Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Faron Pharmaceuticals Ltd
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
1. Written Informed Consent
2. Aged ≥ 18 years male or female
3. Tumour sample should be collected during screening period. If a recent tumour biopsy obtained within six months before the date of consent is available (or older, as agreed on a case by case basis with the sponsor), that may be used. At the discretion of the sponsor, the tumour sample may be optional for certain subjects in Part III
4. Life expectancy \> 12 weeks
5. Histologically confirmed advanced (inoperable or metastatic) malignancies without standard therapeutic options available:
* Hepatocellular carcinoma
* Gallbladder cancer or intra- or extrahepatic cholangiocarcinoma
* Colorectal adenocarcinoma
* Serous poorly differentiated (Grade 3) ovarian adenocarcinoma or undifferentiated ovarian cancer
* Pancreatic ductal adenocarcinoma
* Immunotherapy (IO) refractory cutaneous melanoma (progression either on or after programmed cell death protein-1 (PD-1)/programmed cell death ligand-1 (PD-L1) or cytotoxic T-lymphocyte antigen-4 (CTLA-4) antibody therapy)
* Uveal melanoma in Parts II and III
* Gastric adenocarcinoma (including adenocarcinoma of the distal esophagus / GE junction) in Parts II and III
* ER+ breast cancer in Parts II and III
* Anaplastic thyroid cancer in Parts II and III
6. ECOG performance status 0 or 1
7. Measurable disease in Parts II and III
9. Women of child-bearing potential must have a negative pregnancy test in serum prior to trial entry
10. Women of child-bearing potential and men who have partners of child-bearing potential must be willing to practise highly effective contraception for the duration of the trial and for three months after the completion of treatment
You may not be if
1. Less than 21 days since the last dose of intravenous anticancer chemotherapy or less than five half-lives from a small molecule targeted therapy or oral anticancer chemotherapy before the first IMP administration
2. Any immunotherapy within preceding 6 weeks from the first IMP administration
3. Investigational therapy or major surgery within 4 weeks from the date of consent
4. Active clinically serious infection \> Grade 2 NCI-CTCAE version 5.0 (Appendix 5 - Common Toxicity Criteria Gradings) within preceding 2 weeks from the date of consent
5. Brain metastases
6. Subject has not recovered from the previous therapies to Grade ≤ 1 severity as classified by the NCI-CTCAE version 5.0 (except Grade ≤ 2 alopecia, neuropathy or thyroid disorders)
7. Pregnant or lactating women
8. History of second malignancy except for non-melanotic skin cancer, cervical carcinoma in situ or superficial bladder cancer, or any other malignancy treated previously with curative intent and more than three years without relapse
9. Evidence of severe or uncontrolled systemic diseases, congestive cardiac failure New York Heart Association (NYHA) class 2 (Appendix 7 - NYHA classification), Myocardial Infarction (MI) within 6 months or laboratory finding that in the view of the investigator makes it undesirable for the subject to participate in the trial
10. Any medical condition that the Investigator considers significant to compromise the safety of the subject or that impairs the interpretation of IMP toxicity assessment
11. Confirmed human immunodeficiency virus infection
12. Symptomatic cytomegalovirus infection
13. Subjects with active auto-immune disorder (except type I diabetes, celiac disease, hypothyroidism requiring only hormone replacement, vitiligo, psoriasis, or alopecia)
14. The subject requires systemic corticosteroid or other immunosuppressive treatment
15. Subjects with organ transplants
16. Subjects in dialysis
17. Use of Live (attenuated) vaccines for 30 days prior to the start of study treatment, during treatment, and until last visit
18. Subject is unwilling or unable to comply with treatment and trial instructions
19. Subjects with known hypersensitivity to the IMP or any of the pharmaceutical ingredients
1. Any ablative therapy (Radio Frequency Ablation or Percutaneous Ethanol Injection) for HCC (this should not exclude subjects if target lesion(s) have not been treated and occurred \> 6 weeks prior trial entry)
