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Prostatic NeoplasmsPhase 1/2COMBATNCT05633160

64Cu-SAR-BBN and 67CU SAR-BBN for Identification and Treatment of Gastrin Releasing Peptide Receptor (GRPR)-Expressing Metastatic Castrate Resistant Prostate Cancer in Patients Who Are Ineligible for Therapy With 177Lu-PSMA-617 (COMBAT)

A Phase 1/2 study testing 64Cu-SAR-BBN and 67Cu-SAR-BBN in people with Prostatic Neoplasms and Castration-Resistant, run by Clarity Pharmaceuticals Ltd at 6 sites in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

The aim for this study is to determine the safety and efficacy of 67Cu-SAR-BBN in participants with Gastrin Releasing Peptide Receptor (GRPR)-expressing metastatic castrate resistant prostate cancer in patients who are ineligible for therapy with 177Lu-PSMA-617. Read more about this study

Who is it for?
Ages 18 years and older, men only
Conditions the study is for
Prostatic Neoplasms, Castration-Resistant
What is being tested?
64Cu-SAR-BBN and 67Cu-SAR-BBN
Could I receive a placebo?
No, everyone receives an active treatment
How many people
4 participants
Where
6 sitesUnited States
Study dates
15 Jun 2023to 23 Apr 2025
Phase
Phase 1/2
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

  • Signed informed consent;
  • ≥18 years of age;
  • Eastern Cooperative Oncology Group performance status of 0 to 2;
  • Life expectancy >6 months;
  • Histological, pathological, and/or cytological confirmation of prostate cancer (PCa);
  • ≥1 metastatic lesion that is present at screening computed tomography (CT), magnetic resonance imaging (MRI), or bone scan imaging obtained ≤28 days prior to enrollment into the study;
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  • Positive 64Cu-SAR-BBN PET/CT scan, where 64Cu-SAR-BBN uptake (standardized uptake value [SUV] max) of at least 1 known lesion is positive (higher than that of the liver). Any lesions on anatomical imaging larger in short axis than size as follows: organs ≥ 1 cm, lymph nodes ≥ 2.5 cm, bones (soft tissue component) ≥ 1 cm on the 1 hour positron emission tomography (PET)/ CT scan must also be positive for 64Cu-SAR-BBN uptake. NOTE: ALL OTHER ELIGIBILITY CRITERIA MUST BE FULFILLED BEFORE THE 64Cu-SAR-BBN ADMINISTRATION IS PERMITTED;
  • Castrate level of serum/plasma testosterone (<50 ng/dL or <1.7 nmol/L);
  • Have progressive mCRPC despite prior androgen deprivation therapy and at least either enzalutamide and/or abiraterone (or other such androgen receptor pathway inhibitors). Documented progressive mCRPC will be based on at least 1 of the following criteria:
  • Serum/plasma prostate specific antigen (PSA) progression defined as 2 consecutive increases in PSA over a previous reference value measured at least 1 week prior. The minimal value for study enrollment is 2.0 ng/mL;
  • Soft-tissue progression defined as a ≥20% increase in the sum of the diameter (SOD) (short axis for nodal lesions and long axis for non-nodal lesions) of all target lesions based on the smallest SOD since the last treatment directed at the metastatic cancer has started (not including hormonal therapy) or the appearance of 1 or more new lesions;
  • Progression of bone disease: evaluable disease or new bone lesions(s) by bone scan.
  • Participants must be ineligible for 177Lu-PSMA based therapy due to either of the following criterion:
  • Participant is not a candidate for 177Lu-PSMA-based therapy in the opinion of the investigator, due to PET/CT characteristics predicting a poor response to therapy.
  • Participant experienced disease progression or lack of response (post- or while on- 177Lu-PSMA-based therapy), as determined by clinical or radiological assessment.
  • Participants must have recovered to ≤ Grade 2 from all clinically significant toxicities related to prior therapies (prior chemotherapy, radiation, immunotherapy, etc.);
  • Participants must have adequate organ function:
  • Bone marrow reserve:
  • White blood cell (WBC) count ≥2.5 x 109/L (2.5 x 109/L is equivalent to 2.5 x 103/μL and 2.5 x K/μL and 2.5 x 103/cc and 2500/μL) OR
  • Absolute neutrophil count (ANC) ≥1.5 x 109/L (1.5 x 109/L is equivalent to 1.5 x 103/μL and 1.5 x K/μL and 1.5 x 103/cc and 1500/μL);
  • Platelets ≥100 x 109/L (100 x 109/L is equivalent to 100 x 103/μL and 100 x K/μL and 100 x 103/cc and 100,000/μL);
  • Hemoglobin ≥9 g/dL (5.59 mmol/L);
  • Total bilirubin ≤1.5 x the institutional upper limit of normal (ULN). For participants with known Gilbert's Syndrome ≤3 x ULN is permitted;
  • Alanine aminotransferase or aspartate aminotransferase ≤3.0 x ULN OR ≤5.0 x ULN for participants with liver metastases;
  • Estimated glomerular filtration rate (eGFR) ≥50 mL/min.
  • For participants who are human immunodeficiency virus infected: Participant must be healthy and have a low risk of Acquired Immune Deficiency Syndrome related outcomes in the opinion of the Investigator;
  • For participants who have partners of childbearing potential: Partner and/or participant must use a method of birth control with adequate barrier protection (as described in Section 5.4.3.1).

