Trials / Completed
CompletedNCT04666688
LYT-200 Alone and in Combination With Chemotherapy or Tislelizumab in Patients With Locally Advanced or Metastatic Solid Tumors
A Phase 1/2 Open-label, Multi-center Study of the Safety, Pharmacokinetics, and Anti-tumor Activity of LYT-200 as a Single Agent and in Combination With Chemotherapy or Tislelizumab in Patients With Locally Advanced or Metastatic Solid Tumors
- Status
- Completed
- Phase
- Phase 1 / Phase 2
- Study type
- Interventional
- Enrollment
- 44 (actual)
- Sponsor
- PureTech · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
A Phase 1/2 Open-label, Multi-center Study of the Safety, Pharmacokinetics, and Anti-tumor Activity of LYT-200 Alone and in Combination with Chemotherapy or Tislelizumab in Patients with Metastatic Solid Tumors
Detailed description
This is an open-label, uncontrolled, multicenter Phase 1/2 study with a dose escalation phase (Part 1) and a cohort expansion phase (Part 2) in patients with relapsed/refractory metastatic solid tumors. Part 1: Dose Escalation Phase\_Single Agent A dose-finding study will be conducted using a continuous reassessment method (CRM) to establish dose-limiting toxicities (DLTs) and the recommended Phase 2 dose (RP2D). Part 1: Dose Escalation Phase\_Combination A dose-finding combination study with chemotherapy or tislelizumab will be conducted using a 4+2 study design to establish dose-limiting toxicities (DLTs) and the recommended Phase 2 dose (RP2D). Part 2: The second part of the protocol will be a dose expansion in both/or either single agent or combination based on the RP2D determined in Part 1, in patients with metastatic/advanced solid tumors.
Conditions
- Metastatic Cancer
- Solid Tumor
- Pancreatic Cancer
- Urothelial Carcinoma
- Head and Neck Cancer
- Colorectal Cancer
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | LYT-200 | monoclonal antibody (mAb), targeting galectin-9 protein |
| DRUG | Tislelizumab | anti-PD-1 monoclonal antibody |
| DRUG | Gemcitabine/nab-paclitaxel | chemotherapy |
Timeline
- Start date
- 2020-12-15
- Primary completion
- 2024-12-12
- Completion
- 2024-12-12
- First posted
- 2020-12-14
- Last updated
- 2025-02-12
Locations
12 sites across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT04666688. Inclusion in this directory is not an endorsement.