Clinical Trials Logo

Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT05390645
Other study ID # ECT-001
Secondary ID 2021-000068-30
Status Not yet recruiting
Phase Phase 1/Phase 2
First received
Last updated
Start date November 1, 2023
Est. completion date December 1, 2024

Study information

Verified date May 2022
Source Ectin Research AB
Contact Austin Smith
Phone +44 7970 840160
Email austin.smith@ectinresearch.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This is a multi-center study of MFA-370 in patients with metastatic urothelial cancer. The objective of the study is to assess the safety and efficacy of MFA-370, i.e.a combination of two approved pharmaceuticals today used within other indications. The combination was developed after the finding that a multidiseased man with e.g. muscle-invasive bladder cancer also was treated for his recent parasitic infection resulted in that the parasitic infection together with the cancer got a complete remission. After extensive experimental complementing studies a combination treatment called MFA-370 was developed supporting the rationale for this treatment. This is the first clinical trial where the combination product MFA-370 is evaluated as anti-cancer treatment. Up to 50 patients will participate. MFA-370 is taken orally once daily for up to 24 weeks. If the treatment is of clinical benefit for the patient, as assessed by the investigator, the treatment period can be prolonged to up to 2 years. The patients will be monitored for safety, tolerability, pharmacokinetics, tumor response by RECIST (Response Evaluation Criteria in Solid Tumors) 1.1 and survival.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 50
Est. completion date December 1, 2024
Est. primary completion date December 1, 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: 1. Signed Informed Consent Form before any screening procedures 2. = 18 years of age on the day of giving informed consent 3. Confirmed current metastatic urothelial carcinoma of the bladder, including the urethra and upper urinary tract. The patient needs to have progressive disease and/or symptomatic metastatic disease that is unresponsive to standard therapy. The patient must have received all available approved therapies before being eligible for the study unless contraindications or intolerance exist for one or several of them 4. At least one lesion of measurable disease as defined by RECIST1.1 criteria based on CT or MRI scan within 2 weeks before start at Day -7 5. World Health Organization (WHO) performance status 0-2 6. Life expectancy =12 weeks 7. Patients with reproductive potential will need to use accepted and highly effective means of contraception from study entry until at least 6 weeks for females (women of childbearing potential) and 3 months for males after study drug discontinuation Main Exclusion Criteria: 1. Known CNS metastatic lesions, or evidence of impaired blood-brain barrier as assessed by the investigator 2. Have signs or symptoms of active COVID-19 infection or a positive COVID-19 Polymerase Chain Reaction (PCR) test during the screening period 3. Impaired renal function by estimated Glomerular Filtration Rate (eGFR) <30 ml/min as per local assessment 4. Laboratory values (hematology and biochemistry) within specified ranges to show appropriate organ function 5. Clinically significant cardiac disease, 6. Untreated or uncontrolled hypertension 7. An underlying medical condition that precludes the ability to take oral medication daily 8. Prohibited concomitant therapy 9. The patient has had biologic, hormonal, anti-neoplastic chemotherapy, or radiation therapy other than palliative treatment within 4 weeks prior to screening except for medications with half-lives <5.5 days 10. Hypersensitivity to the active ingredients or to any of the excipients listed in section 6.1 in respective Summary of Product Characteristics (SmPC) 11. Any bleeding disorder or condition where there is an increased risk of bleeding 12. A history of allergic reactions following intake of acetylsalicylic acid or NSAIDs 13. A history of gastrointestinal bleeding or perforation 14. Active or recurrent gastrointestinal ulcer 15. Major surgery within 14 days before enrolment. (Note: trans-urethral resection of bladder tumor is not considered major surgery) 16. For female patients of childbearing potential - pregnancy, as confirmed by a serum pregnancy test at screening, or breast-feeding 17. Any other severe, acute, or chronic medical condition that would interfere with the conduct of the study or interpretation of the study results as judged by the investigator 18. The patient has already participated in the study or been a screening failure

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
MFA-370
MFA-370 is a treatment with a combination of two approved pharmaceuticals

Locations

Country Name City State
Sweden Karolinska University Hospital Stockholm

Sponsors (1)

