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New treatment option for Advanced or Metastatic Solid Tumor
Official title Treatment of Advanced and Metastatic Solid Tumors With MIL97
ClinicalTrials.gov ID: NCT04965077
What this study is testing
What is Recombinant Humanized Monoclonal Antibody MIL97 for Injection?
Recombinant Humanized Monoclonal Antibody MIL97 for Injection is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for advanced or metastatic solid tumor.
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 is a Phase 1, global, multi-center, open-label, multiple-dose, first-in-human study of MIL97 to evaluate the safety, tolerability, pharmacokinetics, biomarkers and efficacy in subjects with advanced or metastatic solid tumor. The study consists of a dose escalation phase and a dose expansion phase.
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Adult patients, \>=18 years of age;
- Diagnosis of Refractory/relapsed metastatic and/or unresectable solid tumors;
- At least one extracranial measurable unirradiated lesion or evaluable lesion (recist v1.1) ;
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1Life expectancy \>=3 months;
- Sufficient organ and bone marrow function within 7 days before enrollment;
You likely can't join if
- have a history of myocardial infarction within 6 months or a history of arterial thromboembolic event within 3 months before the first dose;
- Comorbidity that would interfere with therapy, including interstitial pneumonia, symptomatic congestive heart failure; unstable angina, uncontrolled...
- Patients have a known or suspected history of an autoimmune disorder, except for the following: Type 1 diabetes mellitus, hypothyroidism only...
- Have a history of manifested central nervous system (CNS) metastases or have primary brain tumor. Patients with known or suspected leptomeningeal...
- Receipt of allograft or allogeneic hematopoietic stem cell transplantation;
- Patients have another active invasive malignancy, but history of a non-invasive malignancy and history of malignancy that is in complete remission...
See the full eligibility criteria
- Adult patients, \>=18 years of age;
- Diagnosis of Refractory/relapsed metastatic and/or unresectable solid tumors;
- At least one extracranial measurable unirradiated lesion or evaluable lesion (recist v1.1) ;
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1Life expectancy \>=3 months;
- Sufficient organ and bone marrow function within 7 days before enrollment;
- Life expectancy \>=12 weeks;
- Able and willing to provide written informed consent and to comply with the study protocol.
- have a history of myocardial infarction within 6 months or a history of arterial thromboembolic event within 3 months before the first dose;
- Comorbidity that would interfere with therapy, including interstitial pneumonia, symptomatic congestive heart failure; unstable angina, uncontrolled hypertension; ongoing cardiac arrhythmia ≥ CTCAE 5.0 Grade 3, active...
- Patients have a known or suspected history of an autoimmune disorder, except for the following: Type 1 diabetes mellitus, hypothyroidism only requiring hormone replacement, skin disorders such as vitiligo, or alopecia...
- Have a history of manifested central nervous system (CNS) metastases or have primary brain tumor. Patients with known or suspected leptomeningeal disease or cord compression;
- Receipt of allograft or allogeneic hematopoietic stem cell transplantation;
- Patients have another active invasive malignancy, but history of a non-invasive malignancy and history of malignancy that is in complete remission after treatment with curative intent are allowed;
- Active known clinically serious infections are required intravenous antibiotic treatment;
- Have a history of primary immunodeficiency, including but not limited with human immunodeficiency virus (HIV) or acquired immunodeficiency syndrome (AIDS)-related illness;
- Active and clinical significant bacterial, fungal, or viral infection including hepatitis B virus (HBV) or hepatitis C (HCV) (Hepatitis B should be confirmed as HBV surface antigen (HBsAg) positive or HBV core antibody...
- Any antitumor therapy within prior 4 weeks (including chemotherapy, targeted therapy, hormone therapy, immunotherapy, radiotherapy, tumor embolization, etc), except for palliative radiotherapy for relief bone pain;
- Major surgery within prior 4 weeks or expected to require major surgery during study treatment (Major surgery: laparotomy, thoracotomy, and internal organs excision by laparoscopic surgery);
- Patients have concurrent received or used an immunosuppressive agent within 14 days before study treatment, with the following exceptions and notes: Systemic steroids at physiologic doses, intranasal, inhaled, topical...
- Previous exposure to CD40 antibodies;
- Patients received a live attenuated vaccine within 28 days before study treatment and plan to receive live vaccines during the study unless approved by both investigator and sponsor;
- Toxicities due to prior therapy are unresolved to ≤ CTCAE 5.0 Grade 1 except for AEs not constituting a safety risk to the patient based on the judgment of investigators;
- History of clinically significant sensitivity or allergy to MIL97, their excipients, or intravenous gamma globulin;
- Females who are pregnant or lactating or who intend to become pregnant during the clinical trial period and within 6 months after discontinuation of study treatment. Female or Male who refused using birth control during...
- Participation in a therapeutic clinical study within 4 weeks for biological treatments, and within 1 week or 5 half-lives for small-molecule agents, before study drug treatment, or current participation in other...
- Patients who have any clinically significant psychiatric, social, or medical condition that, in the opinion of the investigator, could increase the patient's risk, interfere with protocol adherence, or affect the...
The study team makes the final eligibility decision.
Where it's taking place
- Beijing, Beijing Municipality, 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 and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Beijing, Beijing Municipality, China. 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.