CancerPhase 1NCT05940571
First Phase Clinical Trial of Single Agent MBF-362 in Solid Tumors
A Phase 1 study testing MBF-362 in people with Cancer, run by Medibiofarma S.L. at 1 site in Spain.
Trial summary
This is an open, single center Phase Iclinical trial to evaluate the safety, tolerability, and preliminary efficacy of MBF-362 in patients with solid tumors. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cancer
- What is being tested?
- MBF-362
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteSpain
- Study dates
- 24 Nov 2022to 16 Jan 2025
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- These criteria are similarly applicable to patients enrolled to the phase I dose escalation and to the phase IB dose expansion portions of the trial.
- Advanced/metastatic histologically confirmed solid tumor. All types of solid tumors are allowed in the study
- At least 1 measurable lesion per Response Evaluation Criteria in solid tumor (RECIST 1.1).
- Patients who have progressed to the standard therapy and have no approved optional therapy available.
- ECOG performance status of 0/1
- Age greater than 18 years (inclusive).
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- Adequate bone marrow, renal and hepatic function
- Able and willing to give valid written consent for available archival tumor samples (mandatory) and tumor biopsies before and during protocol (immune)therapy (optional in escalation phase and mandatory in expansion phase).
- Prior immunotherapy is also allowed.
Who cannot join
- These criteria are similarly applicable to patients enrolled to the phase I dose escalation and to the phase IB dose expansion portions of the trial.
- Participation in another clinical study with an investigational product during the last 4 weeks or 5 half-lives prior to starting on treatment.
- Symptomatic and/or untreated Brain Metastases
- Pregnancy or breast feeding
- Serious uncontrolled medical disorder or active infection that in the investigator's opinion would impair the patient's ability to receive study treatment.
- Concurrent use of other anticancer approved or investigational agents is not allowed.
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- Active or prior documented autoimmune disease within the past 2 years. NOTE: Patients with vitiligo, Grave's disease, or psoriasis not requiring systemic treatment (within the past 2 years) are not excluded.
- Prior malignancy in past 2 years or as identified in Section 7.2 of this protocol.
- Patients receiving oral or systemic steroids 2 weeks prior to dosing with MBF-362
- Patients receiving >4 doses of anti-inflammatory (NSAID) treatments, modulators of the COX-2 pathway or aspirin 1 week prior to dosing with MBF-362
- Patients with a history of gastric/duodenal ulcers, colitis and/or gastrointestinal bleeding, severe gastrointestinal adverse reactions
- Patients with a history of anaphylaxis, uncontrolled asthma or allergy/hypersensitivity/intolerance to NSAIDs, COX-2 inhibitors or aspirin.
Trial locations and contacts
1 site in 1 country.
Spain1 site
Instituto Catalan de Oncología
L'Hospitalet de Llobregat, Barcelona, 08908
About this study
Official title: Phase I/Ib Trial of Single Agent MBF-362 in Solid Tumors
This is an open, single center Phase Iclinical trial to evaluate the safety, tolerability, and preliminary efficacy of MBF-362 in patients with solid tumors.
Read the detailed description
The phase I dose escalation will be conducted utilizing the standard 3+3 dose escalation method. Pharmacokinetic (PK) data will be obtained for MBF-362.
The phase I dose expansion will consist of 1 group including solid tumors cancer patients. Pharmacodynamic (PD) data will be obtained for potential biomarker analysis with pre-treatment and on-treatment tumor biopsies.
Phase I Dose Escalation (3+3 Design): the MTD will be defined as the highest dose level at which less than 2 out of 6 patients (<33%) experience DLT in Cycle 1 (first 28 days).
Phase I Safety Expansion once RP2D has been declared for MBF-362 using the standard 3+3 design, up to 20 additional solid tumor cancer patients may be treated at the RP2D to further explore safety and tolerability of the selected MBF-362 dose.
Patients must have histologically or cytologically confirmed cancer with at least one measurable lesion, with adequate organ and marrow function, and with ECOG performance status of 0-1. Eligible patients must have received at least one prior line of therapy for their disease.
