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Tests treatment safety and results for Advanced NSCLC
Official title A Study to Evaluate the Safety and Efficacy of HB0025 Injection in Patients With Advanced Solid Tumor
ClinicalTrials.gov ID: NCT06758557
What this study is testing
What is HB0025?
HB0025 is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for advanced nsclc.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This study is a multicenter, two-tumor, multi-cohort, dose-escalation and dose-expansion Phase Ib/II clinical trial of HB0025 combined with chemotherapy, consists of two phases: the dose escalation phase (Ib) and the dose expansion phase (II). 1.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 75
You may be able to join if
- Male or female, age between 18-75 years old (include 18- and 75-year-old);
- Be able to fully understand and voluntarily sign the informed consent form, and be willing and able to comply with the clinical research and...
- Dose escalation phase 3.1 Non-small cell lung cancer and meet all following conditions； 3.1.1 Non-small cell lung cancer (NSCLC) confirmed by...
- Dose expansion phase 4.1 Non-small cell lung cancer and meet all following conditions 4.1.1 Non-squamous non-small cell lung cancer (Nonsq-NSCLC) or...
- Patients who have not received anti-tumor treatment or other clinical trial drugs within 4 weeks before the first administration of HB0025 (for small...
You likely can't join if
- Brain metastasis with central nervous system symptoms; for people with asymptomatic brain metastasis: after receiving relevant treatment, imaging and...
- Active autoimmune diseases or a history of autoimmune diseases requiring systemic treatment within 2 years before screening, including...
- Patients who received \>10 mg/day of prednisone or equivalent dose of systemic glucocorticoids or other immunosuppressants within 2 weeks before...
- Any of the following infections: 4.1 Active infection within 2 weeks prior to screening, requiring antibiotic treatment for \>7 days; 4.2 Active...
- Patients who have received immune checkpoint inhibitors (ICI) combined with anti-vascular therapy, such as anti-PD-(L)-1 antibody combined with...
- Patients with a history of severe allergies, previous grade 3-4 immune-related adverse events (irAEs) or treatment discontinuation (except for grade...
See the full eligibility criteria
Who can join
- Male or female, age between 18-75 years old (include 18- and 75-year-old);
- Be able to fully understand and voluntarily sign the informed consent form, and be willing and able to comply with the clinical research and follow-up visit procedures；
- Dose escalation phase 3.1 Non-small cell lung cancer and meet all following conditions； 3.1.1 Non-small cell lung cancer (NSCLC) confirmed by histology or cytology; 3.1.2 Not suitable for surgical resection, recurrence...
- Dose expansion phase 4.1 Non-small cell lung cancer and meet all following conditions 4.1.1 Non-squamous non-small cell lung cancer (Nonsq-NSCLC) or squamous non-small cell lung cancer (Sq-NSCLC) confirmed by histology...
- Patients who have not received anti-tumor treatment or other clinical trial drugs within 4 weeks before the first administration of HB0025 (for small molecule targeted drugs, this is within 2 weeks before the first use...
- There is at least one measurable tumor lesion (according to RECIST 1.1 standard); Note: Lesions that have been previously treated with local therapy (e.g., radiofrequency ablation, anhydrous ethanol or acetic acid...
- ECOG score of 0 or 1;
- The expected survival period is not less than 12 weeks;
- The following laboratory indicators must be met: 9.1 Absolute neutrophil count ≥1.5×10⁹/L; 9.2 Platelet count ≥90×10⁹/L; 9.3 Hemoglobin ≥90 g/L; Note: The above three requirements require that the patient has not...
- The toxicity from previous treatment has recovered to grade 1 (except for toxicity such as alopecia that the investigator determines does not pose a safety risk);
- Females and males of childbearing age must agree to take effective contraceptive measures during the study and within 3 months after the last dose of HB0025 after signing the informed consent form. Female people of...
What rules you out
- Brain metastasis with central nervous system symptoms; for people with asymptomatic brain metastasis: after receiving relevant treatment, imaging and neurological examinations are in a stable state for more than 4...
- Active autoimmune diseases or a history of autoimmune diseases requiring systemic treatment within 2 years before screening, including hypothyroidism, Graves' ophthalmo-pathy, Hashimoto's thyroiditis or type 1 diabetes...
- Patients who received \>10 mg/day of prednisone or equivalent dose of systemic glucocorticoids or other immunosuppressants within 2 weeks before screening, or who received topical, intraocular, intraarticular...
- Any of the following infections: 4.1 Active infection within 2 weeks prior to screening, requiring antibiotic treatment for \>7 days; 4.2 Active pulmonary tuberculosis (based on history); 4.3 HIV positive; 4.4 Active...
- Patients who have received immune checkpoint inhibitors (ICI) combined with anti-vascular therapy, such as anti-PD-(L)-1 antibody combined with anti-VEGF, VEGFR antibody, or TKI drugs with anti-vascular effects such as...
- Patients with a history of severe allergies, previous grade 3-4 immune-related adverse events (irAEs) or treatment discontinuation (except for grade 3 endocrine abnormalities that can be controlled by hormone...
- Uncontrolled arterial hypertension (systolic blood pressure ≥ 150 mmHg or diastolic blood pressure ≥ 100 mmHg) despite standard treatment;
- Suffering from the following serious comorbidities: 8.1 people with a history of arterial thrombosis or deep vein thrombosis within 6 months before screening, or people with evidence or history of bleeding tendency...
- Patients who have used or are currently taking anticoagulants such as warfarin, heparin (except for tube sealing and deep vein catheterization), dabigatran etexilate, rivaroxaban, etc. within 7 days before the first...
- Received major surgical treatment, open biopsy or significant trauma within 4 weeks before drug administration; or required major elective surgical treatment during the study period. Received local invasive procedures...
- Those with past and/or current interstitial lung disease, pneumoconiosis, drug-related pneumonia, severe lung function impairment, etc. that may interfere with the detection and treatment of suspected drug-related...
- Pregnant or breastfeeding women;
- History of allogeneic organ transplantation or hematopoietic stem cell transplantation;
- Second tumor within 5 years before screening, excluding cured cervical cancer in situ, localized skin squamous cell carcinoma, basal cell carcinoma, breast ductal carcinoma in situ or T1 urothelial carcinoma;
- Received live virus vaccine within 30 days before screening;
- During the screening period, patients with advanced Nonsq-NSCLC who are intolerant to the chemotherapy regimen of pemetrexed combined with carboplatin;
- During the screening period, patients with advanced sq-NSCLC or EC who are intolerant to paclitaxel combined with carboplatin chemotherapy;
- people who are assessed by the investigator to be unsuitable for participating in the trial due to other reasons.
The study team makes the final eligibility decision.
Where it's taking place
- Baoding, Hebei, China
- Harbin, Heilongjiang, China
- Luoyang, Henan, China
- Zhengzhou, Henan, China
- Lianyungang, Jiangsu, China
- Shenyang, Liaoning, China
- Jinan, Shandong, China
- Linyi, Shandong, China
- Weifang, Shandong, China
- Shanghai, Shanghai Municipality, China
- Taiyuan, Shanxi, China
- Xi’an, Shanxi, China
- Kunming, Yunnan, China
- Hangzhou, Zhejiang, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Baoding, Hebei, China; Harbin, Heilongjiang, China; Luoyang, Henan, China; Zhengzhou, Henan, China; Lianyungang, Jiangsu, China; Shenyang, Liaoning, China and 8 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.