Neoplasms

Skin and Connective Tissue Diseases

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Breast Neoplasms

Triple Negative Breast Neoplasms

Breast Diseases

Skin Diseases

Antineoplastic Agents

All Drugs and Chemicals

Pembrolizumab

Antineoplastic Agents, Immunological

Immune Checkpoint Inhibitors

Intravenous Pembrolizumab + ADG106 on day 1 of each 3-weekly cycle

Intravenous Pembrolizumab + ADG106 each 3-weekly cycle

Drug: ADG106

Administered as an intravenous infusion over 60-90 minutes in the initial cycle and over 30 minutes in subsequent cycle if well tolerated.

Pembrolizumab

Administered as an intravenous infusion over 30 minutes

Pembrolizumab & ADG106 (Phase Ib)

Pembrolizumab & ADG106 (Phase II)

Soo Chin Lee

This is a phase Ib followed by phase II clinical trial evaluating the safety and efficacy of combination of ADG106 with pembrolizumab in patients with metastatic cancers. The Phase Ib dose finding part will include all solid tumor subtypes with treatment refractory disease, while phase II will focus on only patients with TNBC.

2.1 Hypothesis

* Combination of ADG106 and pembrolizumab is safe with a reasonable toxicity profile.
* Combination of ADG106 and pembrolizumab is effective and can improve outcomes in patients with advanced TNBC.
* Predictive biomarkers may help select patients most likely to benefit from combination therapy.

2.2 Primary Objectives Phase Ib

* Evaluate the safety and tolerability of combination of ADG106 with pembrolizumab in patients with advanced solid tumors.
* Determine recommended phase II dose (RP2D) of ADG106 in combination with pembrolizumab.

Phase II • Evaluate the clinical efficacy of ADG106 plus pembrolizumab in terms of ORR in patient with advanced TNBC with CPS ≥1

2.3 Secondary Objectives Phase Ib

• Evaluate preliminary anti-tumor effect of combination of ADG106 with pembrolizumab in terms of ORR, disease control rate (DCR), PFS and OS in patients with treatment refractory solid tumors

Phase II

* Evaluate clinical efficacy of ADG106 plus pembrolizumab in terms of DCR, PFS and OS in patients with advanced TNBC with CPS≥1
* Evaluate clinical efficacy of ADG106 plus pembrolizumab in terms of ORR, DCR, PFS and OS in patients with advanced TNBC with CPS≥10

2.4 Exploratory Objectives

* Evaluate predictive biomarkers (e.g., tumor PD-L1 CPS score) for response to ADG106 plus pembrolizumab.
* Evaluate changes in tumor microenvironment with combination of ADG106 plus pembrolizumab.
* Evaluate changes in tumor genomic expression profile with combination of ADG106 plus pembrolizumab.

* Phase Ib: Patients with advanced solid tumors will be enrolled in a 3+3 dose escalation fashion, with projected enrolment of between 6-18 patients to determine RP2D. Once the RP2D is confirmed, the study will proceed to phase II.
* Phase II: Up to a total of 33 patients with advanced triple negative breast cancer will be enrolled.

Pembrolizumab and ADG106 in Advanced Solid Cancers and Triple Negative Breast Cancer

A Phase 1b Followed by Phase II Expansion Trial of Combination of Pembrolizumab and ADG106 in Advanced Solid Cancers and Triple Negative Breast Cancer (ComPACT)

Toxicities will be graded using the Common Terminology Criteria for Adverse Events (CTCAE) toxicity grading Version 5

Complete and partial clinical response will be measured by RECIST 1.1.

Spots Global Cancer Trial Database for pembrolizumab & adg106 (phase ii)