Prostate CancerPhase 2ImmProCureNCT07860047
Multi-peptide Vaccination and Bispecific PSMAxCD3 Antibody Treatment in Patients With Prostate Cancer
A Phase 2 study testing PSMAxCD3, bispecific antibody CC-1 and Multipeptide Vaccine VAC-XS15-PC01 in people with Prostate Cancer, run by University Hospital Tuebingen at 4 sites in Germany.
Trial summary
This trial is a phase II, randomized, open label study designed to evaluate safety, tolerability and efficacy of CC-1, a bispecific antibody (bsAb) with PSMAxCD3 specificity, and of VACXS15-PC01, a prostate cancer (PC)-specific multi-peptide vaccine, both administered as single agent or in combination to patients… Read more about this study
- Who is it for?
- Ages 18 to 80 years, men only
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- PSMAxCD3, bispecific antibody CC-1 and Multipeptide Vaccine VAC-XS15-PC01
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 84 participants
- Where
- 4 sitesGermany
- Study dates
- 24 Sep 2026to 31 Mar 2030
- Phase
- Phase 2
- 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 to 80 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Understand and voluntarily sign an IC document prior to any study related assessments/procedures
- Understand and voluntarily sign an IC document prior to any study related assessments/procedures
- Patient is able to understand and comply with the protocol for the duration of the study including treatment and scheduled visits and examinations
- Men aged ≥ 18 and ≤80 years
- Histologic diagnosis of prostatic adenocarcinoma
- Biochemical recurrence (BCR): PSA recurrence after treatment with curative intent; PSA ≥0.2 ng/mL or PSA > nadir + 2 ng/mL (after definitive RT), with two increasing PSA values prior to study treatment; AND no distant metastasis upon PSMA-PET imaging
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- Patients are ineligible to receive available treatment alternatives
- Low risk of rapid disease progression, defined as:
- o PSA-DT > 1 year AND pathological ISUP grade < 4 for men with prior RP OR Interval to BCR > 18 months AND biopsy ISUP grade < 4 for men with prior radiation therapy
- In case of second relapse PSA-DT > 9 months
- Eastern Cooperative Oncology Group (ECOG) performance status ≤1
Who cannot join
- • PSA >5 ng/mL (at screening)
- Patients who are receiving or have previously received androgen deprivation treatment.
- Except testosterone has recovered to normal levels: patients who have previously received anti-hormonal treatment testosterone must be >12 nmol/l.
- Patients who are planned to or are undergoing salvage therapy (e.g. radiation)
- Clinically significant xerostomia (dry mouth >1grade according to CTCAE v6.0)
- Untreated current or prior distant metastasis of PC
Show all 20Show fewer
- Other malignancy within the last 2 years except: adequately treated non-melanoma skin cancer and non-muscle invasive bladder cancer.
- Concurrent or previous treatment within 30 days in another interventional clinical trial with an investigational anti-cancer therapy
- Clinical signs of active infection (> grade 2 according to CTCAE v6.0)
- History of HIV infection
- Viral active or chronic hepatitis (HBV or HCV)
- Autoimmune disease that requires or has required treatment with systemic immunosuppressive treatments, except low dose corticosteroids (< 10 mg/ day), in the past 1 year
- Ongoing relevant CNS pathology (e.g. seizure, paresis, aphasia, cerebrovascular ischemia, severe brain injuries, dementia, Parkinson's disease, cerebellar disease, organic brain syndrome, psychosis, coordination or movement disorder)
- Epilepsy requiring pharmacologic treatment
- Major surgery within 4 weeks of starting study treatment. Patients must have recovered from any effects of major surgery.
- Heart failure 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 the respective drug products (CC-1, VAC-XS15-PC01)
- Refrain from blood donation during the course of the study
- Male patients have to refrain from sperm donations for 6 months after last IMP
Trial locations and contacts
4 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Germany4 sites, 4 recruiting
- Not yet recruiting
Charité - Universitätsmedizin Berlin, Campus Benjamin Franklin - Studienzentrale Onkologie
Berlin, Beriln, 12203
Sebastian Ochsenreither, Prof. Dr., +49 30 450 613 483, kketi@med.uni-tuebingen.de
- Not yet recruiting
Universitätsklinikum Essen, Abteilung Urologie
Essen, North Rhine-Westphalia, 45147
Darr Christopher, Dr. med., +49 (0)201 723-3210, kketi@med.uni-tuebingen.de
- Not yet recruiting
NCT Studienzentrale; Nationales Centrum für Tumorerkrankungen (NCT) Heidelberg
Heidelberg, Baden-Wurttemberg, 69120
Stefanie Zschaebitz, Dr. med., +49 (0)6221-56-35950, kketi@med.uni-tuebingen.de
- Recruiting
CCU Transltional Immunolgy, University Hospital Tübingen
Tübingen, Baden-Wurttemberg, 72076
Susanne Jung, Dr. med., +49 (0)7071-29 83275, kketi@med.uni-tuebingen.de
About this study
Official title: Randomized Phase II Study of Multi-peptide Vaccination and Bispecific PSMAxCD3 Antibody Treatment in Patients With Biochemical Relapse of Prostate Cancer
This trial is a phase II, randomized, open label study designed to evaluate safety, tolerability and efficacy of CC-1, a bispecific antibody (bsAb) with PSMAxCD3 specificity, and of VACXS15-PC01, a prostate cancer (PC)-specific multi-peptide vaccine, both administered as single agent or in combination to patients affected with biochemical recurrence (BCR) of PC after local therapy with curative intent. Patients will not receive other treatments during trial participation.
