Status:
COMPLETED
Study to Evaluate the Safety and Tolerability of RXC004 in Advanced Malignancies
Lead Sponsor:
Redx Pharma Ltd
Conditions:
Cancer
Solid Tumor
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
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 an...
Detailed Description
The study will consist of an ascending monotherapy dose, the doses are pre-defined. The decision to escalate will be made upon the assessment of safety and tolerability data in the first cycle of tre...
Eligibility Criteria
Inclusion
- (Summarized due to limitation of characters)
- 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
- 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.
Key Trial Info
Start Date :
March 18 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 29 2023
Estimated Enrollment :
46 Patients enrolled
Trial Details
Trial ID
NCT03447470
Start Date
March 18 2019
End Date
September 29 2023
Last Update
January 29 2025
Active Locations (5)
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1
Royal Marsden Hospital, Institute of Cancer Research
Sutton, Surrey, United Kingdom, SM2 5PT
2
Guys Hospital
London, United Kingdom, SE1 9RT
3
The Christie NHS Foundation Trust
Manchester, United Kingdom, M20 4BX
4
Sir Bobby Robson Cancer Trials Research Centre
Newcastle, United Kingdom, NE77DN