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Inclusion Criteria.To be eligible to participate in this trial, an individual must meet ALL the following criteria: 1. Patient, or legal representative (if applicable), must be capable to understand the purpose of the study and have signed written ICF prior to beginning specific protocol procedures. 2. Male or female patients ≥ 18 years of age at the time of signing ICF. 3. Radiologically documented locally advanced unresectable or metastatic breast cancer (BC). 4. Histologically confirmed HER2-positive (HER2[+]) breast cancer based on local testing on the most recent analyzed biopsy according to the most recent American Society of Clinical Oncology (ASCO)/College of American Pathologists (CAP) guidelines. 5. Untreated newly diagnosed or progressing brain metastasis (BM) after prior local therapy. Any number of brain lesions is acceptable as long as all the eligibility criteria are fulfilled. 6. Measurable disease according to Response Assessment in Neuro-Oncology Brain Metastases (RANO-BM) criteria, with at least one measurable brain lesion of ≥ 10 mm on T1-weighted, gadolinium-enhanced magnetic resonance imaging (MRI). 7. Patients may or may not have type I leptomeningeal disease (LMD) per European Association of Neuro-Oncology (EANO)- European Society for Molecular Oncology (ESMO) criteria. 8. Stable or decreasing corticosteroid dose, or no use of corticoids, for at least 7 days prior to enrollment. 9. Eastern Cooperative Oncology Group performance status (ECOG PS) ≤ 2. 10. Minimum life expectancy of ≥ 6 weeks at screening. 11. Resolution of all acute toxic effects of prior anticancer therapy to grade ≤ 1 as determined by the US National Cancer Institute (NCI)-Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 (v.5.0). Note: except for alopecia or other toxicities not considered a safety risk for the patient at investigator's discretion. 12. Patient has adequate bone marrow, liver, and renal function within 7 days before first Study treatment dose:

• I. Hematological (without platelet, red blood cell transfusion/plasma transfusion within 1 week prior to screening assessment, and/or granulocyte colony-stimulating factor support): White blood cell (WBC) count > 3.0 x 109/L, absolute neutrophil count (ANC) ≥ 1.5 x 109/L, platelet count ≥ 100.0 x109/L, and hemoglobin ≥ 9.0 g/dL (≥ 5.6 mmol/L).

• II. Hepatic: Serum albumin ≥ 2.5 g/dL; total bilirubin ≤ 1.5 times upper limit of normal (ULN) (≤ 3 in patients with liver metastases or know history of Gilbert's disease); alkaline phosphatase (ALP) ≤ 2.5 times ULN (≤ 5 in patients with liver metastases); aspartate transaminase (AST) and alanine transaminase (ALT) ≤ 3 times ULN (≤ 5 in patients with liver metastases); international normalized ratio (INR) < 1.5.

• III. Renal: serum creatinine ≤ 1.5 x ULN or creatinine clearance ≥ 50 mL/min/1.73 m2 based on Cockcroft-Gault glomerular filtration rate estimation for patients with creatinine levels above institutional normal.

