Denton Research and Clinical Trials

STAR Ph2/3 BI 907828 MDM2 TP53 WT Select Solids (Brightline-2)

Brightline-2: A Phase IIa/IIb open-label single-arm multi-centre trial of brigimadlin (BI 907828) for treatment of patients with locally advanced/ metastatic MDM2 amplified TP53 wild-type biliary tract adenocarcinoma pancreatic ductal adenocarcinoma or other selected solid tumours. (1403-0011) Read Moreabout STAR Ph2/3 BI 907828 MDM2 TP53 WT Select Solids (Brightline-2)

Phase: II/III

STAR: Ph2 Futibatinib in FGFR2 Cholangiocarcinoma

TAS-120-205: Phase 2 Study of Futibatinib 20 mg and 16 mg in Patients with Advanced Cholangiocarcinoma with FGFR2 Fusions or Rearrangements Read Moreabout STAR: Ph2 Futibatinib in FGFR2 Cholangiocarcinoma

Phase: II

Ph3 Dato Deru +/- Dura tri- BC Lymph nodes (TROPION-Breast03)

A Phase 3 Open-label Randomised Study of Datopotamab Deruxtecan (Dato-DXd) With or Without Durvalumab Versus Investigator's Choice of Therapy in Patients With Stage I-III Triple-negative Breast Cancer Who Have Residual Invasive Disease in the Breast and/or Axillary Lymph Nodes at Surgical Resection Following Neoadjuvant Systemic Therapy (TROPION-Breast03)(D926XC00001) Read Moreabout Ph3 Dato Deru +/- Dura tri- BC Lymph nodes (TROPION-Breast03)

Phase: III

Ph3 Study of DB1303 in HER2 with mBreast who has progressed Endocrine Therapy (DYNASTY-BREAST02)

A Phase 3 Randomized Multi-center Open-label Study of DB-1303 Versus Investigator's Choice Chemotherapy in Human Epidermal Growth Factor Receptor 2 (HER2)-low Hormone Receptor Positive (HR+) Metastatic Breast Cancer Patients whose Disease has Progressed on Endocrine Therapy (ET) (DYNASTY-Breast02) (DB-1303-O-3002) Read Moreabout Ph3 Study of DB1303 in HER2 with mBreast who has progressed Endocrine Therapy (DYNASTY-BREAST02)

Phase: III

Ph3 Giredes + Everol or Exemes + Everol ER+ HER2- BC (evERA)

A PHASE III RANDOMIZED OPEN-LABEL MULTICENTER STUDY EVALUATING THE EFFICACY AND SAFETY OF GIREDESTRANT PLUS EVEROLIMUS COMPARED WITH THE PHYSICIAN'S CHOICE OF ENDOCRINE THERAPY PLUS EVEROLIMUS IN PATIENTS WITH ESTROGEN RECEPTOR (ER)-POSITIVE HER2-NEGATIVE LOCALLY ADVANCED OR METASTATIC BREAST CANCER (ML43171) Read Moreabout Ph3 Giredes + Everol or Exemes + Everol ER+ HER2- BC (evERA)

Phase: III

SCRI:BRE 405: Ph3 AZD9833 vs AI or Tamox HR+/HER2- BC (CAMBRIA-1)

CAMBRIA-1: A Phase III Open-Label Randomised Study to Assess the Efficacy and Safety of Extended Therapy with Camizestrant (AZD9833 a Next Generation Oral Selective Estrogen Receptor Degrader) versus Standard Endocrine Therapy (Aromatase Inhibitor or Tamoxifen) in Patients with ER+/HER2- Early Breast Cancer and an Intermediate or High Risk of Recurrence Who Have Completed Definitive LocoregionalTherapy and at Least 2 Years of Standard Adjuvant Endocrine-Based Therapy Without Disease Recurrence (D8531C00002) Read Moreabout SCRI:BRE 405: Ph3 AZD9833 vs AI or Tamox HR+/HER2- BC (CAMBRIA-1)

Phase: III

Ph3 Adjuvant Endocrine Therapy Camizestrant (AZD9833) in ER+/HER2- Early Breast Cancer (CAMBRIA-2)

CAMBRIA-2: A Phase III Open-Label Randomised Study to Assess the Efficacy and Safety of Camizestrant (AZD9833 a Next Generation Oral Selective Estrogen Receptor Degrader) vs Standard Endocrine Therapy (Aromatase Inhibitor or Tamoxifen) as Adjuvant Treatment for Patients With ER+/HER2- Early Breast Cancer and an Intermediate-high or High risk of Recurrence Who Have Completed Definitive Locoregional Treatment and Have No Evidence of Disease (D8535C00001) Read Moreabout Ph3 Adjuvant Endocrine Therapy Camizestrant (AZD9833) in ER+/HER2- Early Breast Cancer (CAMBRIA-2)