Read the detailed description
CC-1 contains a PSMA binder with particular reactivity in PC 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 expected fewer side effects. The multi-peptide vaccine VAC-XS15-PC01 is composed of 10 HLA-restricted antigens, comprising immunopeptidome-defined PC-associated epitopes, adjuvanted with the TLR1/2 ligand XS15 emulsified in Montanide ISA 51 VG.
The study entails three-arms: (1) the multi-peptide vaccine VAC-XS15-PC01 alone, (2) PSMAxCD3 bispecific antibody CC-1 alone and (3) combinatorial treatment of CC-1 and VAC-XS15-PC01. Up to 84 patients are recruited (n = up to 28 per arm) and patients are randomly assigned 1:1:1 (drop-out rate of 15% anticipated). A translational research program comprising, among others, a strict evaluation of prostate specific antigen (PSA) course integrated with analysis of CC-1 induced immune response and immunogenicity of VAC-XS15-PC01 serves to detect early signs of efficacy. Furthermore, safety of the investigational medical products is evaluated, and tolerability of their combination are assessed.
- Conditions
- Prostate Cancer
- Being tested
- PSMAxCD3, bispecific antibody CC-1, Multipeptide Vaccine VAC-XS15-PC01
- Keywords
- biochemical recurrence of prostate cancer
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PSMAxCD3, bispecific antibody CC-1Drug
CC-1 is applied subcutaneously once per week for 12 weeks in Arm 2. Due to priming doses up to 14 applications are planned.
Multipeptide Vaccine VAC-XS15-PC01Drug
The vaccine VAC-XS15-PC01 consists of 300 µg of each of 10 PC-associated peptides. The vaccine cocktail (final volume 500 µL) will be administered subcutaneously (SC), adjuvanted with the TLR1/2 ligand XS15 (50 µg) and emulsified in Montanide ISA 51 VG at a 1:1 ratio. A total of three vaccinations are planned in Arm 1, administered 4 weeks apart from each other.
| Study group | Role | What they receive |
|---|---|---|
| Multi-peptide vaccine VAC-XS15-PC01 | Active comparator | The vaccine VAC-XS15-PC01 consists of 300 µg of each of 10 PC-associated peptides. The vaccine cocktail (final volume 500 µL) will be administered subcutaneously (SC), adjuvanted with the TLR1/2 ligand XS15 (50 µg) and emulsified in Montanide ISA 51 VG at a 1:1 ratio. A total of three vaccinations are planned in Arm 1, administered 4 weeks apart from each other. Receives: Drug: Multipeptide Vaccine VAC-XS15-PC01 |
| PSMAxCD3 bispecific antibody CC-1 | Active comparator | CC-1 is applied subcutaneously once per week for 12 weeks in Arm 2. Due to priming doses up to 14 applications are planned. Receives: Drug: PSMAxCD3, bispecific antibody CC-1 |
| PSMAxCD3 bispecific antibody CC-1 + Multi-peptide vaccine VAC-XS15-PC01 | Experimental | The vaccine VAC-XS15-PC01 consists of 300 µg of each of 10 PC-associated peptides. The vaccine cocktail (final volume 500 µL) will be administered subcutaneously (SC), adjuvanted with the TLR1/2 ligand XS15 (50 µg) and emulsified in Montanide ISA 51 VG at a 1:1 ratio. A total of three vaccinations are planned in Arm 3, administered 4 weeks apart from each other.
CC-1 is applied subcutaneously once per week for 12 weeks in Arm 3. Due to priming doses up to 14 applications are planned. Receives: Drug: PSMAxCD3, bispecific antibody CC-1; Drug: Multipeptide Vaccine VAC-XS15-PC01 |
What is being measured
The primary outcome is the main question the study is designed to answer.
PSA response defined as ≥50% reduction in PSA at FU1 compared to baseline.
PSA serum levels [ng/ml] are determined during screening, before every treatment, and then every 30 days until end of follow up. PSA serum levels for one study patient should be locally assessed in the same lab during the whole study treatment. Furthermore, 5ml serum are taken and should be processed locally and stored at -80 °C at the study site. Tübingen for central assessment of PSA.