13. Women of childbearing potential who are sexually active with a non-sterilized male partner must have a negative serum pregnancy test within 14 days before Study treatment initiation. In addition, they must agree to use one highly effective method of birth control for the full duration of study participation. 14. Male participants who are sexually active with a female partner of childbearing potential must be surgically sterile or using an acceptable method of contraception for the full duration of study participation. 15. Patients must be accessible for treatment and follow-up. Exclusion Criteria.An individual who meets ANY of the following criteria will be excluded from participation in this trial: 1. Participation in another clinical trial, interventional or observational, until the Study's safety visit (participation in retrospective studies or data analysis is allowed). 2. Treatment with approved or investigational cancer therapy within 14 days prior to initiation of study drug. 3. Known history of invasive malignancy and other than the malignancy of interest within 5 years prior to signing informed consent except for adequately treated basal cell or squamous cell skin cancer or in situ cervical cancer. For other cancers considered to have a low risk of recurrence, discussion with the Sponsor's Medical Monitor is required. 4. Known allergy or hypersensitivity reaction to any investigational medicinal products (diagnostic radioligand) or their incorporated substances. 5. Major surgical procedure or significant traumatic injury within 14 days before the first dose of study treatment or anticipation of need for major surgery within the course of the study treatment. 6. Pregnant or breastfeeding females or patients not willing to apply highly effective contraception as defined in the protocol. 7. Receipt of live or attenuated vaccine within 30 days prior to the first dose of study treatment. 8. Has active or uncontrolled infection with hepatitis B virus (HBV), or hepatitis C virus (HCV). Patients with past HBV infection or resolved HBV infection (defined as having a negative hepatitis B surface antigen [HBsAg] test and a positive hepatitis B core antibody [HBcAb] test, accompanied by a negative HBV DNA test) are eligible. Patients positive for HCV antibody are eligible only if polymerase chain reaction (PCR) is negative for HCV RNA. 9. Has known human immunodeficiency virus (HIV) infection that is not well controlled. 10. Other active uncontrolled infection at the time of enrollment. 11. Is receiving systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to the first dose of study treatment. 12. A history of uncontrolled seizures, central nervous system (CNS) disorders, or serious and/or unstable pre-existing psychiatric disability judged by the investigator to be clinically significant and adversely affecting compliance to study drugs or interfering with trial participant safety. 13. Known substance abuse or any other concurrent severe and/or uncontrolled medical condition that would, in the investigator's judgment, contraindicate patient participation. 14. Any serious medical condition or abnormality in clinical laboratory tests that, in the investigator's judgment, precludes the patient's safe participation in and completion of the study. 15. Inability or unwillingness to comply with the requirements of the protocol in the opinion of the investigator.