Who cannot join

  • Major surgery within 12 weeks prior to enrollment into the study;
  • Symptomatic brain metastasis;
  • Histologic diagnosis that is predominantly small cell PCa;
  • Prior history of leukemia or Myelodysplastic Syndrome;
  • Diagnosis of Deep Vein Thrombosis or Pulmonary Embolism within 4 weeks prior to enrollment into the study;
  • Unmanageable urinary tract obstruction;
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  • Evidence of progressive lesion(s) on MRI and/or CT (according to Response Evaluation Criteria in Solid Tumors V1.1) that is gastrin releasing peptide receptor (GRPR) negative on the 1 hour 64Cu-SAR-BBN PET/CT scan as determined at screening;
  • Previous treatment with a systemic radionuclide, including:
  • Strontium-89, Samarium-153, Rhenium-186, Rhenium-188, Actinium-225, Iodine-131 within 6 months or in case of Radium-223 within 3 months or in the case of 177Lu-PSMA-based therapy within 6 weeks of treatment initiation (Day 0), as long as the participant meets all safety eligibility criteria, and the nadir of toxicities has been reached, without prior approval of the medical monitor;
  • Previous treatment with any systemic anti-cancer therapy (e.g., chemotherapy, immunotherapy or biological therapy [including monoclonal antibodies]) within 4 weeks prior to treatment on study with the exception of Luteinizing Hormone Releasing Hormone, any other androgen deprivation therapy (ADT) (if ADT is discontinued prior to enrolment, 14 days must elapse after abiraterone discontinuation and 28 days after enzalutamide before the participant can be enrolled) or low dose corticosteroids;
  • Previous treatment with any investigational agents within 4 weeks prior enrollment into the study;
  • Known hypersensitivity to the components of the investigational products or its analogues;
  • Transfusion for the sole purpose of making a participant eligible for study inclusion;
  • Spinal metastasis with symptomatic cord compression, or clinical or radiologic findings indicative of impending cord compression;
  • Concurrent serious medical conditions, including, but not limited to, New York Heart Association class III or IV congestive heart failure, history of congenital prolonged QT syndrome, uncontrolled infection, known active hepatitis B or C, or other significant co-morbid conditions that in the opinion of the Investigator would impair study participation or cooperation;
  • Diagnosed with other malignancies that are expected to alter life expectancy or may interfere with disease assessment. However, participants with a prior history of malignancy that has been adequately treated and who have been disease free for more than 3 years are eligible, as are participants with adequately treated non-melanoma skin cancer, superficial bladder cancer;
  • Any condition or personal situation that would pose an unacceptable radiation safety risk (as per institution guidelines, state and/or national regulations) to the participant or care giver at the time of release following the completion of therapy (e.g., uncontrolled urinary incontinence, high dependency care);
  • Participants in whom it is known that external beam radiotherapy is scheduled after enrollment into the study;
  • Participants with QTc > 470 msec;
  • Participants with persistent acute and/or chronic pancreatitis.

Trial locations and contacts

6 sites in 1 country.

6 sites in 1 country

United States6 sites

  • Duke University

    Durham, North Carolina, 27710

  • BAMF Health, Inc

    Grand Rapids, Michigan, 49503

  • M D Anderson Cancer Centre

    Houston, Texas, 77030

  • Biogenix Molecular

    Miami, Florida, 33165

  • XCancer Omaha LLC

    Omaha, Nebraska, 68130

  • Stanford University

    Stanford, California, 94305

Other trials in United States

About this study

Official title: A Phase I/IIa Theranostic Study of 64Cu-SAR-BBN and 67Cu-SAR-BBN for Identification and Treatment of GRPR-expressing Metastatic Castrate Resistant Prostate Cancer in Patients Who Are Ineligible for Therapy With 177Lu-PSMA-617

The aim for this study is to determine the safety and efficacy of 67Cu-SAR-BBN in participants with Gastrin Releasing Peptide Receptor (GRPR)-expressing metastatic castrate resistant prostate cancer in patients who are ineligible for therapy with 177Lu-PSMA-617.

