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2021-12-10
2023-11-30
2023-11-30
45
NCT04907851
Redx Pharma Ltd
Redx Pharma Ltd
INTERVENTIONAL
A Study to Assess RXC004 Efficacy in Advanced Solid Tumours After Progression on Standard of Care (SoC) Therapy (PORCUPINE2)
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.
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.
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
| Study Registration Dates | Results Reporting Dates | Study Record Updates |
|---|---|---|
2021-05-25 | 2024-11-07 | 2025-02-25 |
2021-05-28 | 2025-02-25 | 2025-03-17 |
2021-06-01 | 2025-03-17 | 2025-02 |
This section provides details of the study plan, including how the study is designed and what the study is measuring.
Primary Purpose:
Treatment
Allocation:
Non Randomized
Interventional Model:
Parallel
Masking:
None
Arms and Interventions
| Participant Group/Arm | Intervention/Treatment |
|---|---|
| EXPERIMENTAL: Module 1 - RNF43 Mutated Advanced (unresectable)/Metastatic Pancreatic Cancer (Stage III/IV) 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. | DRUG: RXC004
BIOLOGICAL: Denosumab
|
| EXPERIMENTAL: Module 2 -Advanced (unresectable)/Metastatic Biliary Tract Cancer (Stage III/IV) 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. | DRUG: RXC004
BIOLOGICAL: Denosumab
|
| EXPERIMENTAL: Module 3-Advanced (unresectable)/Metastatic Biliary Tract Cancer (Stage Ill/IV) Combination Therapy 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. | DRUG: RXC004
BIOLOGICAL: pembrolizumab
|
| Primary Outcome Measures | Measure Description | Time Frame |
|---|---|---|
| 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. | 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. | Up to 23 months |
| Secondary Outcome Measures | Measure Description | Time Frame |
|---|---|---|
| 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. | 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. | 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. | 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. | 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. | Up to 23 months |
| Maximum Observed Plasma Concentration (Cmax) | The pharmacokinetics (PK) of RXC004 as a monotherapy and as a combination therapy was assessed. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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) |
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.
Ages Eligible for Study:
ALL
Sexes Eligible for Study:
18 Years
Accepts Healthy Volunteers:
This is where you will find people and organizations involved with this study.
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
No publications available
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The information and services provided by the National Pancreatic Cancer Foundation are for informational purposes only. The information and services are not intended to be substitutes for professional medical advice, diagnosis or treatment. The National Pancreatic Cancer Foundation does not recommend nor endorse any specific physicians, products or treatments even though they may be mentioned on this site.