This is an international, multicenter, open-label, multicohort, platform design trial comprising the development of theranostic cards, and diagnostic and therapeutic phases. The THERANOVA platform trial is designed to systematically analyze existing data and results of theranostic agents to further develop each IMP in different indications. Based on the preliminary analysis, the platform identifies the best strategy for the clinical development of each specific IMP in the context of solid tumors and active brain metastases. The flexible design of the trial adapts to the specific developmental needs of each IMP. Theranostic agents will be firstly analyzed via a theranostic card which will be developed based on the evidence-based analysis done for each theranostic agent. The THERANOVA Experts Committee (TEC) will analyze the theranostic card to take decisions of development through the platform. The theranostic agent will then be tested, if considered suitable, in one (diagnostic or therapeutic) or two (diagnostic and therapeutic) developmental phases depending on the result of the analysis for each of the indications considered. After the diagnostic phase, in case of unsatisfactory results, the diagnostic agent will be discarded for the indication. If the results are satisfactory, the diagnostic agent will be further tested in the therapeutic phase. In case the TEC considers that there is enough evidence for target engagement based on the results of the theranostic card, the diagnostic phase will be skipped, and the theranostic agent will be directly tested in the therapeutic phase. Analysis of each agent will be performed extracting preliminary data from available sources and literature review. If the necessary data to support a developmental decision is not available, the platform is designed to fill evidence gaps. Once a molecule starts its development, the theranostic card will be updated with the new data generated. The TEC will also review the new information advising and deciding the next steps of development. The theranostic card for each theranostic agent will include: 1. Primary tumor/brain metastasis: target expression by tumor subtype as per immunohistochemistry (IHC)%, target localization, imaging radioligand(s), target expression by radioligand imaging; 2. Theranostic development phase and indication; 3. Development phase in the platform. Agents for which the TEC considers that the available data are insufficient to enter the therapeutic phase will enter the diagnostic phase of the platform. The diagnostic phase is comprised of three Stages: Stage I/II: In the Stage I patients will receive a single infusion of the diagnostic agent which will be detected by PET/CT imaging. If the results of the interim analysis performed after the first patients treated (Stage I) are positive, in the Stage II additional patients will receive a single dose of the diagnostic agent which will be detected by PET/CT imaging; Stage III: This Stage will only be performed if the primary endpoint for Stages I and II is met, but there are not enough data and information available on the biodistribution and pharmacokinetics of the agent to proceed to therapeutic phase. A single low dose of the diagnostic agent will be administrated to analyze its uptake in a time dependent manner by single photon emission computed tomography (SPECT)/CT scan. Agents for which the TEC considers that satisfactory data are available will enter the therapeutic phase of the platform. The therapeutic phase is comprised of two Stages: Stage I/II: A first set of patients (Stage I) will receive treatment with the therapeutic agent; if the results of the interim analysis are positive, additional patients (Stage II) will be enrolled to receive the therapeutic agent. Patients enrolled must be ≥18 years of age with solid tumors and active brain metastases (BMs), who have evidence of at least one measurable brain lesion of ≥10 mm on T1-weighted, gadolinium-enhanced magnetic resonance imaging (MRI) according to Response Assessment in Neuro-Oncology Brain Metastases (RANO-BM) criteria. Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2, life expectancy ≥ 6 weeks, and adequate bone marrow and organ function are mandatory. The diagnostic phase consists of 2 Stages. In the Stage I, 5 patients will be recruited and, after an interim analysis, if the established criteria are met, 5 additional patients will be recruited in the Stage II for each cohort. If the TEC requires a Stage III, 10 patients will be recruited for each cohort. The therapeutic phase consists of 2 Stages as well. In the Stage I, 10 patients will be recruited and, after an interim analysis, if the established criteria are met, 10 additional patients will be recruited in the Stage II for each cohort. The information gathered from the theranostic card evaluation, and the decision of the TEC will determine which indication (solid tumor with brain metastasis) will be investigated for the specific IMP. After treatment discontinuation (EoT), all patients will have a safety visit scheduled 28 days (± 7 days) after the last dose of IMP, in order to follow up toxicities and changes in concomitant medication. Should alternative timelines be necessary based on the IMP, these will be detailed in the corresponding appendix. After the safety visit, all patients treated in the therapeutic phase will enter a post treatment follow-up period during which survival status and subsequent anticancer therapy information will be collected every 3 months (± 7 days) until death, lost to follow-up, elective withdrawal from the study, or the EoS, whichever occurs first. This information may be collected by telephone call. Patients who discontinue treatment without evidence of disease progression will be followed every 6 months (± 14 days) for tumor assessments until documented progression, elective withdrawal from the study, the start of new anti-cancer treatment, or study completion or termination. Safety long-term follow-up will be established based on the cohort and the specific IMP as explained in the IMP specific appendix section. The TEC took the decision to test the radiotracer targeting SSTR ([68Ga]Ga-DOTA-TOC) in the diagnostic phase for patients with HER2-positive breast cancer and brain metastases as the first cohort. The decision to assess [68Ga]Ga-DOTA-TOC in the diagnostic phase for this population reflects the potential of RLTs to target brain lesions. The current platform Study incorporates essential design components that may be crucial for a comprehensive evaluation of the balance between benefits and risks of [68Ga]Ga-DOTA-TOC in patients with solid tumors and BMs. The eligibility criteria are designed to maximize the diagnostic value of [68Ga]Ga-DOTA-TOC and minimize its potential associated risks.

Arms

Experimental: Arm A

Interventions

Drug: - Radiotracer targeting SSTR2 ([68Ga]Ga-DOTA-TOC)

Patients will receive a single infusion of the diagnostic agent [68Ga]Ga-DOTA-TOC will which will be detected by PET/CT imaging. The recommended activity for an adult weighing 70 kg is 100 to 200 MBq, administered by direct slow intravenous injection and for a single use only.