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Checkpoint Inhibitor

TILT-123 + Pembrolizumab for Ovarian Cancer (PROTA Trial)

Phase 1

Recruiting

Research Sponsored by TILT Biotherapeutics Ltd.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Female over 18 years of age on day of signing informed consent(s).

At least one tumor (>14 mm in diameter) or carcinomatosis must be available for local virus injection (intratumoral and/or intraperitoneal).

Must not have

Has a history of (non-infectious) pneumonitis that required steroids or has current pneumonitis.

Has had an allogenic tissue/solid organ transplant.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a new cancer treatment that uses a virus to kill cancer cells. The treatment is being given to patients with ovarian cancer that has not responded to other treatments.

Who is the study for?

This trial is for women over 18 with ovarian cancer that's resistant to platinum treatment and can't be cured with existing therapies. Participants must have a tumor or carcinomatosis suitable for direct virus injection, good organ function, agree to contraception use, an ECOG/WHO score of 0-1, and a life expectancy over 3 months.

What is being tested?

The trial tests the safety of TILT-123 (an oncolytic adenovirus) combined with Pembrolizumab in patients with advanced ovarian cancer. It's an early-phase study where doses increase gradually to find safe levels. Patients receive both treatments directly into tumors or the abdominal cavity.

What are the potential side effects?

Potential side effects include typical immune therapy reactions like inflammation in various organs, infusion-related symptoms, fatigue, possible autoimmune disease flare-ups if predisposed, and infection risks due to immune system modulation by Pembrolizumab.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am a woman over 18 and can sign a consent form.

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I have a tumor larger than 14 mm or carcinomatosis suitable for direct virus injection.

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My ovarian cancer does not respond to platinum treatments and cannot be cured with current therapies.

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I am fully active or can carry out light work.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have had pneumonitis treated with steroids or have it now.

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I have received an organ or tissue transplant from another person.

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I have been treated for an autoimmune disease in the last 2 years.

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I am currently being treated for an infection.

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I have a history of hepatitis B, hepatitis C, or HIV.

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I am allergic or react badly to pembrolizumab.

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I have not had radiotherapy in the last 2 weeks.

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I stopped a cancer treatment due to severe side effects.

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My cancer has spread to my brain or its coverings.

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I do not have any uncontrolled heart or blood vessel problems.

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I haven't had a heart attack or stroke in the last year, or I've fully recovered from one.

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I have another cancer that is growing or was treated in the last 5 years.

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I have recovered from side effects of previous treatments to my normal or mild condition.

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I have a history of blood clotting issues.

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I am not pregnant, breastfeeding, nor planning to become pregnant.

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I have had serious liver problems.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Group I: Phase 1b part - TILT-123 and pembrolizumab and pegylated liposomal doxorubicinExperimental Treatment3 Interventions

Patients will receive multiple administrations of TILT-123 and pembrolizumab and pegylated liposomal doxorubicin. TILT-123 will be administered at the maximum tolerated dose or maximum feasible dose.

Group II: Phase 1 part - TILT-123 and pembrolizumabExperimental Treatment2 Interventions

Patients will receive multiple administrations of TILT-123 and pembrolizumab. Escalation to the next dose of TILT-123 level will occur when the safety data has been evaluated for all patients in the preceding dose level.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

pegylated liposomal doxorubicin

2010

Completed Phase 2

~190

pembrolizumab

2017

Completed Phase 3

~5890