Trials / Unknown
UnknownNCT05607563
A Study of PM1009 (Anti-TIGIT/PVRIG) in Patients With Advanced Tumours
A Phase I Study to Evaluate the Tolerability, Safety, Pharmacokinetic Characteristics and Preliminary Efficacy of PM1009 (Anti-TIGIT/PVRIG) in Patients With Advanced Tumors
- Status
- Unknown
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 54 (estimated)
- Sponsor
- Biotheus Inc. · Industry
- Sex
- All
- Age
- 18 Years – 75 Years
- Healthy volunteers
- Not accepted
Summary
The study is being conducted to evaluate safety, tolerability, pharmacokinetics and preliminary efficacy of PM1009 for patients with advanced tumors, also to explore the recommended Phase Ⅱ Dose（RP2D） of PM1009. PM1009 is a new novel fully human anti-TIGIT x PVRIG bispecific antibody, containing a wildtype IgG1 Fc and has high monovalent affinity to each target, it can binds to both TIGIT and PVRIG overexpressing target cells and binds to TIGIT and PVRIG simultaneously.
Detailed description
This is a single-arm, open-label, Phase I study contains dose escalation stage and dose expansion stage. The dose escalation stage will be following the accelerated titration design and the classic 3+3 design, with a planned enrollment of 10 to 24 patients with advanced tumors. The dose expansion stage will be used safe and tolerable doses, with a planned enrollment of 30 patients with advanced tumors.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | PM1009 injection | Participants receive PM1009 intravenously, every 2 weeks |
Timeline
- Start date
- 2022-11-21
- Primary completion
- 2023-11-01
- Completion
- 2023-12-01
- First posted
- 2022-11-07
- Last updated
- 2023-02-08
Locations
1 site across 1 country: China
Source: ClinicalTrials.gov record NCT05607563. Inclusion in this directory is not an endorsement.