- Conditions
- Cancer
- Being tested
- MBF-362
- Keywords
- Cancer, solid tumors, Prostaglandin E receptor, immunotherapy
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MBF-362Drug
Drug: One MBF-362 128.7 mg hard gelatin capsule EP2/EP4 antagonist 28 days single oral daily dosing cycles
| Study group | Role | What they receive |
|---|---|---|
| MBF-362 128.7 mg | Experimental | Drug: One MBF-362 128.7 mg hard gelatin capsule EP2/EP4 antagonist 28 days single oral daily dosing cycles Receives: Drug: MBF-362 |
| MBF-362 257.4 mg | Experimental | Drug: Two MBF-362 128.7 mg hard gelatin capsules EP2/EP4 antagonist 28 days single oral daily dosing cycles Receives: Drug: MBF-362 |
| MBF-362 514.8 mg | Experimental | Drug: Four MBF-362 128.7 mg hard gelatin capsules EP2/EP4 antagonist 28 days single oral daily dosing cycles Receives: Drug: MBF-362 |
| MBF-362 772.2 mg | Experimental | Drug: Six MBF-362 128.7 mg hard gelatin capsule EP2/EP4 antagonist 28 days single oral daily dosing cycles Receives: Drug: MBF-362 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Adverse Events (AEs) graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events
AEs will be described by system organ class and preferred tem using the Medical Dictionary for Regulatory Activities (MedDRA)
Measured: 28 Days
The Maximun Tolerated Dose (MTD) of MBF-362
The MTD evaluation will be based on the DLT Evaluable Population which includes all patients enrolled in the dose-escalation portion of the trial, who receive the protocol-assigned treatment with MBF-362 and complete the safety follow-up through the DLT evaluation period or experience a DLT during the DLT evaluation period
Measured: 28 Days
Secondary outcomes (9)
Time to MBF-251 peak concentration in plasma "Tmax"
The parameter will be calculated from plasma samples collected at days 1, day 2, day 8 and day 9 after drug administration for cycle 1, and at days 1 and 2 for cycle 2. It will consist in the time (in minutes) to reach the maximum "MBF-251" concentration in plasma samples of patients after oral administration of MBF-362
Measured: Between day 1 and 2, and day 8 and 9 of cycle 1, and between day 1 and 2 of cycle 2 (each cycle is 28 days)
MBF-251 peak concentration in plasma "Cmax"
The parameter will be calculated from plasma samples collected at days 1, day 2, day 8 and day 9 after drug administration for cycle 1, and at days 1 and 2 for cycle 2. It will consist in the time (in minutes) to reach the maximum "MBF-251" concentration in plasma samples of patients after oral administration of MBF-362
Measured: Between day 1 and 2, and day 8 and 9 of cycle 1, and between day 1 and 2 of cycle 2 (each cycle is 28 days)
The area under MBF-251 plasma concentration-time curve to infinite time "AUC(0-inf)
The parameter will be calculated from plasma samples collected at days 1, day 2, day 8 and day 9 after drug administration for cycle 1, and at days 1 and 2 for cycle 2. It will consist in the area under the concentration-time curve from zero up to ∞ with extrapolation of the terminal phase. "AUC(0-inf)" will be given in Amount·time/ volume units
Measured: Between day 1 and 2, and day 8 and 9 of cycle 1, and between day 1 and 2 of cycle 2 (each cycle is 28 days)
MBF-251 half-life in plasma " t½"
The parameter will be calculated from plasma samples collected at days 1, day 2, day 8 and day 9 after drug administration for cycle 1, and at days 1 and 2 for cycle 2. It will consist in the terminal half-life of PBF-251 in plasma. "t½" will be given in hours (h)
Measured: Between day 1 and 2, and day 8 and 9 of cycle 1, and between day 1 and 2 of cycle 2 (each cycle is 28 days)
Efficacy of MBF-362 treatment as measured by Objective response rate (ORR)
ORR: Response and progression will be evaluated in this study using the new international criteria proposed by the revised Response Evaluation Criteria in Solid Tumors (RECIST) guideline (version 1.1).ORR is defined as confirmed complete response (CR) or partial response (PR) based on modified RECIST v1.1.
Measured: 2 years
Efficacy of MBF-362 treatment as measured by Disease control rate (DCR)
The disease control rate (DCR) will be estimated considering the following variables: Complete response (CR), Partial response (PR) and stable disease (SD) as described by Response Evaluation Criteria in Solid Tumors (RECIST) guideline (version 1.1). These variables will be assessed based on Imaging-based evaluation methods as chest x-ray, conventional computed tomography (CT) and magnetic resonance imaging (MRI).
Measured: 2 years
Efficacy of MBF-362 treatment as measured by duration of response (DoR)
Duration of response (DoR) is defined as the duration from the first documentation of OR to the first documented disease progression or death due to any cause, whichever occurs first.
Measured: 2 years
Efficacy of MBF-362 treatment as measured by progression-free survival (PFS)
Progression-free survival (PFS) will be measured from the start of treatment until the documentation of disease progression or death due to any cause, whichever occurs first. For subjects who are alive and progression-free at the time of data cut-off for analysis, PFS will be censored at the last tumor assessment date.
Measured: 2 years
Efficacy of MBF-362 treatment as measured by overall survival (OS)
Overall survival (OS) will be determined as the time from the start of treatment until death due to any cause
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2023
- Study start24 Nov 2022
- Primary completion26 Nov 2024
- Study completion16 Jan 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medibiofarma S.L.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05940571
- Sponsor's protocol ID
- MBF-362CT-01
- Other IDs
- 2022-001154-30
- Status last verified
- Feb 2025
- First submitted
- 30 Jun 2023
- Last updated
- 3 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I/Ib Trial of Single Agent MBF-362 in Solid Tumors
- ClinicalTrials.gov ID
- NCT05940571
- Acronym / sponsor ID
- MBF-362CT-01
- Conditions
- Cancer
- Keywords
- Cancer, solid tumors, Prostaglandin E receptor, immunotherapy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Medibiofarma S.L.Industry (pharma, biotech, devices)
- Study start
- 24 Nov 2022 (actual)
- Primary completion
- 26 Nov 2024 (actual)
- Study completion
- 16 Jan 2025 (actual)
- First posted
- 11 Jul 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is an open, single center Phase Iclinical trial to evaluate the safety, tolerability, and preliminary efficacy of MBF-362 in patients with solid tumors.