Being tested
64Cu-SAR-BBN, 67Cu-SAR-BBN
Medical subject headings
Prostatic Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 64Cu-SAR-BBNDrug

    64Cu-SAR-BBN

  • 67Cu-SAR-BBNDrug

    67Cu-SAR-BBN

Study groups in NCT05633160
Study groupRoleWhat they receive
67Cu-SAR-BBNExperimentalIn the dose escalation phase: 64Cu-SAR-BBN: Patients will receive up to 2 administrations of 200MBq 67Cu-SAR-BBN: Cohorts 1 - 3: Single administration (dose will be determined based on cohort allocation). Cohort 4: 2 administrations at the recommended dose (determined by cohorts 1-3). In the cohort expansion phase: Patients will receive up to 3 administrations of 200MBq of 64Cu-SAR-BBN and 2 administrations at the recommended dose level of 67Cu-SAR-BBN, determined through the dose escalation. Additional administrations: (up to a maximum total of 4) may be offered to those participants, in either the dose escalation or cohort expansion, with radiological non-progression.
Receives: Drug: 64Cu-SAR-BBN; Drug: 67Cu-SAR-BBN

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Maximum tolerated dose (MTD) or maximum feasible dose (MFD) of a single dose of 67Cu-SAR-BBN

    MTD as determined by cohort observations of dose limiting toxicities or MFD determined by the activity of the dose to be administered, when the MTD has not been reached.

    Measured: Up to 8 weeks

  2. Recommended dose of two doses of 67Cu-SAR-BBN

    Recommended dose as determined by cohort observations of dose limiting toxicities

    Measured: Up to 14 weeks

  3. Efficacy of 67Cu-SAR-BBN in terms of Prostate Specific Antigen (PSA) response

    Proportion of participants with ≥50% decline in PSA

    Measured: Up to 5 years

  4. Efficacy of 67Cu-SAR-BBN in terms of radiographic response

    Efficacy will be assessed via the overall response rate according to RECIST V1.1 for soft tissue disease and according to PCWG3 for bone lesions

    Measured: Up to 5 years

  5. Incidence of dose limiting toxicities [Safety and tolerability] of 67Cu-SAR-BBN

    Incidence of dose limiting toxicities following a single administration of 67Cu-SAR-BBN

    Measured: Up to 8 weeks

  6. Incidence of dose limiting toxicities [Safety and tolerability] of 67Cu-SAR-BBN

    Incidence of dose limiting toxicities following repeated administrations of 67Cu-SAR-BBN

    Measured: Up to 14 weeks

  7. Incidence of 67Cu-SAR-BBN treatment-emergent adverse events [Safety and tolerability]

    Adverse Events will be assessed by Common Terminology Criteria for Adverse Events (CTCAE) Version 5, following single or repeated administrations of 67Cu-SAR-BBN

    Measured: Up to 12 months

  8. Incidence of 67Cu-SAR-BBN adverse event of special interest [Safety and tolerability]

    Protocol defined adverse event of special interest following single or repeated administrations of 67Cu-SAR-BBN

    Measured: Up to 5 years

  9. Safety and tolerability of 67Cu-SAR-BBN: Number of Participants with changes from baseline in vital signs

    Change from baseline in vital signs following single or repeated administrations of 67Cu-SAR-BBN

    Measured: Up to 24 weeks

  10. Safety and tolerability of 67Cu-SAR-BBN: Number of Participants with changes from baseline in electrocardiogram (ECG) parameters

    Change from baseline in ECG parameters following single or repeated administrations 67Cu-SAR-BBN

    Measured: Up to 24 weeks

  11. Safety and tolerability of 67Cu-SAR-BBN: Number of Participants with changes from baseline in laboratory results

    Change from baseline in laboratory results following single or repeated administrations 67Cu-SAR-BBN

    Measured: Up to 52 weeks

  12. Incidence of 64Cu-SAR-BBN treatment-emergent adverse events [Safety and tolerability]

    Adverse Events will be assessed by Common Terminology Criteria for Adverse Events (CTCAE) Version 5, following single or repeated administrations of 64Cu-SAR-BBN

    Measured: Up to 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 Dec 2022
  2. Study start15 Jun 2023
  3. Primary completion23 Apr 2025
  4. Study completion23 Apr 2025

Why it stopped: Sponsor Decision

Resources

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 1/2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Model description
This study is to be conducted in 2 phases, a dose escalation phase and a cohort expansion phase
Masking
None (open label)
Enrolment
4 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05633160
Sponsor's protocol ID
CLB05
Acronym
COMBAT
Status last verified
Aug 2025
First submitted
21 Nov 2022
Last updated
29 Aug 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Publications

  • Taunk NK, Escorcia FE, Lewis JS, Bodei L. Radiopharmaceuticals for Cancer Diagnosis and Therapy: New Targets, New Therapies-Alpha-Emitters, Novel Targets. Cancer J. 2024 May-Jun 01;30(3):218-223. doi: 10.1097/PPO.0000000000000720.

    PubMed 38753757

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing 64Cu-SAR-BBN and 67Cu-SAR-BBN in people with Prostatic Neoplasms and Castration-Resistant, run by Clarity Pharmaceuticals Ltd at 6 sites in United States.

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 27 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: stopped early, as of the sponsor's last update on 29 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 6 sites in United States. 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 combined 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.

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?

The study was stopped early (reason given: Sponsor Decision). 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?

Maximum tolerated dose (MTD) or maximum feasible dose (MFD) of a single dose of 67Cu-SAR-BBN (time frame: Up to 8 weeks). The study lists 12 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05633160, which also lists 1 linked publication.

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 29 Aug 2025.

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