Treatment of Advanced and Metastatic Solid Tumors With MIL97
Recruiting
Phase 1
Interventional Study
Advanced or Metastatic Solid Tumor
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
At a Glance
- Age
- 18 and older
- Sex
- Any
- Trial phase
- Phase 1
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 62 (estimated)
- Sponsor
- Beijing Mabworks Biotech Co., Ltd. · Industry
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About This Trial
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 …
Trial Locations
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Eligibility Criteria
Inclusion Criteria:
1. Adult patients, \>=18 years of age;
2. Diagnosis of Refractory/relapsed metastatic and/or unresectable solid tumors;
3. At least one extracranial measurable unirradiated lesion or evaluable lesion (recist v1.1) ;
4. Eastern Cooperative Oncology Group (ECOG) performance status…
Contacts