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Advanced TumorsPhase 1NCT04151810

Phase I Clinical Trial of CDP1 in Patients With Advanced Solid Tumors

A Phase 1 study testing CDP1 and TIP chemotherapy in people with Advanced Tumors, run by Dragonboat Biopharmaceutical Company Limited at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The main purpose of this study was to evaluate the safety and tolerability of CDP1 in patients with advanced solid tumor, to explore dose limited toxicity (DLT), and to determine the recommended dose (RP2D) for phase II clinical trials. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Advanced Tumors
What is being tested?
CDP1 and TIP chemotherapy
Could I receive a placebo?
No, everyone receives an active treatment
How many people
32 participants
Where
1 siteChina
Study dates
16 Dec 2019to 13 Oct 2022
Phase
Phase 1
Are there results?
None posted in the registry

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 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Age: 18-75 (inclusive), gender unlimited;
  • Dose-escalation phase: Patients with advanced solid tumors confirmed by histology or cytology who have failed to receive the existing standard treatment or are unable to tolerate or unwilling to accept the standard treatment (tumor types benefiting from anti EGFR treatment, including but not limited to colorectal cancer, head and neck squamous cell carcinoma, esophageal squamous cell carcinoma, penile squamous cell carcinoma, etc.); Dose-expansion phase: Patients with recurrent or metastatic advanced penile squamous cell carcinoma confirmed by histology or cytology who are not suitable for radical resection;
  • For colorectal cancer patients, RAS / BRAF was detected as wild-type.
  • ECOG physical strength score: 0-1;
  • Expected survival time over 3 months;
  • According to RECIST1.1, there is at least one tumor lesion that can be assessed;
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  • No serious abnormalities of blood system, liver function, renal function and coagulation function: Neutrophils ≥1.5×10 9 /L, platelets ≥ 75 × 10 g/L, hemoglobin ≥ 90g/L;Total bilirubin ≤ 1.5ULN, ALT ≤ 2.5ULN, AST ≤ 2.5ULN (ALT ≤ 5ULN, AST ≤ 5ULN in patients with liver metastasis); Blood creatinine ≤ 1.5ULN; APTT ≤ 1.5ULN, Pt ≤ 1.5ULN, INR ≤ 1.5ULN;
  • Eligible fertile patients (male and female) must agree to use a reliable method of contraception (hormonal or barrier or abstinence) during the trial and for at least 12 weeks after the last dose; Women of childbearing age must have a negative blood or urine pregnancy test within 7 days of enrollment;
  • Subjects shall give informed consent to the study before the trial and sign written informed consent voluntarily;

Who cannot join

  • Received chemotherapy, biotherapy, radiotherapy, endocrinotherapy, small molecule targeted therapy and other anti-tumor treatment (except for nitrosourea, mitomycin C and fluorouracil oral drugs) within 4 weeks before starting to use the study drug: 6 weeks for nitrosourea or mitomycin C; The interval between the last oral administration of fluorouracil, such as tegio and capecitabine, and the use of the study drug is at least 2 weeks; Received big molecule anti-tumor drugs which had long half-lives (such as anti PD-1 or PD-L1 drugs) within 8 weeks before enrollment;
  • Received other investigational products within 4 weeks before enrollment;
  • Have received EGFR inhibitor treatment before and failed treatment;
  • Patients who have failed previous platinum therapy (Recurrent within 6 months after completion of platinum neoadjuvant/adjuvant therapy defined as treatment failure, cannot be included in this study; If the recurrence occurs after more than 6 months, the patient can be included);
  • Patients who had undergone major organ surgery (excluding puncture biopsy) or had significant trauma but not recovered within 4 weeks before admission;
  • The adverse reactions of the previous anti-tumor treatment have not been restored to CTCAE 5.0 grade evaluation ≤ 1 (except for hair loss); the radiotoxicity has not been restored to CTCAE 5.0 grade evaluation grade 1 and below (except for no effect).
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  • The central nervous system metastasis without treatment or with clinical symptoms is not suitable for the group according to the judgment of the researcher; the patients suspected of brain or pia mater diseases with clinical symptoms need to be excluded by CT / MRI (flow chart notes);
  • Uncontrolled systemic infection;
  • Have a history of immunodeficiency, including HIV antibody test;
  • Treponema pallidum antibody positive;
  • Patients with chronic hepatitis B virus (HBV) infection, and the number of copies of HBV is more than 1000 IU / ml; patients with active hepatitis C virus (HCV) infection (note of index flow chart);
  • Serious cardiovascular disease history: including ventricular arrhythmia requiring clinical intervention; acute coronary syndrome, congestive heart failure, stroke or other cardiovascular events of level III and above within 6 months; NYHA heart function grade ≥ level II or left ventricular ejection fraction (LVEF) < 50%; poor control of hypertension, which is judged to be uncomfortable by researchers Join group;
  • Patients with other serious systemic diseases (including respiratory system, endocrine system, etc.) who are not suitable for clinical trials according to the judgment of researchers;
  • Known dependence on alcohol or drugs;
  • People with mental disorder or poor compliance;
  • Pregnant or lactating women;
  • In the past, when using biological products drugs, severe transfusion reaction occurred;
  • The investigator believes that the subject is not suitable for this clinical study due to any clinical or laboratory examination abnormality or other reasons.

Trial locations and contacts

1 site in 1 country.

