Advanced Solid TumoursPhase 2KEYNOTE-E86NCT04907851
A Study to Assess RXC004 Efficacy in Advanced Solid Tumours After Progression on Standard of Care (SoC) Therapy (PORCUPINE2)
A Phase 2 study testing RXC004, Denosumab and pembrolizumab in people with Advanced Solid Tumours, run by Redx Pharma Ltd at 13 sites in 2 countries.
Trial summary
This study is to evaluate the preliminary efficacy and safety of RXC004 monotherapy and in combination with pembrolizumab in advanced solid tumours that have progressed following SoC treatment. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Advanced Solid Tumours
- What is being tested?
- RXC004, Denosumab and pembrolizumab
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 13 sitesin 2 countries
- Study dates
- 10 Dec 2021to 30 Nov 2023
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Core Inclusion Criteria:
- At least one lesion that is measurable by RECIST 1.1 at baseline (within 6 weeks prior to start of study treatment).
- Mandatory paired biopsies; Patients must have at least one lesion suitable for biopsy at screening
- Adequate organ and marrow function
- Female patients of childbearing potential must have a negative pregnancy test prior to start of dosing
- Female patients of childbearing potential and male patients with female partners of childbearing potential must agree to use a highly effective method of contraception during the study from the time of treatment initiation, and for at least 5 months after the last dose of study drug.
Module 1 (PDAC) Specific Inclusion Criteria
- Histological documentation of advanced (unresectable)/metastatic (Stage III/IV) PDAC, with documented loss of function tumour mutation in RNF43
- Patients must have received one prior systemic treatment for advanced (unresectable)/metastatic PDAC (Stage III/IV), with clear evidence of radiological disease progression
- Patients must be enrolled and receive first dose of study treatment within 6 weeks of radiologically confirmed progression
- Karnofsky performance status ≥70.
Module 2 and Module 3 (BTC) Specific Inclusion Criteria
- Histological documentation of advanced (unresectable)/metastatic (Stage III/IV) BTC (intrahepatic or extrahepatic cholangiocarcinoma, ampulla of Vater, or gallbladder cancer)
- Patients must have received one prior systemic treatment for advanced (unresectable)/metastatic BTC, with clear evidence of radiological disease progression
- Patients must be enrolled and receive first dose of study treatment within 6 weeks of radiologically confirmed progression
- ECOG status 0 or 1.
Core Exclusion Criteria:
- Prior therapy with a compound of the same mechanism of action as RXC004
- Patients at higher risk of bone fractures
- Any known uncontrolled inter-current illness or persistent clinically significant toxicity related to prior anti-cancer treatment
- Patients who have any history of an active (requiring treatment) other malignancy within 2 years of study entry
- Patients with known or suspected brain metastases
- Use of anti-neoplastic agents
- Patients with a known hypersensitivity to any RXC004 excipients
- Patients with a contra-indication for denosumab treatment
- Patients who are pregnant or breast-feeding
- Known active human immunodeficiency viruses (HIV), hepatitis B (HBV), or hepatitis C (HCV) infections
- Use of any live or live-attenuated vaccines against infectious diseases (e.g., influenza nasal spray, varicella) within 4 weeks (28 days) of initiation of study treatment
- Mean resting corrected QTcF >470 ms, obtained from triplicate ECGs performed at screening.
There are no exclusion criteria specific to Modules 1 and 2.
Module 3 Specific Exclusion Criteria:
- Patients with any contraindication to the use of pembrolizumab as per approved label
- Has received prior therapy with an anti-programmed cell death-1 (anti-PD-1), anti-PD-L1, or anti-PD-L2 agent or with an agent directed to another stimulatory or co-inhibitory T-cell receptor, and was discontinued from that treatment due to a Grade 3 or higher AE
- Has received prior radiotherapy within 2 weeks of start of study treatment or have had a history of radiation pneumonitis
- Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior the first dose of pembrolizumab in this study
- Has severe hypersensitivity (≥ Grade 3) to pembrolizumab and/or any of its excipients
- Has an active autoimmune disease that has required systemic treatment in past 2 years
- Has a history of (non-infectious) pneumonitis / interstitial lung disease that required steroids or has current pneumonitis / interstitial lung disease
- Has an active infection requiring systemic therapy
- Patients with a history of allogeneic tissue/solid organ transplant
- Patients with active infections, including tuberculosis, HIV, HBV, or HCV
Trial locations and contacts
13 sites in 2 countries.
