A Study of MFA-370 in Patients with Metastatic Urothelial Cancer

NCT05390645 | Withdrawn Phase 1

• 2 other identifiers: ECT-0012021-000068-30
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Metastatic Urothelial Cancer

Keywords

Metastatic Urothelial Cancer

Outcome Measures

Primary Outcomes (3)

• 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

• 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

• 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 Outcomes (8)

• Overall Response Rate (ORR), Clinical Benefit Rate (CBR), Progression-Free Survival (PFS), Time to Progression (TTP), Best Overall Response (BOR)

  Every six weeks up to 24 weeks

• Incidence and severity of AEs and SAEs

  Up to 30 days after last dose

• Incidence of dose interruptions, reductions, and treatment terminations due to AEs/SAEs

  Up to 30 days after last dose

• 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.

• Plasma concentration profiles

  From start of treatment until 29th day of treatment

Study Arms (1)

MFA-370

EXPERIMENTAL

MFA-370 once daily for up to 8 x 21 days.

Drug: MFA-370

Interventions

MFA-370 DRUG

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

MFA-370

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Signed Informed Consent Form before any screening procedures
• ≥ 18 years of age on the day of giving informed consent
• 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
• 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
• World Health Organization (WHO) performance status 0-2
• Life expectancy ≥12 weeks
• 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

You may not qualify if:

• Known CNS metastatic lesions, or evidence of impaired blood-brain barrier as assessed by the investigator
• Have signs or symptoms of active COVID-19 infection or a positive COVID-19 Polymerase Chain Reaction (PCR) test during the screening period
• Impaired renal function by estimated Glomerular Filtration Rate (eGFR) \<30 ml/min as per local assessment
• Laboratory values (hematology and biochemistry) within specified ranges to show appropriate organ function
• Clinically significant cardiac disease,
• Untreated or uncontrolled hypertension
• An underlying medical condition that precludes the ability to take oral medication daily
• Prohibited concomitant therapy
• 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
• Hypersensitivity to the active ingredients or to any of the excipients listed in section 6.1 in respective Summary of Product Characteristics (SmPC)
• Any bleeding disorder or condition where there is an increased risk of bleeding
• A history of allergic reactions following intake of acetylsalicylic acid or NSAIDs
• A history of gastrointestinal bleeding or perforation
• Active or recurrent gastrointestinal ulcer
• Major surgery within 14 days before enrolment. (Note: trans-urethral resection of bladder tumor is not considered major surgery)

Sponsors & Collaborators

• Ectin Research AB: lead

Study Sites (1)

Karolinska University Hospital

Stockholm, Sweden

Location

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 9, 2022
• First Posted: May 25, 2022
• Study Start: December 1, 2024
• Primary Completion: December 1, 2025
• Study Completion: December 1, 2025
• Last Updated: September 26, 2024

Record last verified: 2024-09

Locations

SE (1)