Liver MetastasesPhase 1NCT02053324
AvidinOX + [177Lu]DOTA-biotin (or 177Lu-ST2210) Complex in Patients With Liver Metastases From Colorectal Cancer
A Phase 1 study testing AvidinOX/ST2210 in people with Liver Metastases, run by Alfasigma S.p.A. at 4 sites in 2 countries.
Trial summary
The purpose of the study is to assess a new treatment for patients with liver tumor metastases from colorectal cancer. The treatment has never been used in humans before. The treatment foresees the use of two compounds: AvdinOX and [177Lu]DOTA-biotin. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Liver Metastases
- What is being tested?
- AvidinOX/ST2210
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 4 sitesin 2 countries
- Study dates
- 11 Nov 2013to 1 Jul 2019
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female ≥ 18 years of age
- Liver metastases from histologically confirmed colorectal cancer and at least one liver metastasis ≥ 1 cm (measurable disease), which is chemo-resistant, not eligible for curative surgery and suitable for intra-lesional injection as assessed by the investigator.
- Total liver tumor burden requiring ≤ 75 ml AvidinOX
- Maximum of 9 liver metastases
- Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 2
- Life expectancy of at least 3 months.
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- Clotting parameters as follows, with local normal ranges to be taken as reference:
- Prothrombin Time (Quick).Patients showing an increase of the Upper Limit of the Normal (ULN) range of about 20% can also be considered for inclusion.
- International Normalised Ratio (INR). Patients showing an increase of the ULN of about 20% can also be considered for inclusion
- Activated Partial Thromboplastin Time (aPTT). Patients showing an increase of the ULN of about 20% can also be considered for inclusion
- Fibrinogen. Patients showing a decrease of the Lower Limit of the Normal range (LLN) of about 20% can also be considered for inclusion.
- Haematological, liver and renal function test results ≤ grade 2 toxicity (according to US National Cancer Institute's "Common Terminology Criteria for Adverse Events v4.03 [CTCAE]"), i.e.:
- Haematology:
- Haemoglobin ≥ 8 g/dl
- White blood cell count ≥ 2 x 109/L
- Platelets ≥ 80x 109/L
- Liver:
- Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Alkaline Phosphatase (AP) ≤ 5 times upper limit of normal
- Bilirubin ≤ 3 times upper limit of normal
- Renal:
- Urine protein dipstick: 0
- estimated Glomerular Filtration Rate (eGFR)> 30 ml/min/1.73 m2 (with CKD-EPI formula)
- Written informed consent
Who cannot join
- Known hypersensitivity to Avidin or AvidinOX (e.g. hen egg)
- Known hypersensitivity to ST2210(DOTA biotin) or any excipient.
- Life limiting metastases outside the liver. Metastases outside the liver are allowed only in case the residual metastases (after liver treatment) are amenable to further treatments (e.g. surgical removal)
- Presence of unreachable (e.g. located in a region in the liver that cannot be reached by needle, or too close to major blood vessels or adjacent to main organs) or untreatable hepatic lesions so that the benefit from the treatment of the treatable lesions does not justify patient's inclusion
- Active infection at screening or history of severe infection within the previous 3 months, if clinically relevant at screening as considered by the investigator
- Known human immunodeficiency virus (HIV) positive serology or chronically active hepatitis B or C.
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- Administration of another investigational medicinal product within 30 days before the screening period.
- Previous treatment with Selective Internal Radiation Therapy (SIRT) spheres or any radiopharmaceutical within a period corresponding to 8 half-lives of the radionuclide used for labeling the respective radiopharmaceutical prior to the administration of study drug.
- Women of child-bearing potential. A permanent postmenopausal status must be proven as follows: history of hysterectomy or hormone analysis in serum: estradiol < 20 pg/ml and follicle stimulating hormone (FSH) > 40 IU/L, or amenorrhea starting at least 1 year prior to the study start andnegativeβHCG .