13 sites in 2 countries
United Kingdom11 sites
Cambridge University Hospital NHS Foundation Trust
Cambridge, CB2 0XY
Beatson West of Scotland Cancer Care
Glasgow, G12 0YN
St James University Hospital
Leeds, LS9 7TF
Barts Cancer Institute - Haemato-Oncology
London, EC1M 6BQ
University College Hospitals NHS Foundation Trust
London, NW1 2BU
Royal Free London Foundation NHS Trust
London, NW3 2QG
Imperial College Healthcare NHS Trust - Hammersmith Hospital
London, W12 0HS
The Christie NHS Foundation Trust - Medical Oncology
Manchester, M20 4BX
Oxford Cancer and Haematology Centre Churchill Hospital
Oxford, OX3 7LE
Weston Park Hospital
Sheffield, S10 2SJ
The Royal Marsden Hospital (Surrey)
Sutton, SM25PT
Australia2 sites
The Alfred Hospital - Alfred Health
Melbourne, Victoria, 3304
Wollongong Hospital
Wollongong, New South Wales, 2500
About this study
Official title: A Modular, Phase II, Open-Label, Multicentre Study to Assess the Preliminary Efficacy and Safety of RXC004, in Patients With Advanced Solid Tumours That Have Progressed Following Therapy With Current Standard of Care
This study is to evaluate the preliminary efficacy and safety of RXC004 monotherapy and in combination with pembrolizumab in advanced solid tumours that have progressed following SoC treatment.
Read the detailed description
This Phase II, modular, open label, multicentre study initially opened with ring finger protein 43 (RNF43) loss of function (LoF) mutation-positive pancreatic ductal adenocarcinoma (PDAC) (Module 1) and molecularly unselected biliary tract cancer (BTC) (Module 2) modules. Module 3 will investigate RXC004 in combination with pembrolizumab in BTC. Modules 1 and 2 are monotherapies and Module 3 is the combination therapy.
The primary objective of the study is to assess the preliminary efficacy of RXC004 in each module. This will be evaluated in terms of progression free survival (PFS) at 6 months in Modules 1 and 2, and in terms of Objective response rate (ORR) in Module 3. Following radiological progression, patients will be followed-up for survival.
- Conditions
- Advanced Solid Tumours
- Being tested
- RXC004, Denosumab, pembrolizumab
- Keywords
- Open-Label, RXC004, Ring finger protein 43, Pancreatic ductal adenocarcinoma, Biliary tract cancer, Efficacy, Safety, Pharmacokinetics, Pancreatic cancer, Cholangiocarcinoma, Gallbladder, Ampullary Cancer, Ampulla of Vater, MK-3475-E86, zamaporvint
- Medical subject headings
- Biliary Tract Neoplasms, Pancreatic Neoplasms, Cholangiocarcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RXC004Drug
Also called zamaporvint
RXC004 will be administered orally, 2 mg QD; Dose Formulation: 0.5 mg or 1 mg capsules.
RXC004Drug
Also called zamaporvint
RXC004 will be administered orally, 2 mg QD (Cohort 1, Module 2) and 1 mg QD (Cohort 2, Module 2); Dose Formulation: 0.5 mg or 1 mg capsules.
RXC004Drug
Also called zamaporvint
RXC004 will be administered orally, 1.5 mg QD; Dose Formulation: 0.5 mg or 1 mg capsules.
DenosumabBiological
Denosumab will be administered via subcutaneous (SC) injection, 120 mg once every month; Use: Prophylactic
pembrolizumabBiological
Also called KEYTRUDA®
Pembrolizumab will be administered via intravenous infusion, 400 mg dose once every 6 weeks
| Study group | Role | What they receive |
|---|---|---|
| Module 1 - RNF43 Mutated Advanced (unresectable)/Metastatic Pancreatic Cancer (Stage III/IV) | Experimental | Patients (Karnofsky performance status ≥70) will be recruited and dosed with RXC004 (2 mg once daily [QD], orally) within 6 weeks of progression following 1st line SoC treatment. Receives: Drug: RXC004; Biological: Denosumab |
| Module 2 -Advanced (unresectable)/Metastatic Biliary Tract Cancer (Stage III/IV) | Experimental | Patients (Eastern Cooperative Oncology Group [ECOG] performance status 0-1) will be recruited and dosed with RXC004 within 6 weeks of progression, following 1st line SoC treatment. Receives: Drug: RXC004; Biological: Denosumab |
| Module 3-Advanced (unresectable)/Metastatic Biliary Tract Cancer (Stage Ill/IV) Combination Therapy | Experimental | Patients (ECOG performance status 0-1) will be recruited and dosed with RXC004 (1.5 mg QD, orally) in combination with pembrolizumab 400 mg IV infusion every 6 weeks (q6w) within 6 weeks of progression, following 1st line Soc treatment. Receives: Drug: RXC004; Biological: Denosumab; Biological: pembrolizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Monotherapy (Modules 1 and 2): Progression Free Survival Rate at 6 Months
The anti-tumour activity of RXC004 was assessed. Progression free survival rate at 6 months was defined as the percentage of patients who remained alive and free of progression at 6 months according to Kaplan-Meier estimates.
