San Antonio Stone Oak Research and Clinical Trials

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

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

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

Phase: III

Ph1b/3 Study of Capivasertib + CDK4/6 Receptor 2-Neg mBreast (CAPItello-292)

A Phase Ib/III Open-label Randomised Study of Capivasertib plus CDK4/6 Inhibitors and Fulvestrant versus CDK4/6 Inhibitors and Fulvestrant in Hormone Receptor-Positive and Human Epidermal Growth Factor Receptor 2-Negative Locally Advanced Unresectable or Metastatic Breast Cancer (CAPItello-292) (D361DC00001) Read Moreabout Ph1b/3 Study of Capivasertib + CDK4/6 Receptor 2-Neg mBreast (CAPItello-292)

Phase: III

Ph3 Deruxtecan with Durvalumab vs Pembrolizumab 3neg BC (Tropion Breast 04)

A Phase III Open-Label Randomized Study of Neoadjuvant Datopotamab Deruxtecan (Dato-DXd) Plus Durvalumab Followed by Adjuvant Durvalumab With or Without Chemotherapy Versus Neoadjuvant Pembrolizumab Plus Chemotherapy Followed by Adjuvant Pembrolizumab With or Without Chemotherapy for the Treatment of Adult Patients with Previously Untreated Triple-Negative or Hormone Receptor-low/HER2-negative Breast Cancer (D926QC00001) Read Moreabout Ph3 Deruxtecan with Durvalumab vs Pembrolizumab 3neg BC (Tropion Breast 04)

Phase: III

Ph3 GDC-9545 ER+ HER2- BC (lidERA)

A PHASE III RANDOMIZED OPEN-LABEL MULTICENTER STUDY EVALUATING THE EFFICACY AND SAFETY OF ADJUVANT GIREDESTRANT COMPARED WITH PHYSICIAN'S CHOICE OF ADJUVANT ENDOCRINE MONOTHERAPY IN PATIENTS WITH ESTROGEN RECEPTOR-POSITIVE HER2-NEGATIVE EARLY BREAST CANCER (GO42784) Read Moreabout Ph3 GDC-9545 ER+ HER2- BC (lidERA)

Phase: III

Ph3 HER2/neu BC (FLAMINGO-01)

A Randomized Multicenter Placebo-controlled Phase 3 study to Evaluate the Efficacy and Safety of HER2/neu Peptide GLSI-100 (GP2 + GM-CSF) in HER2/neu Positive Subjects with Residual Disease or High-Risk PCR after both Neoadjuvant and Postoperative Adjuvant Trastuzumab-based Therapy (FLAMINGO-01) (GLSI-21-01) Read Moreabout Ph3 HER2/neu BC (FLAMINGO-01)

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

Ph3 Saci Govi Pembro vs PC TNBC (ASCENT-05 / OptimICE-RD)

GS-US-595-6184: A Randomized Open-label Phase 3 Study of Adjuvant Sacituzumab Govitecan and Pembrolizumab Versus Treatment of Physicians Choice in Patients with Triple Negative Breast Cancer Who Have Residual Invasive Disease After Surgery and Neoadjuvant Therapy (ASCENT-05/OptimICE-RD) Read Moreabout Ph3 Saci Govi Pembro vs PC TNBC (ASCENT-05 / OptimICE-RD)

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

SCRI: BRE381: IIT - Ph2 Tucatinib combo w/ doxil for HER2+ mBC

Phase 2 Single Arm Trial with a Safety Lead-in of Tucatinib in Combination with Doxil for the Treatment of HER2+ Metastatic Breast Cancer (BRE 381) Read Moreabout SCRI: BRE381: IIT - Ph2 Tucatinib combo w/ doxil for HER2+ mBC

Phase: II

Randomized, Open-Label Study of the BRIA-IMT Regimen and Check Point Inhibitor vs Physician’s Choice in Advanced Metastatic Breast Cancer (BRIA-ABC)

Phase: III

Ph2 Epidemi Colon Cancer

Epidemiological study to determine the prevalence of ctDNA positivity in participants with Stage II (high risk) or Stage III CRC after surgery with curative (R0) intent and subsequent adjuvant chemotherapy with monitoring of ctDNA during clinical follow-up (BNT000-001) Read Moreabout Ph2 Epidemi Colon Cancer

Phase: II/III

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: 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 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 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: Ph1/2 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 MRTX849 Pembro NSCLC KRAS

A Phase 2 Trial of Adagrasib Monotherapy and in Combination with Pembrolizumab and a Phase 3 Trial of Adagrasib in Combination with Pembrolizumab versus Pembrolizumab in Patients with Advanced Non-Small Cell Lung Cancer with KRAS G12C Mutation (849-007) Read Moreabout Ph2 MRTX849 Pembro NSCLC KRAS

Phase: II/III

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

Ph2/3 Study of livmoniplimab in combo with budigalimab in untreated metastatic NSCLC (LIVIGNO-4)

A Randomized Phase 2/3 Study to Evaluate the Optimal Dose Safety and Efficacy of Livmoniplimab in Combination with Budigalimab Plus Chemotherapy Versus Pembrolizumab Plus Chemotherapy in Untreated Metastatic Non-Squamous Non-Small Cell Lung Cancer (NSCLC) - LIVIGNO-4 (M23-721) Read Moreabout Ph2/3 Study of livmoniplimab in combo with budigalimab in untreated metastatic NSCLC (LIVIGNO-4)

Phase: II/III

Biomarker status NSCLC

MASTER SCREENING STUDY TO DETERMINE BIOMARKER STATUS AND POTENTIAL TRIAL ELIGIBILITY FOR PATIENTS WITH MALIGNANT TUMORS (BX43361) Read Moreabout Biomarker status NSCLC

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

Ph3 AZD5305 vs Placebo in Men with Metastatic Castration-sensitive Prostate Cancer

A Randomized 2-cohort Double-blind Placebo-controlled Phase III Study of Saruparib (AZD5305) in Combination with Physician's Choice New Hormonal Agents in Patients with HRRm and non-HRRm Metastatic Castration-Sensitive Prostate Cancer (EvoPAR-Prostate01) D9723C00001 Read Moreabout Ph3 AZD5305 vs Placebo in Men with Metastatic Castration-sensitive Prostate Cancer

Phase: 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

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