Study of A166 in Patients With Relapsed/Refractory Cancers Expressing HER2 Antigen or Having Amplified HER2 Gene

Phase 1 & 2

Waitlist Available

Research Sponsored by Klus Pharma Inc.

Eligibility Criteria Checklist

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

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up minimum of 21 days from date of enrollment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 24 months

Awards & highlights

No Placebo-Only Group

Summary

This trial tests A166, a new drug, on patients with HER2-positive cancers who haven't responded to other treatments. The drug aims to stop cancer cell growth by targeting a specific protein. A166 is a HER2-targeted therapy being tested for its effectiveness in treating resistant HER2 tumors.

Eligible Conditions

Hepatocellular Carcinoma
Breast cancer
Pancreatic Cancer
Oral Cancers
Colon Cancer
Stomach Cancer
Cholangiocarcinoma
Prostate Cancer
Lip Cancer
Breast Cancer
Head and Neck Cancers
Bladder Cancer
Rare Disease
Salivary Gland Cancer
Ovarian Cancer
Laryngeal Cancer
Rectal Cancer
Salivary Gland Tumors
Rare Diseases
Gastric Cancer
Colorectal Cancer
Cervical Cancer
Peritoneal Carcinoma
Lung Cancer
Tonsil Cancer
Mucoepidermoid Carcinoma
Solid Tumors
Bile Duct Cancer
Skin Cancer
Renal Cell Cancer
Tongue Cancer

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ minimum of 21 days from date of enrollment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 24 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~minimum of 21 days from date of enrollment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 24 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and minimum of 21 days from date of enrollment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 24 months for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Phase I: Maximum Tolerated Dose

Awards & Highlights

No Placebo-Only Group

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

Trial Design

5Treatment groups

Experimental Treatment

Group I: Phase II: • Cohort 4Experimental Treatment1 Intervention

All cancers other than breast cancer with low HER2 expression (Immunohistochemistry (IHC) 1+ and IHC 2+ without fluorescence in situ hybridization (FISH) confirmation) and HER2 positive (IHC2+ with FISH confirmation and Immunohistochemistry (IHC) 3+) cancers other than breast and gastric cancer. Treatment with A166 at recommended Phase II dose.

Group II: Phase II: • Cohort 3Experimental Treatment1 Intervention

HER2 low expressing (Immunohistochemistry (IHC) 1+ and IHC 2+ without fluorescence in situ hybridization (FISH) confirmation) breast cancer. Treatment with A166 at recommended Phase II dose.

Group III: Phase II: • Cohort 2Experimental Treatment1 Intervention

HER2 positive (Immunohistochemistry (IHC) 2+ with fluorescence in situ hybridization (FISH) confirmation and Immunohistochemistry (IHC) 3+) gastric cancer. Treatment with A166 at recommended Phase II dose.

Group IV: Phase II: • Cohort 1Experimental Treatment1 Intervention

HER2 positive (Immunohistochemistry (IHC) 2+ with fluorescence in situ hybridization (FISH) confirmation and Immunohistochemistry (IHC) 3+) breast cancer. Treatment with A166 at recommended Phase II dose.

Group V: Phase I: Dose EscalationExperimental Treatment1 Intervention

Six dose levels have been selected for evaluation in the Phase I part of the study: 0.3, 0.6, 1.2, 2.4, 3.6, and 4.8 mg/kg of A166

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

A166

2018

Completed Phase 2

~50

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