Measured: At 6 months
Combination Therapy (Module 3): Objective Response Rate (ORR)
The anti-tumour activity of RXC004 as a combination therapy was assessed. ORR was defined as the percentage of patients with a best overall response of complete response or partial response based on local investigator assessment as defined in RECIST 1.1.
Measured: Up to 23 months
Secondary outcomes (14)
Monotherapy (Modules 1 and 2): ORR
The preliminary efficacy of RXC004 was assessed. ORR was defined as the percentage of patients with a best overall response of complete response (CR) or partial response (PR) based on local Investigator assessment as defined in RECIST 1.1.
Measured: Up to 23 months
Monotherapy (Modules 1 and 2) and Combination Therapy (Module 3): Disease Control Rate (DCR)
The preliminary efficacy of RXC004 as a monotherapy and as a combination therapy was assessed. DCR was defined as the percentage of patients with a best overall response of either CR, PR or stable disease (SD) for at least 6 weeks.
Measured: Up to 23 months
Monotherapy (Modules 1 and 2) and Combination Therapy (Module 3): PFS
The preliminary efficacy of RXC004 as a monotherapy and as a combination therapy was assessed. PFS was defined as the time from first dose of study treatment until the date of disease progression or death (by any cause in the absence of progression) regardless whether the patient withdrew from the assigned study treatment or received another anticancer prior to progression.
Measured: Up to 23 months
Monotherapy (Modules 1 and 2) and Combination Therapy (Module 3): Best Percentage Change in Tumor Size
The preliminary efficacy of RXC004 as a monotherapy and as a combination therapy was assessed. The best percentage change in tumour size was determined at a patient level. For each patient, it represents the largest decrease (or smallest increase) in tumour size. Percentage change in tumour size was derived at each visit by the percentage change from baseline in the sum of diameters of all target lesions.
Measured: Up to 23 months
Monotherapy (Modules 1 and 2) and Combination Therapy (Module 3): Overall Survival (OS)
The preliminary efficacy of RXC004 as a monotherapy and as a combination therapy was assessed. OS was defined as the time from first day of study treatment until death due to any cause.
Measured: Up to 23 months
Maximum Observed Plasma Concentration (Cmax)
The pharmacokinetics (PK) of RXC004 as a monotherapy and as a combination therapy was assessed.
Measured: At Cycle 0 Day 1 and Cycle 1 Day 15 (Each cycle was 21 days in length)
Time to Cmax (Tmax)
The PK (tmax) of RXC004 as a monotherapy and as a combination therapy was assessed.
Measured: At Cycle 0 Day 1 and Cycle 1 Day 15 (Each cycle was 21 days in length)
Minimum Observed Concentration Across the Dosing Interval (Cmin)
The PK (Cmin) of RXC004 as a monotherapy and as a combination therapy was assessed.
Measured: At Cycle 1 Day 15 (The cycle was 21 days in length) (Up to 23 months)
Terminal Rate Constant (λz)
The PK (λz) of RXC004 as a monotherapy and as a combination therapy was assessed.
Measured: At Cycle 0 Day 1 (The cycle was 21 days in length)
Terminal Half-life (t½)
The PK (t½) of RXC004 as a monotherapy and as a combination therapy was assessed.
Measured: At Cycle 0 Day 1(The cycle was 21 days in length)
Area Under the Plasma Concentration-time Curve From Zero to Infinity (AUC0-∞)
The PK (AUC0-∞) of RXC004 as a monotherapy and as a combination therapy was assessed.
Measured: At Cycle 0 Day 1 (The cycle was 21 days in length)
Total Plasma Clearance After Oral Administration (CL/F)
The PK(CL/F) of RXC004 as a monotherapy and as a combination therapy was assessed.
Measured: At Cycle 0 Day 1 (The cycle was 21 days in length)
Apparent Volume of Distribution After Oral Administration (Vz/F)
The PK (Vz/F) of RXC004 as a monotherapy and as a combination therapy was assessed.
