NCT03188328

Safety, Tolerability, PK, Dosimetry, MTD and Preliminary Efficacy of Intra-lesionally Injected AvidinOX, Followed by IV Escalating Doses of [177Lu]DOTA-biotin in Pts With Injectable Solid Tumors or Lymphomas

Terminated Phase 1 Last updated 5 July 2019

What this trial tests

Phase 1 trial testing AvidinOX in Inoperable Solid Tumors or Lymphomas in 3 participants. Terminated before completion.

Timeline

7 August 2017

Primary endpoint
30 June 2019

1 July 2019

Quick facts

Lead sponsor	Alfasigma S.p.A.
Phase	Phase 1
Status	Terminated
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	3
Start date	7 August 2017
Primary completion	30 June 2019
Estimated completion	1 July 2019
Sites	1 location across United States

Drugs / interventions tested

• AvidinOX — full drug profile →
• 177Lu-ST2210 — full drug profile →
• 177Lu-ST2210 — full drug profile →

Conditions studied

• Inoperable Solid Tumors or Lymphomas — all drugs for Inoperable Solid Tumors or Lymphomas →

Sponsor

Alfasigma S.p.A. — full company profile →

Who can join

18 and older, any sex, with Inoperable Solid Tumors or Lymphomas. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Local treatment of unresectable tumors is challenging, particularly with radioactivity. Current practice relies on external beam irradiation or on a variety of medical devices for brachytherapy. Both approaches proved useful in controlling tumor growth but are characterized by poor patient's compliance, significant side effects, high costs and technological complexity hampering wide-spread use. The use of AvidinOX for radionuclide therapy of inoperable cancer lesions will offer a number of advantages compared to current brachytherapy. In fact, the perfusion of a target tissue with AvidinOX, compared to current devices, will allow adapting the therapy to the tumor/organ shape, and it will also make it possible to delay the administration of radioactivity for several days which, according to pre-clinical studies, might be also divided up into repeated doses. AvidinOX linking stably to tissue proteins, does not exhibit the problem of seed migration which is associated with high morbidity. Based on previous findings with AvidinOX in combination with radionuclides in pre-clinical studies as well as data from the clinical use in liver metastases, it can be assumed that intralesional injections of AvidinOX followed by intravenous injections of 177Lu-ST2210 could be a safe and efficacious method for treating inoperable tumor lesions.

Publications & conference data

3 peer-reviewed publications reference this trial (live from Europe PMC):

1. Assessment of Image-Guided Intratumoral Delivery of Immunotherapeutics in Patients With Cancer.
   Sheth RA, Murthy R, Hong DS, Patel S, et al · · 2020 · cited 78× · PMID 32725245 · DOI 10.1001/jamanetworkopen.2020.7911
2. Pretargeting: A Path Forward for Radioimmunotherapy.
   Cheal SM, Chung SK, Vaughn BA, Cheung NV, et al · · 2022 · cited 54× · PMID 36215514 · DOI 10.2967/jnumed.121.262186
3. 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.
   Vesci L, Carollo V, Rosi A, De Santis R. · · 2019 · cited 1× · PMID 30867794 · DOI 10.3892/ol.2019.10003