Study to Evaluate the Safety and Tolerability of RXC004 in Advanced Malignancies
About the study
The purpose of this study is to determine the safety and tolerability of RXC004 as monotherapy and in combination with Nivolumab in patients with advanced malignancies. In order to define the doses and schedules for further clinical evaluation.
Who can take part
You may be eligible to participate in the study if you meet the following criteria:
INCLUSION CRITERIA
Inclusion Criteria:
- Written informed consent
- Aged at least 18 years
- Histological or cytological confirmation of advanced malignancy not considered to be appropriate for further conventional treatment
- Patients must use adequate contraception measures for the duration of the study and for 6 months after the study
- Patients must have adequate organ functions
- Ability to swallow and retain oral medication
EXCLUSION CRITERIA
Exclusion Criteria:
- Prior treatment with a compound of the same mechanism of action as RXC004
- No other anti-cancer therapy or investigational product throughout the study
- Patients with persistent grade 2 or higher diarrhoea
- Patients at high risk of bone fractures
- QTc prolongation
- Known uncontrolled intercurrent illness
- Known severe allergies to any active or inactive ingredients
In addition for Module 2
- Patients with any contraindication/hypersensitivity to Nivolumab of excipients
- Patients with active or prior documented autoimmune of inflammatory disorders within the past 5 years
- Patients with active infections, including tuberculosis, hepatitis B, hepatitis C or human immunodeficiency virus
- Use of any live vaccines against infectious diseases (eg, influenza, varicella) within 4 weeks (28 days) of initiation of study treatment
- Patients with body weight <40kg
- Patients with a history of allogeneic organ transplant or active primary immunodeficiency
In addition to Module 3
Patients with Wnt ligand-dependent solid tumours, defined as:
- Biliary tract cancers
- Thymus cancers (thymic and thymoma WHO classification)
- Any solid tumour with documented aberration in RNF43 and/or RSPO from central pre-screening or from a recognised panel approved by the Sponsor
- Patients willing to have mandatory skin biopsies at baseline and on one occasion while on study treatment.
Study Locations
Enter your ZIP code/Postal code/PIN code to locate study sites near you:
How to Apply
Contact the study center to learn if this study is a good match for you.
Study’s details
Contition
Cancer,Solid Tumor
Age (in years)
18+
Phase
Phase 1
Participants needed
46
Est. Completion Date
Sep 29, 2023
Treatment type
Interventional
Sponsor
Redx Pharma Plc
ClinicalTrials.gov identifier
NCT03447470
Study number
RXC004/0001
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