Neoplasms

Skin and Connective Tissue Diseases

All Conditions

Breast Neoplasms

Breast Diseases

Skin Diseases

Antineoplastic Agents

All Drugs and Chemicals

Antirheumatic Agents

Anti-Infective Agents

Paclitaxel

Albumin-Bound Paclitaxel

Cyclophosphamide

Doxorubicin

Liposomal doxorubicin

Tubulin Modulators

Antimitotic Agents

Immunosuppressive Agents

Immunologic Factors

Antineoplastic Agents, Alkylating

Alkylating Agents

Anti-Bacterial Agents

Antibiotics, Antitubercular

Enzyme Inhibitors

Intravenous ADG106 + 2 weekly doxorubicin and cyclophosphamide

Intravenous ADG106 combined with two weekly doxorubicin and cyclophosphamide followed intravenous ADG106 combined with weekly paclitaxel

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

ADG106

Soo Chin Lee

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.

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

Phase Ib: A 3+3 dose escalation design will be used to determine the RP2D dose of ADG106 in combination with ddAC and paclitaxel respectively.

Phase II: ADG106 will be combined with ddAC followed by paclitaxel as neoadjuvant chemotherapy in patients with stage I-III HER2 negative breast cancer.

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

Toxicities will be graded using the Common Terminology Criteria for Adverse Events (CTCAE) toxicity grading version 5.0.

Biological changes on immunohistochemistry will be evaluated using paraffin-embedded tumor specimens.

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

Defined as the time from the date of study enrolment to the date of death from any cause, regardless of whether the death occurred during the study or following treatment discontinuation.

Correlation of biomarkers with Objective Response Rate, Progression Free Survival, Overall Survival

Defined as the time from the date of study enrolment to the first date of documented disease progression.

Clinical response rate will be measured by calipers

Defined as any patient who demonstrates no histological evidence of invasive tumor in the primary breast site as well as in resected axillary lymph nodes.

Defined as the time from the date of study enrolment to the first date of documented disease relapse.

Adagene Inc

National University Hospital, Singapore

Triple Negative Breast Neoplasms

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)

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

Merck Sharp & Dohme LLC

Respiratory Tract (Lung and Bronchial) Diseases

Symptoms and General Pathology

Lung Neoplasms

Carcinoma, Non-Small-Cell Lung

Disease Progression

Carcinoma

Carcinoma, Bronchogenic

Bronchial Neoplasms

Respiratory Tract Neoplasms

Thoracic Neoplasms

Lung Diseases

Respiratory Tract Diseases

Nivolumab

Eligible patients will receive nivolumab and ADG106 by IV infusion according to the study phases below.

Phase 1b:

3 evaluable patients will be treated at the starting dose, and assessed for tolerability over the first cycle. Treatment related dose-limiting toxicities (DLT) will determine the next dose level to be studied. Dose escalation will follow the 3 + 3 study dose titration design.

Phase 2:

The dose of ADG106 given together with nivolumab will be the recommended dose in combination with nivolumab determined in phase 1b.

Administered together with ADG106 via intravenous infusion.

Administered as an intravenous infusion over 90 minutes.

Boon Cher Goh

Daniel Tan, MBBS, MRCP, PhD

Boon Cher Goh, MBBS, MRCP, MMed, FAMS

This is an open label, non-randomised phase 1b/2 study including patients with non-small cell lung cancer who have progressed after treatment with immune checkpoint inhibitors (anti PD1/PDL1 with or without CTLA4 inhibitors) and platinum-based chemotherapy. The study medications include nivolumab, an anti-PD1 inhibitor and ADG106, an agonist antibody of 4-1-BB.

The investigators hypothesize that the combination of nivolumab and ADG106 would be tolerable, and demonstrate significant clinical anti-tumour activity in patients with NSCLC that has failed antiPD1/antiPDL1 immunotherapy and standard platinum-based chemotherapy. The investigators propose to conduct a phase 1b/2 study to investigate this strategy.