Lead Sponsor Collaborator
Ectin Research AB

Country where clinical trial is conducted

Sweden, 

Outcome

Type Measure Description Time frame Safety issue
Primary Incidence and severity of adverse events (AEs) and serious adverse events (SAEs) Safety of MFA-370 measured by incidence and severity of AEs and serious SAEs with a causal relationship to MFA-370 Up to 30 days safety follow up
Primary Incidence of dose interruptions, reductions, and treatment terminations due to AEs/SAEs Tolerability of MFA-370 measured by incidence of dose interruptions, reductions, and treatment terminations due to AEs/SAEs Up to 30 days safety follow up
Primary Overall Response Rate (ORR) Anti-tumor activity of MFA-370 measured by Overall Response Rate (ORR), assessed by the investigator based on the assessment of the Computed Tomography (CT) or Magnetic Resonance Imaging (MRI) scans made by the responsible Radiologist at each site (scans assessed per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1) At 24 weeks
Secondary Overall Response Rate (ORR), Clinical Benefit Rate (CBR), Progression-Free Survival (PFS), Time to Progression (TTP), Best Overall Response (BOR) Anti-tumor activity of MFA-370 measured by ORR, CBR, PFS, TTP, BOR based on CT/MRI-scans assessed by Radiologist per RECIST 1.1 Every six weeks up to 24 weeks
Secondary Incidence and severity of AEs and SAEs Safety of MFA-370 measured by incidence and severity of AEs and SAEs with a causal relationship to MFA-370 Up to 30 days after last dose
Secondary Incidence of dose interruptions, reductions, and treatment terminations due to AEs/SAEs Tolerability of MFA-370 measured by incidence of dose interruptions, reductions, and treatment terminations due to AEs Up to 30 days after last dose
Secondary Overall Survival Effect of MFA-370 on Overall Survival From the last dose until the date of death or up to 6 months after the last patient's end of treatment, whichever came first.
Secondary Plasma concentration profiles To characterize the pharmacokinetic properties of MFA-370 with respect to time vs plasma concentration profiles From start of treatment until 29th day of treatment
Secondary Peak Plasma Concentration (Cmax) To characterize the pharmacokinetic properties of MFA-370 with respect to Cmax in plasma From start of treatment until 29th day of treatment
Secondary Time to reach peak plasma concentration (tmax) of MFA-370 in plasma To characterize the pharmacokinetic properties of MFA-370 with respect to tmax From start of treatment until 29th day of treatment
Secondary Elimination half-life (t1/2) of MFA-370 in plasma To characterize the pharmacokinetic properties of MFA-370 with respect to t1/2 From start of treatment until 29th day of treatment
See also
  Status Clinical Trial Phase
Active, not recruiting NCT03682068 - Study of Durvalumab Given With Chemotherapy, Durvalumab in Combination With Tremelimumab Given With Chemotherapy, or Chemotherapy in Patients With Unresectable Urothelial Cancer Phase 3
Recruiting NCT05101096 - Study of Sacituzumab Govitecan (SG) in Japanese Participants With Advanced Solid Tumors Phase 1/Phase 2
Completed NCT02826564 - Trial of Stereotactic Body Radiotherapy With Concurrent Pembrolizumab in Metastatic Urothelial Cancer Phase 1
Completed NCT01963052 - ASG-15ME is a Study of Escalating Doses of AGS15E Given as Monotherapy in Subjects With Metastatic Urothelial Cancer Phase 1
Recruiting NCT03745911 - Paclitaxel and TAK-228 in Urothelial Carcinoma Phase 2
Completed NCT03390595 - Avelumab Plus Carboplatin-gemcitabine in Urothelial Carcinoma Phase 2
Completed NCT03451331 - Gemcitabine + Carboplatin + Nivolumab Versus Gemcitabine + Oxaliplatin + Nivolumab in Cisplatin-ineligible Patients With Metastatic Urothelial Cancer Phase 2
Active, not recruiting NCT04995419 - A Study to Evaluate Enfortumab Vedotin (ASG-22CE) in Chinese Participants With Locally Advanced or Metastatic Urothelial Cancer Who Previously Received Platinum-containing Chemotherapy and Programmed Cell Death Protein-1 ( PD 1) / (Programmed Death Ligand-1 (PD-L1) Inhibitor Therapy Phase 2
Completed NCT03679767 - A Study of INCMGA00012 in Participants With Selected Solid Tumors (POD1UM-203) Phase 2
Recruiting NCT06225596 - Study BT8009-230 in Participants With Locally Advanced or Metastatic Urothelial Cancer (Duravelo-2) Phase 2/Phase 3
Completed NCT02240017 - A Study Evaluating Chemotherapy With Fractionated Cisplatin/Gemcitabine Versus Carboplatin/Gemcitabine in the Treatment of Advanced or Metastatic Urothelial Cancer With Impaired Renal Function. Phase 2/Phase 3
Recruiting NCT03547973 - Study of Sacituzumab Govitecan in Participants With Urothelial Cancer That Cannot Be Removed or Has Spread Phase 2
Completed NCT03070990 - A Study of Enfortumab Vedotin in Japanese Subjects With Locally Advanced or Metastatic Urothelial Carcinoma Phase 1
Completed NCT03448718 - Trial of Olaparib in Patients With Metastatic Urothelial Cancer Harboring DNA Damage Response Gene Alterations Phase 2