Measured: At Cycle 0 Day 1 (The cycle was 21 days in length)
Number of Patients With Adverse Events (AEs)
The safety, and tolerability profile of RXC004 as a monotherapy and as a combination therapy was assessed. The grading scales found in the revised National Cancer Institute CTCAE latest version was utilized for all events with an assigned CTCAE grading. Grade refers to the severity of the AE. The CTCAE displays Grades 1 through 5 with unique clinical descriptions of severity for each AE based on this general guideline: Grade 1 Mild; asymptomatic or mild symptoms; clinical or diagnostic observations only; intervention not indicated. Grade 2 Moderate; minimal, local or noninvasive intervention indicated; limiting age-appropriate instrumental ADL. Grade 3 Severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self-care ADL; Grade 4: Life-threatening, urgent intervention required; Grade 5: Death related to AE.
Measured: From time of signature of main study informed consent form throughout the treatment period and until the 30 days after last dose of RXC004 (Up to 23 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jun 2021
- Study start10 Dec 2021
- Primary completion30 Nov 2023
- Study completion30 Nov 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Advanced Solid TumoursStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- Redx Pharma Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Merck Sharp & Dohme LLC
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04907851
- Sponsor's protocol ID
- RXC004/0003
- Other IDs
- MK-3475-E86, KEYNOTE-E86, 2020-005804-20
- Acronym
- KEYNOTE-E86
- Status last verified
- Feb 2025
- First submitted
- 25 May 2021
- Last updated
- 17 Mar 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Modular, Phase II, Open-Label, Multicentre Study to Assess the Preliminary Efficacy and Safety of RXC004, in Patients With Advanced Solid Tumours That Have Progressed Following Therapy With Current Standard of Care
- ClinicalTrials.gov ID
- NCT04907851
- Acronym / sponsor ID
- KEYNOTE-E86 / RXC004/0003
- Conditions
- Advanced Solid Tumours
- Keywords
- Open-Label, RXC004, Ring finger protein 43, Pancreatic ductal adenocarcinoma, Biliary tract cancer, Efficacy, Safety, Pharmacokinetics
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- Redx Pharma LtdIndustry (pharma, biotech, devices)
- Collaborators
- Merck Sharp & Dohme LLC
- Study start
- 10 Dec 2021 (actual)
- Primary completion
- 30 Nov 2023 (actual)
- Study completion
- 30 Nov 2023 (actual)
- First posted
- 1 Jun 2021 (actual)
- Results
- Posted 17 Mar 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is to evaluate the preliminary efficacy and safety of RXC004 monotherapy and in combination with pembrolizumab in advanced solid tumours that have progressed following SoC treatment.
Detailed description
This Phase II, modular, open label, multicentre study initially opened with ring finger protein 43 (RNF43) loss of function (LoF) mutation-positive pancreatic ductal adenocarcinoma (PDAC) (Module 1) and molecularly unselected biliary tract cancer (BTC) (Module 2) modules. Module 3 will investigate RXC004 in combination with pembrolizumab in BTC. Modules 1 and 2 are monotherapies and Module 3 is the combination therapy.
The primary objective of the study is to assess the preliminary efficacy of RXC004 in each module. This will be evaluated in terms of progression free survival (PFS) at 6 months in Modules 1 and 2, and in terms of Objective response rate (ORR) in Module 3. Following radiological progression, patients will be followed-up for survival.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Module 1 - RNF43 Mutated Advanced (unresectable)/Metastatic Pancreatic Cancer (Stage III/IV) | Experimental | Drug: RXC004, Biological: DenosumabPatients (Karnofsky performance status ≥70) will be recruited and dosed with RXC004 (2 mg once daily [QD], orally) within 6 weeks of progression following 1st line SoC treatment. |
| Module 2 -Advanced (unresectable)/Metastatic Biliary Tract Cancer (Stage III/IV) | Experimental | Drug: RXC004, Biological: DenosumabPatients (Eastern Cooperative Oncology Group [ECOG] performance status 0-1) will be recruited and dosed with RXC004 within 6 weeks of progression, following 1st line SoC treatment. |