Phase: III

Ph3 Imlun vs Endo ER+ HER2- BC (EMBER-4)

EMBER-4: A Randomized Open-Label Phase 3 Study of Adjuvant Imlunestrant vs Standard Adjuvant Endocrine Therapy in Patients who have Previously Received 2 to 5 years of Adjuvant Endocrine Therapy for ER+ HER2- Early Breast Cancer with an Increased Risk of Recurrence (J2J-MC-JZLH) Read Moreabout Ph3 Imlun vs Endo ER+ HER2- BC (EMBER-4)

Phase: III

FLEX Registry: Evaluate New Gene Express

MammaPrint BluePrint and Full-genome Data Linked with Clinical Data to Evaluate New Gene EXpression Profiles: An Adaptable Registry (FLEX Registry) Read Moreabout FLEX Registry: Evaluate New Gene Express

STAR: Zanu in Acala intolerant B-Cell

A Phase 2 Multicenter Single-arm Study of Zanubrutinib (BGB-3111) in Patients with Previously Treated B-Cell Lymphoma Intolerant of Prior Treatment with Ibrutinib and/or Acalabrutinib (BGB-3111-215) Read Moreabout STAR: Zanu in Acala intolerant B-Cell

Phase: II

Ph2 Asciminib (ABL001) CP-CML

A Phase II multi-center open-label single-arm dose escalation study of Asciminib monotherapy in 2nd and 1st Line Chronic Phase - Chronic Myelogenous Leukemia (ASC2ESCALATE)(CABL001AUS08) Read Moreabout Ph2 Asciminib (ABL001) CP-CML

Phase: II

STAR Ph3 Furmo v platinum chemo in EXON 20 NSCLC EGFR

A GLOBAL PHASE 3 RANDOMIZED MULTICENTER OPEN-LABEL STUDY TO INVESTIGATE THE EFFICACY AND SAFETY OF FURMONERTINIB COMPARED TO PLATINUM-BASED CHEMOTHERAPY AS FIRST-LINE TREATMENT FOR PATIENTS WITH LOCALLYADVANCED OR METASTATIC NON-SMALL CELL LUNG CANCER WITH EPIDERMAL GROWTH FACTOR RECEPTOR EXON 20 INSERTION MUTATIONS (FURVENT) FURMO-004 Read Moreabout STAR Ph3 Furmo v platinum chemo in EXON 20 NSCLC EGFR

Phase: III

STAR: Ph1/2 VS-6766 + Soto KRAS G12C NSCLC

A Phase 1/2 Study of Avutometinib in Combination with Sotorasib with or without Defactinib in Patients with KRAS G12C mutant Non-Small Cell Lung Cancer (NSCLC) (RAMP 203) (VS-6766-203) Read Moreabout STAR: Ph1/2 VS-6766 + Soto KRAS G12C NSCLC

Phase: I/II

STAR: PH1/3 Biomarker unresectable stg3 NSCLC

A PHASE I-III MULTICENTER STUDY EVALUATING THE EFFICACY AND SAFETY OF MULTIPLE THERAPIES IN COHORTS OF PATIENTS SELECTED ACCORDING TO BIOMARKER STATUS WITH LOCALLY ADVANCED UNRESECTABLE STAGE III NON-SMALL CELL LUNG CANCER (BO42777) Read Moreabout STAR: PH1/3 Biomarker unresectable stg3 NSCLC

Phase: III

STAR Ph3 Adj Selp St1B/3 RET+ NSCLC

A Placebo-controlled Double-Blinded Randomized Phase 3 Study of Adjuvant Selpercatinib following Definitive Locoregional Treatment in Participants with Stage IB-IIIA RET fusion-Positive NSCLC (LIBRETTO-432) (J2G-MC-JZJX) Read Moreabout STAR Ph3 Adj Selp St1B/3 RET+ NSCLC

Phase: III

STAR Ph2/3 BI 907828 MDM2 TP53 WT Select Solids (Brightline-2)

Brightline-2: A Phase IIa/IIb open-label single-arm multi-centre trial of brigimadlin (BI 907828) for treatment of patients with locally advanced/ metastatic MDM2 amplified TP53 wild-type biliary tract adenocarcinoma pancreatic ductal adenocarcinoma or other selected solid tumours. (1403-0011) Read Moreabout STAR Ph2/3 BI 907828 MDM2 TP53 WT Select Solids (Brightline-2)

Phase: II/III

STAR: Zanu in Acala intolerant B-Cell

A Phase 2 Multicenter Single-arm Study of Zanubrutinib (BGB-3111) in Patients with Previously Treated B-Cell Lymphoma Intolerant of Prior Treatment with Ibrutinib and/or Acalabrutinib (BGB-3111-215) Read Moreabout STAR: Zanu in Acala intolerant B-Cell

Phase: II

STAR Ph1/2 PC14586 TP53 Y220C mut Solid Tumors (PYNNACLE)

A Phase 1/2 Open-label Multicenter Study to Assess the Safety Tolerability Pharmacokinetics Pharmacodynamics and Efficacy of PC14586 in Patients with Locally Advanced or Metastatic Solid Tumors Harboring a TP53 Y220C Mutation (PYNNACLE) (PMV-586-101) Read Moreabout STAR Ph1/2 PC14586 TP53 Y220C mut Solid Tumors (PYNNACLE)

Phase: I/II

STAR Ph2/3 BI 907828 MDM2 TP53 WT Select Solids (Brightline-2)

Brightline-2: A Phase IIa/IIb open-label single-arm multi-centre trial of brigimadlin (BI 907828) for treatment of patients with locally advanced/ metastatic MDM2 amplified TP53 wild-type biliary tract adenocarcinoma pancreatic ductal adenocarcinoma or other selected solid tumours. (1403-0011) Read Moreabout STAR Ph2/3 BI 907828 MDM2 TP53 WT Select Solids (Brightline-2)

Phase: II/III

STAR Ph1/2 MRTX849 Solids KRAS G12C

A Phase 1/2 Multiple Expansion Cohort Trial of MRTX849 in Patients with Advanced Solid Tumors with KRAS G12C Mutation (849-001) Read Moreabout STAR Ph1/2 MRTX849 Solids KRAS G12C

Phase: I/II

STAR Ph1/2 PC14586 TP53 Y220C mut Solid Tumors (PYNNACLE)

A Phase 1/2 Open-label Multicenter Study to Assess the Safety Tolerability Pharmacokinetics Pharmacodynamics and Efficacy of PC14586 in Patients with Locally Advanced or Metastatic Solid Tumors Harboring a TP53 Y220C Mutation (PYNNACLE) (PMV-586-101) Read Moreabout STAR Ph1/2 PC14586 TP53 Y220C mut Solid Tumors (PYNNACLE)

Phase: I/II

Ph2 Study of REC-4881 with Advanced or met cancer with AXINI or APC mutation

A PHASE 2 OPEN LABEL STUDY OF REC-4881 IN PARTICIPANTS WITH UNRESECTABLE LOCALLY ADVANCED OR METASTATIC CANCER WITH AXIN1OR APC MUTATION (REC-4881-221) Read Moreabout Ph2 Study of REC-4881 with Advanced or met cancer with AXINI or APC mutation

Phase: II

STAR Ph1/2a Study of ART0380 admin Mono + in Combo mSolid Tumors

A Phase I/IIa Open-label Multi-center Study to Assess the Safety Tolerability Pharmacokinetics and Preliminary Efficacy of the ATR Kinase Inhibitor ART0380 Administered Orally as Monotherapy and in Combination to Patients with Advanced or Metastatic Solid Tumors (ART0380C001) Read Moreabout STAR Ph1/2a Study of ART0380 admin Mono + in Combo mSolid Tumors

Phase: I/II

STAR Ph2/3 BI 907828 MDM2 TP53 WT Select Solids (Brightline-2)

Brightline-2: A Phase IIa/IIb open-label single-arm multi-centre trial of brigimadlin (BI 907828) for treatment of patients with locally advanced/ metastatic MDM2 amplified TP53 wild-type biliary tract adenocarcinoma pancreatic ductal adenocarcinoma or other selected solid tumours. (1403-0011) Read Moreabout STAR Ph2/3 BI 907828 MDM2 TP53 WT Select Solids (Brightline-2)

Phase: II/III

STAR: Zanu in Acala intolerant B-Cell

A Phase 2 Multicenter Single-arm Study of Zanubrutinib (BGB-3111) in Patients with Previously Treated B-Cell Lymphoma Intolerant of Prior Treatment with Ibrutinib and/or Acalabrutinib (BGB-3111-215) Read Moreabout STAR: Zanu in Acala intolerant B-Cell

Phase: II