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 study, the first clinical trial of AVZO-1418, aims to determine the safety, tolerability, pharmacokinetics, pharmacodynamics, maximum tolerated dose, and antitumor activity of AVZO-1418 when administered intravenously as a monotherapy and potentially in combination therapy to patients with locally advanced or metastatic epithelial solid tumors.

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+