A Phase 1 interventional study of RXC004 and Nivolumab in Cancer and Solid Tumor, sponsored by Redx Pharma Ltd. Completed at 5 sites in United Kingdom. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-01-29.
Sponsored by Redx Pharma Ltd · Phase 1, Interventional, and Treatment
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.
The study will consist of an ascending monotherapy dose, the doses are pre-defined.
The decision to escalate will be made upon the assessment of safety and tolerability data in the first cycle of treatment.
Module 1 will commence with a 3+3 dose escalation design up to a recommended Phase 2 monotherapy dose. Patients being monitored for dose limiting toxicities at each dose level.
Characterisation of the PK profile, MTD and/or recommended Phase 2 dose will be defined on the emerging data.
Module 2: RXC004 and Nivolumab - Follows a similar 3+3 dose escalation design using RXC004 plus Nivolumab. The MTD and/or Phase 2 dose will be defined based on the PK profile, emerging safety and the appearance of any dose limiting toxicities.
Module 3: Intermittent dose schedules of RXC004 will be investigated. The intermittent schedules will utilize the module 1 dose which was shown to be safe and tolerated when used continuously. Characterisation of the PK profile; Wnt pathway inhibition; incidence/severity of Wnt pathway related AEs and anti-tumor activity will be evaluated at 2 different dosing schedules.
10,818 studies on the registry are indexed under Neoplasms; 2,324 are open to participants now.
This study's enrollment of 46 is below the median of 60 across 7,703 interventional studies indexed under Neoplasms.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
(Summarized due to limitation of characters)
Inclusion Criteria:
Exclusion Criteria:
In addition for Module 2
In addition to Module 3
Patients with Wnt ligand-dependent solid tumours, defined as:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
On an ECG, the QT interval is the time the heart’s lower chambers take to activate electrically and recover in each beat. QTc is that time adjusted for heart rate (QTcF by Fridericia’s formula, QTcB by Bazett’s). Some medicines lengthen it, and a long QTc can raise the risk of a dangerous heart rhythm.
The study may name a correction formula and a limit in milliseconds, often around 450–480.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Vaccines made with a weakened form of the germ, such as measles–mumps–rubella (MMR), chickenpox and yellow fever. They can be risky when the immune system is weakened. Flu injections are not live; the nasal flu spray is.
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
QT and QTc
On an ECG, the QT interval is the time the heart’s lower chambers take to activate electrically and recover in each beat. QTc is that time adjusted for heart rate (QTcF by Fridericia’s formula, QTcB by Bazett’s). Some medicines lengthen it, and a long QTc can raise the risk of a dangerous heart rhythm.
The study may name a correction formula and a limit in milliseconds, often around 450–480.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Excipients
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Autoimmune disease
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis B tests
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis C tests
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Live vaccines
Vaccines made with a weakened form of the germ, such as measles–mumps–rubella (MMR), chickenpox and yellow fever. They can be risky when the immune system is weakened. Flu injections are not live; the nasal flu spray is.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Biopsy and archival tissue
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Patients were given 0.5 mg RXC004 and monitored for Dose Limiting Toxicities.
Drug: RXC004
Patients were given 1.0 mg RXC004 in combination with a standard dose of Nivolumab and monitored for Dose Limiting Toxicities.
Drug: RXC004 · Drug: Nivolumab
Patients were given 2.0 mg RXC004. The patients were treated for 2 weeks at the same dose, followed by 1 week off for a 21 day cycle.
Drug: RXC004
Patients were given 1.0 mg RXC004 and monitored for Dose Limiting Toxicities.
Drug: RXC004
Patients were given 1.5 mg RXC004 and monitored for Dose Limiting Toxicities.
Drug: RXC004
Patients were given 2.0 mg RXC004 and monitored for Dose Limiting Toxicities.
Drug: RXC004
Patients were given 3.0 mg RXC004 and monitored for Dose Limiting Toxicities.
Drug: RXC004
Patients were given 10.0 mg RXC004 and monitored for Dose Limiting Toxicities.
Drug: RXC004
Patients were given 1.5 mg RXC004 in combination with a standard dose of Nivolumab and monitored for Dose Limiting Toxicities.
