← Back to Search

Monoclonal Antibodies

A166 for Breast Cancer

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 every 3 weeks 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

Study Summary

This trial will test A166, a new drug, on patients with HER2-expressing or amplified cancer who have progressed on or did not respond to available standard therapies.

Eligible Conditions
  • Breast Cancer
  • Bladder Cancer
  • Lip Cancer
  • Laryngeal Cancer
  • Rectal Cancer
  • Salivary Gland Tumors
  • Oral Cancers
  • Gastric Adenocarcinoma
  • Rare Diseases
  • Gastric Cancer
  • Colorectal Cancer
  • Cervical Cancer
  • Cholangiocarcinoma
  • Peritoneal Carcinoma
  • Lung Cancer
  • Tonsil Cancer
  • Mucoepidermoid Carcinoma
  • Solid Tumors
  • Bile Duct Cancer
  • Urologic Cancers
  • Skin Cancer
  • Liver Cancer
  • Renal Cell Cancer
  • Prostate Cancer
  • Ovarian Cancer
  • Tongue Cancer
  • Pancreatic Cancer
  • Salivary Gland Cancer
  • Head and Neck Cancers

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~every 3 weeks 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 every 3 weeks 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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Phase I: Maximum Tolerated Dose
Secondary outcome measures
Phase I Area under the serum or plasma concentration time curve from 0 to infinity (AUC[0-∞]).
Phase I Clearance (CL).
Phase I Maximum observed serum or plasma concentration (Cmax).
+6 more

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

Find a Location

Who is running the clinical trial?

Klus Pharma Inc.Lead Sponsor
3 Previous Clinical Trials
910 Total Patients Enrolled
1 Trials studying Breast Cancer
430 Patients Enrolled for Breast Cancer
Jordi Rodon Ahnert, MD, PhDStudy ChairMD Anderson
2 Previous Clinical Trials
534 Total Patients Enrolled
1 Trials studying Breast Cancer
430 Patients Enrolled for Breast Cancer

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Can new patients still join the research project?

"Unfortunately, this specific clinical trial is not currently looking for new participants. Although, it is important to note that there are over 11 thousand other medical trials actively recruiting patients right now."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Study of A166 in Patients With Relapsed/Refractory Cancers Expressing HER2 Antigen or Having Amplified HER2 Gene
2018. "Study of A166 in Patients With Relapsed/Refractory Cancers Expressing HER2 Antigen or Having Amplified HER2 Gene". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03602079.
~7 spots leftby May 2025
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top