To Access the Safety and Effects of Intravenous Administration of VIR-5818 Alone and in Combination With Pembrolizumab in Adult Participants With Locally Advanced or Metastatic HER2-Expressing Cancers
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: VIR-5818, pembrolizumab.
- Who it may be relevant to
- Registry conditions: Locally Advanced or Metastatic HER2-Expressing Cancers. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Australia, France, Portugal, Spain
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
A Phase 1, Multicenter, Open-Label, First-in-Human Study of the Safety and Pharmacokinetics of VIR-5818 Alone and in Combination With Pembrolizumab in Participants With Locally Advanced or Metastatic HER2-Expressing Cancers
Overview
This first-in-human (FIH) Phase 1 open-label multicenter dose-escalation and dose-expansion study is designed to evaluate the safety, pharmacokinetics, and preliminary activity of VIR-5818 (Formerly AMX-818) as a single agent and in combination with pembrolizumab in participants with HER2+ tumors across multiple tumor types. The study will be conducted in four parts: * Part 1 (dose escalation): Single-agent VIR-5818 * Part 2 (dose escalation): VIR-5818 plus pembrolizumab * Part 3 (dose expansion): Single-agent VIR-5818 * Part 4 (dose expansion): VIR-5818 plus pembrolizumab The total length of the study, from screening of the first participant to the end of the study, is expected to be approximately 52 months.
Interventions
- Drug VIR-5818
Administered as IV infusion - Drug pembrolizumab
Administered as IV infusion
Primary outcome measures
- Incidence of dose-limiting toxicity - Part 1 and Part 2 [Time frame: Up to approximately 21 days (Part 1) and 42 days (Part 2)]
- Number of participants with treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs)- Parts 1, 2, 3, and 4 [Time frame: Up to approximately 55 months]
- Objective Response Rate (ORR) - Part 3 and Part 4 [Time frame: Up to approximately 55 months]
- Duration of Response (DOR) - Part 3 and Part 4 [Time frame: Up to approximately 55 months]
Secondary outcome measures (11)
- ORR - Part 3 and Part 4 [Time frame: Up to approximately 55 months]
- DOR - Part 3 and Part 4 [Time frame: Up to approximately 55 months]
- Pharmacokinetics (PK) parameter: Area under the concentration-time curve (AUC) [Time frame: Predose, intermediate timepoints at multiple cycles (1 Cycle = 21 days) up to approximately 55 months]
- PK parameter: Maximum plasma concentration (Cmax) [Time frame: Predose, intermediate timepoints at multiple cycles (1 Cycle = 21 days) up to approximately 55 months]
- PK parameter: Minimum serum concentration (Cmin) [Time frame: Predose, intermediate timepoints at multiple cycles (1 Cycle = 21 days) up to approximately 55 months]
- PK parameter: Clearance (CL) [Time frame: Predose, intermediate timepoints at multiple cycles (1 Cycle = 21 days) up to approximately 55 months]
- PK parameter: Volume of distribution at steady-state (Vss) [Time frame: Predose, intermediate timepoints at multiple cycles (1 Cycle = 21 days) up to approximately 55 months]
- PK parameter: Accumulation ratio [Time frame: Predose, intermediate timepoints at multiple cycles (1 Cycle = 21 days) up to approximately 55 months]
- PK parameter: Half-life (t1/2) [Time frame: Predose, intermediate timepoints at multiple cycles (1 Cycle = 21 days) up to approximately 55 months]
- Incidence of anti-drug antibodies (ADAs) to VIR-5818 [Time frame: Multiple timepoints at specified cycles (1 Cycle = 21 days) up to approximately 55 months]
- All parts: Disease control rate (DCR) [Time frame: Up to approximately 55 months]
Eligibility criteria
Inclusion criteria
- Written informed consent by the participant (or legally acceptable representative if applicable)
- Life expectancy of at least 12 weeks
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- Diseases under study, prior lines of therapy, and human epidermal growth factor receptor 2 (HER2) status, per local tests
Exclusion criteria
- Significant cardiopulmonary disease and recent cardiac events
- History of major organ autoimmune diseases
- Acute or chronic infections
The above information is not intended to contain all considerations relevant to the potential participation in a clinical trial.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Non-randomized
- Model
- Sequential
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Spain · 6 centers
- Investigational site number #255 — Barcelona
- Investigational site number #251 — Barcelona
- Investigational site number #254 — Madrid
- Investigational site number #252 — Madrid
- Investigational site number #250 — Pamplona
- Investigational site number #253 — Pozuelo de Alarcón
Australia · 2 centers
- Investigational site number #100 — Melbourne
- Investigational site number #101 — Randwick
France · 1 center
- Investigational site number #150 — Toulouse
Portugal · 1 center
- Investigational site number #200 — Porto
Identifiers
NCT: NCT05356741 · VIR-5818-V101 · MK-3475-D14 · KEYNOTE-D14