Clinical trial · Interventional
Study of the Safety and Efficacy of LHC165 Single Agent and in Combination With PDR001 in Patients With Advanced Malignancies
A Phase I/Ib, Open-label, Multi-center Dose-escalation and Dose-expansion Study of the Safety and Tolerability of Intra-tumorally Administered LHC165 Single Agent and in Combination With PDR001 in Patients With Advanced Malignancies
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Business reasons
Summary
Brief summary (as posted)
The purpose of this trial was to explore the clinical utility of two investigational agents in patients with advanced cancer. This was a multi-center, open-label Phase I/Ib study. The primary objectives of the trial were: * To characterize the safety and tolerability of intratumoral LHC165 in patients with solid tumors as a single agent and in combination with PDR001 * To determine and evaluate the maximum tolerated dose (MTD)/recommended dose (RD) for LHC165 as a single agent and in combination with PDR001
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Solid Tumors | Solid Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| LHC165 | Drug | — | UNRESOLVED |
| PDR001 | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- LHC165 single agent
- description
- LHC165 intratumoral injection given alone
- interventionNames
- Drug: LHC165
- type
- EXPERIMENTAL
- label
- LHC165 in combination with PDR001
- description
- LHC165 intratumoral injection given with PDR001 infusion
- interventionNames
- Drug: LHC165
- Biological: PDR001
Primary outcomes (2)
- measure
- Escalation: Incidence of Dose-limiting Toxicities (DLTs) in Cycle 1
- timeFrame
- day 28
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Written informed consent must be obtained prior to any procedures unless considered standard of care. * Adult men and women (≥ 18 years of age) with histologically confirmed diagnosis of metastatic and/or advanced solid tumors not amenable to curative treatment by surgery. * Patients must be willing and able to comply with the protocol for the duration of the study including undergoing treatment and scheduled visits and examinations including follow up. * Dose escalation: Patients with accessible tumors and with measurable disease as determined by RECIST 1.1 and have progressed despite standard treatment or are intolerant of standard treatment, or for whom no standard treatment exists. * Dose expansion: Patients with advanced/metastatic solid tumors: HNSCC, melanoma, accessible tumors and visceral tumors (LHC165 combination with PDR001 only). Patients must have measurable disease as determined by RECIST 1.1 and have progressed despite standard treatment or are intolerant to standard treatment, or for whom no standard treatment exists• Patients must have at least two sites of disease amenable to biopsy. * Patient has an Eastern Cooperative Oncology Group (ECOG) performance status 0-2. Exclusion Criteria: * Presence of symptomatic or uncontrolled central nervous system (CNS) metastases requiring local CNS-directed treatment. * Patients diagnosed with hematological malignancies. * Patients with prior stem cell transplants. * Patients previously treated with TLR-7/8 agonist treatment. * History of primary immunodeficiency * Patients who discontinued prior anti-PD-1/PD-L1 therapy due to an anti-PD-1/PD-L1-related toxicity. * Malignant disease, other than that being treated in this study
References
Publications (0)
Data not yet available