Drug: RXC004 · Drug: Nivolumab
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:
A DLT was defined as an adverse event or abnormal laboratory value. Haematological toxicity of CTCAE grade 4 or higher for more than 4 consecutive days. Grade 3 neutropenia of any duration accompanied by fever 38.5 degrees Celsius or higher. Grade 3 thrombocytopaenia with bleeding. Any other confirmed haematological toxicity CTCAE grade 4 or higher. Non-haematological toxicity CTCAE grade 3 or higher. Any other toxicity that is judged to be a DLT by the Safety Review Committee. An AE resulting in disrupted dosing \>14 days.
Time frame: AE data was collected after each cycle and until 30-day follow-up visit after study exit. The DLT period were assessed from the first dose until the end of 21 days of continuous dosing in each cycle until a Maximum Tolerated Dose (MTD) was identified.
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.
A DLT is defined as an adverse event or abnormal laboratory value. Haematological toxicity of CTCAE grade 4 or higher for more than 4 consecutive days. Grade 3 neutropenia of any duration accompanied by fever 38.5 degrees Celsius or higher. Grade 3 thrombocytopaenia with bleeding. Any other confirmed haematological toxicity CTCAE grade 4 or higher. Non-haematological toxicity CTCAE grade 3 or higher. Any other toxicity that is judged to be a DLT by the Safety Review Committee. An AE resulting in disrupted dosing \>14 days. Any grade 3 or higher immune-related adverse events
Time frame: The DLT period will be assessed from the first dose until the end of 28 days of continuous dosing. This will be completed for each dose level until a Maximum Tolerated Dose (MTD) is identified. Estimated time 12 Months in total
Module 3 - Safety and Tolerability of RXC004 at Intermittent Dosing Schedule.
Haematological toxicity of CTCAE grade 4 or higher present for more than 4 consecutive days. Grade 3 neutropenia of any duration accompanied by fever 38.5 degrees Celsius or higher. Grade 3 thrombocytopaenia with bleeding. Any other confirmed haematological toxicity CTCAE grade 4 or higher. Non-haematological toxicity CTCAE grade 3 or higher. Any other toxicity that is judged to be a DLT by the Safety Review Committee. An AE resulting in disrupted dosing \>14 days. Any grade 3 or higher immune-related adverse events.
Time frame: The assessment period will be from the first dose until the end of 21 days of intermittent dosing or within 7 days of IP discontinuation.
Module 1 - PK Profile - AUC on Cycle 0 Day 1 (C0D1)
Area under the Curve, AUC (0-24) for RXC004 was calculated from the measurement of mean plasma concentration of RXC004 at various time points from 0 - 96 hours following single dose on Cycle 0 Day1.
Time frame: Samples were analyzed from 0 - 96 hours after administration to evaluate PK parameters on Cycle 0 Day 1.
Module 1 - PK Profile - C24 on Cycle 0 Day 1 (C0D1)
Mean Plasma concentration of RXC004 at 24 h post-dose calculated from the measurement of mean RXC004 concentrations at various time points from 0 - 96 hours following single dose on Cycle 0 Day1..
Time frame: Samples were analyzed from 0 - 96 hours after administration to evaluate PK parameters on Cycle 0 Day 1.
Module 1 - PK Profile - Cmax on Cycle 0 Day 1 (C0D1)
Maximum plasma concentration (Cmax) of RXC004 following single dose calculated from the measurement of mean plasma concentration of RXC004 at various time points from 0 - 96 hours following single dose on Cycle 0 Day1..
Time frame: Samples were analyzed from 0 - 96 hours after administration to evaluate PK parameters on Cycle 0 Day 1.
Module 1 - PK Profile - Half-life From PK Analysis on Cycle 0 Day 1 (C0D1)
Half-life of RXC004 following single dose on Cycle 0 Day1 calculated from the measurement of mean plasma concentration of RXC004 at various time points from 0 - 96 hours following single dose on Cycle 0 Day1..
Time frame: Samples were analyzed from 0 - 96 hours after administration to evaluate PK parameters on Cycle 0 Day 1.
Module 2 - PK Profile - AUC on Cycle 0 Day 1 (C0D1)
AUC was calculated from the measurement of mean plasma concentration of RXC004 at various time points from 0 - 48 hours following single dose of RXC004 in combination with Nivolumab on Cycle 0 Day1.
Time frame: Samples were analyzed from 0 - 48 hours after administration to evaluate PK parameters on Cycle 0 Day 1.
Module 2 - PK Profile - C24 on Cycle 0 Day 1 (C0D1)
Mean Plasma concentration of RXC004 at 24 h post-dose when given in combination with Nivolumab.
