A Clinical Study of MIL95 in Advanced Malignancies.
Recruiting
Phase 1
Interventional Study
Advanced Malignancies
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
- 58 (estimated)
- Sponsor
- Beijing Mabworks Biotech Co., Ltd. · Industry
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About This Trial
This study is composed of two stages: Part A initial dose escalation and Part B maintenance dose escalation. Both parts will adopt the classical 3+3 dose escalation design.
The starting dose for phase Ia part A is 0.1 mg/kg QW, followed by 3 dose cohorts (0.3mg/kg QW, 0.8mg/kg QW and 1mg/kg QW). Duration of dose limiting toxicity (DLT) observation is 14 days.
Part B will have 5 dose cohorts(3mg/…
Trial Locations
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Eligibility Criteria
Inclusion Criteria:
1. Adult patients, \>=18 years of age;
2. Diagnosis of Refractory/relapsed lymphomas or solid tumor;
3. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1;
4. Life expectancy \>=3 months;
5. Sufficient organ and bone marrow function;
6. At least one measurabl…
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