A Phase I Study to Evaluate the Safety and Dosimetry of Imaging With 68Ga-OncoACP3 in Prostate Cancer (SWAP)
調査の概要
状態
状態
条件
条件
介入・治療
介入・治療
詳細な説明
This is a phase I, non-randomized, open-label, multicenter clinical trial to evaluate primary the safety and dosimetry of a single dose of [68Ga]Ga-OncoACP3 and, secondly, its uptake, biodistribution, PK and excretion.
The Acid Phosphatase 3 (ACP3) is expressed in primary and metastatic prostate cancer lesions. OncoACP3 is a new ligand for ACP3: its radiolabelled version can be used as a PET radiotracer for the diagnostic imaging of prostate cancer. In this trial, 68Ga-OncoACP3 is offered to prostate cancer patients who already received standard of care imaging and might therefore complement available modalities.
Eligible patients for this trial are prostate cancer patients, aged 18 years or more with:
- suspected metastasis who are candidates for initial definitive therapy
- suspected recurrence based on elevated serum prostate-specific antigen (PSA) level (i.e., a progressive and confirmed serum PSA level > 0.2 ng/mL)
- metastatic disease who might be candidates for treatment with 177Lu-labelled PSMA ligands.
All patients will undergo PET/CT imaging with [68Ga]Ga-OncoACP3.
Patients are divided into two cohorts:
- Cohort A: 5 male patients without visceral or bone metastases, which would interfere with dosimetry evaluation of healthy organs.
- Cohort B: all patients who meet the eligibility criteria (up to 15 patients) Both cohorts are recruited in parallel, and patients are assigned to the respective cohort based on their disease extent. Whenever possible, patients are enrolled in cohort A, unless they are unsuitable for cohort A, or the required number of patients has already been enrolled in cohort A.
All patients will receive a single intravenous bolus administration of 250 MBq (150 - 275 MBq) [68Ga]Ga-OncoACP3 and biodistribution, PK, excretion, and dosimetry of [68Ga]Ga-OncoACP3 will be assessed based on a series of PET/CT scans, blood and urine sampling.
Full dosimetry evaluations will be performed for all patients in cohort A. Dosimetry in the other patients may be performed to the extent that it is possible based on their disease burden (i.e., only organs not affected by malignant lesions can be evaluated), as appropriate.
All patients will be assessed for safety. In addition, relative uptake to appropriate reference tissue of [68Ga]Ga-OncoACP3 as well as semiquantitative parameters such as SUVmax/SUVmean/SUVsd, are determined. The correlation of [68Ga]Ga-OncoACP3 uptake with immunopathology staining for ACP3 will be evaluated in patients undergoing surgery or tumor biopsy collection. For patients who undergo PSMA-PET/CT within 6 weeks before or after the [68Ga]Ga-OncoACP3-PET/CT scan, the lesion detection rate will be compared.
Full dosimetry evaluations will be performed for all patients in cohort A. Dosimetry in the other patients may be performed to the extent that it is possible based on their disease burden (i.e., only organs not affected by malignant lesions can be evaluated), as appropriate.
研究の種類
研究の種類
入学 (推定)
入学
段階
段階
- フェーズ 1
連絡先と場所
研究連絡先
研究連絡先
- 名前：Jacqueline Mock
- 電話番号：+41 43 544 88 02
- メール：regulatory@philogen.com
研究連絡先のバックアップ
- 名前：Francesco Colognese
- 電話番号：+39 0577 17 816
- メール：regulatory@philogen.com
研究場所
-
-
Bergamo
-
Bergamo、Bergamo、イタリア、24127
- 募集
- Azienda Socio Sanitaria Territoriale Papa Giovanni xxiii
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主任研究者：
- Paola Anna Erba, Prof
-
-
Milano
-
Milan、Milano、イタリア、20132
- 募集
- Ospedale San Raffaele S.r.l.
-
主任研究者：
- Arturo Chiti, Prof
-
-
参加基準
適格基準
適格基準
就学可能な年齢
- 大人
- 高齢者
健康ボランティアの受け入れ
説明
Inclusion Criteria:
Prostate cancer patients with:
- suspected metastasis who are candidates for initial definitive therapy
- suspected recurrence based on elevated serum prostate-specific antigen (PSA) level (i.e., a progressive and confirmed serum PSA level > 0.2 ng/mL)
- metastatic disease who might be candidates for treatment with 177Lu-labelled PSMA ligands. (Note: patients with a negative PSMA-PET/CT or discordant PSMA-PET and FDG-PET findings are eligible for this study, providing that they have a histologically confirmed diagnosis of prostate cancer)
- Subjects able to father children must agree to practice effective contraception for three months starting from the study drug administration.
