First Phase Clinical Trial of Single Agent MBF-362 in Solid Tumors

NCT05940571 | Completed Phase 1

• 2 other identifiers: MBF-362CT-012022-001154-30
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Cancer

Keywords

Cancer; solid tumors; Prostaglandin E receptor; immunotherapy

Outcome Measures

Primary Outcomes (2)

• 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)

  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

  28 Days

Secondary Outcomes (9)

• Time to MBF-251 peak concentration in plasma "Tmax"

  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"

  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)

  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"

  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)

  2 years

Study Arms (4)

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

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

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

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

Drug: MBF-362

Interventions

MBF-362 DRUG

Drug: One MBF-362 128.7 mg hard gelatin capsule EP2/EP4 antagonist 28 days single oral daily dosing cycles

MBF-362 128.7 mg; MBF-362 257.4 mg; MBF-362 514.8 mg; MBF-362 772.2 mg

Eligibility Criteria

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

You may qualify if:

• 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).
• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Medibiofarma S.L.: lead

Study Sites (1)

Instituto Catalan de Oncología

L'Hospitalet de Llobregat, Barcelona, 08908, Spain

Location

MeSH Terms

Conditions

Neoplasms

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: June 30, 2023
• First Posted: July 11, 2023
• Study Start: November 24, 2022
• Primary Completion: November 26, 2024
• Study Completion: January 16, 2025
• Last Updated: March 3, 2025

Record last verified: 2025-02

Locations

ES (1)