Lutathera and ASTX727 in Neuroendocrine Tumours (LANTana)

  • STATUS
    Recruiting
  • End date
    Dec 31, 2025
  • participants needed
    27
  • sponsor
    Imperial College London
Updated on 4 October 2022

Summary

Patients entered into the study will receive ASTX727 orally up to 3 to 8 days prior to receiving Lutathera treatment to determine whether pre-treatment with ASTX727 results in re-expression of somatostatin receptor-2 in patients with metastatic neuroendocrine tumours. The study will use [68Ga]-DOTA-TATE PET to image epigenetic modification of the receptor locus.

Details
Condition Neuroendocrine Tumors
Treatment ASTX727
Clinical Study IdentifierNCT05178693
SponsorImperial College London
Last Modified on4 October 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

Be willing and able to provide written informed consent for the trial
Be aged 18 or over at the day of signing consent
histologically or cytologically confirmed diagnosis of neuroendocrine tumour
archival tissue block available
disease that can be readily biopsied by ultrasound guidance (n=5)
Ki67 < 55%(only patients with well differentiated grade 1-3 NETs will be included in the study as patients with poorly differentiated grade 3 NETs have a prognosis of less than 6 months)
Progression or intolerance to first line therapy including somatostatin analogues Version 3.6 - 4th Novermber 2021 IRAS ID 285903 Page 11 of 69
ECOG Performance status 0 - 2
Tumoural uptake on [68Ga]-DOTA-TATE greater than background liver
Measurable disease based on RECIST 1.1. Lesions situated in a previously irradiated area are considered measurable if progression has been demonstrated in such lesions
Adequate organ function (see table 4)
Women of childbearing potential must be willing to use a highly effective method of contraception as outlined in Appendix 4 for the course of the study through 6 months after the last dose of Investigational Medicinal Product (IMP)
Note: Abstinence is acceptable if this is the usual lifestyle and preferred
contraception for the subjects
Sexually active males must agree to use an adequate method of contraception as outlined in Appendix 4 starting with the first dose of IMP through 6 months after the last dose of study therapy
Note: Abstinence is acceptable if this is the usual lifestyle and preferred contraception
for the subject

Exclusion Criteria

Previous treatment with either study medication and/or known hypersensitivity to the
study medication
Serious concurrent medical illness, including serious active infection
History of organ transplant
Has a known history of Human Immunodeficiency Virus (HIV). Note: No HIV testing is
required unless mandated by local health authority
Has a known history of active Bacillus Tuberculosis (TB)
Has known active CNS metastases and/or carcinomatous meningitis. Participants with
previously treated brain metastases may participate provided they are radiologically
stable, i.e. without evidence of progression for at least 4 weeks by repeat imaging
(note that the repeat imaging should be performed during study screening), clinically
stable and without requirement of steroid treatment for at least 14 days prior to
first dose of study treatment
Bleeding or thrombotic disorders or subjects at risk for severe haemorrhage
Is currently participating and receiving therapy or has participated or is
participating in a study of an IMP or used an investigational device within 4 weeks of
the first dose of IMP
Has a known additional malignancy that is progressing or requires active treatment
Exceptions include basal cell carcinoma of the skin or squamous cell carcinoma of the
skin that has undergone potentially curative therapy or in situ cervical cancer
Has a history or current evidence of any condition, therapy, or laboratory abnormality
that might confound the results of the trial, interfere with the subject's
participation for the full duration of the trial, or is not in the best interest of
the subject to Version 3.6 - 4th Novermber 2021 IRAS ID 285903 Page 12 of 69
participate, in the opinion of the treating Principal Investigator (PI)
Has known psychiatric or substance abuse disorders that would interfere with
cooperation with the requirements of the trial
Is pregnant or breastfeeding, or expecting to conceive or father children within the
projected duration of the trial, starting with the screening visit through to 6 months
after the last dose of IMP
Has received a live vaccine within 30 days of first dose of ASTX727 administration
Note: Seasonal influenza vaccines for injection are generally inactivated flu vaccines
and are allowed; however intranasal influenza vaccines (e.g., Flu-Mist®) are live
attenuated vaccines, and are not allowed
Has received prior radiotherapy within 2 weeks of start of study treatment
Participants must have recovered from all radiation-related toxicities, not require
corticosteroids, and not have had radiation pneumonitis. A 1-week washout is permitted
for palliative radiation (≤2 weeks of radiotherapy) to non-CNS disease and
stereotactic radiotherapy to the CNS
Other clinically significant co-morbidities that could compromise the subject's
participating in the study
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