Metastatic Castration Resistant Prostate CancerPhase 1NCT05124795
IMU-935 in Patients With Progressive, Metastatic Castration Resistant Prostate Cancer
A Phase 1 study testing IMU-935 in people with Metastatic Castration Resistant Prostate Cancer, run by Immunic AG at 1 site in United Kingdom.
Trial summary
Dose escalation study to evaluate the safety, tolerability and anti-tumor activity of single agent IMU-935 in patients with progressive, metastatic castration resistant prostate cancer (mCRPC). Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Metastatic Castration Resistant Prostate Cancer
- What is being tested?
- IMU-935
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 9 Dec 2021to 31 May 2023
- Phase
- Phase 1
- Are there results?
- None posted in the registry
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
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥18 years
- Male patients with histologically or cytologically confirmed adenocarcinoma of the prostate with no evidence of small cell or neuroendocrine features
- Metastatic disease with limited therapeutic options, prior treatment with at least one next-generation hormonal agent (e.g., abiraterone, enzalutamide, apalutamide, darolutamide) and one taxane line of treatment is allowed
- Progressive disease is defined as rising prostate-specific antigen (PSA) levels ≥2ng/mL and/or radiographic progression according to Prostate Cancer Working Group 3 (PCWG3) criteria at screening
- Able and willing to comply with all study requirements for the duration of the study
- Patients must sign an ICF prior to the start of any study-related procedures
Who cannot join
- Anti-tumor therapy (chemotherapy, antibody therapy, molecular targeted therapy) within 28 days prior to starting study treatment
- Uncontrolled intercurrent illness such as active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, uncontrolled hypertension, or psychiatric illness/social situations that would limit compliance with the study protocol
- Malignancy within the previous 2 years with a ≥30% probability of recurrence within 12 months, with the exception of non-melanoma skin cancer or superficial bladder cancer
- Patients receiving strong inhibitors or inducers of cytochrome P450 (CYP) 3A4
- Chronic use of systemic steroid therapy (>1 month of >10 mg prednisone per day or equivalent, except replacement therapy)
- Patients for whom biopsies cannot be taken or are not willing to undergo biopsies
- Positive hepatitis B virus (HBV) surface antigen, hepatitis B core antibody, positive hepatitis C virus (HCV) antibody, and/or HIV-antigen-antibody test at screening
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Dose Escalation Study to Evaluate the Safety, Tolerability, and Anti-Tumor Activity of Single Agent IMU-935 in Patients With Progressive, Metastatic Castration Resistant Prostate Cancer
Dose escalation study to evaluate the safety, tolerability and anti-tumor activity of single agent IMU-935 in patients with progressive, metastatic castration resistant prostate cancer (mCRPC).
Read the detailed description
This is an open-label, non-randomized Phase 1 dose escalation, followed by dose expansion, study to define the safety, tolerability, biomarker change and anti-tumor activity of IMU-935 in patients with mCRPC. Throughout the study, safety, anti-tumor activity, biomarkers and IMU-935 plasma concentrations will be evaluated at regular intervals as per schedule of assessments. Disease progression will be assessed as per standard medical practice.
The dose escalation and expansion parts of the study will have the same treatment duration with similarly structured treatment cycles.
The study will consist of the following periods:
- Screening Period: Approximately 28 days
- Treatment Phase:
Main treatment over 3 cycles of 28 days each, extended treatment as long as patient benefits
- Being tested
- IMU-935
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IMU-935Drug
IMU-935 capsules
| Study group | Role | What they receive |
|---|---|---|
| IMU-935 - low dose, administered twice daily | Experimental | main treatment phase of 3 cycles of 28 days; followed by extended treatment cycles for patients that show clinical benefit from treatment Receives: Drug: IMU-935 |
| IMU-935 - medium dose, administered twice daily | Experimental | main treatment phase of 3 cycles of 28 days; followed by extended treatment cycles for patients that show clinical benefit from treatment Receives: Drug: IMU-935 |
| IMU-935 - high dose, administered twice daily | Experimental | main treatment phase of 3 cycles of 28 days; followed by extended treatment cycles for patients that show clinical benefit from treatment Receives: Drug: IMU-935 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence and the grade (severity) of dose-limiting toxicities (DLTs) within 28 days after start of study treatment to identify the MTD and the RP2D
DLTs are abnormal laboratory parameters or adverse events (per National Cancer Institute (NCI) - Common Terminology Criteria for Adverse Events V5.0) occurring during the DLT observation period of 28 days from treatment start, assessed as toxicities being related to IMU-935.
Measured: Within 28 days after start of study treatment
Number and severity of adverse events (AEs) reported according to the National Cancer Institute (NCI) - Common Terminology Criteria for Adverse Events (CTCAE) V5.0
Incidence and severity of adverse events as assessed by CTCAE Version 5.0.
Measured: 6 months
Secondary outcomes (3)
Proportion of patients considered responders to IMU-935 related to decline in prostate specific antigen (PSA) level
Patients with a serum prostate specific antigen (PSA) level decline of ≥30% from their pre-treatment level will be considered responders.
Measured: 6 months
Proportion of patients considered responders to IMU-935 related to decline in circulating tumor cells (CTC) numbers
Patients showing a conversion of circulating tumor cells (CTC) from ≥5 cells/7.5 mL blood at Cycle 1 Day 1 (pre-dose) to ≤4 cells/7.5 mL blood will be considered responders.
Measured: 6 months
Proportion of patients considered responders to IMU-935 related to the objective response based on the Response Evaluation Criteria in Solid Tumors (RECIST) V 1.1
Response rate as per RECIST V 1.1 will be evaluated centrally to identify responders.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2021
- Study start9 Dec 2021
- Primary completion31 May 2023
- Study completion31 May 2023
Why it stopped: Lack of Efficacy
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metastatic Castration Resistant Prostate CancerStudies 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 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Immunic AG
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- J. B., MD, Principal investigator, Institute of Cancer Research, United Kingdom
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05124795
- Sponsor's protocol ID
- P1-IMU-935-CRPC
- Status last verified
- Jan 2024
- First submitted
- 29 Oct 2021
- Last updated
- 17 Jan 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dose Escalation Study to Evaluate the Safety, Tolerability, and Anti-Tumor Activity of Single Agent IMU-935 in Patients With Progressive, Metastatic Castration Resistant Prostate Cancer
- ClinicalTrials.gov ID
- NCT05124795
- Acronym / sponsor ID
- P1-IMU-935-CRPC
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Lack of Efficacy
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Immunic AGIndustry (pharma, biotech, devices)
- Study start
- 9 Dec 2021 (actual)
- Primary completion
- 31 May 2023 (actual)
- Study completion
- 31 May 2023 (actual)
- First posted
- 18 Nov 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Dose escalation study to evaluate the safety, tolerability and anti-tumor activity of single agent IMU-935 in patients with progressive, metastatic castration resistant prostate cancer (mCRPC).
Detailed description
This is an open-label, non-randomized Phase 1 dose escalation, followed by dose expansion, study to define the safety, tolerability, biomarker change and anti-tumor activity of IMU-935 in patients with mCRPC. Throughout the study, safety, anti-tumor activity, biomarkers and IMU-935 plasma concentrations will be evaluated at regular intervals as per schedule of assessments. Disease progression will be assessed as per standard medical practice.
The dose escalation and expansion parts of the study will have the same treatment duration with similarly structured treatment cycles.
The study will consist of the following periods:
- Screening Period: Approximately 28 days
- Treatment Phase:
Main treatment over 3 cycles of 28 days each, extended treatment as long as patient benefits
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| IMU-935 - low dose, administered twice daily | Experimental | Drug: IMU-935main treatment phase of 3 cycles of 28 days; followed by extended treatment cycles for patients that show clinical benefit from treatment |
| IMU-935 - medium dose, administered twice daily | Experimental | Drug: IMU-935main treatment phase of 3 cycles of 28 days; followed by extended treatment cycles for patients that show clinical benefit from treatment |
| IMU-935 - high dose, administered twice daily | Experimental | Drug: IMU-935main treatment phase of 3 cycles of 28 days; followed by extended treatment cycles for patients that show clinical benefit from treatment |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age ≥18 years
- Male patients with histologically or cytologically confirmed adenocarcinoma of the prostate with no evidence of small cell or neuroendocrine features
- Metastatic disease with limited therapeutic options, prior treatment with at least one next-generation hormonal agent (e.g., abiraterone, enzalutamide, apalutamide, darolutamide) and one taxane line of treatment is allowed
- Progressive disease is defined as rising prostate-specific antigen (PSA) levels ≥2ng/mL and/or radiographic progression according to Prostate Cancer Working Group 3 (PCWG3) criteria at screening
- Able and willing to comply with all study requirements for the duration of the study
Key exclusion criteria (7 listed)
- Anti-tumor therapy (chemotherapy, antibody therapy, molecular targeted therapy) within 28 days prior to starting study treatment
- Uncontrolled intercurrent illness such as active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, uncontrolled hypertension, or psychiatric illness/social situations that would limit compliance with the study protocol
- Malignancy within the previous 2 years with a ≥30% probability of recurrence within 12 months, with the exception of non-melanoma skin cancer or superficial bladder cancer
- Patients receiving strong inhibitors or inducers of cytochrome P450 (CYP) 3A4
- Chronic use of systemic steroid therapy (>1 month of >10 mg prednisone per day or equivalent, except replacement therapy)
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 |
|---|---|---|
| IMU-935IMU-935 capsules | Drug | IMU-935 - high dose, administered twice daily, IMU-935 - low dose, administered twice daily, IMU-935 - medium dose, administered twice daily |
Primary outcome
Incidence and the grade (severity) of dose-limiting toxicities (DLTs) within 28 days after start of study treatment to identify the MTD and the RP2D
Time frame: Within 28 days after start of study treatment
DLTs are abnormal laboratory parameters or adverse events (per National Cancer Institute (NCI) - Common Terminology Criteria for Adverse Events V5.0) occurring during the DLT observation period of 28 days from treatment start, assessed as toxicities being related to IMU-935.
Number and severity of adverse events (AEs) reported according to the National Cancer Institute (NCI) - Common Terminology Criteria for Adverse Events (CTCAE) V5.0
Time frame: 6 months
Incidence and severity of adverse events as assessed by CTCAE Version 5.0.
3 secondary outcomes
Proportion of patients considered responders to IMU-935 related to decline in prostate specific antigen (PSA) level
Time frame: 6 months
Proportion of patients considered responders to IMU-935 related to decline in circulating tumor cells (CTC) numbers
Time frame: 6 months
Proportion of patients considered responders to IMU-935 related to the objective response based on the Response Evaluation Criteria in Solid Tumors (RECIST) V 1.1
Time frame: 6 months
Results and safety
The study was stopped early (reason given: Lack of Efficacy). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jan 2024.
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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.
J. B., MD principal investigator
Institute of Cancer Research, United Kingdom
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing IMU-935 in people with Metastatic Castration Resistant Prostate Cancer, run by Immunic AG at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 7 exclusion criteria. 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: stopped early, as of the sponsor's last update on 17 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Lack of Efficacy). Results are not available in the source record.
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?
Incidence and the grade (severity) of dose-limiting toxicities (DLTs) within 28 days after start of study treatment to identify the MTD and the RP2D (time frame: Within 28 days after start of study treatment). 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 Jan 2024.