Time frame: Samples were analyzed from 0 - 48 hours after administration to evaluate PK parameters on Cycle 0 Day 1.
Module 2 - PK Profile - Cmax on Cycle 0 Day 1 (C0D1)
Maximum plasma concentration (Cmax) of RXC004 following single dose on Cycle 0 Day1 when given in combination with Nivolumab..
Time frame: Samples were analyzed from 0 - 48 hours after administration to evaluate PK parameters on Cycle 0 Day 1.
Module 2 - PK Profile - Half-life From PK Analysis on Cycle 0 Day 1 (C0D1)
Half-life of RXC004 following single dose on Cycle 0 Day1 when given in combination with Nivolumab.
Time frame: Samples were analyzed from 0 - 48 hours after administration to evaluate PK parameters on Cycle 0 Day 1.
Module 3 - PK Profile - AUC on Cycle 0 Day 1 (C0D1)
AUC was calculated from the measurement of mean plasma concentration of RXC004 at various time points from 0 - 48 hours following single dose of RXC004
Time frame: Samples were analyzed from 0 - 48 hours after administration to evaluate PK parameters on Cycle 0 Day 1.
Module 3 - PK Profile - C24 on Cycle 0 Day 1 (C0D1)
Mean Plasma concentration of RXC004 at 24 h post-dose
Time frame: Samples were analyzed from 0 - 48 hours after administration to evaluate PK parameters on Cycle 0 Day 1.
Module 3 - PK Profile - Cmax on Cycle 0 Day 1 (C0D1)
Maximum plasma concentration (Cmax) of RXC004 following single dose
Time frame: Samples were analyzed from 0 - 48 hours after administration to evaluate PK parameters on Cycle 0 Day 1.
Module 3 - PK Profile - Half-life on Cycle 0 Day 1 (C0D1)
Half-life of RXC004 following single dose.
Time frame: Cycle 0 Day 1
Participants were enrolled into one of the modules of the study.
| Milestone | Module 1 Arm 1 - Monotherapy RXC004 (0.5 mg) | Module 1 Arm 2 - Monotherapy RXC004 (1.0 mg) | Module 1 Arm 3 - Monotherapy RXC004 (1.5 mg) | Module 1 Arm 4 - Monotherapy RXC004 (2.0 mg) | Module 1 Arm 5 - Monotherapy RXC004 (3.0 mg) | Module 1 Arm 6 - Monotherapy RXC004 (10.0 mg) | Module 2 Arm 1 - RXC004 (1.0 mg) Plus Nivolumab | Module 2 Arm 2 - RXC004 (1.5 mg) Plus Nivolumab | Module 3 - Intermittent Schedules of Monotherapy RXC004 |
|---|---|---|---|---|---|---|---|---|---|
| Started | 4 | 3 | 7 | 6 | 4 | 1 | 6 | 8 | 7 |
| Completed | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Not completed | 4 | 3 | 7 | 6 | 4 | 1 | 6 | 8 | 7 |
| Withdrew: Death | 0 | 1 | 3 | 0 | 1 | 0 | 3 | 3 | 1 |
| Withdrew: Withdrawal by subject | 1 | 0 | 0 | 0 | 1 | 0 | 1 | 1 | 3 |
| Withdrew: Treatment discontinued | 3 | 2 | 4 | 6 | 2 | 1 | 2 | 4 | 3 |
A DLT was defined as an adverse event or abnormal laboratory value. Haematological toxicity of CTCAE grade 4 or higher for more than 4 consecutive days. Grade 3 neutropenia of any duration accompanied by fever 38.5 degrees Celsius or higher. Grade 3 thrombocytopaenia with bleeding. Any other confirmed haematological toxicity CTCAE grade 4 or higher. Non-haematological toxicity CTCAE grade 3 or higher. Any other toxicity that is judged to be a DLT by the Safety Review Committee. An AE resulting in disrupted dosing \>14 days.