Detailed description
The phase I dose escalation will be conducted utilizing the standard 3+3 dose escalation method. Pharmacokinetic (PK) data will be obtained for MBF-362.
The phase I dose expansion will consist of 1 group including solid tumors cancer patients. Pharmacodynamic (PD) data will be obtained for potential biomarker analysis with pre-treatment and on-treatment tumor biopsies.
Phase I Dose Escalation (3+3 Design): the MTD will be defined as the highest dose level at which less than 2 out of 6 patients (<33%) experience DLT in Cycle 1 (first 28 days).
Phase I Safety Expansion once RP2D has been declared for MBF-362 using the standard 3+3 design, up to 20 additional solid tumor cancer patients may be treated at the RP2D to further explore safety and tolerability of the selected MBF-362 dose.
Patients must have histologically or cytologically confirmed cancer with at least one measurable lesion, with adequate organ and marrow function, and with ECOG performance status of 0-1. Eligible patients must have received at least one prior line of therapy for their disease.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| MBF-362 128.7 mg | Experimental | Drug: MBF-362Drug: One MBF-362 128.7 mg hard gelatin capsule EP2/EP4 antagonist 28 days single oral daily dosing cycles |
| MBF-362 257.4 mg | Experimental | Drug: MBF-362Drug: Two MBF-362 128.7 mg hard gelatin capsules EP2/EP4 antagonist 28 days single oral daily dosing cycles |
| MBF-362 514.8 mg | Experimental | Drug: MBF-362Drug: Four MBF-362 128.7 mg hard gelatin capsules EP2/EP4 antagonist 28 days single oral daily dosing cycles |
| MBF-362 772.2 mg | Experimental | Drug: MBF-362Drug: Six MBF-362 128.7 mg hard gelatin capsule EP2/EP4 antagonist 28 days single oral daily dosing cycles |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- These criteria are similarly applicable to patients enrolled to the phase I dose escalation and to the phase IB dose expansion portions of the trial.
Key exclusion criteria (12 listed)
- These criteria are similarly applicable to patients enrolled to the phase I dose escalation and to the phase IB dose expansion portions of the trial.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MBF-362Drug: One MBF-362 128.7 mg hard gelatin capsule EP2/EP4 antagonist 28 days single oral daily dosing cycles | Drug | MBF-362 128.7 mg, MBF-362 257.4 mg, MBF-362 514.8 mg, MBF-362 772.2 mg |
Primary outcome
Number of Adverse Events (AEs) graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events
Time frame: 28 Days
AEs will be described by system organ class and preferred tem using the Medical Dictionary for Regulatory Activities (MedDRA)
The Maximun Tolerated Dose (MTD) of MBF-362
Time frame: 28 Days
The MTD evaluation will be based on the DLT Evaluable Population which includes all patients enrolled in the dose-escalation portion of the trial, who receive the protocol-assigned treatment with MBF-362 and complete the safety follow-up through the DLT evaluation period or experience a DLT during the DLT evaluation period
9 secondary outcomes
Time to MBF-251 peak concentration in plasma "Tmax"
Time frame: Between day 1 and 2, and day 8 and 9 of cycle 1, and between day 1 and 2 of cycle 2 (each cycle is 28 days)
MBF-251 peak concentration in plasma "Cmax"
Time frame: Between day 1 and 2, and day 8 and 9 of cycle 1, and between day 1 and 2 of cycle 2 (each cycle is 28 days)
The area under MBF-251 plasma concentration-time curve to infinite time "AUC(0-inf)
Time frame: Between day 1 and 2, and day 8 and 9 of cycle 1, and between day 1 and 2 of cycle 2 (each cycle is 28 days)
MBF-251 half-life in plasma " t½"
Time frame: Between day 1 and 2, and day 8 and 9 of cycle 1, and between day 1 and 2 of cycle 2 (each cycle is 28 days)
Efficacy of MBF-362 treatment as measured by Objective response rate (ORR)
Time frame: 2 years
Efficacy of MBF-362 treatment as measured by Disease control rate (DCR)
Time frame: 2 years
Efficacy of MBF-362 treatment as measured by duration of response (DoR)
Time frame: 2 years
Efficacy of MBF-362 treatment as measured by progression-free survival (PFS)
Time frame: 2 years
Efficacy of MBF-362 treatment as measured by overall survival (OS)
Time frame: 2 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Mar 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing MBF-362 in people with Cancer, run by Medibiofarma S.L. at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Adverse Events (AEs) graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (time frame: 28 Days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Mar 2025.