← Back to Search

Antibody-Drug Conjugate

U3-1402 for Non-Small Cell Lung Cancer

Phase 1
Waitlist Available
Research Sponsored by Daiichi Sankyo
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Has documentation of EGFR-activating mutation(s) detected from tumor tissue: G719X, exon deletion 19, L858R, or L861Q (Cohorts 1, 3a, 3b, and 4 of Dose Expansion)
Is currently receiving and able to discontinue erlotinib, gefinitib, afatinib, or osimertinib
Timeline
Screening 3 weeks
Treatment Varies
Follow Up approximately within 36 months
Awards & highlights

Study Summary

This trial will study U3-1402, a new drug for treating non-small cell lung cancer. The study will evaluate safety and effectiveness in two parts: dose escalation and dose expansion.

Who is the study for?
This trial is for adults with advanced or inoperable non-small cell lung cancer (NSCLC) who have previously been treated with EGFR tyrosine kinase inhibitors. Participants must have at least one measurable lesion, be in good physical condition (ECOG status of 0 or 1), and not have other active cancers or serious heart conditions.Check my eligibility
What is being tested?
The study tests U3-1402, a new drug for NSCLC. It has two parts: Dose Escalation to find the safe dosage for those with an EGFR mutation after TKI therapy failure, and Dose Expansion to assess effectiveness in broader NSCLC cases post systemic treatment failure.See study design
What are the potential side effects?
While specific side effects are not listed here, common ones may include fatigue, nausea, skin reactions at the injection site, allergic reactions to the drug components, and potential impacts on blood pressure and heart rhythm.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
My cancer has a specific EGFR mutation.
Select...
I am currently taking a specific cancer medication but can stop if needed.
Select...
I am fully active or restricted in physically strenuous activity but can do light work.
Select...
I have been on erlotinib, gefitinib, afatinib, or osimertinib for 6+ weeks with manageable side effects.
Select...
My lung cancer cannot be cured with surgery or radiation.
Select...
I benefited from EGFR treatment but my cancer progressed while still on it.
Select...
I have been treated with erlotinib, gefitinib, or afatinib and do not have the EGFR T790M mutation.
Select...
I have been treated with a platinum-based chemotherapy for my advanced cancer.
Select...
My cancer progressed after treatment with an EGFR inhibitor.
Select...
My cancer progressed despite treatment with specific lung cancer medications.
Select...
My cancer has worsened after my last treatment.
Select...
I have previously been treated with anti-PD-1 or anti-PD-L1 drugs for advanced cancer, unless I was unable or unwilling.
Select...
I can provide a recent biopsy sample or am willing to have a new biopsy if I've been treated with specific cancer drugs.
Select...
My lung cancer is confirmed to be adenocarcinoma type.
Select...
My lung cancer is confirmed by lab tests and does not have EGFR mutations.
Select...
My lung cancer is confirmed to be adenocarcinoma type.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~by the global end of trial date, approximately within 36 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and by the global end of trial date, approximately within 36 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
Serum
Dose-limiting toxicities (DLTs) during dose escalation
Maximum serum concentration (Cmax) of U3-1402, total anti-HER3 antibody, and MAAA 1181a during dose expansion (Cohort 4)
+2 more
Secondary outcome measures
Area under the serum concentration-time curve from time 0 to 8 hours (AUC[0-8]) and up to last quantifiable time (AUC[last]) of U3-1402, total anti-HER3 antibody, and MAAA 1181a during dose escalation
Area under the serum concentration-time curve from time 0 to 8 hours (AUC[0-8]), from time 0 to Day 21 (AUC-21d), and up to last quantifiable time (AUC[last]) of U3-1402, total anti-HER3 antibody, and MAAA 1181a during dose expansion
Disease control rate (DCR) during dose escalation
+25 more

