Olorofim in Early Coccidioidal Meningitis

NCT07385638 | Not Yet Recruiting Phase 2 FDA Drug

• 1 other identifier: Study 00006853
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief Summary

This research study is being conducted to learn more about the use of olorofim in Coccidioidal (Cocci) meningitis, a rare but serious fungal infection that affects the brain and spinal cord. The study is exploratory, meaning that early information is being gathered to better understand the effectiveness of olorofim in coccidioidal meningitis in its early stages. The study plans to enroll approximately 10 to 12 participants who have been recently diagnosed-within the last 4 to 8 weeks-and who do not have a ventriculoperitoneal (VP) shunt, a medical device sometimes used to relieve pressure in the brain. Participants will be followed for approximately 6 months, during which health information will be collected to evaluate disease progression and response to treatment. Participants may have the opportunity to enroll in the olorofim Managed Access Program to continue treatment after completion of the study period.

Conditions

Coccidioidal Meningitis

Keywords

coccidioidomycosis

Outcome Measures

Primary Outcomes (1)

• Safety: Number of participants with ≥1 treatment-emergent adverse event

  Counts and proportions of participants experiencing at least one adverse event after initiation of olorofim, regardless of causality. Adverse events will be coded and graded according to CTCAE v5.0.

  First dose through end of treatment and 4-week follow-up

Secondary Outcomes (9)

• Efficacy: Investigator-assessed clinical response over 24 weeks

  Baseline through Week 24 (End of Treatment)

• Efficacy: Change from baseline in Coccidioides serum complement fixation titers

  Baseline through Week 24

• Efficacy: Radiological response assessed by imaging

  Baseline through Week 24

• Efficacy: Investigator-assessed overall treatment response

  Baseline through Week 24

• Efficacy: All-cause mortality

  Baseline through Week 24 and 4-week follow-up

Study Arms (1)

olorofim

EXPERIMENTAL

Participants will receive treatment with olorofim

Drug: olorofim

Interventions

olorofim DRUG

Single group study - all participants will receive olorofim treatment

olorofim

Eligibility Criteria

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

You may qualify if:

• Male and female patients aged ≥ 18 years and weighing ≥ 40 kg, able to understand and consent in English, who have been fully informed and:
• a) who have given voluntary written informed consent, or whose legally authorized representative(s) has been fully informed and has given voluntary written informed consent if applicable, and in compliance with local regulations OR
• b) who have given oral informed consent witnessed in writing by an independent person and in compliance with local regulations for patients who are unable to write and/or read but who fully understand the oral information given by the Investigator (or nominated representative).
• Ongoing coccidioidomycotic meningitis diagnosed within 8 weeks prior to enrolment.
• Ongoing symptoms due to coccidioidomycosis are such that the risk-benefit of treatment with an investigational agent with a hepatic signal requiring careful monitoring is judged favorable based on meeting criteria
• Female patients must be non-lactating and at no risk of pregnancy for one of the following reasons:
• Postmenopausal for at least 1 year;
• Post-hysterectomy and/or post-bilateral oophorectomy;
• Of childbearing potential, with a negative urine or serum human chorionic gonadotropin pregnancy test at the screening visit and must be using one of listed below highly effective method of birth control throughout the course of the study period and up to and including 30 days after stopping study drug
• Established use of oral, injected, transdermal, intravaginal, or implanted hormonal methods of contraception associated with inhibition of ovulation
• Placement of an intrauterine device or intrauterine hormone-releasing system
• Male sterilization
• Bilateral tubal occlusion
• Sexual abstinence (reliable sexual abstinence is acceptable but periodic abstinence \[e.g., calendar, ovulation, symptom-thermal, or post-ovulation methods\] and withdrawal are not acceptable).
• Male patients with female partners of childbearing potential must either totally abstain from sexual intercourse or use a highly effective means of contraception throughout study participation and agree to continue its use for 30 days after stopping study drug and may not donate semen during this time.

You may not qualify if:

• Patients who are unconscious.
• Patients who are pregnant or breastfeeding.
• Known history of allergy, hypersensitivity, or any serious reaction to any component of the olorofim.
• Patients with or planned placement of indwelling CNS hardware (e.g. reservoirs, shunts, ventriculostomies, or external drainage tubes).
• Patients with a second fungal infection requiring systemic antifungal treatment or prophylaxis, other than Pneumocystis jirovecii infections and cutaneous fungal infections treated topically.
• Patients with microbiological findings (e.g., bacteriological, virological) or other potential conditions that are temporally related and suggest a different than study indication etiology.
• HIV infection but not currently receiving antiretroviral therapy. In cases where HIV infection is first diagnosed at the same time as the invasive fungal infection, if antiretroviral therapy is commenced at the time of enrollment, then such patients are eligible for enrolment
• Any known or suspected medical condition or social circumstance of the patient that may jeopardize adherence to the protocol requirements or impede the accurate measurement of efficacy.
• Patients with a concomitant medical condition that, in the opinion of the Investigator, may be an unacceptable additional risk to the patient should he/she participate in the study.
• Patients who have received prior treatment with olorofim/F901318.
• Treatment with any investigational drug within the 30 days prior to the first administration of study drug except for unblinded protocols (eg, open-label oncological regimen variations or biologic studies). Prior to enrolling patients who are on other open-label studies, it is the site's responsibility to ensure that the study criteria for that study allow for enrollment into this study.
• Patients receiving treatment limited to supportive care due to predicted short survival time.
• Patients with a baseline prolongation of QT using Fridericia's Correction Formula (QTcF) ≥ 500 msec, or at high risk for QT/QTc prolongation, eg,
• A family history of long QT syndrome
• Other known pro-arrhythmic conditions

Sponsors & Collaborators

• Fariba Donovan: lead
• F2G Biotech GmbH: collaborator

Study Sites (1)

Banner University Medical Center

Tucson, Arizona, 85719, United States

Location

MeSH Terms

Conditions

Coccidioidal Meningitis; Coccidioidomycosis

Interventions

olorofim

Condition Hierarchy (Ancestors)

Meningitis, Fungal; Central Nervous System Fungal Infections; Mycoses; Bacterial Infections and Mycoses; Infections; Central Nervous System Infections; Central Nervous System Diseases; Nervous System Diseases; Meningitis; Neuroinflammatory Diseases

Study Officials

• Fariba Donovan, MD, PhD

  University of Arizona

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jose Elizondo

CONTACT

5206210316; joselizondo5@arizona.edu

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: MD, PhD

Study Record Dates

• First Submitted: January 23, 2026
• First Posted: February 4, 2026
• Study Start: March 15, 2026
• Primary Completion (Estimated): March 15, 2027
• Study Completion (Estimated): June 15, 2027
• Last Updated: February 4, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: CSR
• Access Criteria: Access to the de-identified IPD will be limited to F2G Ltd. and authorized third-party vendors acting on behalf of the collaborator, under data use agreements that specify permitted uses and prohibit re-identification. Data will not be made publicly available. Study results may be disseminated through scientific publications and presentations.

Locations

US (1)