Study to Evaluate the Safety and Tolerability of RXC004 in Advanced Malignancies

• Status: Recruiting
• Trial end date: 2021-12-01
• Target enrollment: 0
• Participant gender: All

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 and schedules for further clinical evaluation.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Redx Pharma Plc
• Treatments: Nivolumab

Criteria

(Summarized due to limitation of characters)

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:

• 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