Trial Design

9Treatment groups
Experimental Treatment
Group I: Dose Expansion: Cohort 4, EGFR mutantExperimental Treatment1 Intervention
Participants with NSCLC (including any histology other than small-cell or combined small-cell and non-small cell) with an EGFR-activating mutation will receive U3-1402 IV at 5.6 mg/kg every 3 weeks.
Group II: Dose Expansion: Cohort 3b, EGFR mutantExperimental Treatment1 Intervention
Randomized participants with NSCLC and EGFR mutations in the Dose Expansion Cohort 3b will receive U3-1402 IV once every three weeks following an up-titration regimen (Cycle 1, Day 1: 57% of RDE or aRDE; Cycle 2, Day 1: 86% of RDE or, if applicable aRDE; Cycle 3 and subsequent cycles, Day 1: 114% of RDE or aRDE).
Group III: Dose Expansion: Cohort 3a, EGFR mutantExperimental Treatment1 Intervention
Randomized participants with NSCLC and EGFR mutations in the Dose Expansion Cohort 3a will receive U3-1402 IV once every three weeks at the established recommended dose for expansion (RDE) or, if applicable, adjusted RDE (aRDE).
Group IV: Dose Expansion: Cohort 2, EGFR wild-typeExperimental Treatment1 Intervention
Participants with squamous or non-squamous NSCLC without EGFR-activating mutations in the Dose Expansion Cohort 2 will receive U3-1402 IV once every three weeks at the established recommended dose for expansion (RDE).
Group V: Dose Expansion: Cohort 1, EGFR mutantExperimental Treatment1 Intervention
Participants with adenocarcinoma NSCLC with EGFR mutations in the Dose Expansion Cohort 1 will receive U3-1402 IV once every three weeks at the established recommended dose for expansion (RDE).
Group VI: Dose Escalation: Cohort 4, 6.4 mg/kgExperimental Treatment1 Intervention
Participants in Dose Escalation Cohort 3 will receive U3-1402 intravenously (IV) once every three weeks at 6.4 mg/kg.
Group VII: Dose Escalation: Cohort 3, 5.6 mg/kgExperimental Treatment1 Intervention
Participants in Dose Escalation Cohort 3 will receive U3-1402 intravenously (IV) once every three weeks at 5.6 mg/kg.
Group VIII: Dose Escalation: Cohort 2, 4.8 mg/kgExperimental Treatment1 Intervention
Participants in Dose Escalation Cohort 2 will receive U3-1402 intravenously (IV) once every three weeks at 4.8 mg/kg.
Group IX: Dose Escalation: Cohort 1, 3.2 mg/kgExperimental Treatment1 Intervention
Participants in the Dose Escalation Cohort 1 will receive U3-1402 intravenously (IV) once every three weeks at 3.2 mg/kg.

Find a Location

Who is running the clinical trial?

Daiichi SankyoLead Sponsor
388 Previous Clinical Trials
409,240 Total Patients Enrolled
Daiichi Sankyo, Inc.Lead Sponsor
389 Previous Clinical Trials
414,838 Total Patients Enrolled
Global Clinical LeaderStudy DirectorDaiichi Sankyo
161 Previous Clinical Trials
78,573 Total Patients Enrolled

Media Library

U3-1402 (Antibody-Drug Conjugate) Clinical Trial Eligibility Overview. Trial Name: NCT03260491 — Phase 1
Non-Small Cell Lung Cancer Clinical Trial 2023: U3-1402 Highlights & Side Effects. Trial Name: NCT03260491 — Phase 1

Frequently Asked Questions

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

How many locations are administering this experiment?

"This medical study is being conducted in the City of Hope located in Duarte, California; Winship Cancer Institute of Emory University situated inside Atlanta Georgia; and Seattle Cancer Care Alliance established in Seattle Washington. Additionally, there are 4 other trial sites currently being utilized."

Answered by AI

What risks associated with U3-1402 are of most concern to researchers?

"Given the limited clinical data backing up U3-1402's safety and efficacy, our team at Power has scored it a 1 on its scale from 1 to 3."

Answered by AI

Is enrollment for this clinical research ongoing?

"Affirmative, clinicaltrials.gov reveals that this study is actively enrolling individuals. It was first posted on October 30th 2017 and has been recently revised on July 5th 2022. The trial requires 264 participants to be recruited from 4 distinct sites."

Answered by AI

How many participants are actively engaged in this research program?

"Affirmative. Clinicaltrials.gov indicates that this study is actively seeking subjects, first posted on October 30th 2017 and updated recently on July 5th 2022. A total of 264 patients must be recruited across 4 sites to complete the trial."

Answered by AI
~37 spots leftby Mar 2025