OncoMatch/Clinical Trials/NCT04965077
Treatment of Advanced and Metastatic Solid Tumors With MIL97
Is NCT04965077 recruiting? Yes, currently enrolling (May 2026). This Phase 1 trial studies Recombinant Humanized Monoclonal Antibody MIL97 for for advanced or metastatic solid tumor.
Treatment: Recombinant Humanized Monoclonal Antibody MIL97 for — 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. An accelerated titration design (cohorts 1-2 only) followed by 3+3 dose-escalation design will be used in dose escalation phase. The starting dose for dose escalation phase is 0.01 mg/kg Q3W, followed by 5 dose cohorts (0.03mg/kg Q3W, 0.1mg/kg Q3W, 0.2mg/kg Q3W, 0.3mg/kg Q3W and 0.45mg/kg Q3W). Duration of dose limiting toxicity (DLT) observation is 21 days. Based on data of 3-week treatment regimen, one or two dose levels may be chosen for Q2w regimen. Duration of dose limiting toxicity (DLT) observation is 28 days. One or two dose cohorts will be chosen (either 2-week regimen or 3-week regimen cohorts) to expand to total of 10 subjects in each cohort for further exploration of PK as well as safety and efficacy.
Check if I qualifyExtracted eligibility criteria
Cancer type
Tumor Agnostic
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Cannot have received: any antitumor therapy
Exception: palliative radiotherapy for relief bone pain
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
Cannot have received: major surgery
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)
Cannot have received: immunosuppressive agent
Exception: Systemic steroids at physiologic doses, intranasal, inhaled, topical, intra-articular, and ocular corticosteroids with minimal systemic absorption, transient courses of steroids may be approved by the Medical Monitor
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, intra-articular, and ocular corticosteroids with minimal systemic absorption, transient courses of steroids may be approved by the Medical Monitor
Cannot have received: CD40 antibody
Previous exposure to CD40 antibodies
Cannot have received: live attenuated vaccine
Exception: unless approved by both investigator and sponsor
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
Cannot have received: biological treatment
Participation in a therapeutic clinical study within 4 weeks for biological treatments
Cannot have received: small-molecule agent
Participation in a therapeutic clinical study within 1 week or 5 half-lives for small-molecule agents, before study drug treatment
Lab requirements
Blood counts
Sufficient organ and bone marrow function within 7 days before enrollment
Kidney function
Sufficient organ and bone marrow function within 7 days before enrollment
Liver function
Sufficient organ and bone marrow function within 7 days before enrollment
Cardiac function
No history of myocardial infarction within 6 months, arterial thromboembolic event within 3 months, symptomatic congestive heart failure, unstable angina, uncontrolled hypertension, ongoing cardiac arrhythmia ≥ CTCAE 5.0 Grade 3, QTcF>450ms (Male) or QTcF>470ms (Female) at screening
Sufficient organ and bone marrow function within 7 days before enrollment; history of myocardial infarction within 6 months or a history of arterial thromboembolic event within 3 months before the first dose; symptomatic congestive heart failure; unstable angina, uncontrolled hypertension; ongoing cardiac arrhythmia ≥ CTCAE 5.0 Grade 3, QTcF>450ms (Male) or QTcF>470ms (Female) at screening
Structured fields extracted by AI. May contain errors — verify against the official protocol.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualify