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CPO-100 for Solid Tumors
Phase 1
Recruiting
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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up screening to up to 4 years
Awards & highlights
Study Summary
This trial is testing a new drug to treat cancer. It will see if the drug is safe and effective.
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.Check my eligibility
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.See study design
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 belowSelect...
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.
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
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
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 outcome measures
Area Under the Curve (AUC0-t) for CPO-100
Area Under the Curve (AUC0-∞) for CPO-100
Cmax for CPO-100
+5 moreTrial 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
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 solid tumors of gastric, head and neck, lung, and ovarian.
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).
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Who is running the clinical trial?
Conjupro Biotherapeutics, Inc.Lead Sponsor
7 Previous Clinical Trials
145 Total Patients Enrolled
CSPC ZhongQi Pharmaceutical Technology Co., Ltd.Industry Sponsor
141 Previous Clinical Trials
19,144 Total Patients Enrolled
Study OfficialsStudy DirectorConjupro Biotherapeutics, Inc.
3 Previous Clinical Trials
36 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have liver, kidney, or pancreatic disease.I finished my last chemotherapy less than 14 days ago or still have noticeable side effects.I regularly use corticosteroids or medications to increase red blood cell count.My brain cancer has not been treated yet.My major organs and blood clotting ability are functioning well.My cancer has spread to the lining of my brain or spinal cord, or is pressing on my spinal cord.I have a measurable tumor that is not prostate cancer.I use herbal medications.I am 18 years old or older.I am willing and able to follow the study's requirements.My cancer type has been confirmed by a pathology test for my treatment group.I received wide field radiotherapy within the last 28 days or limited field radiation for palliation within the last 7 days.I do not have a serious infection right now.I am using effective birth control methods.I have an active hepatitis B or C infection.My cancer is advanced or has spread to other parts of my body.I have tried at least 2 standard treatments without success, or there are no standard treatments left for me.I haven't taken any experimental drugs in the last 28 days or 5 half-lives before starting CPO-100.I have not had any heart diseases in the last 6 months.I have not been treated for any invasive cancer in the last 3 years.I haven't had major surgery in the last 28 days.I am not taking any strong CYP3A4 inhibitors or inducers.I can take care of myself and am up and about more than half of my waking hours.
Research Study Groups:
This trial has the following groups:- Group 1: Part B: Cohort 4
- Group 2: Part B: Cohort 3
- Group 3: Part A-1: Dose Escalation
- Group 4: Part A-2: Dose escalation
- Group 5: Part B: Cohort 1
- Group 6: Part B: Cohort 2
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Has CPO-100 received regulatory endorsement from the FDA?
"CPO-100 is still in its initial stages of clinical trials, so the safety rating for this medication falls at 1. This reflects that there is only limited data regarding efficacy and safety currently available."
Answered by AI
What objectives are medical professionals hoping to attain through this experiment?
"This clinical trial will primarily measure the number of patients who experience dose limiting toxicities (DLTs) at the end of cycle one. Secondary objectives include assessing Tmax, Cmax, and Duration of Response for CPO-100."
Answered by AI
At how many facilities are the results of this research being collected?
"Currently, 8 different medical sites are running this trial. Locations include Fairfax, Las Vegas and Lyndhurst in addition to 5 other cities; it is recommended that patients opt for the most proximate centre to minimise travel requirements."
Answered by AI
Is this research endeavor still open to new participants?
"Affirmative. Clinicaltrials.gov displays that this study is currently recruiting; it was first posted on March 24th 2021 and recently modified on September 6th 2022. The team behind the trial hopes to find 126 participants at 8 different clinical sites."
Answered by AI
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