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CPO-100 for Solid Tumors

Phase 1

Waitlist Available

Research Sponsored by Conjupro Biotherapeutics, Inc.

Eligibility Criteria Checklist

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

Must have

Having at least one measurable target lesion present and documented by RECIST 1.1 for each cancer other than prostate cancer

Presence of a pathologically documented locally advanced or metastatic solid tumor cancer

Must not have

Acute or chronic liver, renal, or pancreatic disease

Most recent chemotherapy ≤14 days or residual NCI CTCAE greater than Grade 1 chemotherapy-related side effects

Timeline

Screening 3 weeks

Treatment Varies

Follow Up screening to up to 4 years

Awards & highlights

No Placebo-Only Group

Summary

This trial tests a new drug called CPO-100 for adults with advanced cancers. It aims to find the safest dose and see if it can shrink tumors. The drug is given through an IV periodically, and the study looks at how well patients tolerate it and its initial effectiveness.

Who is the study for?

Adults with advanced solid tumors who have tried at least two other treatments without success can join this trial. They must be able to perform daily activities with minimal assistance, use effective contraception, and not donate sperm. People are excluded if they've had recent chemotherapy or radiation, uncontrolled health conditions like high blood pressure or active infections, known allergies to similar drugs, heart problems within the last six months, untreated brain metastases, or are pregnant.

What is being tested?

The study is testing CPO-100 in patients with advanced solid tumors. It's a Phase 1 trial where participants receive CPO-100 intravenously over cycles of three weeks on treatment followed by one week off. The goal is to find out how safe it is and what effects it has on their cancer.

What are the potential side effects?

While specific side effects for CPO-100 aren't listed here as it's an early-phase trial assessing safety and tolerability, common side effects from similar cancer treatments include fatigue, nausea, allergic reactions, changes in blood counts leading to increased infection risk or bleeding tendencies.

Eligibility Criteria

Inclusion Criteria

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

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I have a measurable tumor that is not prostate cancer.

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My cancer is advanced or has spread to other parts of my body.

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I have tried at least 2 standard treatments without success, or there are no standard treatments left for me.

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I can take care of myself and am up and about more than half of my waking hours.

Exclusion Criteria

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

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I have liver, kidney, or pancreatic disease.

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I finished my last chemotherapy less than 14 days ago or still have noticeable side effects.

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I regularly use corticosteroids or medications to increase red blood cell count.

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My brain cancer has not been treated yet.

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My cancer has spread to the lining of my brain or spinal cord, or is pressing on my spinal cord.

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I do not have a serious infection right now.

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I have an active hepatitis B or C infection.

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I haven't taken any experimental drugs in the last 28 days or 5 half-lives before starting CPO-100.

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I have not had any heart diseases in the last 6 months.

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I haven't had major surgery in the last 28 days.

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I am not taking any strong CYP3A4 inhibitors or inducers.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ screening to up to 4 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~screening to up to 4 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and screening to up to 4 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Part A-1: Number of subjects with Dose Limiting Toxicities (DLTs)

Part A-2: Number of subjects with Dose Limiting Toxicities (DLTs) when prophylactic use of G-CSF is allowed during Cycle 1

Part B: Dose Expansion - Incidence and severity of Adverse Events

Secondary study objectives

Area Under the Curve (AUC0-t) for CPO-100

Area Under the Curve (AUC0-∞) for CPO-100

Cmax for CPO-100

+5 more

Awards & Highlights

No Placebo-Only Group

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

Trial Design

6Treatment groups

Experimental Treatment

Group I: Part B: Cohort 4Experimental Treatment1 Intervention

CPO-100 administered intravenously in cycles of 3 weekly doses with 1 week rest (1 cycle = 4 weeks) at the recommended Phase 2 dose (X mg/m2) in 15 patients with either ovarian or/and breast cancer who have failed prior taxane treatment (ie, either progressed on a taxane regimen or within 6 months of receiving a taxane regimen).

Group II: Part B: Cohort 3Experimental Treatment1 Intervention

CPO-100 administered intravenously in cycles of 3 weekly doses with 1 week rest (1 cycle = 4 weeks) at the recommended Phase 2 dose (X mg/m2) in 15 patients with taxane naïve advanced prostate cancer.

Group III: Part B: Cohort 2Experimental Treatment1 Intervention

CPO-100 administered intravenously in cycles of 3 weekly doses with 1 week rest (1 cycle = 4 weeks) at the recommended Phase 2 dose (X mg/m2) in 15 patients with taxane naïve advanced breast cancer.

Group IV: Part B: Cohort 1Experimental Treatment1 Intervention

Group V: Part A-2: Dose escalationExperimental Treatment1 Intervention

CPO-100 administered intravenously in cycles of 3 weekly doses with 1 week rest (1 cycle = 4 weeks) with the option to administer G-CSF in cycle one. Starting dose will be 45 mg/m2.

Group VI: Part A-1: Dose EscalationExperimental Treatment1 Intervention

CPO-100 administered intravenously in cycles of 3 weekly doses with 1 week rest (1 cycle = 4 weeks).

0 / 15Eligibility criteria met