Methodist Dallas Cancer Center 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

CORE HH Cancer ORigin Epigenetics Sample Collection Screening Test

Harbinger Health Collection of Blood and Tissue Samples from Cancer and Non-Cancer Subjects for Validation of a Novel Blood-Based Multi-Cancer Screening Test (HH-PRT-0001) Read Moreabout CORE HH Cancer ORigin Epigenetics Sample Collection Screening Test

Phase: IV

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

CORE HH Cancer ORigin Epigenetics Sample Collection Screening Test

Harbinger Health Collection of Blood and Tissue Samples from Cancer and Non-Cancer Subjects for Validation of a Novel Blood-Based Multi-Cancer Screening Test (HH-PRT-0001) Read Moreabout CORE HH Cancer ORigin Epigenetics Sample Collection Screening Test

Phase: IV

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 study of HER2-positive controlled by physicians with metastatic breast cancer

A Phase 3 randomized open-label multicenter controlled study to evaluate the efficacy and safety of zanidatamab in combination with physician's choice chemotherapy compared to trastuzumab in combination with physician's choice chemotherapy for the treatment of participants with metastatic HER2-positive breast cancer who have progressed on or are intolerant to previous trastuzumab deruxtecan treatment (JZP598-303) Read Moreabout Ph3 study of HER2-positive controlled by physicians with metastatic breast cancer

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

CORE HH Cancer ORigin Epigenetics Sample Collection Screening Test

Harbinger Health Collection of Blood and Tissue Samples from Cancer and Non-Cancer Subjects for Validation of a Novel Blood-Based Multi-Cancer Screening Test (HH-PRT-0001) Read Moreabout CORE HH Cancer ORigin Epigenetics Sample Collection Screening Test

Phase: IV

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

CORE HH Cancer ORigin Epigenetics Sample Collection Screening Test

Harbinger Health Collection of Blood and Tissue Samples from Cancer and Non-Cancer Subjects for Validation of a Novel Blood-Based Multi-Cancer Screening Test (HH-PRT-0001) Read Moreabout CORE HH Cancer ORigin Epigenetics Sample Collection Screening Test

Phase: IV

CORE HH Cancer ORigin Epigenetics Sample Collection Screening Test

Harbinger Health Collection of Blood and Tissue Samples from Cancer and Non-Cancer Subjects for Validation of a Novel Blood-Based Multi-Cancer Screening Test (HH-PRT-0001) Read Moreabout CORE HH Cancer ORigin Epigenetics Sample Collection Screening Test

Phase: IV

CORE HH Cancer ORigin Epigenetics Sample Collection Screening Test

Harbinger Health Collection of Blood and Tissue Samples from Cancer and Non-Cancer Subjects for Validation of a Novel Blood-Based Multi-Cancer Screening Test (HH-PRT-0001) Read Moreabout CORE HH Cancer ORigin Epigenetics Sample Collection Screening Test

Phase: IV

CORE HH Cancer ORigin Epigenetics Sample Collection Screening Test

Harbinger Health Collection of Blood and Tissue Samples from Cancer and Non-Cancer Subjects for Validation of a Novel Blood-Based Multi-Cancer Screening Test (HH-PRT-0001) Read Moreabout CORE HH Cancer ORigin Epigenetics Sample Collection Screening Test

Phase: IV

Ph3 Mirv Sora +/-Beva FRa+ Epi Ova FT PPC (GLORIOSA)

IMGN853-0421: Randomized multicenter open-label Phase 3 study of mirvetuximab soravtansine in combination with bevacizumab versus bevacizumab alone as maintenance therapy for patients with folate receptor alpha-high recurrent platinum-sensitive epithelial ovarian fallopian tube or primary peritoneal cancers who have not progressed after second-line platinum-based chemotherapy plus bevacizumab (GLORIOSA) Read Moreabout Ph3 Mirv Sora +/-Beva FRa+ Epi Ova FT PPC (GLORIOSA)

Phase: III

CORE HH Cancer ORigin Epigenetics Sample Collection Screening Test

Harbinger Health Collection of Blood and Tissue Samples from Cancer and Non-Cancer Subjects for Validation of a Novel Blood-Based Multi-Cancer Screening Test (HH-PRT-0001) Read Moreabout CORE HH Cancer ORigin Epigenetics Sample Collection Screening Test

