Preliminary Evaluation of Uptake of [68Ga]P16-093 in Metastatic Prostate and Renal Cancer

Five Eleven Pharma

Status and phase: Completed; Phase 1

Conditions: Renal Cancer; Prostate Cancer

Treatments: Drug: [68Ga]P16-093

Study type: Interventional

Funder types: Industry

Identifiers

NCT03073395

511-0003-A

Details and patient eligibility

About

An phase I study to evaluate the uptake of [68Ga]P16-093 in known or suspected metastatic prostate or renal cancer to establish the feasibility of using [68Ga]P16-093 to image PSMA expressing cancer. Measurement of the whole body biodistribution of [68Ga]P16-093 in prostate cancer patients post primary curative-intent treatment with stable PSA to generate human radiation dosimetry data.

Enrollment: 30 patients

Sex: Male

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

DYNAMIC GROUP:

Inclusion Criteria:

1. Participants will be male ≥ 18 years of age

2. History of histologically confirmed cancer that meets criteria for either a) or b)

   1. Prostate cancer with known or suspected recurrent or metastatic disease based on clinical imaging (e.g. CT, bone scan, MRI, ultrasound, FDG PET/CT, FACBC PET/CT) within 12 months of screening. If subject is post curative-intent local treatment (e.g. radical prostatectomy, local radiotherapy, brachytherapy) they must have had no intervening change in cancer treatment.

      OR

   2. Renal Cell cancer with known or suspected metastatic disease based on clinical imaging (e.g. CT, bone scan, MRI, ultrasound, FDG PET/CT)

3. Participants must be informed of the investigational nature of this study and be willing to provide written informed consent and participate in this study in accordance with institutional and federal guidelines prior to study-specific procedures.

Exclusion Criteria:

1. Estimated creatinine clearance (eGFR) < 30 mL/min (calculated from serum creatinine result within 30 days of screening)
2. Chemotherapy or radiation therapy within 2 weeks of screening
3. Inability to tolerate imaging procedures in the opinion of an investigator or treating physician
4. Any current medical condition, illness, or disorder as assessed by medical record review and/or self-reported that is considered by a physician investigator to be a condition that could compromise participant safety or successful completion of the study

BIODISTRIBUTION GROUP:

Inclusion Criteria:

1. Participants will be male ≥ 18 years of age

2. History of prostate cancer that is post curative-intent local treatment (e.g. radical prostatectomy, local radiotherapy, brachytherapy) with clinical PSA levels that meet one of the following criteria

   1. Post-Prostatectomy (with or without adjuvant RT): PSA level that is < 0.2 ng/mL measured over at least 2 consecutive tests OR
   2. Post-Radiotherapy: PSA level that has not risen from nadir measured over at least 2 consecutive tests

3. If clinical imaging (e.g. bone scan, CT, MRI, ultrasound, PET/CT) has been done within 3 months of screening as part of standard clinical surveillance it must be negative or equivocal for sites of recurrent or metastatic disease (clinical imaging is not required for enrollment)

4. Participants must be informed of the investigational nature of this study and be willing to provide written informed consent and participate in this study in accordance with institutional and federal guidelines prior to study-specific procedures.

Exclusion Criteria:

1. Estimated creatinine clearance (eGFR) < 30 mL/min (calculated from serum creatinine result within 30 days of screening)
2. Androgen deprivation therapy (ADT) within 3 months prior to screening
3. Chemotherapy or radiation therapy within 2 weeks of screening
4. Inability to tolerate imaging procedures in the opinion of an investigator or treating physician
5. Any current medical condition, illness, or disorder as assessed by medical record review and/or self-reported that is considered by a physician investigator to be a condition that could compromise participant safety or successful completion of the study

Trial design

Primary purpose: Diagnostic

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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30 participants in 2 patient groups

Dynamic group

Experimental group

Description:

Dynamic imaging of suspected metastatic lesions with the investigation drug \[68Ga\]P16-093 in patients with a history of histologically confirmed cancer.

Treatment:

Drug: [68Ga]P16-093

Biodistribution group

Experimental group

Description:

Whole body imaging to determine human dosimetry of the investigational drug \[68Ga\]P16-093

Treatment:

Drug: [68Ga]P16-093