Measured: Screening: 21 days before Cycle (C1);C1: Day (D) -1, D0 to D3, D8, D15, and D22; C2-3: D1, D8, D15, and D22 (each cycle is 22 days); End of Treatment (EOT): D29 of C3; Follow-Up 1-5: every 30 days after the EOT; End of study (EOS): 12 months after EOT
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Oct 2026
- Study start24 Sep 2026 (estimated)
- Primary completion31 Mar 2029 (estimated)
- Study completion31 Mar 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostate CancerStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The study entails three-arms: (1) the multi-peptide vaccine VAC-XS15-PC01 alone, (2) PSMAxCD3 bispecific antibody CC-1 alone and (3) combinatorial treatment of CC-1 and VAC-XS15-PC01. Up to 84 patients are recruited (n = up to 28 per arm) and patients are randomly assigned 1:1:1 (drop-out rate of 15% anticipated). A translational research program comprising, among others, a strict evaluation of prostate specific antigen (PSA) course integrated with analysis of CC-1 induced immune response and immunogenicity of VAC-XS15-PC01 serves to detect early signs of efficacy. Furthermore, safety of the investigational medical products is evaluated, and tolerability of their combination are assessed.
- Masking
- None (open label)
- Enrolment
- 84 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital Tuebingen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07860047
- Sponsor's protocol ID
- ImmProCure
- Other IDs
- 2025-522144-41-00, 2025
- Acronym
- ImmProCure
- Status last verified
- Oct 2026
- First submitted
- 24 Sep 2026
- Last updated
- 6 Oct 2026
- 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 6 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Phase II Study of Multi-peptide Vaccination and Bispecific PSMAxCD3 Antibody Treatment in Patients With Biochemical Relapse of Prostate Cancer
- ClinicalTrials.gov ID
- NCT07860047
- Acronym / sponsor ID
- ImmProCure / ImmProCure
- Conditions
- Prostate Cancer
- Keywords
- biochemical recurrence of prostate cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 84 participants (estimated)
- Lead sponsor
- University Hospital TuebingenUniversity, hospital or other
- Study start
- 24 Sep 2026 (estimated)
- Primary completion
- 31 Mar 2029 (estimated)
- Study completion
- 31 Mar 2030 (estimated)
- First posted
- 6 Oct 2026 (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 II, randomized, open label study designed to evaluate safety, tolerability and efficacy of CC-1, a bispecific antibody (bsAb) with PSMAxCD3 specificity, and of VACXS15-PC01, a prostate cancer (PC)-specific multi-peptide vaccine, both administered as single agent or in combination to patients affected with biochemical recurrence (BCR) of PC after local therapy with curative intent. Patients will not receive other treatments during trial participation.
Detailed description
CC-1 contains a PSMA binder with particular reactivity in PC 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 expected fewer side effects. The multi-peptide vaccine VAC-XS15-PC01 is composed of 10 HLA-restricted antigens, comprising immunopeptidome-defined PC-associated epitopes, adjuvanted with the TLR1/2 ligand XS15 emulsified in Montanide ISA 51 VG.
The study entails three-arms: (1) the multi-peptide vaccine VAC-XS15-PC01 alone, (2) PSMAxCD3 bispecific antibody CC-1 alone and (3) combinatorial treatment of CC-1 and VAC-XS15-PC01. Up to 84 patients are recruited (n = up to 28 per arm) and patients are randomly assigned 1:1:1 (drop-out rate of 15% anticipated). A translational research program comprising, among others, a strict evaluation of prostate specific antigen (PSA) course integrated with analysis of CC-1 induced immune response and immunogenicity of VAC-XS15-PC01 serves to detect early signs of efficacy. Furthermore, safety of the investigational medical products is evaluated, and tolerability of their combination are assessed.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- The study entails three-arms: (1) the multi-peptide vaccine VAC-XS15-PC01 alone, (2) PSMAxCD3 bispecific antibody CC-1 alone and (3) combinatorial treatment of CC-1 and VAC-XS15-PC01. Up to 84 patients are recruited (n = up to 28 per arm) and patients are randomly assigned 1:1:1 (drop-out rate of 15% anticipated). A translational research program comprising, among others, a strict evaluation of prostate specific antigen (PSA) course integrated with analysis of CC-1 induced immune response and immunogenicity of VAC-XS15-PC01 serves to detect early signs of efficacy. Furthermore, safety of the investigational medical products is evaluated, and tolerability of their combination are assessed.
