Phase 1
Completed N=46
Study to Evaluate the Safety and Tolerability of RXC004 in Advanced Malignancies
Source: ClinicalTrials.gov NCT03447470 ↗Enrolled (actual)
46
Serious AEs
50.0%
Results posted
Jan 2025
Primary outcomePrimary: Module 1 - Safety and Tolerability of RXC004 by Assessment of Whether Any Dose Limiting Toxicities (DLT) Arise From First Dose Until the End of 21 Days of Continuous Dosing: — 0; 0; 0; 1 Participants
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Module 1 - Safety and Tolerability of RXC004 by Assessment of Whether Any Dose Limiting Toxicities (DLT) Arise From First Dose Until the End of 21 Days of Continuous Dosing: |
0; 0; 0; 1; 2; 1 | — |
| PRIMARY Module 2 - Safety and Tolerability of RXC004 in Combination With Nivolumab by Assessment of Whether Any Dose Limiting Toxicities (DLT) Arise From First Dose Until the End of 28 Days of Continuous Dosing. |
0; 1; 0; 1 | — |
| PRIMARY Module 3 - Safety and Tolerability of RXC004 at Intermittent Dosing Schedule. |
— | — |
| SECONDARY Module 1 - PK Profile - AUC on Cycle 0 Day 1 (C0D1) |
138.8; 334.8; 464.9; 552.5; 1350.6; 2702.2 | — |
| SECONDARY Module 1 - PK Profile - C24 on Cycle 0 Day 1 (C0D1) |
1.74; 5.28; 7.26; 6.55; 16.05; 49.5 | — |
| SECONDARY Module 1 - PK Profile - Cmax on Cycle 0 Day 1 (C0D1) |
20.58; 47.77; 69.59; 84.03; 198.50; 369 | — |
| SECONDARY Module 1 - PK Profile - Half-life From PK Analysis on Cycle 0 Day 1 (C0D1) |
16.77; 15.04; 16.88; 15.37; 14.44; 20.0 | — |
| SECONDARY Module 2 - PK Profile - AUC on Cycle 0 Day 1 (C0D1) |
303.3; 431.23 | — |
| SECONDARY Module 2 - PK Profile - C24 on Cycle 0 Day 1 (C0D1) |
6.18; 7.54 | — |
| SECONDARY Module 2 - PK Profile - Cmax on Cycle 0 Day 1 (C0D1) |
49.63; 50.93 | — |
| SECONDARY Module 2 - PK Profile - Half-life From PK Analysis on Cycle 0 Day 1 (C0D1) |
16.35; 10.31 | — |
| SECONDARY Module 3 - PK Profile - AUC on Cycle 0 Day 1 (C0D1) |
547.51 | — |
| SECONDARY Module 3 - PK Profile - C24 on Cycle 0 Day 1 (C0D1) |
7.65 | — |
| SECONDARY Module 3 - PK Profile - Cmax on Cycle 0 Day 1 (C0D1) |
84.87 | — |
| SECONDARY Module 3 - PK Profile - Half-life on Cycle 0 Day 1 (C0D1) |
10.5 | — |
Eligibility 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
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.
Data sourced from ClinicalTrials.gov (NCT03447470). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.