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

A Phase Ib Safety lead-in, Followed by Phase II Trial of ADG106 in Combination With Neoadjuvant Doxorubicin and Cyclophosphamide Followed by Paclitaxel in Stage I-III HER2 Negative Breast Cancer

NCT05275777•National University Hospital, Singapore

View on ClinicalTrials.gov

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.

Detailed Description

The phase Ib segment will be carried out with a standard 3+3 dose de-escalation design. Patients with advanced/ metastatic solid organ cancers will be enrolled in 2 parallel cohorts. Cohort 1 will receive ADG106 in combination with dose dense doxorubicin/ cyclophosphamide (AC). Cohort 2 will receive ADG106 in combination with weekly paclitaxel. In the phase II portion, patients with stage I-III HER2 negative breast cancer planned for neoadjuvant chemotherapy will be enrolled. Patients will be treated with neoadjuvant chemotherapy (ddAC followed by paclitaxel for 12 weeks) combined with ADG106, before definitive breast cancer surgery

Eligibility

Age

18 - 99 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Patients may be included in the study only if they meet all of the following criteria:
•1. All patients must sign an informed consent in accordance with local institutional guidelines.
•2. 18 years and above of age.
•3. Estimated life expectancy of at least 12 weeks.
•4. Has recovered from acute toxicities from prior anti-cancer therapies (phase Ib).
•5. a) Phase Ib: Patients with histologically or cytologically confirmed advanced or metastatic solid tumors who have radiological evidence of progressive disease on study entry that are deemed likely to benefit from either dose dense doxorubicin/ cyclophosphamide or weekly paclitaxel.

Exclusion Criteria

•* Prior receipt of immunotherapy is allowed. b) Phase II: Untreated stage I-III HER2 negative breast cancer patients who are planned for neoadjuvant chemotherapy followed by definitive breast cancer surgery.
•6. Measurable disease by RECIST 1.1 criteria.
•7. Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-1.
•8. Left ventricular ejection fraction of ≥ 50% for Cohort 1 in phase Ib and all patients in phase II.
•9. Adequate bone marrow function and organ function within 2 weeks of study treatment.
•1. Adequate hematologic function defined as:
•* Absolute neutrophil count (ANC) ≥ 1.5 x 109/L
•* Platelets ≥ 100 x 109/L
•* Hemoglobin ≥ 9 x 109/L
•2. Adequate hepatic function defined as:
+32 more criteria

Locations (1)

National University Hospital

Singapore, Singapore

Key Dates

Start Date

May 19, 2022

Primary Completion Date

December 1, 2027

Completion Date

February 1, 2030

Last Updated

July 25, 2025

Enrollment

ESTIMATED participants

Conditions

HER2-negative Breast CancerAdvanced Solid Tumor

Interventions

ADG106

DRUG

Doxorubicin

DRUG

Cyclophosphamide

DRUG

Paclitaxel

DRUG

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: July 25, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

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