China1 site

  • Dragonboat Biopharmaceutical,Co.,Ltd

    Shanghai, Shanghai Municipality

Other trials in China

About this study

Official title: Phase I Clinical Trial to Evaluate Safety, Tolerance and Pharmacokinetics of Recombinant Anti-EGFR Human Mouse Chimeric Monoclonal Antibody Injection (CDP1) in Patients With Advanced Solid Tumors

The main purpose of this study was to evaluate the safety and tolerability of CDP1 in patients with advanced solid tumor, to explore dose limited toxicity (DLT), and to determine the recommended dose (RP2D) for phase II clinical trials.

Read the detailed description

OBJECTIVES:

Primary:

To evaluate the safety and tolerability of CDP1 in patients with advanced solid tumor, to explore the dose limited toxicity (DLT), and to determine the recommended dose (RP2D) for phase II clinical trial.

Secondary:

To evaluate the pharmacokinetics of CDP1 in patients with advanced solid tumor.

To evaluate the immunogenicity of CDP1 in patients with advanced solid tumor.

To evaluate the initial efficacy of CDP1 in patients with advanced solid tumor.

Conditions
Advanced Tumors
Being tested
CDP1, TIP chemotherapy

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • CDP1Drug

    Also called Recombinant anti-EGFR human mouse chimeric monoclonal antibody

    Single dose part:

    Cohort 1:400 mg/m2; Cohort 2: 500 mg/m2; Cohort 3: 750 mg/m2;

    Multi-dose Part:

    Starting dose: Cohort 1:400 mg/m2; Cohort 2/3: 500 mg/m2; Maintenance dose: Cohort 1:250 mg/m2, QW; Cohort 2/3: 500 mg/m2, Q2W;

  • CDP1Drug

    Also called Recombinant anti-EGFR human mouse chimeric monoclonal antibody

    Starting dose: 400 mg/m2; Maintenance dose: 250 mg/m2,QW;

  • TIP chemotherapyDrug

    Paclitaxel: 175 mg/m2 in day 1, Q3W; Ifosfamide: 1200 mg/m2 in day 1, day 2 and day 3, Q3W; Cisplatin: 25 mg/m2 in day 1, day 2 and day 3, Q3W; Participants received TIP chemotherapy up to 6 cycles (21 days per cycle).

Study groups in NCT04151810
Study groupRoleWhat they receive
anti-EGFR monoclonal antibodyExperimentalThis is a dose-escalation phase, all participants will receive treatment with CDP1. Participants enrolled in this trial may receive one of the following doses dependent upon time of enrolment into the study.
Receives: Drug: CDP1
anti-EGFR monoclonal antibody + chemotherapyExperimentalThis is a dose-expansion phase, participants with penile squamous cell carcinoma will receive CDP1 in combination with TIP chemotherapy.
Receives: Drug: CDP1; Drug: TIP chemotherapy

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Dose Limiting Toxicities (DLT)

    Number of participants with dose limiting toxicity (DLT)

    Measured: At the end of Cycle 1 (28 days).

  2. Recommended phase II dose (RP2D)

    Recommended phase II dose (RP2D) evaluated on the first cycle.

    Measured: At least one cycle of treatment(6 months).

Secondary outcomes (8)

  1. Pharmacokinetic parameters: Observed Maximum Serum Concentration (Cmax) of CDP1 After Infusion

    Pharmacokinetic parameters Cmax for CDP1

    Measured: Up to 28 Days

  2. Pharmacokinetic Parameters: Area Under the Serum Concentration-time Curve From Time Zero to the Last Sampling Time (AUC0-t) After Infusion AUC(0-t) for CDP1

    AUC(0-t) for CDP1

    Measured: Up to 28 Days

  3. Pharmacokinetic parameters: Area Under the Serum Concentration-time Curve From Time Zero to Infinity (AUC0-00) After Infusion Pharmacokinetic parameters: AUC(0-00) for CDP1

    Pharmacokinetic parameters: AUC(0-00) for CDP1

    Measured: Up to 28 Days

  4. Pharmacokinetic parameters: Apparent Terminal Half-life (t1/2) of CDP1 After Infusion

    Pharmacokinetic parameters T1/2 for CDP1

    Measured: Up to 28 Days

  5. Immunogenicity indicators: Number of participants with positive anti-drug antibodies (ADA)

    Immunogenicity indicators: Number of participants with positive anti-drug

    Measured: an average of 6 months

  6. Immunogenicity indicators: Number of participants with positive neutralizing antibodies

    Immunogenicity indicators: Number of participants with positive neutralizing antibodies

    Measured: an average of 6 months

  7. Objective response rate (ORR)

    The ORR is defined as the proportion of subjects with confirmed CR or confirmed PR, based on RECIST Version 1.1.

    Measured: an average of 6 months

  8. Progression-free survival (PFS)

    Progression-free survival is defined as the time from the start of treatment with CDP1 until the first documentation of disease progression or death due to any cause, whichever occurs first.

    Measured: an average of 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Nov 2019
  2. Study start16 Dec 2019
  3. Primary completion13 Oct 2022
  4. Study completion13 Oct 2022

Resources

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
32 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04151810
Sponsor's protocol ID
CDP100003
Status last verified
Aug 2024
First submitted
29 Oct 2019
Last updated
27 Aug 2024
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing CDP1 and TIP chemotherapy in people with Advanced Tumors, run by Dragonboat Biopharmaceutical Company Limited 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 9 inclusion and 18 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: finished, as of the sponsor's last update on 27 Aug 2024. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Dose Limiting Toxicities (DLT) (time frame: At the end of Cycle 1 (28 days).). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04151810.

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 27 Aug 2024.

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