CPO-100 for Solid Tumors

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

126 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

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.

What data supports the effectiveness of the drug CPO-100 for solid tumors?

CPT-11, a component similar to CPO-100, has shown effectiveness in treating various cancers, such as breast and gastric cancer, by improving progression-free survival (the time during which the cancer does not get worse). This suggests potential benefits for CPO-100 in treating solid tumors. ^{1 2 3 4 5}

How is the drug CPO-100 different from other treatments for solid tumors?

CPO-100, also known as CPT-11, is unique because it is a camptothecin derivative that works by inhibiting topoisomerase-I, an enzyme important for DNA replication in cancer cells. This mechanism is different from many other cancer drugs, and it has shown effectiveness in treating various cancers, including gastrointestinal malignancies, by stopping tumor growth. ^{6 7 8 9 10}

Research Team

Study Officials

Principal Investigator

Conjupro Biotherapeutics, Inc.

Eligibility Criteria

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 18 years old or older.

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

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

Treatment Details

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.

Participant Groups

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

Findings from Research

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]

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 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]

References

1. Japan pubmed.ncbi.nlm.nih.gov

[Utility of CPT-11 as salvage chemotherapy for progressive or recurrent breast cancer patients with multiple drug resistance]. [2018]

2. United States 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. [2022]

3. England pubmed.ncbi.nlm.nih.gov

A randomized phase II clinical trial of tailored CPT-11 + S-1 vs S-1 in patients with advanced or recurrent gastric carcinoma as the first line chemotherapy. [2018]

4. China pubmed.ncbi.nlm.nih.gov

[Campto (CPT-11) treatment of advanced large intestinal cancer: clinical experience]. [2018]

5. United States pubmed.ncbi.nlm.nih.gov

Phase I study of CPT-11 and etoposide in patients with refractory solid tumors. [2018]

6. Japan pubmed.ncbi.nlm.nih.gov

[CPT-11 hepatic arterial infusion chemotherapy for metastatic liver tumor from gastric cancer]. [2018]

7. Greece pubmed.ncbi.nlm.nih.gov

Intraperitoneal versus intravenous CPT-11 for peritoneal seeding and liver metastasis. [2018]

8. England pubmed.ncbi.nlm.nih.gov

Cytotoxicity of CPT-11 for gastrointestinal cancer cells cultured on fixed-contact-sensitive plates. [2019]

9. Switzerland pubmed.ncbi.nlm.nih.gov

Antitumor effect of CPT-11, a camptothecin derivative, on human testicular tumor xenografts in nude mice. [2019]

10. Greece pubmed.ncbi.nlm.nih.gov

In vitro antitumor effect of topoisomerase-I inhibitor, CPT-11, on freshly isolated human gastric and colorectal cancer. [2018]