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

Inclusion Criteria:

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

2. Dose-escalation phase: Patients with advanced solid tumors confirmed by histology orcytology who have failed to receive the existing standard treatment or are unable totolerate or unwilling to accept the standard treatment (tumor types benefiting fromanti EGFR treatment, including but not limited to colorectal cancer, head and necksquamous cell carcinoma, esophageal squamous cell carcinoma, penile squamous cellcarcinoma, etc.); Dose-expansion phase: Patients with recurrent or metastaticadvanced penile squamous cell carcinoma confirmed by histology or cytology who arenot 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 andcoagulation 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 ≤ 5ULNin 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 ofcontraception (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 bloodor urine pregnancy test within 7 days of enrollment;

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

Exclusion Criteria:

1. Received chemotherapy, biotherapy, radiotherapy, endocrinotherapy, small moleculetargeted therapy and other anti-tumor treatment (except for nitrosourea, mitomycin Cand fluorouracil oral drugs) within 4 weeks before starting to use the study drug: 6weeks for nitrosourea or mitomycin C; The interval between the last oraladministration of fluorouracil, such as tegio and capecitabine, and the use of thestudy drug is at least 2 weeks; Received big molecule anti-tumor drugs which hadlong 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 aftercompletion 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 hadsignificant trauma but not recovered within 4 weeks before admission;

6. The adverse reactions of the previous anti-tumor treatment have not been restored toCTCAE 5.0 grade evaluation ≤ 1 (except for hair loss); the radiotoxicity has notbeen restored to CTCAE 5.0 grade evaluation grade 1 and below (except for noeffect).

7. The central nervous system metastasis without treatment or with clinical symptoms isnot suitable for the group according to the judgment of the researcher; the patientssuspected of brain or pia mater diseases with clinical symptoms need to be excludedby 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 ofHBV 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 requiringclinical intervention; acute coronary syndrome, congestive heart failure, stroke orother cardiovascular events of level III and above within 6 months; NYHA heartfunction grade ≥ level II or left ventricular ejection fraction (LVEF) < 50%; poorcontrol of hypertension, which is judged to be uncomfortable by researchers Joingroup;

13. Patients with other serious systemic diseases (including respiratory system,endocrine system, etc.) who are not suitable for clinical trials according to thejudgment 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 reactionoccurred;

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