| Participants | Module 1 Arm 1 - Monotherapy RXC004 (0.5 mg) | Module 1 Arm 2 - Monotherapy RXC004 (1.0 mg) | Module 1 Arm 3 - Monotherapy RXC004 (1.5 mg) | Module 1 Arm 4 - Monotherapy RXC004 (2.0 mg) | Module 1 Arm 5 - Monotherapy RXC004 (3.0 mg) | Module 1 Arm 6 - Monotherapy RXC004 (10.0 mg) |
|---|---|---|---|---|---|---|
| Patients with any DLT | 0 | 0 | 0 | 1 | 2 | 1 |
| Colitis | 0 | 0 | 0 | 0 | 1 | 0 |
| Diarrhoea | 0 | 0 | 0 | 0 | 0 | 1 |
| Enteritis | 0 | 0 | 0 | 0 | 1 | 0 |
| Pancreatitis | 0 | 0 | 0 | 1 | 0 | 0 |
A DLT is defined as an adverse event or abnormal laboratory value. Haematological toxicity of CTCAE grade 4 or higher for more than 4 consecutive days. Grade 3 neutropenia of any duration accompanied by fever 38.5 degrees Celsius or higher. Grade 3 thrombocytopaenia with bleeding. Any other confirmed haematological toxicity CTCAE grade 4 or higher. Non-haematological toxicity CTCAE grade 3 or higher. Any other toxicity that is judged to be a DLT by the Safety Review Committee. An AE resulting in disrupted dosing \>14 days. Any grade 3 or higher immune-related adverse events
| Participants | Module 2 Arm 1 - RXC004 (1.0 mg) Plus Nivolumab | Module 2 Arm 2 - RXC004 (1.5 mg) Plus Nivolumab |
|---|---|---|
| Patients with any DLT | 0 | 1 |
| Drug-induced Liver Injury | 0 | 1 |
Haematological toxicity of CTCAE grade 4 or higher present for more than 4 consecutive days. Grade 3 neutropenia of any duration accompanied by fever 38.5 degrees Celsius or higher. Grade 3 thrombocytopaenia with bleeding. Any other confirmed haematological toxicity CTCAE grade 4 or higher. Non-haematological toxicity CTCAE grade 3 or higher. Any other toxicity that is judged to be a DLT by the Safety Review Committee. An AE resulting in disrupted dosing \>14 days. Any grade 3 or higher immune-related adverse events.
| Participants | Module 3 - Intermittent Schedules of Monotherapy RXC004 |
|---|---|
| Module 3 - Safety and Tolerability of RXC004 at Intermittent Dosing Schedule. | 0 |
Area under the Curve, AUC (0-24) for RXC004 was calculated from the measurement of mean plasma concentration of RXC004 at various time points from 0 - 96 hours following single dose on Cycle 0 Day1.
| h*ng/ml | Module 1 Arm 1 - Monotherapy RXC004 (0.5 mg) | Module 1 Arm 2 - Monotherapy RXC004 (1.0 mg) | Module 1 Arm 3 - Monotherapy RXC004 (1.5 mg) | Module 1 Arm 4 - Monotherapy RXC004 (2.0 mg) | Module 1 Arm 5 - Monotherapy RXC004 (3.0 mg) | Module 1 Arm 6 - Monotherapy RXC004 (10.0 mg) |
|---|---|---|---|---|---|---|
| Module 1 - PK Profile - AUC on Cycle 0 Day 1 (C0D1) | 138.8 ± 27.9 | 334.8 ± 118.8 | 464.9 ± 223.2 | 552.5 ± 215.3 | 1350.6 ± 217.8 | 2702.2 |
Mean Plasma concentration of RXC004 at 24 h post-dose calculated from the measurement of mean RXC004 concentrations at various time points from 0 - 96 hours following single dose on Cycle 0 Day1..
| ng/ml | 0.5 mg | 1 mg | 1.5 mg | 2 mg | 3 mg | 10 mg |
|---|---|---|---|---|---|---|
| Module 1 - PK Profile - C24 on Cycle 0 Day 1 (C0D1) | 1.74 ± 0.86 | 5.28 ± 3.66 | 7.26 ± 4.67 | 6.55 ± 4.62 | 16.05 ± 4.71 | 49.5 |
Maximum plasma concentration (Cmax) of RXC004 following single dose calculated from the measurement of mean plasma concentration of RXC004 at various time points from 0 - 96 hours following single dose on Cycle 0 Day1..
| ng/ml | 0.5 mg | 1 mg | 1.5 mg | 2 mg | 3 mg | 10 mg |
|---|---|---|---|---|---|---|
| Module 1 - PK Profile - Cmax on Cycle 0 Day 1 (C0D1) | 20.58 ± 3.07 | 47.77 ± 18.68 | 69.59 ± 33.1 | 84.03 ± 36.83 | 198.50 ± 57.81 | 369 |
Half-life of RXC004 following single dose on Cycle 0 Day1 calculated from the measurement of mean plasma concentration of RXC004 at various time points from 0 - 96 hours following single dose on Cycle 0 Day1..
