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

Phase 1

Completed

• Conditions: Advanced Tumors

• Registration Number: NCT04151810
• Lead Sponsor: Dragonboat Biopharmaceutical Company Limited

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2019-10-29
• Last Update Posted: 2 September 2024

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 32

Inclusion Criteria

Inclusion Criteria:<br><br> 1. Age: 18-75 (inclusive), gender unlimited;<br><br> 2. Dose-escalation phase: Patients with advanced solid tumors confirmed by histology or<br> cytology who have failed to receive the existing standard treatment or are unable to<br> tolerate or unwilling to accept the standard treatment (tumor types benefiting from<br> anti EGFR treatment, including but not limited to colorectal cancer, head and neck<br> squamous cell carcinoma, esophageal squamous cell carcinoma, penile squamous cell<br> carcinoma, etc.); Dose-expansion phase: Patients with recurrent or metastatic<br> advanced penile squamous cell carcinoma confirmed by histology or cytology who are<br> not suitable for radical resection;<br><br> 3. For colorectal cancer patients, RAS / BRAF was detected as wild-type.<br><br> 4. ECOG physical strength score: 0-1;<br><br> 5. Expected survival time over 3 months;<br><br> 6. According to RECIST1.1, there is at least one tumor lesion that can be assessed;<br><br> 7. No serious abnormalities of blood system, liver function, renal function and<br> coagulation function: Neutrophils =1.5×10 9 /L, platelets = 75 × 10 g/L, hemoglobin<br> = 90g/L;Total bilirubin = 1.5ULN, ALT = 2.5ULN, AST = 2.5ULN (ALT = 5ULN, AST = 5ULN<br> in patients with liver metastasis); Blood creatinine = 1.5ULN; APTT = 1.5ULN, Pt =<br> 1.5ULN, INR = 1.5ULN;<br><br> 8. Eligible fertile patients (male and female) must agree to use a reliable method of<br> contraception (hormonal or barrier or abstinence) during the trial and for at least<br> 12 weeks after the last dose; Women of childbearing age must have a negative blood<br> or urine pregnancy test within 7 days of enrollment;<br><br> 9. Subjects shall give informed consent to the study before the trial and sign written<br> informed consent voluntarily;<br><br>Exclusion Criteria:<br><br> 1. Received chemotherapy, biotherapy, radiotherapy, endocrinotherapy, small molecule<br> targeted therapy and other anti-tumor treatment (except for nitrosourea, mitomycin C<br> and fluorouracil oral drugs) within 4 weeks before starting to use the study drug: 6<br> weeks for nitrosourea or mitomycin C; The interval between the last oral<br> administration of fluorouracil, such as tegio and capecitabine, and the use of the<br> study drug is at least 2 weeks; Received big molecule anti-tumor drugs which had<br> long half-lives (such as anti PD-1 or PD-L1 drugs) within 8 weeks before enrollment;<br><br> 2. Received other investigational products within 4 weeks before enrollment;<br><br> 3. Have received EGFR inhibitor treatment before and failed treatment;<br><br> 4. Patients who have failed previous platinum therapy (Recurrent within 6 months after<br> completion of platinum neoadjuvant/adjuvant therapy defined as treatment failure,<br> cannot be included in this study; If the recurrence occurs after more than 6 months,<br> the patient can be included);<br><br> 5. Patients who had undergone major organ surgery (excluding puncture biopsy) or had<br> significant trauma but not recovered within 4 weeks before admission;<br><br> 6. The adverse reactions of the previous anti-tumor treatment have not been restored to<br> CTCAE 5.0 grade evaluation = 1 (except for hair loss); the radiotoxicity has not<br> been restored to CTCAE 5.0 grade evaluation grade 1 and below (except for no<br> effect).<br><br> 7. The central nervous system metastasis without treatment or with clinical symptoms is<br> not suitable for the group according to the judgment of the researcher; the patients<br> suspected of brain or pia mater diseases with clinical symptoms need to be excluded<br> by CT / MRI (flow chart notes);<br><br> 8. Uncontrolled systemic infection;<br><br> 9. Have a history of immunodeficiency, including HIV antibody test;<br><br> 10. Treponema pallidum antibody positive;<br><br> 11. Patients with chronic hepatitis B virus (HBV) infection, and the number of copies of<br> HBV is more than 1000 IU / ml; patients with active hepatitis C virus (HCV)<br> infection (note of index flow chart);<br><br> 12. Serious cardiovascular disease history: including ventricular arrhythmia requiring<br> clinical intervention; acute coronary syndrome, congestive heart failure, stroke or<br> other cardiovascular events of level III and above within 6 months; NYHA heart<br> function grade = level II or left ventricular ejection fraction (LVEF) < 50%; poor<br> control of hypertension, which is judged to be uncomfortable by researchers Join<br> group;<br><br> 13. Patients with other serious systemic diseases (including respiratory system,<br> endocrine system, etc.) who are not suitable for clinical trials according to the<br> judgment of researchers;<br><br> 14. Known dependence on alcohol or drugs;<br><br> 15. People with mental disorder or poor compliance;<br><br> 16. Pregnant or lactating women;<br><br> 17. In the past, when using biological products drugs, severe transfusion reaction<br> occurred;<br><br> 18. The investigator believes that the subject is not suitable for this clinical study<br> due to any clinical or laboratory examination abnormality or other reasons.

Exclusion Criteria

Not provided

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Dose Limiting Toxicities (DLT);Recommended phase II dose (RP2D)

Secondary Outcome Measures

Name	Time	Method
Pharmacokinetic parameters: Observed Maximum Serum Concentration (Cmax) of CDP1 After Infusion;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;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: Apparent Terminal Half-life (t1/2) of CDP1 After Infusion;Immunogenicity indicators: Number of participants with positive anti-drug antibodies (ADA);Immunogenicity indicators: Number of participants with positive neutralizing antibodies;Objective response rate (ORR);Progression-free survival (PFS)