- Men unwilling to use appropriate contraceptive methods during the study and up to six months after the end of the study
- Inability or unwillingness to be catheterized
- History of somatic or psychiatric disease/condition that may interfere with the objectives of the study
- Clinically significant illness or clinically relevant trauma within 15 days before the screening period
- Patient who underwent chemotherapy, radiation therapy within 15 days before the screening period
Trial locations and contacts
4 sites in 2 countries.
4 sites in 2 countries
Italy3 sites
Ospedale S. Maria Goretti
Latina, ROME, 04100
Ospedale dell' Angelo di Mestre
Mestre, Venice, 30174
S. Andrea Hospital
Rome, 00189
About this study
Official title: A Dose Escalation Study to Evaluate Safety, Tolerability, Pharmacokinetics, Dosimetry, Maximum Tolerated Dose and Preliminary Efficacy of Intra-lesionally Injected AvidinOX, Followed by Systemic IV Administration of Escalating Doses of [177Lu]DOTA-biotin in Patients With Liver Metastases From Colorectal Cancer
The purpose of the study is to assess a new treatment for patients with liver tumor metastases from colorectal cancer. The treatment has never been used in humans before. The treatment foresees the use of two compounds: AvdinOX and [177Lu]DOTA-biotin.
AvidinOX is a new compound, essentially a natural protein obtained from hen eggs, while [177Lu]DOTA-biotin is a new chemical compound resulting from the combination of the DOTA-biotin (also deriving from a natural vitamin which is biotin) with the 177Lutetium, an atom which emits radiation.
Read more
AvidinOX will be injected directly into the metastases in the liver and [177Lu]DOTA-biotin will be injected into the arm vein.
One specific property of AvidinOX is that it chemically links to the tumor tissues when it is injected while maintaining the capacity to take up [177Lu]DOTA-biotin. Once locally bound in tumor tissue, AvidinOX becomes an "artificial receptor" for intravenously injected [177Lu]DOTA-biotin, which allows an internal radiation therapy of the tumor tissue.
The treatment of liver metastases with local injection of AvidinOX and the following intra-venous injection of [177Lu]DOTA-biotin could be simpler and more tolerable than the current available treatments.
Read the detailed description
Primary objectives
- To identify the Maximum Tolerated Dose (MTD) of 177Lu-ST2210 after prior intra-lesional injection of AvidinOX in the liver.
- To assess safety and tolerability of intra-lesionally injected AvidinOX + IV injected 177Lu-ST2210
- To evaluate intra-lesional distribution and retention of AvidinOX + 177Lu-ST2210 complex in liver metastases
- To evaluate systemic biodistribution and pharmacokinetics of 177Lu-ST2210 and {AvidinOX + 177Lu-ST2210}- complex
Secondary objectives
- To evaluate proportional 177Lu-ST2210 tumor binding, as a function of total tumor load, and AvidinOX dose injected
- To demonstrate AvidinOX post-deposition reactivity with 177Lu-ST2210 over time
- To evaluate whole body dosimetry of IV 177Lu-ST2210 after prior AvidinOX injection (radiation safety dosimetry)
- To record individual tumor dosimetry
- To evaluate preliminary efficacy of {AvidinOX + 177Lu-ST2210}-complex in reducing tumor size
- To evaluate whole body safety dosimetry and dose linearity of IV administered 177Lu-ST2210 after prior intra-lesional injection of AvidinOX
- To evaluate pharmacokinetics of ST2210 in plasma and urine
- Conditions
- Liver Metastases
- Being tested
- AvidinOX/ST2210
- Keywords
- AvidinOX
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AvidinOX/ST2210Combination product
