Study of Radspherin® in Recurrent Ovarian Cancer Subjects With Peritoneal Carcinomatosis

• Status: Recruiting
• Trial end date: 2023-10-01
• Target enrollment: 0
• Participant gender: Female

Summary

RAD-18-001 is a First-In-Man, Dose Escaltion study conducted at 2 sites. The dose escalation will be performed based on a 3 + 3 design. Increasing dose levels starting at 1 MBq will be followed by 2, 4 and 7 MBq. If the highest dose level of 7 MBq is reached without Dose Limiting Toxicicities (which will stop the dose escalation), this will be the recommended dose for further exploration. Acceptability of up to 7 MBq gives the opportunity to explore the doses of the dose escalation split into two administrations, and given as two separate injections 1 week apart. Split doses of 1, 2 and 3.5 MBq will be administered as two injections. Each subject will be followed until disease progression (in the abdominal cavity), or for 12 months after the administration of Radspherin® (whichever comes first).

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

Details

• Lead Sponsor: Oncoinvent AS

Criteria

Inclusion Criteria:

1. Able and willing to provide written informed consent and to comply with the clinical study protocol

2. Age ≥ 18 years

3. Histologically confirmed epithelial ovarian, fallopian tube and primary peritoneal carcinoma

4. Platinum sensitive recurrences of ovarian carcinoma who are eligible for debulking surgery to R0.

5. AEs recovered to at least grade 1 from the effects (excluding alopecia) of any prior medical therapy for malignancy at time of first administration of Radspherin®

6. ECOG Performance Status Score of 0 - 1

7. Adequate renal function

• Creatinine ≤ 1.8 mg/dl (159 μmol/l) and

• calculated creatinine clearance using the Cockcroft-Gault formula ≥ 45 ml/min, or

• measured creatinine clearance ≥ 45 ml/min

8. Adequate hepatic function

• Serum bilirubin <1.5 x upper limit of normal (ULN)

• Aspartate transaminase (AST) and alanine transaminase (ALT) ≤ 3 x ULN

9. Adequate bone marrow function:

• Absolute neutrophil count (ANC) ≥ 1.5 x 109/l

• Platelets ≥ 100 x 109/l

• Haemoglobin ≥ 9 g/dL

10. Adequate coagulation tests: INR ≤ 1.5 x ULN

11. For females of childbearing potential, a negative pregnancy test must be documented prior to enrolment

12. For females of childbearing potential who have a male partner: agreement to use two adequate methods of contraception (e.g. barrier, intrauterine device, hormonal implants, combined oral contraceptives or vasectomized partner), during the treatment period and for at least 3 months after the last dose of IMP.

Exclusion Criteria:

1. Neuroendocrine tumors, or non-epithelial ovarian cancers (e.g. germ cell tumors, Sex-cord tumors)

2. Tumors of borderline malignancy

3. Other synchronous visceral metastatic lesions, symptomatic CNS metastases. Metastatic lymph nodes are acceptable, except thoracic lymph nodes.

4. Pregnant or lactating (nursing) women

5. Active infections requiring antibiotics, and/or physician monitoring or recurrent fever >38.0 ⁰C associated with a clinical diagnosis of active infection

6. Active liver disease with positive serology for active hepatitis B, hepatitis C or known HIV

7. Administration of an investigational medicinal product within 28 days, or at least 5 times the half-life, prior to enrolment

8. Concurrent administration of any cancer therapy other than planned study treatment within 4 weeks prior to, and up to 4 weeks after the last study treatment

9. Another primary malignancy within the past 3 years (except for non-melanoma skin cancer, cervical cancer in situ or in situ stage 1 synchronous endometrial cancer)

10. Concurrent congestive heart failure or prior history of New York Heart Association (NYHA) class III/IV cardiac disease

11. Any condition or illness that, in the opinion of the Investigator or the medical monitor, would compromise the safety of the subjects or interfere with the evaluation of the safety of the IMP

12. In the Investigator's opinion not able to comply with study procedures. Any medical or psychological condition that would preclude participation in the study or compromise the ability to give informed consent

13. Treatment with bevacizumab (Avastin®) within 5 weeks prior to CRS

14. Known hypersensitivity to any of the excipients in the study drug

15. Persons who have been placed in an institution under an official or judicial order

16. Persons who are dependent on the sponsor financially must be excluded from participation

17. Persons with active SARS-CoV-2 infection must be excluded from participation