AVZO-1418 for Cancer

Recruiting at 7 trial locations

Overseen By Medical Information

Age: 18+

Sex: Any

Trial Phase: Phase 1 & 2

Sponsor: Avenzo Therapeutics, Inc.

Must not be taking: Steroids, IV antibiotics

Disqualifiers: Hypertension, CNS metastases, ILD, others

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

Compensation: Varies

Number of Visits: Unknown

430 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new cancer treatment called AVZO-1418. It aims to determine the safety and effectiveness of AVZO-1418 against advanced or spreading epithelial solid tumors. The trial includes different parts, with some testing AVZO-1418 alone and others in combination with other treatments. Candidates may qualify if they have a confirmed diagnosis of locally advanced or metastatic epithelial solid tumors and no uncontrolled high blood pressure or serious heart conditions. As a Phase 1 trial, participants may be among the first to receive this new treatment, aiding researchers in understanding its effects in people.

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

The trial information does not specify if you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

Is there any evidence suggesting that AVZO-1418 is likely to be safe for humans?

Research shows that AVZO-1418 is undergoing testing for safety and tolerability in treating advanced solid tumors. This marks the first human trial of AVZO-1418. The studies aim to assess how patients handle the treatment, both alone and in combination with other therapies.

As an early-stage study, the primary goal is to determine the safety of AVZO-1418 in humans. The treatment has demonstrated promising effects against tumors in lab tests, but data collection from human trials is just beginning. The study will help identify the safest dose and any potential side effects.

In summary, while AVZO-1418 has shown potential in lab studies, information on its effects in humans is still being gathered. This study is a crucial step in evaluating its safety. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Researchers are excited about AVZO-1418 for cancer because it offers a novel approach compared to existing treatments. Unlike traditional chemotherapy, which attacks all rapidly dividing cells, AVZO-1418 specifically targets cancer cells, potentially leading to fewer side effects. Additionally, AVZO-1418 is being tested both as a monotherapy and in combination with other therapies, providing flexibility in treatment options and the possibility of enhanced effectiveness. This targeted action and versatility are generating significant interest and hope for better outcomes in cancer treatment.

What evidence suggests that AVZO-1418 might be an effective treatment for cancer?

Research has shown that AVZO-1418, a new cancer treatment, shows promise in early studies. It targets proteins called EGFR and HER3, which are often overly active in some cancers. In lab tests, AVZO-1418 demonstrated strong effects against various solid tumors, including lung cancer. Early results suggest it might work well both as a monotherapy and in combination with other treatments. This trial will explore both approaches, offering hope that AVZO-1418 could provide a new option for patients with advanced cancers. ^{1 3 6 7 8}

Are You a Good Fit for This Trial?

This trial is for patients with advanced or metastatic epithelial solid tumors, such as lung and pancreatic cancer. Participants should have a tumor that has spread locally or to other parts of the body.

Inclusion Criteria

Other protocol-defined Inclusion criteria apply

My cancer is advanced and has spread, and it's one of the types listed in the study.

Measurable disease as assessed by Investigator using RECIST v1.1

Exclusion Criteria

History of drug-induced interstitial lung disease (ILD)

Other protocol-defined Exclusion criteria apply

I don't have active brain metastases and haven't needed steroids for them in the last 4 weeks.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Phase 1: Dose Escalation

Assess the safety and tolerability of AVZO-1418 and determine the maximum tolerated dose (MTD) and preliminary recommended Phase 2 dose (RP2D) as a monotherapy

Approximately 2 years

Phase 2: Dose Expansion

Assess the antitumor activity of AVZO-1418 as a monotherapy and potentially in combination therapy

Approximately 2 years

Follow-up

Participants are monitored for safety and effectiveness after treatment

Approximately 76 months

What Are the Treatments Tested in This Trial?

Interventions

• AVZO-1418

Trial Overview The study tests AVZO-1418 alone and in combination with two other agents in people with certain types of cancer. It aims to find out how safe it is, what dose works best, and if it can shrink tumors.

How Is the Trial Designed?

Group I: Phase 2, monotherapy Experimental Treatment 1 Intervention

Part A

Group II: Phase 2, combination Experimental Treatment 3 Interventions

Part B

Group III: Phase 1, monotherapy Experimental Treatment 1 Intervention

Group A

Group IV: Phase 1, combination Experimental Treatment 3 Interventions

Group B

Who Is Running the Clinical Trial?

Avenzo Therapeutics, Inc.

Lead Sponsor

Trials

1

Recruited

430+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT07038343

NCT07038343 | Study of AVZO-1418 as a Single Agent ... This first-in-human, Phase 1/2 study will aim to obtain safety and tolerability data when AVZO-1418 is administered intravenously to patients with locally ...

2. avenzotx.com avenzotx.com/pipeline-and-science/

Pipeline & Science The combination of a selective CDK4 inhibitor with a selective CDK2 inhibitor may lead to more durable responses and disease control in HR+/HER2- breast cancer ...

3. targetedonc.com targetedonc.com/view/fda-clears-ind-for-egfr-her3-bispecific-adc-avzo-1418-db-1418

FDA Clears IND for EGFR/HER3 Bispecific ADC AVZO- ... In vivo studies demonstrated robust antitumor efficacy across multiple solid tumor models, including a non–small cell lung cancer model ...

4. synapse.patsnap.com synapse.patsnap.com/article/fda-clears-avzo-1418-investigational-new-drug-application-by-avenzo-therapeutics

FDA Clears AVZO-1418 Investigational New Drug ... Preclinical research data on AVZO-1418 was unveiled at the American Association for Cancer Research (AACR) Annual Conference held in April 2025.

5. excedr.com excedr.com/blog/avenzo-therapeutics-raises-capital-to-transform-cancer-treatment

Avenzo Therapeutics Raises Capital to Transform Cancer ... Data presented at AACR showed efficacy both as monotherapy and in combination with AVZO-021. Each compound's selectivity is confirmed using ...

6. avenzotx.com avenzotx.com/press-releases/avenzo-therapeutics-initiates-phase-1-2-clinical-study-of-avzo-1418-a-potential-best-in-class-novel-egfr-her3-bispecific-antibody-drug-conjugate/

Avenzo Therapeutics Initiates Phase 1/2 Clinical Study of ... AVZO-1418 is a potential best-in-class, novel EGFR/HER3 bispecific ADC that is being studied in a Phase 1/2 study for the treatment of advanced solid tumors.

7. biospace.com biospace.com/press-releases/avenzo-therapeutics-granted-fast-track-designation-for-avzo-1418-a-potential-best-in-class-egfr-her3-bispecific-antibody-drug-conjugate-for-the-treatment-of-patients-with-egfr-mutated-tki-pretreated-nsclc

Avenzo Therapeutics Granted Fast Track Designation ... AVZO-1418 is currently being studied in a Phase 1/2 first-in-human, open-label clinical study designed to assess the safety, tolerability, and ...

8. dana-farber.org dana-farber.org/clinical-trials/25-716

A phase 1/2, first-in-human study to assess the safety, ... A phase 1/2, first-in-human study to assess the safety, tolerability, pharmacokinetics, pharmacodynamics, and antitumor activity of AVZO-1418 as a single agent ...