| Arm | Type | Receives |
|---|---|---|
| Multi-peptide vaccine VAC-XS15-PC01 | Active comparator | Drug: Multipeptide Vaccine VAC-XS15-PC01The vaccine VAC-XS15-PC01 consists of 300 µg of each of 10 PC-associated peptides. The vaccine cocktail (final volume 500 µL) will be administered subcutaneously (SC), adjuvanted with the TLR1/2 ligand XS15 (50 µg) and emulsified in Montanide ISA 51 VG at a 1:1 ratio. A total of three vaccinations are planned in Arm 1, administered 4 weeks apart from each other. |
| PSMAxCD3 bispecific antibody CC-1 | Active comparator | Drug: PSMAxCD3, bispecific antibody CC-1CC-1 is applied subcutaneously once per week for 12 weeks in Arm 2. Due to priming doses up to 14 applications are planned. |
| PSMAxCD3 bispecific antibody CC-1 + Multi-peptide vaccine VAC-XS15-PC01 | Experimental | Drug: PSMAxCD3, bispecific antibody CC-1, Drug: Multipeptide Vaccine VAC-XS15-PC01The vaccine VAC-XS15-PC01 consists of 300 µg of each of 10 PC-associated peptides. The vaccine cocktail (final volume 500 µL) will be administered subcutaneously (SC), adjuvanted with the TLR1/2 ligand XS15 (50 µg) and emulsified in Montanide ISA 51 VG at a 1:1 ratio. A total of three vaccinations are planned in Arm 3, administered 4 weeks apart from each other. CC-1 is applied subcutaneously once per week for 12 weeks in Arm 3. Due to priming doses up to 14 applications are planned. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Understand and voluntarily sign an IC document prior to any study related assessments/procedures
- o PSA-DT > 1 year AND pathological ISUP grade < 4 for men with prior RP OR Interval to BCR > 18 months AND biopsy ISUP grade < 4 for men with prior radiation therapy
Key exclusion criteria (20 listed)
- • PSA >5 ng/mL (at screening)
- Except testosterone has recovered to normal levels: patients who have previously received anti-hormonal treatment testosterone must be >12 nmol/l.
- Patients who are planned to or are undergoing salvage therapy (e.g. radiation)
- Clinically significant xerostomia (dry mouth >1grade according to CTCAE v6.0)
- Untreated current or prior distant metastasis of PC
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 |
|---|---|---|
| PSMAxCD3, bispecific antibody CC-1CC-1 is applied subcutaneously once per week for 12 weeks in Arm 2. Due to priming doses up to 14 applications are planned. | Drug | PSMAxCD3 bispecific antibody CC-1, PSMAxCD3 bispecific antibody CC-1 + Multi-peptide vaccine VAC-XS15-PC01 |
| Multipeptide Vaccine VAC-XS15-PC01The vaccine VAC-XS15-PC01 consists of 300 µg of each of 10 PC-associated peptides. The vaccine cocktail (final volume 500 µL) will be administered subcutaneously (SC), adjuvanted with the TLR1/2 ligand XS15 (50 µg) and emulsified in Montanide ISA 51 VG at a 1:1 ratio. A total of three vaccinations are planned in Arm 1, administered 4 weeks apart from each other. | Drug | Multi-peptide vaccine VAC-XS15-PC01, PSMAxCD3 bispecific antibody CC-1 + Multi-peptide vaccine VAC-XS15-PC01 |
Primary outcome
PSA response defined as ≥50% reduction in PSA at FU1 compared to baseline.
Time frame: Screening: 21 days before Cycle (C1);C1: Day (D) -1, D0 to D3, D8, D15, and D22; C2-3: D1, D8, D15, and D22 (each cycle is 22 days); End of Treatment (EOT): D29 of C3; Follow-Up 1-5: every 30 days after the EOT; End of study (EOS): 12 months after EOT
PSA serum levels [ng/ml] are determined during screening, before every treatment, and then every 30 days until end of follow up. PSA serum levels for one study patient should be locally assessed in the same lab during the whole study treatment. Furthermore, 5ml serum are taken and should be processed locally and stored at -80 °C at the study site. Tübingen for central assessment of PSA.
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 6 Oct 2026.
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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.
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing PSMAxCD3, bispecific antibody CC-1 and Multipeptide Vaccine VAC-XS15-PC01 in people with Prostate Cancer, run by University Hospital Tuebingen at 4 sites 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 11 inclusion and 20 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 6 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites 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 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?
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 Susanne Jung, Dr. med. (+49 (0)7071-29 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?
PSA response defined as ≥50% reduction in PSA at FU1 compared to baseline. (time frame: Screening: 21 days before Cycle (C1);C1: Day (D) -1, D0 to D3, D8, D15, and D22; C2-3: D1, D8, D15, and D22 (each cycle is 22 days); End of Treatment (EOT): D29 of C3; Follow-Up 1-5: every 30 days after the EOT; End of study (EOS): 12 months after EOT). 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 6 Oct 2026.