study completion
- Jun 2028 (estimated)
- First posted
- 30 Jan 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dose Escalation Phase | Experimental | Drug: CD-001Determine the recommended dose for expansion (RDE) and/ maximum tolerated dose (MTD) of CD-001 monotherapy. |
| Dose Expansion Phase | Experimental | Drug: CD-001Further evaluate the safety tolerability and the preliminary efficacy of CD-001 monotherapy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CD-001CD-001 administered as an intravenous (IV) infusion. | Drug | Dose Escalation Phase, Dose Expansion Phase |
Primary outcome
Number of Participants with Dose Limiting Toxicities (DLTs)
Time frame: 28 days
Incidence of AE and serious adverse events (SAE)
Time frame: 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
Time frame: Up to 3 Years
9 secondary outcomes
Maximum Observed Plasma Concentration (Cmax) of CD-001
Time frame: Up to 3 Years
Time to Achieve Cmax (Tmax) of CD-001
Time frame: Up to 3 Years
Area Under the Plasma Concentration-time Curve (AUC) of CD-001
Time frame: Up to 3 Years
Objective Response (OR)
Time frame: Up to 3 Years
Duration of Response (DOR)
Time frame: Up to 3 Years
Progression-Free Survival (PFS)
Time frame: Up to 1 Years
Disease Control Rate (DCR)
Time frame: Up to 3 Years
Overall Survival (OS)
Time frame: Up to 3 Years
Frequency of anti-drug antibody (ADA) to CD-001
Time frame: Up to 3 Years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Feb 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing CD-001 in people with Advanced Solid Tumors, run by CD (Suzhou) Biopharma Co., Ltd. at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 7 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Daqing Tang (+86-0512-68765766, daqing.tang@cdbiopharma.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants with Dose Limiting Toxicities (DLTs) (time frame: 28 days). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Feb 2025.