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Monoclonal Antibodies

CF33-CD19 + Blinatumomab for Solid Cancers (OASIS Trial)

Phase 1
Recruiting
Research Sponsored by Imugene Limited
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Any histologically or cytologically confirmed advanced or metastatic solid tumor with documented radiological progression per RECIST v1.1 following at least one prior line of treatment. Eligible subjects must have received at least two prior lines of approved therapies, including targeted therapies, for which they are eligible and failed or relapsed on or after that treatment
Eastern Cooperative Oncology Group (ECOG) performance status 0 - 1
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from first dose of study drug through treatment discontinuation, an average of 6 months
Awards & highlights

OASIS Trial Summary

This trial studies the safety and effectiveness of combining two drugs to treat advanced solid tumors in adults.

Who is the study for?
Adults over 18 with advanced or metastatic solid tumors that have worsened after at least one treatment line, including targeted therapies. Participants must be in good physical condition (ECOG 0-1), have a measurable lesion, proper organ function, and a life expectancy of over 3 months. Excluded are those on high-dose steroids or immunosuppressants, recent radiation therapy recipients, certain heart conditions, active infections or autoimmune diseases, severe skin disease with open wounds, lung issues requiring steroids, history of pancreatitis or significant neuropathy.Check my eligibility
What is being tested?
The trial is testing the safety and effectiveness of CF33-CD19 given through IV or directly into the tumor combined with blinatumomab for treating solid tumors. It's an early-phase study where doses will gradually increase to find the safest amount that can be given.See study design
What are the potential side effects?
Potential side effects may include typical reactions from immune-based cancer treatments such as flu-like symptoms (fever, chills), fatigue; infusion-related reactions; possible organ inflammation due to immune activation; and local site reaction if injected directly into the tumor.

OASIS Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My advanced cancer has worsened after treatment, and I've had at least two prior treatments.
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I am fully active or can carry out light work.
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My kidneys are working well.
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My liver is working well.
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My blood counts are within a healthy range.
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I am 18 years old or older.

OASIS Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from first dose of study drug through treatment discontinuation, an average of 6 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and from first dose of study drug through treatment discontinuation, an average of 6 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
All Treatment Arms - Incidence and severity of Adverse Events
Monotherapy Treatment Arms - Determination of RP2D to apply to Dose Escalation Combination Phase as supported by anti-tumor activity
Monotherapy Treatment Arms - Determination of RP2D to apply to Dose Escalation Combination Phase as supported by immune response as seen in cytokines
+1 more
Secondary outcome measures
All Treatment Arms - Disease Control Rate
All Treatment Arms - Duration of Response
All Treatment Arms - Overall Response Rate
+4 more

OASIS Trial Design

4Treatment groups
Experimental Treatment
Group I: CF33-CD19 IV Administration in Combination with BlinatumomabExperimental Treatment2 Interventions
Group II: CF33-CD19 IV Administration MonotherapyExperimental Treatment1 Intervention
Group III: CF33-CD19 IT Administration in Combination with BlinatumomabExperimental Treatment2 Interventions
Group IV: CF33-CD19 IT Administration MonotherapyExperimental Treatment1 Intervention
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Blinatumomab
2014
Completed Phase 3
~1210

Find a Location

Who is running the clinical trial?

Imugene LimitedLead Sponsor
6 Previous Clinical Trials
296 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Has CF33-CD19 IT Administration Monotherapy been approved by the U.S. Federal Drug Administration?

"As this is only a Phase 1 clinical trial, limited data exists to back up the safety and efficacy of CF33-CD19 IT Administration Monotherapy; so our team determined it was suitable for a score of 1."

Answered by AI

Are there any available slots in this research program for participants?

"Affirmative, the details on clinicaltrials.gov reveal that this investigation is currently recruiting individuals. The original listing was posted on October 2nd 2023 and recently modified on October 10th 2023. This trial requires 52 participants from one location to participate."

Answered by AI

What are the desired outcomes of this clinical experiment?

"The main focus of this trial, which is expected to extend for the duration of 6 months from first dose to treatment discontinuation, is to identify a Recommended Phase 2 Dose (RP2D) with monotherapy. Secondary objectives include determining Duration of Response (DoR), Disease Control Rate (DCR), and Overall Response Rate (ORR)."

Answered by AI

How many participants are currently taking part in this clinical trial?

"Affirmative. According to the current information hosted on clinicaltrials.gov, this medical trial is actively seeking participants. The experiment was first advertised on October 2nd 2023 and has since been updated as of October 10th 2023. To date, only 52 individuals have been accepted at a singular site location."

Answered by AI
~21 spots leftby Sep 2024