| hours | 0.5 mg | 1 mg | 1.5 mg | 2 mg | 3 mg | 10 mg |
|---|---|---|---|---|---|---|
| Module 1 - PK Profile - Half-life From PK Analysis on Cycle 0 Day 1 (C0D1) | 16.77 (11.8 to 30.2) | 15.04 (8.5 to 21.2) | 16.88 (7.8 to 22.5) | 15.37 (9.9 to 21.2) | 14.44 (11.6 to 26.3) | 20.0 |
AUC was calculated from the measurement of mean plasma concentration of RXC004 at various time points from 0 - 48 hours following single dose of RXC004 in combination with Nivolumab on Cycle 0 Day1.
| h*ng/ml | 1 mg + Nivolumab | 1.5 mg + Nivolumab |
|---|---|---|
| Module 2 - PK Profile - AUC on Cycle 0 Day 1 (C0D1) | 303.3 ± 93.57 | 431.23 ± 109.63 |
Mean Plasma concentration of RXC004 at 24 h post-dose when given in combination with Nivolumab.
| ng/ml | 1 mg + Nivolumab | 1.5 mg + Nivolumab |
|---|---|---|
| Module 2 - PK Profile - C24 on Cycle 0 Day 1 (C0D1) | 6.18 ± 6.75 | 7.54 ± 3.12 |
Maximum plasma concentration (Cmax) of RXC004 following single dose on Cycle 0 Day1 when given in combination with Nivolumab..
| ng/ml | 1 mg + Nivolumab | 1.5 mg + Nivolumab |
|---|---|---|
| Module 2 - PK Profile - Cmax on Cycle 0 Day 1 (C0D1) | 49.63 ± 13.55 | 50.93 ± 18.15 |
Half-life of RXC004 following single dose on Cycle 0 Day1 when given in combination with Nivolumab.
| hours | 1 mg + Nivolumab | 1.5 mg + Nivolumab |
|---|---|---|
| Module 2 - PK Profile - Half-life From PK Analysis on Cycle 0 Day 1 (C0D1) | 16.35 (9.9 to 22.1) | 10.31 (7.1 to 14.5) |
AUC was calculated from the measurement of mean plasma concentration of RXC004 at various time points from 0 - 48 hours following single dose of RXC004
| h*ng/ml | 2.0 mg (2 Weeks on/1 Week Off Dosing) |
|---|---|
| Module 3 - PK Profile - AUC on Cycle 0 Day 1 (C0D1) | 547.51 ± 160.18 |
Mean Plasma concentration of RXC004 at 24 h post-dose
| ng/ml | 2.0 mg (2 Weeks on/1 Week Off Dosing) |
|---|---|
| Module 3 - PK Profile - C24 on Cycle 0 Day 1 (C0D1) | 7.65 ± 3.6 |
Maximum plasma concentration (Cmax) of RXC004 following single dose
| ng/ml | 2.0 mg (2 Weeks on/1 Week Off Dosing) |
|---|---|
| Module 3 - PK Profile - Cmax on Cycle 0 Day 1 (C0D1) | 84.87 ± 34.56 |
Half-life of RXC004 following single dose.
