Advanced solid tumors, including but not limited to NSCLC, breast cancer (BC), head and neck squamous cell carcinoma (HNSCC), cervical cancer (CC), ovarian cancer (OC), gastric cancer (GC), adenocarcinoma of the esophagogastric junction (AEG), colorectal cancer (CRC), pancreatic ductal adenocarcinoma (PDAC), castration resistant prostate cancer (CRPC), etc.
Conditions
Interventions
experimental group:Infusion YL202
Sponsors
Jilin Cancer Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1.Subjects who are aware of relevant study information prior to the start of the study, and voluntarily sign and date on the informed consent form (ICF); 2.Subjects aged from 18-75 (inclusive) years (patients, mainly for those with BC or prostate cancer, who aged >75 years may be enrolled on a case-by-case basis after discussion with the sponsor); 3.Body mass index (BMI) within the range of 18 to 32 kg/m2. Patients with BMI falling outside the specified range may be enrolled on a case-by-case basis after discussion with and approval by the sponsor; 4.Subjects to be enrolled in Cohort A1 should meet the following conditions: Histologically or cytologically confirmed NSCLC;Patients with locally advanced (stage IIIB/IIIC) or metastatic (stage IV) diseases (per Union for International Cancer Control (UICC) and American Joint Committee on Cancer (AJCC) staging system [version 8]) who are not suitable for radical surgery or radiotherapy at enrollment;• Clearly documented EGFR activation mutation (exon 19 deletion or L858R); note: Relevant patients should provide previous tissue sample test report issued by a tertiary first-class hospital or a third-party testing institution prior to enrollment (PCR and NGS test methods are allowed). Subjects with EGFR mutations detected in blood samples may be enrolled on a case-by-case basis after discussion with the sponsor; • Patients with locally advanced or metastatic diseases who received only the first-line treatment with the third-generation EGFR TKIs and progressed as evidenced by imaging or had documented PD or intolerance during or after the treatment; For patients who received only the first-line treatment with the first-generation or second-generation EGFR TKIs, a negative T790M mutation test report should be provided with no requirement of the third-generation EGFR TKI treatment; • Patients with locally advanced or metastatic diseases who received no other systemic anti-tumor therapies in the systemic treatment stage. Subjects to be enrolled in Cohort A2 should meet the following conditions: • Histologically or cytologically confirmed NSCLC; • Patients with locally advanced (stage IIIB/IIIC) or metastatic (stage IV) diseases (per UICC and AJCC staging system [version 8]) who are not suitable for radical surgery or radiotherapy at enrollment; • Clearly documented EGFR activation mutation (exon 19 deletion or L858R); note: Relevant patients should provide previous tissue sample test report issued by a tertiary first-class hospital or a third-party testing institution prior to enrollment (PCR and NGS test methods are allowed). Subjects with EGFR mutations detected in blood samples may be enrolled on a case-by-case basis after discussion with the sponsor; • Patients with locally advanced or metastatic diseases who received the third-generation EGFR TKIs; For patients who received the first-generation or second-generation EGFR TKIs, a negative T790M mutation test report is required with no requirement of the third-generation EGFR TKI treatment; • Patients with locally advanced or metastatic diseases who received platinum-based chemotherapy in the systemic treatment stage; • Patients with locally advanced or metastatic diseases who had PD as evidenced by imaging or had documented PD or intolerance during or after the most recent line of systemic anti-tumor therapy. Subjects to be enrolled in Cohort B should meet the following conditions: • Histologically or cytologically confirmed BC; • Patients with
Exclusion criteria
Exclusion criteria: 1. Prior drug therapy targeting HER3 (including antibodies, antibody-drug conjugates [ADCs]), chimeric antigen receptor T-cell immunotherapy (CAR-T), and other drugs); 2. Previously intolerant to topoisomerase I inhibitors or ADC therapy composed of topoisomerase I inhibitors, including but not limited to topotecan, irinotecan, and DXd (for severe diarrhea, etc.). ? For Cohorts F and G: Patients who received topoisomerase I inhibitors or ADC therapy composed of topoisomerase I inhibitors, including but not limited to topotecan, irinotecan, and DXd, in the systemic treatment stage should be excluded; 3. Are participating in another clinical study, unless it is an observational (non-interventional) clinical study or in the follow-up period of an interventional study; 4. The washout period from the previous anti-tumor therapy is insufficient prior to the first dose of the investigational product, which is defined as follows: • Chemotherapy or small molecule targeted therapy 20 mg/day or equivalent) or other immunosuppressive treatment within 2 weeks prior to the first dose of the investigational product, except for the following cases: • Intranasal, inhaled, topical steroids, or local steroid injection (such as intra-articular injection); • Systemic steroids at the physiological dose as replacement therapy (such as physiological corticosteroid replacement therapy for adrenal or pituitary dysfunction); • Steroids that are used as prophylactic agents for the prevention of hypersensitivity or vomiting, etc. (such as prophylactic medication for computed tomography [CT]); 8. Patients who received any live vaccine within 4 weeks prior to the first dose of the investigational product or those who plan to receive live vaccine during the study period; 9. Meningeal metastatic or cancerous meningitis; 10. Brain metastases or spinal cord compression, except in the following cases: • Subjects with brain metastases that have
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| PK parameter;ADA antibody;Objective response rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Clinical benefit rate;Duration of response;Time to response;AE;Deepness of response;Disease control rate;Progression free survival;Overall survival;Laboratory test results, physical examination results, ECOG PS, vital signs, peripheral SpO2, and ECG parameters;PSA50 response rate, 12-week PSA50 response rate, time To PSA progression, PSA deepness of Response, PSA duration of response, and time To PSA progression; | — |
Countries
China
Contacts
Public Contactcheng ying
Jilin Cancer Hospital
Outcome results
None listed