- Age ≥ 18
- ECOG ≤ 1
- Patient must not have any concomitant infections or active concomitant disease.
- All acute toxic effects (excluding alopecia and fatigue) of any prior therapy (including surgery, radiation therapy, chemotherapy) must have resolved to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) (v. 6.0) Grade ≤ 1.
- Life expectancy of more than 12 weeks.
- Ability to undergo imaging study procedures.
- Evidence of a personally signed and dated informed consent document indicating that the subject has been informed of all pertinent aspects of the study.
- Willingness and ability to comply with the scheduled visits, plan, laboratory tests and other study procedures.
Exclusion Criteria:
- Chronically impaired renal function as expressed by creatinine clearance < 60 mL/min or serum creatinine > 1.5 x ULN. Note: it is sufficient to evaluate either creatinine clearance or serum creatinine
- Presence of active hepatitis.
- Presence of significant cardiac disorders (congestive heart failure, NYHA class III-IV, myocardial infarction within one year prior to study entry, uncontrolled hypertension, or arrhythmia).
- Any concomitant condition which in the opinion of investigators makes it undesirable for the patient to participate in the study or which could jeopardize compliance with the protocol.
- Major trauma including major surgery (such as abdominal/cardiac/thoracic surgery) within 4 weeks of administration of the study drug. Minimally invasive procedures such as biopsies are not considered as exclusion criteria.
- Serious, non-healing wound, ulcer, or bone fracture.
- Allergy to study medication or excipients in study medication.
- Any anti-cancer therapy (e.g., cytotoxic chemotherapy, immunotherapy, radiation, surgery, etc.) within 3 weeks before [68Ga]Ga-OncoACP3-PET/CT scan.
- Subject has received, or is scheduled to receive, another investigational medicinal product (IMP) from one month before [68Ga]Ga-OncoACP3 injection to end of study participation.
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：診断
- 割り当て：非ランダム化
- 介入モデル：並列代入
- マスキング：なし（オープンラベル）
アーム数
武器と介入
参加者グループ / アーム参加者グループ / アーム |
介入・治療介入・治療 |
|---|---|
|
実験的：Cohort A
5 male patients without visceral or bone metastases, which would interfere with dosimetry evaluation of healthy organs.
|
単一の静脈内ボーラス注射。
|
|
実験的：Cohort B
All patients who meet the eligibility criteria (up to 15 patients).
|
単一の静脈内ボーラス注射。
|
この研究は何を測定していますか？
主要な結果の測定
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Adverse events (AEs) and Serious Adverse Events (SAEs)
時間枠：Throughout study, until a maximum of 7 days after the administration of the study drug.
|
Adverse events (AEs) and Serious Adverse Events (SAEs) according to Common Terminology Criteria for Adverse Events (CTCAE) v.6.0.
|
Throughout study, until a maximum of 7 days after the administration of the study drug.
|
|
Effective dose equivalent (mSv) and absorbed doses (mGy)
時間枠：Assessed on day 1
|
Effective dose equivalent (mSv) and absorbed doses (mGy) of normal organs following administration of a single dose of [68Ga]Ga-OncoACP3.
|
Assessed on day 1
|
協力者と研究者
研究記録日
主要日程の研究
研究開始 (実際)
研究開始
一次修了 (推定)
一次修了
研究の完了 (推定)
研究の完了
試験登録日
最初に提出
最初に提出
QC基準を満たした最初の提出物
QC基準を満たした最初の提出物
最初の投稿 (実際)
最初の投稿
学習記録の更新
投稿された最後の更新 (実際)
投稿された最後の更新
QC基準を満たした最後の更新が送信されました
QC基準を満たした最後の更新が送信されました
最終確認日
最終確認日
詳しくは
本研究に関する用語
キーワード
その他の研究ID番号
その他の研究ID番号
- PH-ACP3GA-03/25
- 2025-524594-16-00 (Ctis)
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
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