| hours | 2.0 mg (2 Weeks on/1 Week Off Dosing) |
|---|---|
| Module 3 - PK Profile - Half-life on Cycle 0 Day 1 (C0D1) | 10.5 (8.8 to 14.9) |
Collected over AE data was collected after each cycle and until 30-day follow-up visit after the last dose or study exit. The median duration of exposure for Module 1 was 7.0 weeks across all dose cohorts. For Module 2 - 7.1 weeks in the 1.0 mg group and 8.4 weeks in the 1.5 mg group; Module 3 - 5.0 weeks.. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Module 1 Arm 1 - Monotherapy RXC004 (0.5 mg) | 0/4 (0%) | 0/4 (0%) | 0/4 (0%) |
| Module 1 Arm 2 - Monotherapy RXC004 (1.0 mg) | 1/3 (33.3%) | 1/3 (33.3%) | 0/3 (0%) |
| Module 1 Arm 3 - Monotherapy RXC004 (1.5 mg) | 3/7 (42.9%) | 5/7 (71.4%) | 0/7 (0%) |
| Module 1 Arm 4 - Monotherapy RXC004 (2.0 mg) | 0/6 (0%) | 1/6 (16.7%) | 0/6 (0%) |
| Module 1 Arm 5 - Monotherapy RXC004 (3.0 mg) | 1/4 (25%) | 3/4 (75%) | 0/4 (0%) |
| Module 1 Arm 6 - Monotherapy RXC004 (10.0 mg) | 0/1 (0%) | 1/1 (100%) | 0/1 (0%) |
| Module 2 Arm 1 - RXC004 (1.0 mg) Plus Nivolumab | 3/6 (50%) | 4/6 (66.7%) | 0/6 (0%) |
| Module 2 Arm 2 - RXC004 (1.5 mg) Plus Nivolumab | 3/8 (37.5%) | 4/8 (50%) | 0/8 (0%) |
| Intermittent Schedules of Monotherapy RXC004 - Module 3 | 1/7 (14.3%) | 4/7 (57.1%) | 0/7 (0%) |
| Event | Module 1 Arm 1 - Monotherapy RXC004 (0.5 mg) | Module 1 Arm 2 - Monotherapy RXC004 (1.0 mg) | Module 1 Arm 3 - Monotherapy RXC004 (1.5 mg) | Module 1 Arm 4 - Monotherapy RXC004 (2.0 mg) | Module 1 Arm 5 - Monotherapy RXC004 (3.0 mg) | Module 1 Arm 6 - Monotherapy RXC004 (10.0 mg) | Module 2 Arm 1 - RXC004 (1.0 mg) Plus Nivolumab | Module 2 Arm 2 - RXC004 (1.5 mg) Plus Nivolumab | Intermittent Schedules of Monotherapy RXC004 - Module 3 |
|---|---|---|---|---|---|---|---|---|---|
| DiarrhoeaGastrointestinal disorders | 0/4 | 0/3 | 1/7 | 0/6 | 0/4 | 1/1 | 0/6 | 1/8 | 0/7 |
| Gastroenteritis viralInfections and infestations | 0/4 | 1/3 | 0/7 | 0/6 | 0/4 | 0/1 | 0/6 | 0/8 | 0/7 |
| SepsisInfections and infestations | 0/4 | 0/3 | 0/7 | 0/6 | 0/4 | 0/1 | 0/6 | 0/8 | 2/7 |
| ColitisGastrointestinal disorders | 0/4 | 0/3 | 0/7 | 0/6 | 1/4 | 0/1 | 0/6 | 0/8 | 0/7 |
| EnteritisGastrointestinal disorders | 0/4 | 0/3 | 0/7 | 0/6 | 1/4 | 0/1 | 0/6 | 0/8 | 0/7 |
| Biliary tract infectionInfections and infestations | 0/4 | 0/3 | 0/7 | 0/6 | 1/4 | 0/1 | 0/6 | 0/8 | 0/7 |
| Humerus fractureInjury, poisoning and procedural complications | 0/4 | 0/3 | 0/7 | 0/6 | 1/4 | 0/1 | 0/6 | 0/8 | 0/7 |
| Subdural haematomaInjury, poisoning and procedural complications | 0/4 | 0/3 | 0/7 | 0/6 | 1/4 | 0/1 | 0/6 | 0/8 | 0/7 |
| Stoma site infectionInfections and infestations | 0/4 | 0/3 | 0/7 | 1/6 | 0/4 | 0/1 | 0/6 | 0/8 | 0/7 |
| Atrial fibrillationCardiac disorders | 0/4 | 0/3 | 0/7 | 0/6 | 0/4 | 0/1 | 1/6 | 0/8 | 0/7 |
The Baseline Analysis Population described here per module include: In Module 1, participants enrolled, into 6 arms at different dose levels: 0.5 mg; 1 mg; 1.5 mg; 2 mg; 3 mg; 10 mg. In Module 2, participants enrolled, into 2 arms at different dose levels (1.0 mg and 1.5 mg) of RXC004 in combination with Nivolumab. In Module 3, the enrolled participants received a dose of 2.0 mg of RXC004 at 2 weeks on/1 week off.
