Clinical Trials/NCT04151810

NCT04151810

Completed

Phase 1

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

Dragonboat Biopharmaceutical Company Limited1 site in 1 country32 target enrollmentDecember 16, 2019

ConditionsAdvanced Tumors

InterventionsCDP1 TIP chemotherapy

DrugsCDP1 TIP chemotherapy

Overview

Phase: Phase 1
Intervention: CDP1
Conditions: Advanced Tumors
Sponsor: Dragonboat Biopharmaceutical Company Limited
Enrollment: 32
Locations: 1
Primary Endpoint: Dose Limiting Toxicities (DLT)
Status: Completed
Last Updated: last year

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

December 16, 2019

End Date

October 13, 2022

Last Updated

last year

Study Type

Interventional

Study Design

Sequential

Sex

All

Investigators

Sponsor

Dragonboat Biopharmaceutical Company Limited

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•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;

Exclusion Criteria

•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;

Arms & Interventions

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.

Intervention: CDP1

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.

Intervention: CDP1

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.

Intervention: TIP chemotherapy

Outcomes

Primary Outcomes

Dose Limiting Toxicities (DLT)

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

Number of participants with dose limiting toxicity (DLT)

Recommended phase II dose (RP2D)

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

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

Secondary Outcomes

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)
Immunogenicity indicators: Number of participants with positive neutralizing antibodies(an average of 6 months)
Objective response rate (ORR)(an average of 6 months)
Pharmacokinetic parameters: Observed Maximum Serum Concentration (Cmax) of CDP1 After Infusion(Up to 28 Days)
Immunogenicity indicators: Number of participants with positive anti-drug antibodies (ADA)(an average of 6 months)
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)
Progression-free survival (PFS)(an average of 6 months)