Proof of Principle Study Evaluating Gonyautoxins NEURO SERUM, on Chemotherapy-induced Peripheral Neuropathy

• Status: Recruiting
• Trial end date: 2023-01-14
• Target enrollment: 0
• Participant gender: All

Summary

Proof-of-concept study to assess the effects of gonyautoxins (PSP NEURO SERUM) on safety and tactile sensitivity on patients with chemotherapy-induced peripheral neuropathy (CIPN). This is a multicenter, prospective proof-of-concept study in patients with solid tumors affected by CIPN. The study will be divided into two parts: Part 1 will assess the activity and tolerability of PSP NEURO SERUM and part 2 consists of a randomized cohort that will compare the activity of PSP NEURO SERUM vs placebo. Part 2 will depend on the results of part 1. If there are less than 8 responses in part 1, the study will be interrupted, and it will not be recommended to proceed with part 2. The detailed description of the study will be given only for part 1.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Algenis SpA
• Collaborator: Oncoclínicas

Criteria

Inclusion Criteria:

1. Written informed consent

2. Age ≥18 years.

3. Histological diagnosis of cancer (hematologic or solid tumors).

4. Treatment with chemotherapy in the neoadjuvant, adjuvant or metastatic setting.

5. Peripheral sensory neuropathy grade 2 or higher on upper limbs as per NCI-CTCAE v5.0.

6. Diagnosis of peripheral sensory neuropathy during treatment with chemotherapy or at least 2 weeks after the last infusion.

7. Patients who completed treatment with chemotherapy over 2 weeks, but have chronic symptoms related to peripheral sensory neuropathy and no exclusion criteria can be included.

8. Patients on neuropathic pain modulators will be allowed if on stable dose, if there were no dose changes in dosages in the last 2 weeks or if the use is for another reason.

9. Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) of 0 to 2,

10. Documented willingness to use an effective means of contraception while participating in the study.

11. Skin of the hands and cuticles should be intact.

Exclusion Criteria:

1. Prior treatment with gonyautoxins or any small molecule neurotoxins.

2. Female participants who are pregnant (positive urine pregnancy test), who have an infant they are breastfeeding, or intend to become pregnant within 3 months.

3. History of sensory peripheral neuropathy attributed to any cause other than chemotherapy.

4. Currently receiving chemotherapy or having had received chemotherapy in the past 2 weeks. Patients on systemic treatment that peripheral neuropathy is a commonly known side effect or received treatment in the last 2 weeks. Patients receiving systemic treatment, such as hormonal therapy or other agents where peripheral neuropathy is not a common side effect will be allowed.

5. Patients with grade 2 CIPN with perceived improvement of symptoms.

6. Changes in neuropathic pain modulators will not be allowed.

7. Any other therapies for chemotherapy-induced peripheral neuropathy must be discontinued at least 2 weeks before the first dose of study drug.

8. Hypersensitivity reaction to PSP Neuro serum.

9. Patients with a known or suspected shellfish allergy.

10. Patients receiving steroids or having received steroids in the past 2 weeks except for maximum of 10mg of prednisone or equivalent.

11. No dermatologic lesions on hands and cuticles that might increase systemic exposure of the investigational medicinal product (IMP).

12. Distal muscle weakness and/or atrophy.

13. History of alcoholism or regular (> 3 months) weekly alcohol intake of 168 g (21 units) for men and 112g (14units) for women. 1 unit = 10ml = 8g of pure alcohol.

14. Clinically significant abnormalities of glucose metabolism as defined by any of the following:

1. Diagnosis of diabetes mellitus type I or II (irrespective of management) with preexisting symptoms related to peripheral neuropathy. Asymptomatic diabetic patients with well controlled glucose levels are allowed.

2. Glycosylated hemoglobin (HbA1C) ≥8.0% at screening.

3. Fasting serum glucose ≥ 160 mg/dL at screening. Fasting is defined as no caloric intake for at least 8 hours.

15. Vitamin B12 deficiency defined as < 250 ng/mL.

16. Phosphate levels above upper limit of normal (ULN).

17. ECG: corrected QT interval (QTc) (Fridericia Formula) ≥ 450ms.

18. Positive Tinel and/or Phalen test.

19. Participation in another clinical trial and any concurrent treatment with any investigational drug within 4 weeks prior to trial entry / randomization.

20. Surgery, radiotherapy, or other anti-cancer therapy that in the investigators' opinion might interfere/ worsen symptoms or the evaluation of peripheral neuropathy within 2 weeks prior to trial entry /randomization.

21. Any other finding giving reasonable suspicion of a disease or condition that contraindicates the use of an investigational drug or that may affect the interpretation of the results or renders the patients at high risk from treatment complications.

22. Unresolved clinically significant toxicity from prior therapy except for alopecia.

23. Inability to comply with study and follow-up procedures.