A Study to Evaluate the Safety and Dosimetry of 68Ga-labelled OncoFAP Derivatives in Solid Tumors

Inclusion Criteria:

1. Patients with a confirmed diagnosis of breast cancer, colorectal cancer, oesophagealcancer and pancreatic adenocarcinoma. Confirmation by histopathology is required forbreast, colorectal and oesophageal cancer. For pancreatic adenocarcinoma,confirmation by histopathology or cytology obtained by endoscopic ultrasound isaccepted.

2. Requirement for diagnostic imaging or imaging performed within 4 weeks prior to the [68Ga]Ga-OncoFAP-PET/CT scan for staging.

3. Male or non-pregnant and non-breastfeeding female.

4. For female patients: negative serum pregnancy test for women of childbearingpotential* (WOCBP). WOCBP must agree to use, from the screening to six months following the study drugadministration, highly effective contraception methods, as defined by the "Recommendations for contraception and pregnancy testing in clinical trials" issuedby the Head of Medicine Agencies' Clinical Trial Facilitation Group (www.hma.eu/ctfg.html) and which include, for instance, progesterone-only orcombined (estrogen- and progesterone-containing) hormonal contraception associatedwith inhibition of ovulation, intrauterine devices, intrauterine hormone-releasingsystems, bilateral tubal occlusion or vasectomized partner.

5. For male patients: male subject able to father children must agree to practiceeffective contraception for three months starting from the study drugadministration.

6. Age 18 - 75

7. ECOG ≤ 1

8. Patient must not have any concomitant infections or active concomitant disease.

9. Life expectancy of more than 12 weeks.

10. Ability to undergo imaging study procedures.

11. Evidence of a personally signed and dated informed consent document indicating thatthe subject has been informed of all pertinent aspects of the study.

12. Willingness and ability to comply with the scheduled visits, plan, laboratory testsand other study procedures.

• Women of childbearing potential are defined as females who have experiencedmenarche, are not postmenopausal (12 months with no menses without analternative medical cause) and are not permanently sterilized (e.g., tubalocclusion, hysterectomy, bilateral oophorectomy, or bilateral salpingectomy).

Exclusion Criteria:

1. Chronically impaired renal function as expressed by creatinine clearance < 60 mL/minor serum creatinine > 1.5 x ULN.

2. Presence of active hepatitis.

3. Presence of significant cardiac disorders (congestive heart failure, NYHA classIII-IV, myocardial infarction within one year prior to study entry, uncontrolledhypertension, or arrhythmia).

4. Pregnant or breastfeeding during participation in the study.

5. Any concomitant condition which in the opinion of investigators makes it undesirablefor the patient to participate in the study or which could jeopardize compliancewith the protocol.

6. Major trauma including major surgery (such as abdominal/cardiac/thoracic surgery)within 4 weeks of administration of the study drug. Minimally invasive proceduressuch as biopsies are not considered as exclusion criteria.

7. Serious, non-healing wound, ulcer, or bone fracture.

8. Allergy to study medication or excipients in study medication.

9. Any anti-cancer therapy (e.g. cytotoxic chemotherapy, immunotherapy, radiation,surgery, etc.) within 3 weeks before [68Ga]Ga-OncoFAP-PET/CT scan

10. Subject has received, or is scheduled to receive, another investigational medicinalproduct (IMP) from 1 month before [68Ga]Ga-OncoFAP injection to end of studyparticipation.