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

NCT ID: NCT04151810

Last Updated: 2024-08-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 32 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-12-16
• Study Completion Date: 2022-10-13

Brief 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.

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

Study Design

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

Study Groups

anti-EGFR monoclonal antibody

This 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.

Group Type: EXPERIMENTAL

CDP1

Intervention Type: DRUG

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;

anti-EGFR monoclonal antibody + chemotherapy

This is a dose-expansion phase, participants with penile squamous cell carcinoma will receive CDP1 in combination with TIP chemotherapy.

Group Type: EXPERIMENTAL

CDP1

Intervention Type: DRUG

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

TIP chemotherapy

Intervention Type: DRUG

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).

Interventions

CDP1

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;

Intervention Type: DRUG

CDP1

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

Intervention Type: DRUG

TIP chemotherapy

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).

Intervention Type: DRUG

Other Intervention Names

Recombinant anti-EGFR human mouse chimeric monoclonal antibody; Recombinant anti-EGFR human mouse chimeric monoclonal antibody

Eligibility Criteria

Inclusion Criteria

1. Age: 18-75 (inclusive), gender unlimited;

2. 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;

3. For colorectal cancer patients, RAS / BRAF was detected as wild-type.

4. ECOG physical strength score: 0-1;

5. Expected survival time over 3 months;

6. According to RECIST1.1, there is at least one tumor lesion that can be assessed;

7. 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;

8. 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;

9. Subjects shall give informed consent to the study before the trial and sign written informed consent voluntarily;

Exclusion Criteria

1. 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;

2. Received other investigational products within 4 weeks before enrollment;

3. Have received EGFR inhibitor treatment before and failed treatment;

4. 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);

5. Patients who had undergone major organ surgery (excluding puncture biopsy) or had significant trauma but not recovered within 4 weeks before admission;

6. 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).

7. 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);

8. Uncontrolled systemic infection;

9. Have a history of immunodeficiency, including HIV antibody test;

10. Treponema pallidum antibody positive;

11. 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);

12. 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;

13. 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;

14. Known dependence on alcohol or drugs;

15. People with mental disorder or poor compliance;

16. Pregnant or lactating women;

17. In the past, when using biological products drugs, severe transfusion reaction occurred;

18. The investigator believes that the subject is not suitable for this clinical study due to any clinical or laboratory examination abnormality or other reasons.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Dragonboat Biopharmaceutical Company Limited

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Li Zheng, doctor

Role: PRINCIPAL_INVESTIGATOR

West China Hospital

Locations

Dragonboat Biopharmaceutical,Co.,Ltd

Shanghai, Shanghai Municipality, China

Countries

China

Other Identifiers

CDP100003

Identifier Type: -

Identifier Source: org_study_id