Overview

A Phase Ib Safety lead-in, Followed by Phase II Trial of ADG106 in Combination With Neoadjuvant Chemotherapy in HER2 Negative Breast Cancer

Status:
Not yet recruiting

Trial end date:
2030-02-01

Target enrollment:

Participant gender:

Summary

This is an open label, lead in phase Ib dose confirmation study in patients with advanced solid tumors, followed by a phase II single arm study as neoadjuvant therapy in stage I-III HER2 negative breast cancer. Primary Objectives - To determine the safety profile of combination of ADG106 with dose dense doxorubicin/cyclophosphamide, and with weekly paclitaxel. - To determine the Recommended Phase 2 Dose (RP2D) of ADG106 in combination with dose dense doxorubicin/cyclophosphamide, and with weekly paclitaxel. - To evaluate biological changes on immunohistochemistry in HER2 negative breast cancer after treatment with ADG106 alone and in combination with chemotherapy. Secondary Objectives - To determine the efficacy of combination of ADG106 with standard neoadjuvant combination chemotherapy in HER2 negative breast cancer: objective response rates. - To correlate tumor and plasma biomarkers with efficacy outcomes.

Phase:

Phase 1/Phase 2

Details

Lead Sponsor:

National University Hospital, Singapore

Collaborator:

Adagene Inc

Treatments:

Cyclophosphamide
Doxorubicin
Paclitaxel