Clinical trial · Interventional
Study to Evaluate the Safety and Tolerability of RXC004 in Advanced Malignancies
A Modular Multi-Arm, Phase 1, Adaptive Design Study to Evaluate the Safety and Tolerability of RXC004, Alone and in Combination With Anti-cancer Treatments, in Patients With Advanced Malignancies
NCT03447470CI-TRIAL-00085218completedPhase 1Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cancer | Malignant Neoplasm | ALIAS | 0.90 |
| Solid Tumor | Solid Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Nivolumab | Drug | Nivolumab | ALIAS |
| RXC004 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (9)
- type
- EXPERIMENTAL
- label
- Module 1 Arm 1 - Monotherapy RXC004 (0.5 mg)
- description
- Patients were given 0.5 mg RXC004 and monitored for Dose Limiting Toxicities.
- interventionNames
- Drug: RXC004
- type
- EXPERIMENTAL
- label
- Module 2 Arm 1 - RXC004 (1.0 mg) plus Nivolumab
- description
- Patients were given 1.0 mg RXC004 in combination with a standard dose of Nivolumab and monitored for Dose Limiting Toxicities.
- interventionNames
- Drug: RXC004
- Drug: Nivolumab
- type
- EXPERIMENTAL
- label
- Module 3 - Intermittent schedules of monotherapy RXC004
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
(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.
References
Publications (0)
Data not yet available
No reference posted for this study.