One intralesion injection of AvidinOX followed by an intravenous infusion of ST2210
| Study group | Role | What they receive |
|---|---|---|
| AvidinOX/ST2210 | Experimental | AvidinOX/ST2210 - vial containing 22.5 mg AvidinOX + vials containing 10 ml of water for injection (WFI) for the reconstitution in a clear solution with an AvidinOX concentration of 3 mg/ml. One Intralesion administration of a volume of reconstituted AvidinOX equal to 15 % of the lesion volume followed by intravenous infusion of 177Lu-ST2210 Diagnostic dose : 10 ml, 250 MBq±10%177Lu, approximately 1 mg ST2210, 100 mg/mL ascorbic acid, followed by intravenous infusion of a therapeutic dose: 25 ml, escalating 177Lu dose starting at 5 Gigabequerel (GBq) ±10%with escalation steps of 2.5 GBq up to 15 GBq ±10%, approximately 1 mg ST2210, 100 mg/ml ascorbic acid Receives: Combination Product: AvidinOX/ST2210 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dose Limiting Toxicity evaluated using NCI Common Toxicity Criteria (CTCAE 4.03)
Measured: up to six weeks
Secondary outcomes (1)
Adverse Events
Measured: up to 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Feb 2014 (estimated)
- Study start11 Nov 2013
- Primary completion1 Jun 2019
- Study completion1 Jul 2019
Why it stopped: Low recruitment rate
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Liver MetastasesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- 3+3 dose escalation design
- Masking
- None (open label)
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- Alfasigma S.p.A.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Alexander Haug, MD, Principal investigator, Allgemeines Krankenhaus Wien (Austria)Andreas Wicki, MD, Principal investigator, Universitatsspital Basel (Switzerland)Francesco Scopinaro, MD, Principal investigator, St. Andrea Hospital Rome (Italy)Roberto Cianni, MD, Principal investigator, S Maria Goretti Hospital - Latina (Italy)Michele Sicolo, MD, Principal investigator, Dell'Angelo Hospital - Mestre (Italy)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02053324
- Sponsor's protocol ID
- AvOX/ST2210-CR-12-001
- Other IDs
- 2012-005577-32
- Status last verified
- Jul 2019
- First submitted
- 24 Jan 2014
- Last updated
- 5 Jul 2019
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Publications
Vesci L, Carollo V, Rosi A, De Santis R. Therapeutic efficacy of intra-tumor AvidinOX and low systemic dose biotinylated cetuximab, with and without cisplatin, in an orthotopic model of head and neck cancer. Oncol Lett. 2019 Mar;17(3):3529-3536. doi: 10.3892/ol.2019.10003. Epub 2019 Feb 1.
PubMed 30867794Milazzo FM, Anastasi AM, Chiapparino C, Rosi A, Leoni B, Vesci L, Petronzelli F, De Santis R. AvidinOX-anchored biotinylated trastuzumab and pertuzumab induce down-modulation of ErbB2 and tumor cell death at concentrations order of magnitude lower than not-anchored antibodies. Oncotarget. 2017 Apr 4;8(14):22590-22605. doi: 10.18632/oncotarget.15145.
PubMed 28186982Vesci L, Milazzo FM, Anastasi AM, Petronzelli F, Chiapparino C, Carollo V, Roscilli G, Marra E, Luberto L, Aurisicchio L, Pacello ML, Spagnoli LG, De Santis R. Intra-tumor AvidinOX allows efficacy of low dose systemic biotinylated Cetuximab in a model of head and neck cancer. Oncotarget. 2016 Jan 5;7(1):914-28. doi: 10.18632/oncotarget.6089.
PubMed 26575422Albertoni C, Leoni B, Rosi A, D'Alessio V, Carollo V, Spagnoli LG, van Echteld C, De Santis R. Radionuclide Therapy of Unresectable Tumors with AvidinOX and (90)Y-biotinDOTA: Tongue Cancer Paradigm. Cancer Biother Radiopharm. 2015 Sep;30(7):291-8. doi: 10.1089/cbr.2015.1837. Epub 2015 Jul 13.
