Overview
Sponsor-declared trial summary
Epithelial tumours
To characterise the safety and tolerability of NG-350A in combination with pembrolizumab in patients with metastatic or advanced epithelial tumours To determine the recommended dose of NG-350A in combination with pembrolizumab for further development in patients with metastatic or advanced epithelial tumours
Key facts
- Sponsor
- Akamis Bio Limited
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Neoplasms [C04]
- Trial duration
- completed 13 Dec 2023
- Decision date (initial)
- 2023-06-12
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- No
External identifiers
- EU CT number
- 2023-503457-35-00
- ClinicalTrials.gov
- NCT05165433
- ISRCTN
- ISRCTN94964671
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Pharmacodynamic, Safety, Dose response
To characterise the safety and tolerability of NG-350A in combination with pembrolizumab in patients with metastatic or advanced epithelial tumours
To determine the recommended dose of NG-350A in combination with pembrolizumab for further development in patients with metastatic or advanced epithelial tumours
Secondary objectives 1
- To explore the preliminary anti-tumour activity of NG-350A in combination with pembrolizumab in patients with metastatic or advanced epithelial tumours
Conditions and MedDRA coding
Epithelial tumours
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 6
- Patients must have histologically or cytologically documented metastatic or advanced epithelial cancer
- At least one measurable site of disease according to RECIST v1.1
- Provide written informed consent to participate
- Aged 18 years or over on day of signing informed consent
- Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
- Tumour accessible for biopsy
Exclusion criteria 7
- Prior or planned allogeneic or autologous bone marrow or tissue/organ transplantation
- Splenectomy
- Active infections requiring systemic anti-infective treatment, physician monitoring/hospital admission or recurrent fevers (>38.0˚C) associated with a clinical diagnosis of active infection within 20 days of the anticipated first dose of study drug
- Treatment with the antiviral agents: ribavirin, adefovir, lamivudine, cidofovir or paxlovid within 10 days prior to the first dose of study treatment
- Known history of hepatitis B infection or known active hepatitis C infection, known history of HIV infection
- Patients who have active autoimmune disease that has required systemic therapy in the past 2 years, are immunocompromised in the opinion of the Investigator, or are receiving chronic systemic immunosuppressive treatment
- Treatment with any live, live-attenuated or COVID-19 vaccine in the 30 days before first dose of study drug
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 2
- Incidence of AEs, SAEs, AEs leading to discontinuation and AEs resulting in death
- Incidence of AEs meeting protocol defined DLT criteria
Secondary endpoints 3
- ORR according to Investigator (phase 1a) and IRR (phase 1b) assessments, and using RECIST v1.1
- Median PFS and PFS rates according to investigator (phase 1a) and IRRC assessments (phase 1b)
- Overall survival rate
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 2
PRD9578950 · Product
- Active substance
- NG-350A
- Pharmaceutical form
- SUSPENSION FOR INJECTION
- Route of administration
- INTRAVENOUS USE
- Max daily dose
- 3 ml millilitre(s)
- Max total dose
- 123.5 ml millilitre(s)
- Max treatment duration
- 24 Month(s)
- Authorisation status
- Not Authorised
- MA holder
- PSIOXUS THERAPEUTICS LTD.
- Paediatric formulation
- No
- Orphan designation
- No
KEYTRUDA 25 mg/mL concentrate for solution for infusion
PRD4323105 · Product
- Active substance
- Pembrolizumab
- Substance synonyms
- Lambrolizumab, MK-3475, SCH-900475, ABP 234
- Pharmaceutical form
- SOLUTION FOR INFUSION
- Route of administration
- SOLUTION FOR INFUSION
- Max daily dose
- 400 mg milligram(s)
- Max total dose
- 7200 mg milligram(s)
- Max treatment duration
- 24 Month(s)
- Authorisation status
- Authorised
- ATC code
- L01FF02 — -
- Marketing authorisation
- EU/1/15/1024/002
- MA holder
- MERCK SHARP & DOHME BV
- MA country
- EU
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Akamis Bio Limited
- Sponsor organisation
- Akamis Bio Limited
- Address
- 4-10 The Quadrant
- City
- Abingdon
- Postcode
- OX14 3YS
- Country
- United Kingdom
Scientific contact point
- Organisation
- Akamis Bio Limited
- Contact name
- Andrew Fox
Public contact point
- Organisation
- Akamis Bio Limited
- Contact name
- Andrew Fox
Locations
2 EU/EEA countries · 2 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Belgium | Ended | 35 | 1 |
| Spain | Ended | 50 | 1 |
| Rest of world
United Kingdom, United States
|
— | 113 | — |
Investigational sites
Application history
1 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2023-02-02 | Belgium | Acceptable 2023-06-05
|
2023-06-12 |