What is the mechanism of action of this treatment?

Antibody-drug conjugates (ADCs) like CPO301 target specific cancer cells by using an antibody to bind to a particular antigen on the cancer cell surface, delivering a cytotoxic agent directly into the cell. This targeted approach minimizes damage to healthy cells, reducing side effects and improving treatment efficacy. Other common treatments include chemotherapy, which kills rapidly dividing cells but can affect both cancerous and healthy cells, and immunotherapy, which enhances the body's immune system to fight cancer. Understanding these mechanisms is crucial for tailoring therapy to individual patient needs and improving outcomes.

What side effects are associated with this type of intervention?

Antibody drug conjugates (ADCs) like CPO301, which target specific cancer cells and deliver cytotoxic agents, commonly cause side effects such as fatigue, nausea, peripheral neuropathy, and hematologic toxicities (e.g., neutropenia, anemia). Other targeted therapies and immunotherapies may also lead to immune-related adverse events, including pneumonitis, colitis, and endocrinopathies. General chemotherapy side effects include hair loss, gastrointestinal issues (e.g., diarrhea, constipation), and increased risk of infections due to immunosuppression.

What prior FDA approvals exist?

Antibody-drug conjugates (ADCs) have been approved by the FDA for various cancer treatments due to their targeted approach in delivering cytotoxic agents directly to cancer cells. Notable ADCs include Brentuximab vedotin (Adcetris) for Hodgkin lymphoma and systemic anaplastic large cell lymphoma, and Trastuzumab emtansine (Kadcyla) for HER2-positive metastatic breast cancer. These treatments exemplify the efficacy of ADCs in targeting specific cancer cells while minimizing damage to healthy tissues, similar to the investigational drug CPO301.

What other types of research exist?

Promising alternatives to CPO301 for cancer treatment in 2024 include: 1) Atezolizumab combined with carboplatin and etoposide for extensive-stage small cell lung cancer, which has shown improved overall survival and progression-free survival. 2) Durvalumab plus platinum-etoposide for extensive-stage small cell lung cancer, which has also demonstrated improved survival outcomes. 3) Pembrolizumab combined with chemotherapy for recurrent or metastatic cervical cancer, which has shown significant improvements in progression-free survival and overall survival. 4) Bevacizumab combined with platinum-based chemotherapy followed by maintenance bevacizumab for platinum-sensitive recurrent epithelial ovarian cancer, which has shown efficacy in prolonging progression-free survival.

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Monoclonal Antibodies

CPO301 for Cancer

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

At least 1 measurable target lesion present and documented by CT or MRI according to RECIST v1.1

In Part A, patients with solid tumors including but not limited to NSCLC (adenocarcinoma and squamous cell carcinoma), breast cancer, KRAS-wild type colorectal cancer, and head & neck cancer based on previous biopsy result

Must not have

Known, active, or uncontrolled central nervous system (CNS) metastasis or carcinomatous meningitis

Timeline

Screening 3 weeks

Treatment Varies

Follow Up through study completion, an average of 1 year

Awards & highlights

No Placebo-Only Group

Summary

This trial tests CPO301, a drug that targets and kills cancer cells, in adults with advanced or metastatic solid tumors who have limited treatment options. The drug uses an antibody to find cancer cells and deliver chemotherapy directly to them.

Who is the study for?

Adults with advanced or metastatic solid tumors, including lung cancer, who have progressed after prior treatments or can't tolerate them. Participants must be over 18, have a life expectancy of more than 12 weeks and at least one measurable tumor. Those with specific EGFR mutations in their lung cancer are also eligible.

What is being tested?

CPO301 is being tested for safety and effectiveness in two parts: first to find the right dose (Part A) and then to test it on non-small cell lung cancer patients with EGFR mutations and other cancers (Part B). It's given by IV every three weeks.

What are the potential side effects?

Possible side effects of CPO301 include reactions related to the immune system since it's an antibody drug conjugate. Specific side effects will be monitored but may involve typical chemotherapy-related issues like fatigue, nausea, or allergic reactions.

Eligibility Criteria

Inclusion Criteria

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

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I have at least one tumor that can be measured on a scan.

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I have a solid tumor such as lung, breast, colorectal (without KRAS mutation), or head & neck cancer.

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I am fully active or restricted in physically strenuous activity but can do light work.

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I am 18 years old or older.

Exclusion Criteria

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

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I do not have active brain metastasis or carcinomatous meningitis.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ through study completion, an average of 1 year

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~through study completion, an average of 1 year

This trial's timeline: 3 weeks for screening, Varies for treatment, and through study completion, an average of 1 year for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Safety and tolerability at RP2D of CPO301 as monotherapy

To determine the dose to be used in Part B (RP2D)

Secondary study objectives

Efficacy assessment

Expression of anti-drug antibody (ADA)

Pharmacokinetics (PK)

Other study objectives

Parts A and B, Exploratory: Correlatives

Awards & Highlights

No Placebo-Only Group

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

Trial Design

2Treatment groups

Experimental Treatment

Group I: Part B, Dose ExpansionExperimental Treatment1 Intervention

Participants receive CPO301 at the recommended phase 2 dose (RP2D) determined in Part A, administered by IVI every 3 weeks (Q3W), with 21 days as a treatment cycle.

Group II: Part A, Dose EscalationExperimental Treatment1 Intervention

Participants receive escalating doses of CPO301 of 0.6 mg/kg, 1.8mg/kg, 3.6 mg/kg, 4.8 mg/kg, 6.4 mg/kg and 8 mg/kg administered by IVI every 3 weeks (Q3W), with 21 days as a treatment cycle.

0 / 5Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Antibody-drug conjugates (ADCs) like CPO301 target specific cancer cells by using an antibody to bind to a particular antigen on the cancer cell surface, delivering a cytotoxic agent directly into the cell. This targeted approach minimizes damage to healthy cells, reducing side effects and improving treatment efficacy. Other common treatments include chemotherapy, which kills rapidly dividing cells but can affect both cancerous and healthy cells, and immunotherapy, which enhances the body's immune system to fight cancer. Understanding these mechanisms is crucial for tailoring therapy to individual patient needs and improving outcomes.