| Age, Categorical(Participants) | Module 1 Arm 1 - Monotherapy RXC004 (0.5 mg) | Module 1 Arm 2 - Monotherapy RXC004 (1.0 mg) | Module 1 Arm 3 - Monotherapy RXC004 (1.5 mg) | Module 1 Arm 4 - Monotherapy RXC004 (2.0 mg) | Module 1 Arm 5 - Monotherapy RXC004 (3.0 mg) | Module 1 Arm 6 - Monotherapy RXC004 (10.0 mg) | Module 2 Arm 1 - RXC004 (1.0 mg) Plus Nivolumab | Module 2 Arm 2 - RXC004 (1.5 mg) Plus Nivolumab | Intermittent Schedules of Monotherapy RXC004 - Module 3 | Total |
|---|---|---|---|---|---|---|---|---|---|---|
| <=18 years | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Between 18 and 65 years | 1 | 3 | 4 | 2 | 1 | 1 | 4 | 4 | 4 | 24 |
| >=65 years | 3 | 0 | 3 | 4 | 3 | 0 | 2 | 4 | 3 | 22 |
| Age, Continuous(Years) | Module 1 Arm 1 - Monotherapy RXC004 (0.5 mg) | Module 1 Arm 2 - Monotherapy RXC004 (1.0 mg) | Module 1 Arm 3 - Monotherapy RXC004 (1.5 mg) | Module 1 Arm 4 - Monotherapy RXC004 (2.0 mg) | Module 1 Arm 5 - Monotherapy RXC004 (3.0 mg) | Module 1 Arm 6 - Monotherapy RXC004 (10.0 mg) | Module 2 Arm 1 - RXC004 (1.0 mg) Plus Nivolumab | Module 2 Arm 2 - RXC004 (1.5 mg) Plus Nivolumab | Intermittent Schedules of Monotherapy RXC004 - Module 3 | Total |
|---|---|---|---|---|---|---|---|---|---|---|
| Median | 73 (60 to 76) | 57 (44 to 62) | 62 (46 to 77) | 67 (56 to 73) | 68.5 (60 to 75) | 59 (59 to 59) | 46.5 (39 to 74) | 64.5 (30 to 75) | 63 (42 to 84) | 63.2 (30 to 84) |
| Sex: Female, Male(Participants) | Module 1 Arm 1 - Monotherapy RXC004 (0.5 mg) | Module 1 Arm 2 - Monotherapy RXC004 (1.0 mg) | Module 1 Arm 3 - Monotherapy RXC004 (1.5 mg) | Module 1 Arm 4 - Monotherapy RXC004 (2.0 mg) | Module 1 Arm 5 - Monotherapy RXC004 (3.0 mg) | Module 1 Arm 6 - Monotherapy RXC004 (10.0 mg) | Module 2 Arm 1 - RXC004 (1.0 mg) Plus Nivolumab | Module 2 Arm 2 - RXC004 (1.5 mg) Plus Nivolumab | Intermittent Schedules of Monotherapy RXC004 - Module 3 | Total |
|---|---|---|---|---|---|---|---|---|---|---|
| Female | 2 | 1 | 3 | 2 | 3 | 0 | 5 | 2 | 4 | 22 |
| Male | 2 | 2 | 4 | 4 | 1 | 1 | 1 | 6 | 3 | 24 |
| Race (NIH/OMB)(Participants) | Module 1 Arm 1 - Monotherapy RXC004 (0.5 mg) | Module 1 Arm 2 - Monotherapy RXC004 (1.0 mg) | Module 1 Arm 3 - Monotherapy RXC004 (1.5 mg) | Module 1 Arm 4 - Monotherapy RXC004 (2.0 mg) | Module 1 Arm 5 - Monotherapy RXC004 (3.0 mg) | Module 1 Arm 6 - Monotherapy RXC004 (10.0 mg) | Module 2 Arm 1 - RXC004 (1.0 mg) Plus Nivolumab | Module 2 Arm 2 - RXC004 (1.5 mg) Plus Nivolumab | Intermittent Schedules of Monotherapy RXC004 - Module 3 | Total |
|---|---|---|---|---|---|---|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Asian | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 1 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Black or African American | 0 | 0 | 0 | 2 | 0 | 0 | 1 | 0 | 0 | 3 |
| White | 4 | 3 | 6 | 4 | 3 | 1 | 5 | 7 | 7 | 40 |
| More than one race | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Unknown or Not Reported | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 1 | 0 | 2 |
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Studies of the drug tested here: Zamaporvint
Redx Pharma Ltd