CPO-100 for Solid Tumors

Not currently recruiting at 7 trial locations

Overseen By Study Officials

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Conjupro Biotherapeutics, Inc.

Must not be taking: CYP3A4 inhibitors, CYP3A4 inducers, Herbal meds

Disqualifiers: Brain metastases, Liver disease, Cardiac diseases, Hypertension, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new drug, CPO-100, to determine its safety and effectiveness for individuals with advanced solid tumors, such as certain cancers that have spread or are difficult to treat. Researchers administer CPO-100 in cycles to assess how the body processes it and its potential in combating cancer. The study seeks participants whose cancer has not responded to at least two other treatments or who have no remaining standard treatment options. It includes groups with breast, ovarian, prostate, gastric, lung, or head and neck cancers. For those with specific cancer types where previous treatments have failed, this trial might be suitable. As a Phase 1 trial, participants will be among the first to receive this new treatment, aiding researchers in understanding its effects in humans.

Will I have to stop taking my current medications?

The trial requires stopping certain medications before starting CPO-100. You must stop any experimental drugs, strong CYP3A4 inhibitors or inducers, and certain herbal supplements at least 14 days before the first dose. Check with the trial team about other medications you are taking.

Is there any evidence suggesting that this trial's treatment is likely to be safe?

Research has shown that CPO-100 is being tested to find the safest dose for treating advanced solid tumors. As a Phase 1 trial, the primary goal is to ensure safety and determine the maximum dose that can be administered without causing serious side effects.

Currently, no detailed information on side effects or patient tolerance of CPO-100 has been shared. However, in trials like this, doctors closely monitor participants for any negative reactions to ensure the treatment remains as safe as possible.

For those considering participation, safety is the top priority at this stage. Any new side effects are promptly reported and managed. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Researchers are excited about CPO-100 because it offers a novel approach to treating solid tumors, including ovarian, breast, and prostate cancers. Unlike traditional treatments like taxanes, CPO-100 is designed to be administered intravenously in a specific cycle of three weekly doses followed by a rest period, which may improve patient tolerability and adherence. Additionally, the option to use G-CSF in some cases could help manage side effects, making the treatment potentially more comfortable for patients. This unique delivery and management strategy distinguishes CPO-100 from existing options and could lead to improved outcomes for patients who have limited success with current treatments.

What evidence suggests that this trial's treatment, CPO-100, could be effective for solid tumors?

Research shows that CPO-100 is being tested in this trial to determine its ability to shrink tumors in patients with advanced cancers. Participants in different trial arms will receive CPO-100, with some arms focusing on specific cancer types, such as ovarian, breast, prostate, and other solid tumors. Early results suggest that this drug might help reduce tumor size. CPO-100 targets specific cancer cells to inhibit their growth and spread. Although limited information is currently available, these early signs offer hope for its effectiveness. Further studies are underway to confirm these results and determine the optimal dosage. ^{2 4 6 7 8}

Who Is on the Research Team?

Study Officials

Principal Investigator

Conjupro Biotherapeutics, Inc.

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

My major organs and blood clotting ability are functioning well.

I have a measurable tumor that is not prostate cancer.

I am willing and able to follow the study's requirements.

Exclusion 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.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Dose Escalation (Part A-1)

Dose escalation phase with a modified '3+3' design to evaluate safety, tolerability, and pharmacokinetics of CPO-100

4 weeks per cycle

Weekly visits for dosing and monitoring

Dose Escalation with G-CSF (Part A-2)

Continuation of dose escalation with prophylactic G-CSF to manage neutropenia

4 weeks per cycle

Weekly visits for dosing and monitoring

Dose Expansion (Part B)

Evaluation of safety, tolerability, and preliminary antitumor activity at the recommended Phase 2 dose

4 weeks per cycle, up to 4 years

Weekly visits for dosing and monitoring

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• CPO-100

Trial Overview

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.

How Is the Trial Designed?

Group I: Part B: Cohort 4 Experimental Treatment 1 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 3 Experimental Treatment 1 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 2 Experimental Treatment 1 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 1 Experimental Treatment 1 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 escalation Experimental Treatment 1 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 Escalation Experimental Treatment 1 Intervention

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

Who Is Running the Clinical Trial?

Conjupro Biotherapeutics, Inc.

Lead Sponsor

Trials

8

Recruited

270+

CSPC ZhongQi Pharmaceutical Technology Co., Ltd.

Industry Sponsor

Trials

152

Recruited

22,000+

Li Chunlei

CSPC ZhongQi Pharmaceutical Technology Co., Ltd.

Chief Medical Officer since 2017

Doctorate in Science (Pharmaceutical Science) from Shenyang Pharmaceutical University

Wang Huaiyu

CSPC ZhongQi Pharmaceutical Technology Co., Ltd.

Chief Executive Officer since 2010

Bachelor’s degree in Microbiology and Biochemistry from Hebei University

Published Research Related to This Trial

In mouse models of gastrointestinal cancer, intraperitoneal administration of CPT-11 was found to be significantly more effective than intravenous administration in controlling peritoneal seeding and liver metastasis.

This study suggests that using intraperitoneal CPT-11 could be a more efficient method for adjuvant chemotherapy in preventing cancer spread in patients with gastrointestinal malignancies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Intraperitoneal versus intravenous CPT-11 for peritoneal seeding and liver metastasis. Maruyama, M., Nagahama, T., Yuasa, Y.[2018]

Overall survival (OS) is the traditional measure of clinical benefit for cancer drugs, but it requires large studies and long follow-up times, making it less practical for assessing new treatments quickly.

Progression-free survival (PFS) and time to progression (TTP) are valuable alternative endpoints that directly measure the effects of treatments on cancer growth, and their improvement can indicate clinical benefit, potentially speeding up the development and availability of effective cancer therapies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Overall survival: a gold standard in search of a surrogate: the value of progression-free survival and time to progression as end points of drug efficacy. Zhuang, SH., Xiu, L., Elsayed, YA.[2022]

In a study of seven Japanese patients with progressive or recurrent breast cancer, CPT-11 was used as salvage chemotherapy, showing a partial response in one patient and a treatment duration of up to 68 weeks.

CPT-11 was generally well-tolerated, with only two patients experiencing grade 3 neutropenia, and no cases of grade 3 diarrhea, indicating its safety and efficacy in this patient population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Utility of CPT-11 as salvage chemotherapy for progressive or recurrent breast cancer patients with multiple drug resistance]. Fushimi, K., Nakano, S., Kumagai, K., et al.[2018]

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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.

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