ZZ06 for Solid Tumors

Recruiting at 5 trial locations

Overseen By Shiqi Bai

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Changchun Intellicrown Pharmaceutical Co. LTD

Must not be taking: Steroids, Anticonvulsants, EGF inhibitors

Disqualifiers: CNS metastases, Cardiovascular disease, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: up to 28 weeks

60 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to test the safety and effectiveness of a new treatment, ZZ06, for adults with advanced solid tumors that are positive for EGFR (a protein that helps cells grow). Researchers seek to determine how well ZZ06 is tolerated and how it interacts with the body. Participants will receive varying doses of ZZ06 to identify the most effective amount. The study seeks individuals with an EGFR-positive tumor who have tried other treatments without success and have at least one measurable tumor. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive this new treatment.

Do I need to stop my current medications to join the trial?

The trial does not clearly specify if you need to stop taking your current medications. However, you cannot have had certain anticancer therapies or investigational agents within 4 weeks before starting the trial, except for tamoxifen in specific cases.

Is there any evidence suggesting that ZZ06 is likely to be safe for humans?

Research has shown that ZZ06 is in the early stages of testing to determine its safety for people with advanced solid tumors. Since this is early research, only a few people have tried ZZ06 so far. The main goal is to find out how much of the drug can be given safely and if it helps reduce tumors.

In these early tests, doctors closely monitor for any side effects. They also aim to find the best dose that balances benefits with potential risks. Currently, detailed information on how well people are handling ZZ06 is unavailable, but early-stage trials like this are essential for understanding safety.

Because ZZ06 is still in the first phase of testing, side effects are being carefully monitored. This stage helps doctors learn how the treatment works in the body and what dose might be safe. More research will provide a clearer picture of its safety over time. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Most treatments for solid tumors involve chemotherapy, radiation, or surgery, which aim to remove or shrink tumors. However, ZZ06 offers a novel approach by using a potentially more targeted therapy. Researchers are excited about ZZ06 because it is administered in multiple doses, ranging from 0.03 mg/kg to 1.00 mg/kg, and delivered twice weekly. This regimen allows for flexibility and precision in dosing, meaning it could be adjusted based on patient response, possibly leading to fewer side effects and improved outcomes. This innovative dosing strategy sets ZZ06 apart from conventional treatments and is a key reason why researchers are enthusiastic about its potential.

What evidence suggests that this trial's treatment, ZZ06, could be effective for advanced EGFR-positive solid tumors?

Research shows that ZZ06 targets a protein called EGFR, often found in high amounts in some cancers. Treatments focusing on EGFR have shown promise in studies by slowing down or even shrinking tumors. Although ZZ06 remains under testing, it is designed to block signals that promote tumor growth. Early signs suggest it might benefit individuals whose cancers haven't responded to other treatments. While data on its effectiveness is still being gathered, this treatment offers hope for those with advanced tumors with high levels of EGFR. Participants in this trial will receive different dosages of ZZ06 to evaluate its effectiveness and safety. ^{1 2 3 6 7}

Who Is on the Research Team?

Sanjay Goel, MD

Principal Investigator

Montefiore Medical Center

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

Patients must provide written informed consent prior to any study procedures

I have a sample of my tumor available for EGFR testing.

I am not pregnant or breastfeeding and agree to use birth control.

Exclusion Criteria

I had major surgery less than 4 weeks ago.

I have a serious heart condition.

My brain metastases are stable for 4 weeks without needing steroids or seizure medicine.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive ZZ06 at varying doses administered twice weekly in 28-day cycles, with an initial treatment course of 2 cycles and up to 6 additional cycles

up to 28 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

8 weeks

What Are the Treatments Tested in This Trial?

Interventions

• ZZ06

Trial Overview 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.

How Is the Trial Designed?

Group I: ZZ06 1.00 mg/kg dose group Experimental Treatment 1 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 group Experimental Treatment 1 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 group Experimental Treatment 1 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 group Experimental Treatment 1 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 group Experimental Treatment 1 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 group Experimental Treatment 1 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 group Experimental Treatment 1 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.

Who Is Running the Clinical Trial?

Changchun Intellicrown Pharmaceutical Co. LTD

Lead Sponsor

Trials

3

Recruited

240+

Covance

Industry Sponsor

Trials

124

Recruited

13,300+

Dr. Paul Kirchgraber

Covance

Chief Executive Officer since 2019

MD

Dr. Robert Dow

Covance

Chief Medical Officer since 2020

MD

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT04412616

ZZ06 in Adult Patients With Advanced Solid Tumor ... This is a Phase 1, Multicenter, Open-label study to assess the safety, tolerability and preliminary efficacy of ZZ06 in participants with all Adult Patients ...

2. kucancercenter.org kucancercenter.org/cancer-clinical-trials/find-trial/clinical-trial-results/study00145787

A Phase I, Multicenter, Open-label Study to Evaluate ... ... ZZ06 in Adult Patients with Advanced Solid Tumor Malignancies. Brief Summary ... By taking part in a clinical trial, you have access to potentially effective ...

3. clinconnect.io clinconnect.io/trials/NCT04412616

ZZ06 in Adult Patients With Advanced Solid Tumor - ClinConnect This study is for patients who have already tried standard treatments but did not see improvement or have no other options available.

4. ascopubs.org ascopubs.org/doi/10.1200/PO.24.00038

Fusion Challenges in Solid Tumors: Shaping the ... A recent study on rare and advanced tumors revealed that 51% of the tumors analyzed had ≥1 potentially actionable alteration. Nowadays, ...

5. cancer.gov cancer.gov/research/participate/clinical-trials/intervention/anti-egfr-monoclonal-antibody-zz06?pn=1

Clinical Trials Using Anti-EGFR Monoclonal Antibody ZZ06 NCI supports clinical trials that test new and more effective ways to treat cancer. Find clinical trials studying anti-egfr monoclonal antibody zz06.

6. trial.medpath.com trial.medpath.com/clinical-trial/533db8ca99b0617b/nct06933069-cmab017-solid-tumors-safety

Safety and Tolerability of CMAB017 In Patients With Advanced ... This is a multicenter, open-lable, phase Ia study of CMAB017 which is planned to enroll about 55 patients with advanced solid tumors.

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11371109/

Fusion Challenges in Solid Tumors This article provides a comprehensive overview of the actionability and clinical development of targeted agents aimed at driver fusions.