What is the mechanism of action of this treatment?

The most common treatments for solid tumors include chemotherapy, targeted therapy, and immunotherapy. Chemotherapy works by killing rapidly dividing cells, but it can also affect healthy cells, leading to side effects. Targeted therapies, such as EGFR inhibitors, specifically block the epidermal growth factor receptor (EGFR) pathway, which is often overactive in certain cancers. This inhibition prevents cancer cell proliferation and survival. Immunotherapy boosts the body's immune system to recognize and destroy cancer cells. For patients with solid tumors, especially those with EGFR-positive malignancies, targeted therapies like EGFR inhibitors offer a more precise treatment option with potentially fewer side effects compared to traditional chemotherapy. This precision is crucial as it can lead to better outcomes and improved quality of life.

What side effects are associated with this type of intervention?

The most common treatments for solid tumors, particularly those targeting the EGFR pathway, such as gefitinib and erlotinib, often result in side effects including diarrhea, rash, nausea, and dry skin. Chemotherapy, another common treatment, can lead to neutropenia, fatigue, and gastrointestinal issues. These side effects are important considerations for patients undergoing treatment for solid tumors.

What prior FDA approvals exist?

FDA-approved EGFR inhibitors for the treatment of solid tumors include erlotinib, gefitinib, afatinib, and osimertinib, primarily used in non-small cell lung cancer (NSCLC) with specific EGFR mutations. These drugs block the EGFR pathway, which is often overactive in various solid tumors, thereby inhibiting tumor cell growth and survival. The trial ZZ06 is exploring a new agent targeting the EGFR pathway, potentially expanding treatment options for patients with advanced EGFR-positive solid tumors.

What other types of research exist?

Promising alternatives to ZZ06 for EGFR pathway inhibition in solid tumors include osimertinib, a third-generation EGFR inhibitor, and combination therapies such as EGFR inhibitors with immune checkpoint inhibitors (e.g., pembrolizumab) or anti-angiogenic agents (e.g., bevacizumab). These alternatives have shown efficacy in clinical trials and may offer improved outcomes for patients.

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Monoclonal Antibodies

ZZ06 for Solid Tumors

Phase 1

Waitlist Available

Led By Sanjay Goel, MD

Research Sponsored by Changchun Intellicrown Pharmaceutical Co. LTD

Eligibility Criteria Checklist

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

Must have

Age ≥ 18 years

Eastern Cooperative Oncology Group performance status of 0 or 1

Must not have

Major surgery ≤ 4 weeks

Clinically significant cardiovascular disease

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 36 weeks

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a new drug called ZZ06 in adults with advanced cancers that haven't responded to other treatments. The goal is to see if ZZ06 is safe, how the body handles it, and if it can help reduce tumor size.

Who is the study for?

Adults over 18 with advanced solid tumors positive for EGFR, who've exhausted standard treatments or have none available. They must be relatively healthy, not pregnant, agree to use contraception, and can't have active brain metastases or recent heart attacks. Prior treatment targeting EGF within 6 months is a disqualifier.

What is being tested?

The trial tests ZZ06's safety and effectiveness in treating EGFR-positive solid tumors. It aims to find the highest dose patients can tolerate without severe side effects while also studying how the drug behaves in the body and its impact on tumor size.

What are the potential side effects?

Specific side effects of ZZ06 aren't listed but may include typical reactions to cancer drugs such as nausea, fatigue, skin reactions, blood count changes leading to increased infection risk or bleeding problems. Organ-specific inflammation could also occur.

Eligibility Criteria

Inclusion Criteria

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

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I am 18 years old or older.

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I am fully active or can carry out light work.

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My blood, kidney, and liver tests meet the required health standards.

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My cancer is EGFR positive and has worsened despite treatment or lacks a standard treatment.

Exclusion Criteria

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

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I had major surgery less than 4 weeks ago.

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I have a serious heart condition.