Phase: IV

CORE HH Cancer ORigin Epigenetics Sample Collection Screening Test

Harbinger Health Collection of Blood and Tissue Samples from Cancer and Non-Cancer Subjects for Validation of a Novel Blood-Based Multi-Cancer Screening Test (HH-PRT-0001) Read Moreabout CORE HH Cancer ORigin Epigenetics Sample Collection Screening Test

Phase: IV

CORE HH Cancer ORigin Epigenetics Sample Collection Screening Test

Harbinger Health Collection of Blood and Tissue Samples from Cancer and Non-Cancer Subjects for Validation of a Novel Blood-Based Multi-Cancer Screening Test (HH-PRT-0001) Read Moreabout CORE HH Cancer ORigin Epigenetics Sample Collection Screening Test

Phase: IV

CORE HH Cancer ORigin Epigenetics Sample Collection Screening Test

Harbinger Health Collection of Blood and Tissue Samples from Cancer and Non-Cancer Subjects for Validation of a Novel Blood-Based Multi-Cancer Screening Test (HH-PRT-0001) Read Moreabout CORE HH Cancer ORigin Epigenetics Sample Collection Screening Test

Phase: IV

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

CORE HH Cancer ORigin Epigenetics Sample Collection Screening Test

Harbinger Health Collection of Blood and Tissue Samples from Cancer and Non-Cancer Subjects for Validation of a Novel Blood-Based Multi-Cancer Screening Test (HH-PRT-0001) Read Moreabout CORE HH Cancer ORigin Epigenetics Sample Collection Screening Test

Phase: IV

CORE HH Cancer ORigin Epigenetics Sample Collection Screening Test

Harbinger Health Collection of Blood and Tissue Samples from Cancer and Non-Cancer Subjects for Validation of a Novel Blood-Based Multi-Cancer Screening Test (HH-PRT-0001) Read Moreabout CORE HH Cancer ORigin Epigenetics Sample Collection Screening Test

Phase: IV

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

Ph2 Study of EIK1001 in combo with pembro in patients with stage 4 NSCLC

A Phase 2 Study of EIK1001 in Combination with Pembrolizumab and Chemotherapy in Patients with Stage 4 Non-Small Cell Lung Cancer (EIK1001-005) Read Moreabout Ph2 Study of EIK1001 in combo with pembro in patients with stage 4 NSCLC

Phase: 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

An Observational, Prospective, Multicenter Study of Non-Small Cell Lung Cancer Patients in the US Receiving Standard-of-Care and Initiating an Approved Therapy with Risk of Pneumonitis/ILD

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

CORE HH Cancer ORigin Epigenetics Sample Collection Screening Test

Harbinger Health Collection of Blood and Tissue Samples from Cancer and Non-Cancer Subjects for Validation of a Novel Blood-Based Multi-Cancer Screening Test (HH-PRT-0001) Read Moreabout CORE HH Cancer ORigin Epigenetics Sample Collection Screening Test

Phase: IV

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

CORE HH Cancer ORigin Epigenetics Sample Collection Screening Test

Harbinger Health Collection of Blood and Tissue Samples from Cancer and Non-Cancer Subjects for Validation of a Novel Blood-Based Multi-Cancer Screening Test (HH-PRT-0001) Read Moreabout CORE HH Cancer ORigin Epigenetics Sample Collection Screening Test

Phase: IV

CORE HH Cancer ORigin Epigenetics Sample Collection Screening Test

Harbinger Health Collection of Blood and Tissue Samples from Cancer and Non-Cancer Subjects for Validation of a Novel Blood-Based Multi-Cancer Screening Test (HH-PRT-0001) Read Moreabout CORE HH Cancer ORigin Epigenetics Sample Collection Screening Test

Phase: IV

CORE HH Cancer ORigin Epigenetics Sample Collection Screening Test

Harbinger Health Collection of Blood and Tissue Samples from Cancer and Non-Cancer Subjects for Validation of a Novel Blood-Based Multi-Cancer Screening Test (HH-PRT-0001) Read Moreabout CORE HH Cancer ORigin Epigenetics Sample Collection Screening Test

