THEO-260 for Ovarian Cancer

(OCTOPOD-IP Trial)

Overseen By Robert Nutbrown

Age: 18+

Sex: Female

Trial Phase: Phase 1

Sponsor: Theolytics Limited

Must not be taking: QTc prolonging drugs

Disqualifiers: Cerebral metastases, Active infections, Heart failure, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 6

Duration: 2 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment called THEO-260, a potential drug for ovarian cancer, to determine its safety and effectiveness. Researchers aim to identify possible side effects and the optimal dosage. It suits women whose ovarian cancer has not responded well to standard platinum treatments. Participants will receive six doses over two weeks and attend regular check-ups to monitor progress. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, and participants will be among the first to receive this new drug.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop all current medications, but you cannot take medications that prolong the QTc interval (a heart rhythm measure) or increase the risk for Torsades de Pointes (a type of heart rhythm problem) unless they can be safely stopped or replaced before starting the trial.

Is there any evidence suggesting that THEO-260 is likely to be safe for humans?

Research has shown that THEO-260 is considered safe based on earlier studies. One study confirmed that THEO-260 was effective and safe enough to begin testing in humans with high-grade serous ovarian cancer. Another study found that animals tolerated THEO-260 well, even at doses similar to those humans would receive.

Since this trial is in its early phase, it primarily focuses on safety, marking the first time the treatment is tested in humans. Available data so far suggest the treatment is manageable, but detailed human safety information is still being collected. Researchers will closely monitor participants to ensure any side effects are quickly addressed. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for ovarian cancer?

THEO-260 is unique because it targets ovarian cancer differently than traditional treatments like chemotherapy and targeted therapies. While most treatments focus on killing cancer cells directly or blocking specific cancer growth signals, THEO-260 works by utilizing a novel mechanism that may enhance the body's immune response against the cancer. Researchers are excited about this treatment as it could potentially offer a more effective and less toxic option for patients, with the possibility of longer-lasting results compared to current therapies.

What evidence suggests that THEO-260 might be an effective treatment for ovarian cancer?

Research has shown that THEO-260, the investigational treatment studied in this trial, is a promising therapy for ovarian cancer. This treatment uses a virus to locate and destroy cancer cells. Early studies demonstrated that THEO-260 can effectively kill ovarian cancer cells and other types of tumor cells. It breaks down cancer cells and also impacts the area surrounding the tumors. These early findings suggest that THEO-260 could be an effective treatment option for ovarian cancer. ^{2 3 4 5 6}

Are You a Good Fit for This Trial?

This trial is for adult women with ovarian cancer. Participants will receive THEO-260 directly into the peritoneal cavity, which holds organs in the abdomen. The study seeks individuals who have not yet found effective treatment and are able to attend regular clinic visits for monitoring.

Inclusion Criteria

Voluntary, written informed consent prior to trial procedures. Willingness and ability to comply with the protocol

Life expectancy of > 6 months

My blood counts and organ functions are within normal ranges.

Exclusion Criteria

Any other concurrent severe and/or uncontrolled medical or surgical condition which, in the view of the Investigator, could compromise the patient's participation in the trial due to safety, compliance concerns or ability to evaluate response

Known contra-indications or hypersensitivity to the excipients of the IP

Known contra-indications or hypersensitivity to acetaminophen

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive 6 doses of THEO-260 via an intraperitoneal route over 2 weeks

2 weeks

6 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, including check-ups and tests

4 weeks

Regular intervals (in-person)

Long-term follow-up

Participants are monitored for safety and efficacy, including assessment of DLTs, AEs, and efficacy measures

Up to 16 months

What Are the Treatments Tested in This Trial?

Interventions

• THEO-260

Trial Overview THEO-260's safety and effectiveness against ovarian cancer are being tested. Administered intraperitoneally over two weeks, this study uses a dose escalation design to find the safest and most effective dosage level for future phases of research.

How Is the Trial Designed?

Group I: THEO-260 Experimental Treatment 1 Intervention

Who Is Running the Clinical Trial?

Theolytics Limited

Lead Sponsor

Trials

1

Recruited

30+

Citations

1. ascopubs.org ascopubs.org/doi/10.1200/JCO.2023.41.16_suppl.e14573

Evaluation of THEO-260 as a novel oncolytic virus therapy ... THEO-260 is a potent, mechanistically novel oncolytic virus therapy intrinsically capable of lysing both cancer cells and CAFs, and is currently in development ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT06618235

Trial of THEO-260 in Ovarian Cancer Patients (OCTOPOD) The goal of this clinical trial is to establish if THEO-260 is safe to administer to adult females with ovarian cancer. It will also aim to establish if ...

3. annalsofoncology.org annalsofoncology.org/article/S0923-7534(23)02136-1/fulltext

2271P Development of an oncolytic virus for the treatment ... Conclusions. Our data confirms that THEO-260 is efficacious and safe, supporting the initiation of FIH clinical trials in high grade serous ovarian cancer ...

4. jitc.bmj.com jitc.bmj.com/content/12/Suppl_2/A1438

1283 Oncolytic immunotherapy THEO-260 enters ... Results THEO-260 was highly efficacious in a panel of OC cell lines (n=8), different stromal rich tumour types (n=9) and a panel of fresh OC ...

5. biospace.com biospace.com/press-releases/theolytics-doses-first-patient-in-phase-i-iia-trial-of-theo-260-in-ovarian-cancer

Theolytics Doses First Patient in Phase I/IIa Trial of THEO ... THEO-260 is a mechanistically novel oncolytic immunotherapy developed to tackle the stromal rich tumour microenvironment (TME) evident in ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT07211659

Trial of THEO-260 (Administered Via Intraperitoneal Route) ... The goal of this clinical trial is to establish if THEO-260 is safe to administer to adult females with ovarian cancer.