| Module 3-Advanced (unresectable)/Metastatic Biliary Tract Cancer (Stage Ill/IV) Combination Therapy | Experimental | Drug: RXC004, Biological: Denosumab, Biological: pembrolizumabPatients (ECOG performance status 0-1) will be recruited and dosed with RXC004 (1.5 mg QD, orally) in combination with pembrolizumab 400 mg IV infusion every 6 weeks (q6w) within 6 weeks of progression, following 1st line Soc treatment. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RXC004Also: zamaporvintRXC004 will be administered orally, 2 mg QD; Dose Formulation: 0.5 mg or 1 mg capsules. | Drug | Module 1 - RNF43 Mutated Advanced (unresectable)/Metastatic Pancreatic Cancer (Stage III/IV) |
| RXC004Also: zamaporvintRXC004 will be administered orally, 2 mg QD (Cohort 1, Module 2) and 1 mg QD (Cohort 2, Module 2); Dose Formulation: 0.5 mg or 1 mg capsules. | Drug | Module 2 -Advanced (unresectable)/Metastatic Biliary Tract Cancer (Stage III/IV) |
| RXC004Also: zamaporvintRXC004 will be administered orally, 1.5 mg QD; Dose Formulation: 0.5 mg or 1 mg capsules. | Drug | Module 3-Advanced (unresectable)/Metastatic Biliary Tract Cancer (Stage Ill/IV) Combination Therapy |
| DenosumabDenosumab will be administered via subcutaneous (SC) injection, 120 mg once every month; Use: Prophylactic | Biological | Module 1 - RNF43 Mutated Advanced (unresectable)/Metastatic Pancreatic Cancer (Stage III/IV), Module 2 -Advanced (unresectable)/Metastatic Biliary Tract Cancer (Stage III/IV), Module 3-Advanced (unresectable)/Metastatic Biliary Tract Cancer (Stage Ill/IV) Combination Therapy |
| pembrolizumabAlso: KEYTRUDA®Pembrolizumab will be administered via intravenous infusion, 400 mg dose once every 6 weeks | Biological | Module 3-Advanced (unresectable)/Metastatic Biliary Tract Cancer (Stage Ill/IV) Combination Therapy |
Primary outcome
Monotherapy (Modules 1 and 2): Progression Free Survival Rate at 6 Months
Time frame: At 6 months
The anti-tumour activity of RXC004 was assessed. Progression free survival rate at 6 months was defined as the percentage of patients who remained alive and free of progression at 6 months according to Kaplan-Meier estimates.
Combination Therapy (Module 3): Objective Response Rate (ORR)
Time frame: Up to 23 months
The anti-tumour activity of RXC004 as a combination therapy was assessed. ORR was defined as the percentage of patients with a best overall response of complete response or partial response based on local investigator assessment as defined in RECIST 1.1.
14 secondary outcomes
Monotherapy (Modules 1 and 2): ORR
Time frame: Up to 23 months
Monotherapy (Modules 1 and 2) and Combination Therapy (Module 3): Disease Control Rate (DCR)
Time frame: Up to 23 months
Monotherapy (Modules 1 and 2) and Combination Therapy (Module 3): PFS
Time frame: Up to 23 months
Monotherapy (Modules 1 and 2) and Combination Therapy (Module 3): Best Percentage Change in Tumor Size
Time frame: Up to 23 months
Monotherapy (Modules 1 and 2) and Combination Therapy (Module 3): Overall Survival (OS)
Time frame: Up to 23 months
Maximum Observed Plasma Concentration (Cmax)
Time frame: At Cycle 0 Day 1 and Cycle 1 Day 15 (Each cycle was 21 days in length)
Time to Cmax (Tmax)
Time frame: At Cycle 0 Day 1 and Cycle 1 Day 15 (Each cycle was 21 days in length)
Minimum Observed Concentration Across the Dosing Interval (Cmin)
Time frame: At Cycle 1 Day 15 (The cycle was 21 days in length) (Up to 23 months)
Terminal Rate Constant (λz)
Time frame: At Cycle 0 Day 1 (The cycle was 21 days in length)
Terminal Half-life (t½)
Time frame: At Cycle 0 Day 1(The cycle was 21 days in length)
Area Under the Plasma Concentration-time Curve From Zero to Infinity (AUC0-∞)
Time frame: At Cycle 0 Day 1 (The cycle was 21 days in length)
Total Plasma Clearance After Oral Administration (CL/F)
Time frame: At Cycle 0 Day 1 (The cycle was 21 days in length)
Apparent Volume of Distribution After Oral Administration (Vz/F)
Time frame: At Cycle 0 Day 1 (The cycle was 21 days in length)
Number of Patients With Adverse Events (AEs)
Time frame: From time of signature of main study informed consent form throughout the treatment period and until the 30 days after last dose of RXC004 (Up to 23 months)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Mar 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
13 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing RXC004, Denosumab and pembrolizumab in people with Advanced Solid Tumours, run by Redx Pharma Ltd at 13 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 13 sites in United Kingdom, Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 17 Mar 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Monotherapy (Modules 1 and 2): Progression Free Survival Rate at 6 Months (time frame: At 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Mar 2025.