Phase: IV

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

CORE HH Cancer ORigin Epigenetics Sample Collection Screening Test

Harbinger Health Collection of Blood and Tissue Samples from Cancer and Non-Cancer Subjects for Validation of a Novel Blood-Based Multi-Cancer Screening Test (HH-PRT-0001) Read Moreabout CORE HH Cancer ORigin Epigenetics Sample Collection Screening Test

Phase: IV

Ph3 Mirv Sora +/-Beva FRa+ Epi Ova FT PPC (GLORIOSA)

IMGN853-0421: Randomized multicenter open-label Phase 3 study of mirvetuximab soravtansine in combination with bevacizumab versus bevacizumab alone as maintenance therapy for patients with folate receptor alpha-high recurrent platinum-sensitive epithelial ovarian fallopian tube or primary peritoneal cancers who have not progressed after second-line platinum-based chemotherapy plus bevacizumab (GLORIOSA) Read Moreabout Ph3 Mirv Sora +/-Beva FRa+ Epi Ova FT PPC (GLORIOSA)

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

CORE HH Cancer ORigin Epigenetics Sample Collection Screening Test

Harbinger Health Collection of Blood and Tissue Samples from Cancer and Non-Cancer Subjects for Validation of a Novel Blood-Based Multi-Cancer Screening Test (HH-PRT-0001) Read Moreabout CORE HH Cancer ORigin Epigenetics Sample Collection Screening Test

Phase: IV

Ph3 Mirv Sora +/-Beva FRa+ Epi Ova FT PPC (GLORIOSA)

IMGN853-0421: Randomized multicenter open-label Phase 3 study of mirvetuximab soravtansine in combination with bevacizumab versus bevacizumab alone as maintenance therapy for patients with folate receptor alpha-high recurrent platinum-sensitive epithelial ovarian fallopian tube or primary peritoneal cancers who have not progressed after second-line platinum-based chemotherapy plus bevacizumab (GLORIOSA) Read Moreabout Ph3 Mirv Sora +/-Beva FRa+ Epi Ova FT PPC (GLORIOSA)

Phase: III

CORE HH Cancer ORigin Epigenetics Sample Collection Screening Test

Harbinger Health Collection of Blood and Tissue Samples from Cancer and Non-Cancer Subjects for Validation of a Novel Blood-Based Multi-Cancer Screening Test (HH-PRT-0001) Read Moreabout CORE HH Cancer ORigin Epigenetics Sample Collection Screening Test

Phase: IV

CORE HH Cancer ORigin Epigenetics Sample Collection Screening Test

Harbinger Health Collection of Blood and Tissue Samples from Cancer and Non-Cancer Subjects for Validation of a Novel Blood-Based Multi-Cancer Screening Test (HH-PRT-0001) Read Moreabout CORE HH Cancer ORigin Epigenetics Sample Collection Screening Test

Phase: IV

CORE HH Cancer ORigin Epigenetics Sample Collection Screening Test

Harbinger Health Collection of Blood and Tissue Samples from Cancer and Non-Cancer Subjects for Validation of a Novel Blood-Based Multi-Cancer Screening Test (HH-PRT-0001) Read Moreabout CORE HH Cancer ORigin Epigenetics Sample Collection Screening Test

Phase: IV

CORE HH Cancer ORigin Epigenetics Sample Collection Screening Test

Harbinger Health Collection of Blood and Tissue Samples from Cancer and Non-Cancer Subjects for Validation of a Novel Blood-Based Multi-Cancer Screening Test (HH-PRT-0001) Read Moreabout CORE HH Cancer ORigin Epigenetics Sample Collection Screening Test

Phase: IV

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

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

CORE HH Cancer ORigin Epigenetics Sample Collection Screening Test

Harbinger Health Collection of Blood and Tissue Samples from Cancer and Non-Cancer Subjects for Validation of a Novel Blood-Based Multi-Cancer Screening Test (HH-PRT-0001) Read Moreabout CORE HH Cancer ORigin Epigenetics Sample Collection Screening Test

Phase: IV

CORE HH Cancer ORigin Epigenetics Sample Collection Screening Test

Harbinger Health Collection of Blood and Tissue Samples from Cancer and Non-Cancer Subjects for Validation of a Novel Blood-Based Multi-Cancer Screening Test (HH-PRT-0001) Read Moreabout CORE HH Cancer ORigin Epigenetics Sample Collection Screening Test

Phase: IV

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