Trials / Unknown
UnknownNCT05024305
Safety, Tolerability, PK, PD, Immunogenicity and Efficacy of TWP-102 in Patients With Advanced Malignancies.
A Multi-center, Phase I, Open Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, Immunogenicity and Efficacy of TWP-102 in Patients With Advanced Malignancies.
- Status
- Unknown
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 81 (estimated)
- Sponsor
- Shandong TheraWisdom Biopharma Co., Ltd. · Industry
- Sex
- All
- Age
- 18 Years – 75 Years
- Healthy volunteers
- Not accepted
Summary
This is a multi-center, phase I, open clinical study to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, immunogenicity and efficacy of TWP-102 injection in patients with advanced malignancies. This study consists of two parts, including a dose escalation study and a dose expansion study. The criteria for dose escalation will be based on the Bayesian optimal interval (BOIN) design with sequentially enrolled cohorts.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | TWP-102 injection | IV infusion |
Timeline
- Start date
- 2022-03-08
- Primary completion
- 2022-12-31
- Completion
- 2023-06-30
- First posted
- 2021-08-27
- Last updated
- 2022-03-09
Locations
1 site across 1 country: China
Source: ClinicalTrials.gov record NCT05024305. Inclusion in this directory is not an endorsement.