PubMed 26167947
Study at a glance
From the registry record, last updated by the sponsor on 5 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Dose Escalation Study to Evaluate Safety, Tolerability, Pharmacokinetics, Dosimetry, Maximum Tolerated Dose and Preliminary Efficacy of Intra-lesionally Injected AvidinOX, Followed by Systemic IV Administration of Escalating Doses of [177Lu]DOTA-biotin in Patients With Liver Metastases From Colorectal Cancer
- ClinicalTrials.gov ID
- NCT02053324
- Acronym / sponsor ID
- AvOX/ST2210-CR-12-001
- Conditions
- Liver Metastases
- Keywords
- AvidinOX
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Low recruitment rate
- Enrolment
- 14 participants (actual)
- Lead sponsor
- Alfasigma S.p.A.Industry (pharma, biotech, devices)
- Study start
- 11 Nov 2013 (actual)
- Primary completion
- 1 Jun 2019 (actual)
- Study completion
- 1 Jul 2019 (actual)
- First posted
- 3 Feb 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of the study is to assess a new treatment for patients with liver tumor metastases from colorectal cancer. The treatment has never been used in humans before. The treatment foresees the use of two compounds: AvdinOX and [177Lu]DOTA-biotin.
AvidinOX is a new compound, essentially a natural protein obtained from hen eggs, while [177Lu]DOTA-biotin is a new chemical compound resulting from the combination of the DOTA-biotin (also deriving from a natural vitamin which is biotin) with the 177Lutetium, an atom which emits radiation.
AvidinOX will be injected directly into the metastases in the liver and [177Lu]DOTA-biotin will be injected into the arm vein.
One specific property of AvidinOX is that it chemically links to the tumor tissues when it is injected while maintaining the capacity to take up [177Lu]DOTA-biotin. Once locally bound in tumor tissue, AvidinOX becomes an "artificial receptor" for intravenously injected [177Lu]DOTA-biotin, which allows an internal radiation therapy of the tumor tissue.
The treatment of liver metastases with local injection of AvidinOX and the following intra-venous injection of [177Lu]DOTA-biotin could be simpler and more tolerable than the current available treatments.
Detailed description
Primary objectives
- To identify the Maximum Tolerated Dose (MTD) of 177Lu-ST2210 after prior intra-lesional injection of AvidinOX in the liver.
- To assess safety and tolerability of intra-lesionally injected AvidinOX + IV injected 177Lu-ST2210
- To evaluate intra-lesional distribution and retention of AvidinOX + 177Lu-ST2210 complex in liver metastases
- To evaluate systemic biodistribution and pharmacokinetics of 177Lu-ST2210 and {AvidinOX + 177Lu-ST2210}- complex
Secondary objectives
- To evaluate proportional 177Lu-ST2210 tumor binding, as a function of total tumor load, and AvidinOX dose injected
- To demonstrate AvidinOX post-deposition reactivity with 177Lu-ST2210 over time
- To evaluate whole body dosimetry of IV 177Lu-ST2210 after prior AvidinOX injection (radiation safety dosimetry)
- To record individual tumor dosimetry
- To evaluate preliminary efficacy of {AvidinOX + 177Lu-ST2210}-complex in reducing tumor size
- To evaluate whole body safety dosimetry and dose linearity of IV administered 177Lu-ST2210 after prior intra-lesional injection of AvidinOX
- To evaluate pharmacokinetics of ST2210 in plasma and urine
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- 3+3 dose escalation design
| Arm | Type | Receives |
|---|---|---|
| AvidinOX/ST2210 | Experimental | Combination Product: AvidinOX/ST2210AvidinOX/ST2210 - vial containing 22.5 mg AvidinOX + vials containing 10 ml of water for injection (WFI) for the reconstitution in a clear solution with an AvidinOX concentration of 3 mg/ml. One Intralesion administration of a volume of reconstituted AvidinOX equal to 15 % of the lesion volume followed by intravenous infusion of 177Lu-ST2210 Diagnostic dose : 10 ml, 250 MBq±10%177Lu, approximately 1 mg ST2210, 100 mg/mL ascorbic acid, followed by intravenous infusion of a therapeutic dose: 25 ml, escalating 177Lu dose starting at 5 Gigabequerel (GBq) ±10%with escalation steps of 2.5 GBq up to 15 GBq ±10%, approximately 1 mg ST2210, 100 mg/ml ascorbic acid |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (23 listed)
- Male or female ≥ 18 years of age
- Liver metastases from histologically confirmed colorectal cancer and at least one liver metastasis ≥ 1 cm (measurable disease), which is chemo-resistant, not eligible for curative surgery and suitable for intra-lesional injection as assessed by the investigator.
