A Phase I/II Open-Label, Three-Part, Dose-Finding and Separate Cohort Expansion Trial to Assess the Safety, Tolerability and Preliminary Efficacy of Repeated Doses of CLEVER-1 Antibody FP-1305, in Subjects with Advanced Solid Tumours.

Recruiting

• Conditions: 10027655; advanced solid tumours

• Registration Number: NL-OMON54504
• Lead Sponsor: Faron Pharmaceuticals Ltd

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 15 April 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: Not specified
• Target Recruitment: 84

Inclusion Criteria

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 in
which (according to the view of the investigator) no curative, effective or
suitable treatment options exist:
o Hepatocellular carcinoma
o Gallbladder cancer or intra- or extrahepatic cholangiocarcinoma
o Colorectal adenocarcinoma
o Serous poorly differentiated (Grade 3) ovarian adenocarcinoma or
undifferentiated ovarian cancer
o Pancreatic ductal adenocarcinoma
o Immunotherapy (IO) resistant cutaneous melanoma (progression during
programmed cell death protein-1 (PD-1)/programmed cell death ligand-1 (PD-L1)
or cytotoxic T-lymphocyte antigen-4 (CTLA-4) antibody therapy)
o Uveal melanoma in Parts II and III
o Gastric adenocarcinoma (including adenocarcinoma of the distal esophagus / GE
junction) in Parts II and III
o ER+ breast cancer in Parts II and III
o Anaplastic thyroid cancer in Parts II and III
6) ECOG performance status 0 or 1
7) Measurable disease in Parts II and III
8) Adequate bone marrow, liver and kidney function defined as
Blood white blood cell >= lower limit of normal
Blood neutrophil count >= 1x109/L Blood platelet count >= 100x109/L, for HCC >=
50x109/L
Blood haemoglobin >= 9.0 g/dL
Creatinine clearance > 40 mL/min calculated by Cockcroft-Gault
formula AST <= 3 X ULN (<= 5 x ULN when HCC or hepatic metastases are
present)
ALT <= 3 X ULN (<= 5 x ULN when HCC or hepatic metastases present)
Bilirubin <= 1.5 X ULN
Albumin >= 3.0 g/dL
The most recent measurements taken during the screening period must be within
the required limits for the patient to be considered eligible (i.e. criteria
met once during the screening period are not sufficient if there are more
recent measurements available that are not within the required
limits. It is however acceptable to repeat measurements if the initial
measurements or subsequent measurements taken during the screening period are
not within the required limits; the patient is eligible providing that the
newest measurements are within the required limits). However,
once a subject is out of the screening period, and has had eligibility
confirmed and been enrolled, the pre-dose laboratory assessments are not
subjected to inclusion criteria limits, but only for investigators assessment
of subject safety.
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

Exclusion Criteria

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 before the first IMP
administration
4) Active clinically serious infection > Grade 2 NCI-CTCAE version 5.0 within
preceding 2 weeks before first IMP administration
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 class >= 2, Myocardial Infarction 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

Study & Design

• Study Type: Interventional
• Study Design: Not specified