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 study of standard endocrine therapy with breast cancer

Elacestrant versus Standard Endocrine Therapy in Women and Men with Node -positive Estrogen Receptor-positive HER2-negative Early Breast Cancer with High Risk of Recurrence - A Global Multicenter Randomized Open-label Phase 3 Study (ELEGANT)(STML-ELA-0422) Read Moreabout Ph3 study of standard endocrine therapy with breast cancer

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

Ph3 study with HR+ HER2 negative breast cancer who have completed (OVELIA Study)

Open-label Safety Extension Study for Subjects with Hormone-Receptor-Positive (HR+) Human Epidermal Growth Factor Receptor 2 (HER2)-Negative Breast Cancer Who Have Completed the OVarian Suppression Evaluating Subcutaneous LeuprolIde Acetate in Breast Cancer (OVELIA) Study (TOL2506A-EXT) Read Moreabout Ph3 study with HR+ HER2 negative breast cancer who have completed (OVELIA Study)

Phase: III

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

Ph3 study of FOLFIRI in participants with metastatic colorectal cancer

A Randomized Open-label Phase 3 Study of Amivantamab + FOLFIRI Versus Cetuximab/Bevacizumab + FOLFIRI in Participants with KRAS/NRAS and BFAF Wild-Type Recurrent Unresectable or Metastatic Colorectal Cancer Who Have Received Prior Chemotherapy (61186372COR3002) Read Moreabout Ph3 study of FOLFIRI in participants with metastatic colorectal cancer

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 Ph3 study to evaluate to treat patients with HNSCC

A phase 3 open-label randomized controlled study to evaluate the efficacy and safety of petosemtamab compared with investigator's choice monotherapy treatment in previously treated patients with incurable metastatic/recurrent head and neck squamous cell carcinoma (MCLA-158-CL02) Read Moreabout STAR Ph3 study to evaluate to treat patients with HNSCC

Phase: III

Ph3 Study of Nemtabrutinib w/untreated Lymphocytic Leukemia (BELLWAVE-011)

A Phase 3 Randomized Study to Compare the Efficacy and Safety ofNemtabrutinib Versus Ibrutinib or Acalabrutinib in Participants With Untreated Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma (BELLWAVE-011) (MK-1026-011) Read Moreabout Ph3 Study of Nemtabrutinib w/untreated Lymphocytic Leukemia (BELLWAVE-011)

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

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 Ph3 study with patients previously treated KRAS G12C-positive advanced or metastastatic NSCLC

A phase 3 randomized open-label multicenter study evaluating the efficacy and safety of divarasib versus sotorasib or adagrasib in patients with previously treated KRAS G12C-positive advanced or metastatic Non-Small Cell Lung Cancer (BO45217) Read Moreabout STAR Ph3 study with patients previously treated KRAS G12C-positive advanced or metastastatic NSCLC

Phase: 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

Ph3 Multiregional Study of Ivonescimab combined with Pembro for mNSCLC (HARMONi-3)

A Randomized Double-blind Multiregional Phase 3 Study of Ivonescimab Combined with Chemotherapy Versus Pembrolizumab Combined with Chemotherapy for the First-line Treatment of Metastatic Non- small Cell Lung Cancer (HARMONi-3) (SMT112-3003) Read Moreabout Ph3 Multiregional Study of Ivonescimab combined with Pembro for mNSCLC (HARMONi-3)

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

ONC-392 vs. Docetaxel in PD-1 Resistant Non-small Cell Lung Cancer

Phase 3 Two-stage Randomized Study of ONC-392 Versus Docetaxel in Metastatic Non-Small Cell Lung Cancers that Progressed on PD-1/PD-L1 Inhibitors (PRESERVE-003) Read Moreabout ONC-392 vs. Docetaxel in PD-1 Resistant Non-small Cell Lung Cancer

Phase: III

Ph3 study comparing CC-92480 in subjects with RRMM (SUCCESSOR-1)

A Phase 3 Two-Stage Randomized Multicenter Open-Label Study Comparing Mezigdomide (CC-92480) Bortezomib and Dexamethasone (MEZIVd) Versus Pomalidomide Bortezomib and Dexamethasone (PVd) in Subjects with Relapsed or Refractory Multiple Myeloma (RRMM):Successor-1 (CA057-001) Read Moreabout Ph3 study comparing CC-92480 in subjects with RRMM (SUCCESSOR-1)

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

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

Ph3 study of FOLFIRI in participants with metastatic colorectal cancer

A Randomized Open-label Phase 3 Study of Amivantamab + FOLFIRI Versus Cetuximab/Bevacizumab + FOLFIRI in Participants with KRAS/NRAS and BFAF Wild-Type Recurrent Unresectable or Metastatic Colorectal Cancer Who Have Received Prior Chemotherapy (61186372COR3002) Read Moreabout Ph3 study of FOLFIRI in participants with metastatic colorectal 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

STAR Clinical Study to Further Evaluate Trametinib with rare BRAF V600E or met Solid Tumors

Clinical Study To Further Evaluate The Efficacy Of Dabrafenib Plus Trametinib In Patients With Rare BRAF V600E Mutation-Positive Unresectable or Metastatic Solid Tumors (CDRB436IIC01) Read Moreabout STAR Clinical Study to Further Evaluate Trametinib with rare BRAF V600E or met Solid Tumors

Phase: IV