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I do not have any serious ongoing infections.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 36 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 36 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 36 weeks for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Incidence of abnormal laboratory test results

Physical Examination

ZZ06 AEs

Secondary study objectives

PK parameters: Area under curve (AUC)

PK parameters: Clearance rate (CL)

PK parameters: Cmax

+2 more

Awards & Highlights

No Placebo-Only Group

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

Trial Design

7Treatment groups

Experimental Treatment

Group I: ZZ06 1.00 mg/kg dose groupExperimental Treatment1 Intervention

ZZ06 1.00 mg/kg will be administered twice weekly.A cycle is defined as continuous treatment for 28 days, and the initial treatment course is 2 cycles. Patients can receive up to 6 additional cycles unless disease progression, unacceptable toxicity, or other protocol specified stopping criteria occur. After 6 cycles, additional cycles may be given upon request by the Investigator and approval by the Medical Monitor.

Group II: ZZ06 0.70 mg/kg dose groupExperimental Treatment1 Intervention

ZZ06 0.70 mg/kg will be administered twice weekly.A cycle is defined as continuous treatment for 28 days, and the initial treatment course is 2 cycles. Patients can receive up to 6 additional cycles unless disease progression, unacceptable toxicity, or other protocol specified stopping criteria occur. After 6 cycles, additional cycles may be given upon request by the Investigator and approval by the Medical Monitor.

Group III: ZZ06 0.39 mg/kg dose groupExperimental Treatment1 Intervention

ZZ06 0.39 mg/kg will be administered twice weekly.A cycle is defined as continuous treatment for 28 days, and the initial treatment course is 2 cycles. Patients can receive up to 6 additional cycles unless disease progression, unacceptable toxicity, or other protocol specified stopping criteria occur. After 6 cycles, additional cycles may be given upon request by the Investigator and approval by the Medical Monitor.

Group IV: ZZ06 0.22 mg/kg dose groupExperimental Treatment1 Intervention

ZZ06 0.22 mg/kg will be administered twice weekly.A cycle is defined as continuous treatment for 28 days, and the initial treatment course is 2 cycles. Patients can receive up to 6 additional cycles unless disease progression, unacceptable toxicity, or other protocol specified stopping criteria occur. After 6 cycles, additional cycles may be given upon request by the Investigator and approval by the Medical Monitor.

Group V: ZZ06 0.12 mg/kg dose groupExperimental Treatment1 Intervention

ZZ06 0.12 mg/kg will be administered twice weekly.A cycle is defined as continuous treatment for 28 days, and the initial treatment course is 2 cycles. Patients can receive up to 6 additional cycles unless disease progression, unacceptable toxicity, or other protocol specified stopping criteria occur. After 6 cycles, additional cycles may be given upon request by the Investigator and approval by the Medical Monitor.

Group VI: ZZ06 0.06 mg/kg dose groupExperimental Treatment1 Intervention

ZZ06 0.06 mg/kg will be administered twice weekly.A cycle is defined as continuous treatment for 28 days, and the initial treatment course is 2 cycles. Patients can receive up to 6 additional cycles unless disease progression, unacceptable toxicity, or other protocol specified stopping criteria occur. After 6 cycles, additional cycles may be given upon request by the Investigator and approval by the Medical Monitor.

Group VII: ZZ06 0.03 mg/kg dose groupExperimental Treatment1 Intervention

ZZ06 0.03 mg/kg will be administered twice weekly.A cycle is defined as continuous treatment for 28 days, and the initial treatment course is 2 cycles. Patients can receive up to 6 additional cycles unless disease progression, unacceptable toxicity, or other protocol specified stopping criteria occur. After 6 cycles, additional cycles may be given upon request by the Investigator and approval by the Medical Monitor.

0 / 7Eligibility 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

The most common treatments for solid tumors include chemotherapy, targeted therapy, and immunotherapy. Chemotherapy works by killing rapidly dividing cells, but it can also affect healthy cells, leading to side effects. Targeted therapies, such as EGFR inhibitors, specifically block the epidermal growth factor receptor (EGFR) pathway, which is often overactive in certain cancers. This inhibition prevents cancer cell proliferation and survival. Immunotherapy boosts the body's immune system to recognize and destroy cancer cells. For patients with solid tumors, especially those with EGFR-positive malignancies, targeted therapies like EGFR inhibitors offer a more precise treatment option with potentially fewer side effects compared to traditional chemotherapy. This precision is crucial as it can lead to better outcomes and improved quality of life.

Breast Cancer Resistance to Cyclin-Dependent Kinases 4/6 Inhibitors: Intricacy of the Molecular Mechanisms.Towards pathway-centric cancer therapies via pharmacogenomic profiling analysis of ERK signalling pathway.