- Total liver tumor burden requiring ≤ 75 ml AvidinOX
- Maximum of 9 liver metastases
- Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 2
Key exclusion criteria (14 listed)
- Known hypersensitivity to Avidin or AvidinOX (e.g. hen egg)
- Known hypersensitivity to ST2210(DOTA biotin) or any excipient.
- Life limiting metastases outside the liver. Metastases outside the liver are allowed only in case the residual metastases (after liver treatment) are amenable to further treatments (e.g. surgical removal)
- Presence of unreachable (e.g. located in a region in the liver that cannot be reached by needle, or too close to major blood vessels or adjacent to main organs) or untreatable hepatic lesions so that the benefit from the treatment of the treatable lesions does not justify patient's inclusion
- Active infection at screening or history of severe infection within the previous 3 months, if clinically relevant at screening as considered by the investigator
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AvidinOX/ST2210One intralesion injection of AvidinOX followed by an intravenous infusion of ST2210 | Combination product | AvidinOX/ST2210 |
Primary outcome
Dose Limiting Toxicity evaluated using NCI Common Toxicity Criteria (CTCAE 4.03)
Time frame: up to six weeks
1 secondary outcome
Adverse Events
Time frame: up to 1 year
Results and safety
The study was stopped early (reason given: Low recruitment rate). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jul 2019.
- Derived from this study: PubMed 30867794Vesci L, Carollo V, Rosi A, De Santis R. Therapeutic efficacy of intra-tumor AvidinOX and low systemic dose biotinylated cetuximab, with and without cisplatin, in an orthotopic model of head and neck cancer. Oncol Lett. 2019 Mar;17(3):3529-3536. doi: 10.3892/ol.2019.10003. Epub 2019 Feb 1.
- Derived from this study: PubMed 28186982Milazzo FM, Anastasi AM, Chiapparino C, Rosi A, Leoni B, Vesci L, Petronzelli F, De Santis R. AvidinOX-anchored biotinylated trastuzumab and pertuzumab induce down-modulation of ErbB2 and tumor cell death at concentrations order of magnitude lower than not-anchored antibodies. Oncotarget. 2017 Apr 4;8(14):22590-22605. doi: 10.18632/oncotarget.15145.
- Derived from this study: PubMed 26575422Vesci L, Milazzo FM, Anastasi AM, Petronzelli F, Chiapparino C, Carollo V, Roscilli G, Marra E, Luberto L, Aurisicchio L, Pacello ML, Spagnoli LG, De Santis R. Intra-tumor AvidinOX allows efficacy of low dose systemic biotinylated Cetuximab in a model of head and neck cancer. Oncotarget. 2016 Jan 5;7(1):914-28. doi: 10.18632/oncotarget.6089.
- Derived from this study: PubMed 26167947Albertoni C, Leoni B, Rosi A, D'Alessio V, Carollo V, Spagnoli LG, van Echteld C, De Santis R. Radionuclide Therapy of Unresectable Tumors with AvidinOX and (90)Y-biotinDOTA: Tongue Cancer Paradigm. Cancer Biother Radiopharm. 2015 Sep;30(7):291-8. doi: 10.1089/cbr.2015.1837. Epub 2015 Jul 13.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alexander Haug, MD principal investigator
Allgemeines Krankenhaus Wien (Austria)
Andreas Wicki, MD principal investigator
Universitatsspital Basel (Switzerland)
Francesco Scopinaro, MD principal investigator
St. Andrea Hospital Rome (Italy)
4 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing AvidinOX/ST2210 in people with Liver Metastases, run by Alfasigma S.p.A. at 4 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 23 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 5 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Italy, Austria. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Low recruitment rate). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dose Limiting Toxicity evaluated using NCI Common Toxicity Criteria (CTCAE 4.03) (time frame: up to six weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02053324, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jul 2019.