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DXP-106 in Solid Tumor Patients.

RecruitingPhase 1Ages 18 Years - 80 YearsAllSinglomics Biopharmaceuticals Zhuhai Co., Ltd.
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In plain words

What the trial is, and whether it could suit you

The goal of this clinical trial is to evaluate the safety and tolerability of DXP-106 in Chinese patients with advanced solid tumors. The main questions it aims to answer are: For Part I: 1. The safety and tolerability of DXP-106 monotherapy in patients with advanced solid tumors; 2. The dose-limiting toxicities (DLTs) and determine the maximum tolerated dose (MTD) and/or the recommended Phase II dose (RP2D); 3. The pharmacokinetics (PK) profile, the immunogenicity of DXP-106 following administration in patients with advanced solid tumors; 4. The preliminary efficacy of DXP-106 in patients with advanced solid tumors; 5. The pharmacodynamic (PD) profiles of DXP-106 following administration in patients with advanced solid tumors as exploratory objective; For Part2: 1. The safety and tolerability of DXP-106 in combination with standard of care chemotherapy in patients with advanced soli

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📋 Eligibility rules (as published)
Inclusion criteria: * Participants who fully understand the trial objectives, nature, procedures, and potential adverse reactions, and who voluntarily agree to participate in the study and provide signed informed consent. * Patients aged 18 to 80 years (inclusive, based on the date of signing the informed consent form), both male and female. * Measurable disease as assessed by computed tomography (CT) or magnetic resonance imaging (MRI) per RECIST criteria within 4 weeks prior to screening. * Study Population * Part 1: Patients with histologically or cytologically confirmed locally advanced or metastatic solid tumors who are ineligible for surgery or curative radiotherapy and have experienced disease progression after standard treatment or are intolerant to such therapy. Target tumor types include but are not limited to colorectal cancer, pancreatic ductal adenocarcinoma (PDAC), head and neck squamous cell carcinoma, lung cancer (LC), Ewing sarcoma (ES), and triple-negative breast cancer (TNBC). * Part 2: If the participant received adjuvant/neoadjuvant therapy before or after completing prior curative treatment, and the participant's disease has recurred, the interval between the end of adjuvant/neoadjuvant therapy and the first dose in this study must exceed 6 months. * LC patients: Patients with locally advanced/metastatic lung cancer confirmed by histology or cytology, who relapsed after first-line treatment and must meet the criteria for receiving platinum-based chemotherapy as first-line or second-line standard treatment; * PDAC Patients: Patients with newly diagnosed histologically or cytologically confirmed, unresectable or radiotherapeutically ineligible locally advanced or metastatic PDAC, who have not received previous treatment and are eligible for standard of care chemotherapy regimens. * ES patients: Patients with pathologically confirmed unresectable or locally advanced or metastatic Ewing's sarcoma that has failed standard treatment, and a detailed pathological report must be provided. Patients have received at least 1 but no more than 2 lines of systemic therapy previously, and must be eligible for standard chemotherapy regimens. * TNBC patients (for patients with bilateral breast cancer, both sides must be TNBC): Patients with histologically or cytologically confirmed, inoperable locally advanced or metastatic breast cancer, with ER, PR, and HER-2 all negative. The definition of ER and PR negativity is: IHC ER \< 1%, IHC PR \< 1%. The definition of HER-2 negativity is: IHC HER-2 (-) or (1+); for those with HER-2 (2+), FISH testing must be performed and the result must be negative. Patients must be eligible for standard chemotherapy regimens; * Eastern Cooperative Oncology Group (ECOG) performance score of 0 to 1. * Life expectancy \> 3 months. * Adequate organ function meeting the following criteria: * Hematology (without transfusion, hematopoietic growth factors, or medication to correct blood cell counts within 14 days prior to first dose): absolute neutrophil count (ANC) ≥ 1.5 × 109/L, platelet count ≥ 75 × 109/L (part1) or platelet count ≥ 100 × 109/L (part2), hemoglobin ≥ 9.0 g/dL. * Coagulation function: International normalized ratio (INR) and activated partial thromboplastin time (APTT) ≤ 1.5 × upper limit of normal (ULN) (for patients not receiving anticoagulant therapy); patients on oral anticoagulants with an INR between 2 and 3 were eligible. * Hepatic function: Total bilirubin (TBIL) ≤ 1.5 × ULN ); alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 2.5 × ULN; ALT and AST≤ 5.0 × ULN for patients with primary hepatocellular carcinoma (HCC) or hepatic metastases. * Renal function: Serum creatinine ≤ 1.5 × ULN or creatinine clearance \> 50 mL/min (calculated using the Cockcroft-Gault formula). * Both female and male patients of reproductive potential must have agreed to use reliable contraceptive methods during the trial and for 6 months after the last dose. Exclusion criteria * Participants with a history of hypersensitivity, particularly those allergic to the investigational drug or its excipients, or those who have previously experienced severe allergic reactions to macromolecular protein preparations/monoclonal antibodies. * Participants who have received live/live attenuated vaccines, etanercept or other TNF-α inhibitors, or any other investigational drug during or prior to participation in this study (within 4 weeks before the first dose of the investigational drug or within 5 half-life of the investigational drug, whichever is longer). * In Part 2, LC patients have received other anti-tumor drug treatments in addition to first-line treatment medications; patients with gene mutations that can be used as targets for targeted therapy (including but not limited to EGFR, ALK, ROS, KRAS) (excluding patients who have progressed on standard targeted therapy and whose next-line standard treatment is a platinum-based dual-drug regimen). * The toxicity from previous treatments has not alleviated to the level specified in the inclusion/exclusion criteria or to NCI CTCAE ≤ Grade 1 (except for alopecia, pigmentation, Grade 2 peripheral neuropathy, adrenal insufficiency, and other toxicities deemed by the investigator to pose no safety risk to the participant). * Presence of other active malignancies besides the primary tumor within the past 2 years, with the following exceptions: participants cured with curative-intent therapy and without evidence of recurrence, such as basal cell carcinoma, cutaneous squamous cell carcinoma, superficial bladder carcinoma, papillary thyroid carcinoma, carcinoma in situ of the cervix, or breast carcinoma in situ. * History of active autoimmune disease requiring treatment with systemic immunosuppressive agents, or participants requiring systemic immune-related therapy due to immunocompromise from any cause, including but not limited to autoimmune conditions such as systemic lupus eryt
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What it tests

  • DXP-106
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Where

4 sites
Harbin Medical University Cancer Hospital
Harbin, China
Zhongshan Hospital, Fudan University
Shanghai, China
The First Hospital of Shanxi Medical University
Taiyuan, China
Sir Run Run Shaw Hospital, School of Medicine, Zhejiang University
Hangzhou, China
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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