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

NCT04151810 | Completed Phase 1

• 1 other identifier: CDP100003
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

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.

Conditions

Advanced Tumors

Outcome Measures

Primary Outcomes (2)

• Dose Limiting Toxicities (DLT)

  Number of participants with dose limiting toxicity (DLT)

  At the end of Cycle 1 (28 days).

• Recommended phase II dose (RP2D)

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

  At least one cycle of treatment(6 months).

Secondary Outcomes (8)

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

  Up to 28 Days

• 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

  Up to 28 Days

• 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

  Up to 28 Days

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

  Up to 28 Days

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

  an average of 6 months

Study Arms (2)

anti-EGFR monoclonal antibody

EXPERIMENTAL

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.

Drug: CDP1

anti-EGFR monoclonal antibody + chemotherapy

EXPERIMENTAL

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

Drug: CDP1; Drug: TIP chemotherapy

Interventions

CDP1 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;

Also known as: Recombinant anti-EGFR human mouse chimeric monoclonal antibody

anti-EGFR monoclonal antibody

TIP chemotherapy 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).

anti-EGFR monoclonal antibody + chemotherapy

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;
• 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;

You may not qualify if:

• 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).
• 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;

Sponsors & Collaborators

• Dragonboat Biopharmaceutical Company Limited: lead

Study Sites (1)

Dragonboat Biopharmaceutical,Co.,Ltd

Shanghai, Shanghai Municipality, China

Location

Study Officials

• Li Zheng, doctor

  West China Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 29, 2019
• First Posted: November 5, 2019
• Study Start: December 16, 2019
• Primary Completion: October 13, 2022
• Study Completion: October 13, 2022
• Last Updated: August 27, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)