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Anti-tumor antibiotic
CUSP06 for Ovarian Cancer
Phase 1
Recruiting
Research Sponsored by OnCusp Therapeutics, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Patients with histologically or cytologically confirmed advanced solid tumors previously treated with standard of care systemic therapy, or for whom no standard therapy is available
Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 and life expectancy of ≥12 weeks
Must not have
Clinically significant lung disease requiring systemic corticosteroid treatment within the last 6 months of randomization/registration
Prior allogeneic bone marrow transplantation
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 42 months
Awards & highlights
No Placebo-Only Group
Summary
"This trial will test a new drug called CUSP06 in patients with ovarian cancer and other advanced solid tumors to see if it is safe and effective."
Who is the study for?
This trial is for adults over 18 with advanced solid tumors, including ovarian cancer that's not responding to platinum-based treatments. Participants need a certain level of health (ECOG status 0 or 1), enough white blood cells, platelets, and hemoglobin without recent transfusions. They must provide tumor tissue samples and consent to biopsies if needed.
What is being tested?
CUSP06 is being tested in this phase 1 study for safety and effectiveness in treating resistant ovarian cancer and other solid tumors. The trial will assess how the body processes the drug (pharmacokinetics) as well as its impact on the disease.
What are the potential side effects?
Since CUSP06 is under investigation, specific side effects are not listed but may include typical reactions seen with cancer therapies such as nausea, fatigue, allergic reactions, or changes in blood counts.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have an advanced solid tumor and have either been treated with standard therapy or no standard therapy exists for me.
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I can care for myself and am expected to live at least 12 more weeks.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have a lung condition that needed steroid treatment in the last 6 months.
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I have had a bone marrow transplant from another person.
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I have been treated with a drug that targets cancer cells and carries a specific toxin.
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I have had a liver transplant.
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My cancer has spread to my brain or is affecting the lining of my brain and spinal cord.
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I have lasting side effects from cancer treatment, but not hair loss or skin changes.
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I haven't taken any cancer drugs or been in a drug study within the last 4 weeks.
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I haven't had extensive radiotherapy in the last 4 weeks or targeted palliative radiotherapy in the last 2 weeks.
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I have pancreatitis or cirrhosis, but not mild cirrhosis (Child-Pugh A).
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I do not have any serious infections including HBV, HCV, or HIV.
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I haven't had any cancer other than my current one in the last 3 years.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 42 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~42 months
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Characterize the safety and tolerability of CUSP06 (Phase 1a and 1b)
Evaluate preliminary efficacy of CUSP06 as per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 (Phase 1b)
Secondary study objectives
Clinical benefit rate (CBR) as per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 (Phase 1a and 1b)
Disease control rate (DCR) as per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 (Phase 1a and 1b)
Duration of response (DoR) as per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 (Phase 1a and 1b)
+4 moreAwards & 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: Monotherapy Dose Finding - Phase 1aExperimental Treatment1 Intervention
Group II: Expansion as Monotherapy - Phase 1bExperimental Treatment1 Intervention
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Who is running the clinical trial?
OnCusp Therapeutics, Inc.Lead Sponsor