JY016 Injection in Patients With Advanced Solid Tumors Expressing EGFR
ConditionSolid Cancers
Trial statusNot yet recruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18-75
SponsorBiotech Pharmaceutical Co., Ltd.
About this trial
This study is a single-arm, open-label, multi-center Phase I/II clinical trial, consisting of Part A: the Phase I dose escalation stage, and Part B: the Phase II expansion stage. The objective of the Phase I dose escalation stage is to evaluate the safety, pharmacokinetic characteristics, and preliminary efficacy of JY016 injection in patients with advanced solid tumors expressing EGFR (immunohistochemistry 1+, 2+, or 3+). In the Phase II stage, the efficacy of JY016 in pancreatic cancer, non-small cell lung cancer, esophageal cancer, colorectal cancer, and squamous cell carcinoma of the head and neck with EGFR expression will be further evaluated.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
1. Age ≥ 18 years and ≤ 75 years;
2. Tumor diagnosis and previous anti-tumor treatment: Phase I dose escalation stage: Subjects with advanced solid tumors with EGFR expression (immunohistochemistry 1+, 2+ or 3+) who have undergone standard treatment failure, or lack effective treatment options, or are unable to tolerate standard treatment, diagnosed by histological or cytological methods; Phase II expansion stage: Several tumor types with confirmed EGFR expression (initially determined as immunohistochemistry 1+, 2+ or 3+, and can be adjusted based on the exploratory results of EGFR expression in the dose escalation stage) confirmed by the central laboratory.
3. ECOG physical condition score is 0-1 point;
4. Expected survival exceeds 12 weeks;
Disqualifiers
1. The time interval between the last anti-tumor treatment and the first administration: for cytotoxic drugs and small molecule targeted drugs, ≤ 3 weeks; for large molecule monoclonal antibodies, ≤ 4 weeks; for radiotherapy (except for local radiotherapy for relieving pain) ≤ 4 weeks; for traditional Chinese medicine with anti-tumor indications approved by NMPA, ≤ 2 weeks;
2. Known to be allergic to injectable JY016 or any of its excipient components; or having a history of allergy to drugs containing monoclonal components; other drug-induced liver toxicity or allergy history; or having a specific allergic reaction history (asthma, rubella, eczematous dermatitis); the subjects who have undergone previous anti-tumor treatment with central nervous system metastasis cancer, cancerous meningitis, or other central nervous system diseases or abnormalities;
3. Have received targeted CD3 drug treatment before;
4. Known to have central nervous system metastatic cancer, cancerous meningitis, or other central nervous system diseases or abnormalities;
Trial design
Design model
Single group
Treatments tested in this trial
JY016
Drug0.08μg/kg\~30μg/kg,QW
Treatment groups
228 Participants
are divided into 1 treatment groupGroup A: study groupExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
MTD
The Maximum Tolerated Dose (MTD) is defined as the highest dose level of a drug or treatment that does not cause unacceptable side effects (Dose-Limiting Toxicities) in a specified number of patients during a 4-weeks treatment period.
Time frame
from baseline up to 4 weeks2
Incidence of AEs
Incidence of Adverse Events
Time frame
through study completion, an average of 1 yearSecondary outcomes
1
Cmax
Maximum Plasma Concentration
Time frame
from baseline up to 4 weeks2
ORR
The objective response rate(ORR) is defined as the sum of the proportions of patients achieving a Complete Response (CR) and a Partial Response (PR).
Time frame
From date of enrollment until the date of first documented progression, assessed up to 24 monthsLocations
Sponsors and contacts
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Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: