Prostate Cancer RecurrentPhase 1ProSperACC-1NCT05646550
Antibody CC-1 in Men With Biochemical Recurrence of Prostate Cancer
A Phase 1 study testing CC-1 Infusion in people with Prostate Cancer Recurrent, run by University Hospital Tuebingen at 1 site in Germany.
Trial summary
This trial is a phase I open-label, single center study designed to evaluate the safety, tolerability and preliminary efficacy of the bispecific prostate specific membrane antigen (PSMA) and cluster of differentiation protein 3 (CD3) antibody CC-1 in men with biochemical recurrence (BCR) of prostate cancer (PC). Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Prostate Cancer Recurrent
- What is being tested?
- CC-1 Infusion
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 56 participants
- Where
- 1 siteGermany
- Study dates
- 11 Nov 2022to Dec 2026
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
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
- Written informed consent
- Patient is able to understand and comply with the protocol for the duration of the study including undergoing treatment and scheduled visits and examinations
- Men aged 18 and above
- Earlier histologic diagnosis of prostatic adenocarcinoma
- Low risk of rapid disease progression, defined as:
- PSA-detection Time (DT) > 1 year AND pathological International Society of Urological Pathology (ISUP) grade < 4 for men with prior radical prostatectomy or Interval to biochemical recurrence > 18 months and biopsy ISUP grade < 4 for men with prior radiation therapy
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- Biochemical recurrence (BCR) in compliance with the following 3 conditions:
- after having finished last definitive treatment
- PSA ≥0.2 ng/mL or PSA > nadir + 2 ng/mL (after definitive RT), with two increasing PSA values prior to study treatment
- no distant metastasis upon PSMA- positron emission tomography (PET) imaging
- Eastern Cooperative Oncology Group (ECOG) Performance Status ≤ 1
- Male patients with partners of child-bearing potential, who are sexually active, must agree to the use of one highly effective form of contraception and one barrier method. This should be started from the signing of the informed consent and continue throughout period of taking study treatment and for 4 months after the last dose of study drug
- Adequate bone marrow, renal, and hepatic function defined by laboratory tests within 21 days prior to study treatment:
- Hemoglobin ≥ 9 g/dl (Transfusion of packed red blood cells prior to enrolment allowed)
- Neutrophil count ≥ 1,500/mm3
- Platelet count ≥ 100,000/µl
- Bilirubin ≤ 1.5 x upper limit of normal (ULN)
- alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 2.5 x ULN
- gamma-glutamyl-transferase (γ-GT) ≤ 2.5 x ULN
- prothrombin time (PT) - international normalised ratio (INR) / partial thromboplastin time (PTT) ≤ 1.5 x ULN
- Creatine kinase ≤ 2.5 x ULN
- Serum creatinine ≤ 1.5 mg/dl or creatinine clearance ≥ 60 ml/min
Who cannot join
- PSA >5 ng/ml.
- For men with prior radical prostatectomy:
- PSA-DT < 1 year or
- pathological ISUP grade 4-5
- For men with prior radiation therapy:
- Interval to biochemical recurrence < 18 months or
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- biopsy ISUP grade 4-5
- Other malignancy within the last 2 years except: adequately treated non-melanoma skin cancer and low-grade non-muscle invasive papillary bladder cancer.
- Concurrent or previous treatment within 30 days in another interventional clinical trial with an investigational anticancer therapy
- Patients who are receiving androgen-deprivation therapy.
- Patients who have received prior Androgen Deprivation Therapy (ADT) are not eligible with the exception of those that received ADT ≤ 36 months in duration and ≥9 months before enrolment and administered only in the neoadjuvant/adjuvant setting.
- Castrate level of serum testosterone <50 ng/dL at screening.
- History of HIV infection
- Viral active or chronic hepatitis (HBV or HCV)
- Ongoing autoimmune disease
- Current relevant central nervous system pathology (e.g. seizure, paresis, aphasia, cerebrovascular ischemia/hemorrhage, severe brain injuries, dementia, Parkinson's disease, cerebellar disease, organic brain syndrome, psychosis, coordination or movement disorder)
- Therapeutic anticoagulation
- Non-controlled hypertension, defined as mean blood pressure values in 24-hours blood pressure measurement of >130 mmHg or >90 mmHg for systolic or diastolic, respectively
- Heart failure defined as New York Heart Association (NYHA) III/IV
- Severe obstructive or restrictive ventilation disorder
- Known intolerance to CC-1 or other immunoglobulin drug products as well as hypersensitivity to any of the excipients present in CC-1
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Germany1 site, 1 recruiting
- Recruiting
University Hospital Tuebingen
Tübingen, 72076
Helmut Salih, Prof. Dr., +49(0)707129 ext. 83275, KKETI@med.uni-tuebingen.de
+49(0)707129 ext. 85275, zks-pm@med.uni-tuebingen.de
About this study
Official title: Phase I Study to Evaluate the Safety, Tolerability and Preliminary Efficacy of the Bispecific Antibody CC-1 in Men With Biochemical Recurrence of Prostate Cancer
This trial is a phase I open-label, single center study designed to evaluate the safety, tolerability and preliminary efficacy of the bispecific prostate specific membrane antigen (PSMA) and cluster of differentiation protein 3 (CD3) antibody CC-1 in men with biochemical recurrence (BCR) of prostate cancer (PC). The PSMA binder in CC-1 reacts with tumor cells and also binds to tumor vessels, thereby allowing for a dual mode of anti-cancer action. CC-1 was developed in a novel format, which not only prolongs serum half-life, but most importantly reduces off-target T-cell activation with accordingly reduced side effects. The study entails a part I (dose escalation part) to identify the maximally tolerated dose of CC-1, which then will be further evaluated in part II of the study (dose expansion part). After application of two low doses as safety steps in the first cycle, CC-1 will be applied twice weekly for three consecutive weeks within 4 week cycles as a short-term intravenous infusion (3 hours). The planned trial ultimately shall define the recommended phase II dose (RP2D) of CC-1 in the disease setting of BCR of PC.
- Conditions
- Prostate Cancer Recurrent
- Being tested
- CC-1 Infusion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CC-1 InfusionDrug
Short term (3h) infusion of CC-1
| Study group | Role | What they receive |
|---|---|---|
| Dose Escalation Part | Experimental | In the dose escalation part, up to 7 dose cohorts will be included depending on occurrence of dose-limiting toxicity (DLT). Each dose cohort has a predefined day 3 dose level (DL): cohort 1, 78µg; cohort 2, 110µg; cohort 3, 150µg; cohort 4, 210µg; cohort 5, 300µg; cohort 6, 400µg; cohort 7, 600µg. Each dose cohort will consist of at least three patients evaluable for DLT. Maximum tolerated dose (MTD) is defined on at least six patients Receives: Drug: CC-1 Infusion |
| Dose Expansion Part | Experimental | CC-1 is administered as a 3-hour short-term intravenous infusion started at the MTD dose level identified in the dose escalation part of the study or based on the discretion of the sponsors delegate and DSMB recommendation supported by preliminary safety and efficacy data to constitute a modified MTD, e.g. to be one or more dose levels lower than the MTD determined. Patients can be treated simultaneously during the dose expansion phase. Patients must be hospitalized during step dosing, i.e. from day 1-4 (last dosing on day 3) of the first cycle. Thereafter inpatient treatment (overnight stay) depends on the discretion of the investigator, an outpatient treatment is preferred. Receives: Drug: CC-1 Infusion |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dose escalation part: To define the maximum tolerated dose (MTD) of CC-1 as 3 hours infusion
Data Safety and Monitoring Board (DSMB) and Sponsor meeting about determination of the MTD for each cohort and the dose expansion phase
Measured: during the procedure
Dose expansion part: To define the recommended phase-II dose of CC-1
Data Safety and Monitoring Board and Sponsor meeting about determination of the recommended phase II dose of CC-1 for potential phase II trials.
Measured: up to 1 month after procedure
Secondary outcomes (5)
To evaluate safety and tolerability of CC-1
Number of participants with Adverse Events (AEs) and with abnormal laboratory test results
Measured: during the procedure
To assess efficacy in terms of Prostata-Specific-Antigen (PSA) response and no PSA progression after CC-1 treatment
PSA response will be defined as ≥50% PSA decrease. In addition, "No PSA doubling", defined as PSA measured at visits C1-6, End Of Treatment (EOT), End Of Safety follow up (EOSf) and Follow-up (FU)1-5 divided by PSA measured at baseline, will be assessed as further efficacy endpoint. Furthermore, percentage of patients with no clinical relapse, no salvage and no subsequent antineoplastic therapy will be assessed
Measured: during the procedure and through study completion, an average of 6 months
To assess clinical outcome in terms of progression-free survival, treatment-free survival, overall survival
Overall and progression free survival status as percentage of patients alive at EOSf and each follow-up assessment
Measured: through study completion, an average of 6 months
To assess CC-1 serum concentrations
CC-1 serum concentrations assessed prior to and after start of infusion on each treatment day in the first cycle (each cycle is 28 days).
Measured: during the procedure prior to and after start of infusion on each treatment day in the first cycle (each cycle is 28 days).
To assess quality of life
Quality of life is defined as overall quality of life scores European Organization for Research and Treatment of Cancer (EORTC) quality of life questionnaire (QLQ).
Measured: through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Dec 2022
- Study start11 Nov 2022
- Primary completionDec 2025 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostate Cancer RecurrentStudies of the same condition, open and under way.
- More trials run by University Hospital TuebingenThe sponsor's other registered studies.
- 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
- Other
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 56 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital Tuebingen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Walz, Prof. Dr., Principal investigator, CCU Translational Immunology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05646550
- Sponsor's protocol ID
- ProSperA_CC-1
- Other IDs
- 2022-002420-13, 2024-511430-12-00
- Acronym
- ProSperACC-1
- Status last verified
- May 2024
- First submitted
- 27 Sep 2022
- Last updated
- 16 May 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: No individual participant data (IPD) will be shared with other researchers
Study at a glance
From the registry record, last updated by the sponsor on 16 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I Study to Evaluate the Safety, Tolerability and Preliminary Efficacy of the Bispecific Antibody CC-1 in Men With Biochemical Recurrence of Prostate Cancer
- ClinicalTrials.gov ID
- NCT05646550
- Acronym / sponsor ID
- ProSperACC-1 / ProSperA_CC-1
- Conditions
- Prostate Cancer Recurrent
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 56 participants (estimated)
- Lead sponsor
- University Hospital TuebingenUniversity, hospital or other
- Study start
- 11 Nov 2022 (actual)
- Primary completion
- Dec 2025 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 12 Dec 2022 (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.
This trial is a phase I open-label, single center study designed to evaluate the safety, tolerability and preliminary efficacy of the bispecific prostate specific membrane antigen (PSMA) and cluster of differentiation protein 3 (CD3) antibody CC-1 in men with biochemical recurrence (BCR) of prostate cancer (PC). The PSMA binder in CC-1 reacts with tumor cells and also binds to tumor vessels, thereby allowing for a dual mode of anti-cancer action. CC-1 was developed in a novel format, which not only prolongs serum half-life, but most importantly reduces off-target T-cell activation with accordingly reduced side effects. The study entails a part I (dose escalation part) to identify the maximally tolerated dose of CC-1, which then will be further evaluated in part II of the study (dose expansion part). After application of two low doses as safety steps in the first cycle, CC-1 will be applied twice weekly for three consecutive weeks within 4 week cycles as a short-term intravenous infusion (3 hours). The planned trial ultimately shall define the recommended phase II dose (RP2D) of CC-1 in the disease setting of BCR of PC.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dose Escalation Part | Experimental | Drug: CC-1 InfusionIn the dose escalation part, up to 7 dose cohorts will be included depending on occurrence of dose-limiting toxicity (DLT). Each dose cohort has a predefined day 3 dose level (DL): cohort 1, 78µg; cohort 2, 110µg; cohort 3, 150µg; cohort 4, 210µg; cohort 5, 300µg; cohort 6, 400µg; cohort 7, 600µg. Each dose cohort will consist of at least three patients evaluable for DLT. Maximum tolerated dose (MTD) is defined on at least six patients |
| Dose Expansion Part | Experimental | Drug: CC-1 InfusionCC-1 is administered as a 3-hour short-term intravenous infusion started at the MTD dose level identified in the dose escalation part of the study or based on the discretion of the sponsors delegate and DSMB recommendation supported by preliminary safety and efficacy data to constitute a modified MTD, e.g. to be one or more dose levels lower than the MTD determined. Patients can be treated simultaneously during the dose expansion phase. Patients must be hospitalized during step dosing, i.e. from day 1-4 (last dosing on day 3) of the first cycle. Thereafter inpatient treatment (overnight stay) depends on the discretion of the investigator, an outpatient treatment is preferred. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (22 listed)
- Written informed consent
- Patient is able to understand and comply with the protocol for the duration of the study including undergoing treatment and scheduled visits and examinations
- Men aged 18 and above
- Earlier histologic diagnosis of prostatic adenocarcinoma
- Low risk of rapid disease progression, defined as:
Key exclusion criteria (21 listed)
- PSA >5 ng/ml.
- For men with prior radical prostatectomy:
- For men with prior radiation therapy:
- Other malignancy within the last 2 years except: adequately treated non-melanoma skin cancer and low-grade non-muscle invasive papillary bladder cancer.
- Concurrent or previous treatment within 30 days in another interventional clinical trial with an investigational anticancer 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 |
|---|---|---|
| CC-1 InfusionShort term (3h) infusion of CC-1 | Drug | Dose Escalation Part, Dose Expansion Part |
Primary outcome
Dose escalation part: To define the maximum tolerated dose (MTD) of CC-1 as 3 hours infusion
Time frame: during the procedure
Data Safety and Monitoring Board (DSMB) and Sponsor meeting about determination of the MTD for each cohort and the dose expansion phase
Dose expansion part: To define the recommended phase-II dose of CC-1
Time frame: up to 1 month after procedure
Data Safety and Monitoring Board and Sponsor meeting about determination of the recommended phase II dose of CC-1 for potential phase II trials.
5 secondary outcomes
To evaluate safety and tolerability of CC-1
Time frame: during the procedure
To assess efficacy in terms of Prostata-Specific-Antigen (PSA) response and no PSA progression after CC-1 treatment
Time frame: during the procedure and through study completion, an average of 6 months
To assess clinical outcome in terms of progression-free survival, treatment-free survival, overall survival
Time frame: through study completion, an average of 6 months
To assess CC-1 serum concentrations
Time frame: during the procedure prior to and after start of infusion on each treatment day in the first cycle (each cycle is 28 days).
To assess quality of life
Time frame: through study completion, an average of 1 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 May 2024.
- Individual participant dataSharing planned: No. No individual participant data (IPD) will be shared with other researchers
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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.
Walz, Prof. Dr. principal investigator
CCU Translational Immunology
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 CC-1 Infusion in people with Prostate Cancer Recurrent, run by University Hospital Tuebingen at 1 site in Germany.
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 22 inclusion and 21 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: looking for participants now, as of the sponsor's last update on 16 May 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 Germany. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Walz (+49(0)707129 ext. 83275, kketi@med.uni-tuebingen.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dose escalation part: To define the maximum tolerated dose (MTD) of CC-1 as 3 hours infusion (time frame: during the procedure). 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 16 May 2024.