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Anti-tumor antibiotic

Monotherapy Dose Finding - Phase 1a 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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 42 months

Awards & highlights

Study 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.Check my eligibility

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.See study design

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 below

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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.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 42 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~42 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 42 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

Characterize the safety and tolerability of CUSP06 (Phase 1a and 1b)

Determine the recommended dose for expansion (RDE) of CUSP06 (Phase 1a)

Evaluate preliminary efficacy of CUSP06 as per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 (Phase 1b)

Secondary outcome measures

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)

+10 more

Trial Design

2Treatment groups

Experimental Treatment

Group I: Monotherapy Dose Finding - Phase 1aExperimental Treatment1 Intervention

Group II: Expansion as Monotherapy - Phase 1bExperimental Treatment1 Intervention

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

OnCusp Therapeutics, Inc.Lead Sponsor

Frequently Asked Questions

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

Are there currently ongoing patient enrollments for this clinical trial?

"As per clinicaltrials.gov, recruitment for this particular trial has ceased. The listing was first published on 2/1/2024 and most recently revised on 2/8/2024. However, it is worth noting that while this study no longer seeks participants, there are currently 1106 active studies actively seeking candidates."

Answered by AI

What risks are associated with Monotherapy Dose Finding - Phase 1a in patients?

"Given that this is a Phase 1 clinical trial, the safety rating for Monotherapy Dose Finding - Phase 1a has been evaluated as a score of 1 by our team at Power. This assessment reflects the limited data available supporting both safety and efficacy at this early stage of research."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

A Study of CUSP06 in Patients With Platinum-Refractory/Resistant Ovarian Cancer and Other Advanced Solid Tumors

2024. "A Study of CUSP06 in Patients With Platinum-Refractory/Resistant Ovarian Cancer and Other Advanced Solid Tumors". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06234423.

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