A Study to Evaluate the Combination of Nivolumab With ADG106 in Metastatic NSCLC

A Phase 1b/2 Study to Evaluate the Combination of Nivolumab (Anti PD1 Monoclonal Ab) With ADG106 (4-1-BB Agonist Monoclonal Ab) in Metastatic NSCLC After Progression With antiPD1 Therapy and Platinum-based Chemotherapy (ADIVO Lung Study)

Adverse events profile, safety profile of the combination of ADG106 and nivolumab according to the NCI Common Terminology Criteria for Adverse Events Version 5.0 (CTCAE v5.0).

Objective response rate (CR + PR) using RECIST 1.1 of the combination of ADG106 and nivolumab in patients with metastatic NSCLC that have progressed after antiPD1/PDL1 treatment and platinum-based chemotherapy (phase 2).

Progression free survival at 6 months of the combination of ADG106 and nivolumab in patients with metastatic NSCLC that have progressed after antiPD1/PDL1 treatment and platinum-based chemotherapy (phase 2) and the irRECIST objective response rate.

Pharmacokinetics of nivolumab/ADG106 will be measured using blood samples collected at specify timepoint

Bristol-Myers Squibb

Singapore Translational Cancer Consortium

Blood and Lymph Conditions

Immune System Diseases

Rare Diseases

Lymphoma

Lymphoma, Non-Hodgkin

Neoplasms by Histologic Type

Lymphoproliferative Disorders

Lymphatic Diseases

Immunoproliferative Disorders

Lymphosarcoma

IV infusion over 60 minutes on Day 1 of each cycle, at doses of 0.03 mg/kg, 0.1 mg/kg, 0.3 mg/kg, 1 mg/kg, 3 mg/kg,10 mg/kg or 300mg flat dose depending on cohort at enrollment.

This is a Phase 1, open-label, dose-escalation, multicenter study of ADG106 in subjects with advanced or metastatic solid tumors and/or relapsed/refractory non-Hodgkin lymphoma. ADG106 is a fully human ligand-blocking, agonistic anti-CD137 IgG4 mAb. It binds to the activated human T cells via a T cell receptor CD137. T cell is a kind of lymphocyte (a subtype of white blood cells) that protects bodies by eliminating tumor cells, and normal cells infected with viruses or bacteria. By binding to CD137, the study drug is expected to enhance the activity of activated T cells and thus stimulate a more intense immune attack to kill tumor cells. ADG106 is expected to enhance the activity of activated T cells.

The primary objective of the study is to assess safety and tolerability at increasing dose levels of single agent ADG106 in subjects with advanced or metastatic solid tumors and/or non Hodgkin lymphoma Secondary Objectives

* To characterize the pharmacokinetic (PK) profiles of ADG106
* To evaluate the immunogenicity of ADG106
* To evaluate the potential anti-tumor effect of ADG106 Exploratory Objective To identify the potential biomarkers of ADG106

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
A Phase Ib Safety lead-in, Followed by Phase II Trial of ADG106 in Combination With Neoadjuvant Chemotherapy in HER2 Negative Breast Cancer	NCT05275777	HER2-negative B... Advanced Solid ...	ADG106 Doxorubicin Cyclophosphamid... Paclitaxel	18 Years - 99 Years	National University Hospital, Singapore
Pembrolizumab and ADG106 in Advanced Solid Cancers and Triple Negative Breast Cancer	NCT05491083	Advanced Solid ... Triple Negative...	Pembrolizumab &... Pembrolizumab &...	21 Years - 99 Years	National University Hospital, Singapore
A Study to Evaluate the Combination of Nivolumab With ADG106 in Metastatic NSCLC	NCT05236608	Metastatic Non ...	Nivolumab ADG106	21 Years - 99 Years	National University Hospital, Singapore
Study of CD137 Agonist ADG106 With Advanced or Metastatic Solid Tumors and/or Non-Hodgkin Lymphoma	NCT03707093	Solid Tumors, N...	ADG106	18 Years -	Adagene Inc

Spots Global Cancer Trial Database for adg106

Every month we try and update this database with for adg106 cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for adg106

Every month we try and update this database with for adg106 cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for adg106 cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.