Waco Research and Clinical Trials

Ph2/3 CTX-009 + Paclitaxel vs. Paclitaxel in mBiliary Tract

A Phase 2/3 Randomized Controlled Study of CTX-009 in Combination with Paclitaxel versus Paclitaxel Alone in Adult Patients with Unresectable Advanced Metastatic or Recurrent Biliary Tract Cancers who have received One Prior Systemic Chemotherapy Regimen (CTX-009-002) Read Moreabout Ph2/3 CTX-009 + Paclitaxel vs. Paclitaxel in mBiliary Tract

Phase: II/III

STAR: Ph2 TT-00420 Advanced Cholangiocarcinoma

A Phase II Open Label Multicenter Study to Evaluate the Efficacy and Safety of TT-00420 (tinengotinib) Tablet in Adult Patients with Advanced Cholangiocarcinoma (TT420C1206) Read Moreabout STAR: Ph2 TT-00420 Advanced Cholangiocarcinoma

Phase: 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

Ph3 Palb Fulv SOC HR+ HER2- BC CDK4/6 (VIKTORIA-1)

A Phase 3 Open-Label Randomized Two-Part Study Comparing Gedatolisib in Combination with Palbociclib and Fulvestrant to Standard-of-Care Therapies in Patients with HR-Positive HER2-Negative Advanced Breast Cancer Previously Treated with a CDK4/6 Inhibitor in Combination with Non-Steroidal Aromatase Inhibitor Therapy (VIKTORIA-1) (CELC-G-301) Read Moreabout Ph3 Palb Fulv SOC HR+ HER2- BC CDK4/6 (VIKTORIA-1)

Phase: III

Registry study with Breast Cancer Index

Breast Cancer Index (BCI) Registry Study (BTX-BCI-016-PRT) Read Moreabout Registry study with Breast Cancer Index

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

STAR: Ph2 TT-00420 Advanced Cholangiocarcinoma

A Phase II Open Label Multicenter Study to Evaluate the Efficacy and Safety of TT-00420 (tinengotinib) Tablet in Adult Patients with Advanced Cholangiocarcinoma (TT420C1206) Read Moreabout STAR: Ph2 TT-00420 Advanced Cholangiocarcinoma

Phase: II

Ph2 SKB264 + Pembro in Select Solid Tumors

A multicenter open-label phase 2 basket study to evaluate the efficacy and safety of SKB264 in combination with pembrolizumab in subjects with selected solid tumors (SKB264-II-06) Read Moreabout Ph2 SKB264 + Pembro in Select Solid Tumors

Phase: II

Phase 2/3 Navtemadlin as Maintenance Tx in TP53WT Advanced/Recurrent Endometrial Cancer

A Phase 2/3 Study of Navtemadlin as Maintenance Therapy in Subjects with TP53WT Advanced or Recurrent Endometrial Cancer Who Responded to Chemotherapy (KRT-232-118) Read Moreabout Phase 2/3 Navtemadlin as Maintenance Tx in TP53WT Advanced/Recurrent Endometrial Cancer

Phase: II/III

Ph2 Girdes Endo Carcinoma

A PHASE II SINGLE-ARM STUDY OF GIREDESTRANT IN PATIENTS WITH GRADE 1 ENDOMETRIAL CANCER (CO44195) Read Moreabout Ph2 Girdes Endo Carcinoma

Phase: II

STAR Ph2 ZN-c3 Tumor DNA Repair CCGA

A Phase 2 Open-Label Multicenter Study to Evaluate Efficacy and Safety of ZN-c3 in Subjects with High-Grade Serous Ovarian Fallopian Tube or Primary Peritoneal Cancer (ZN-c3-005 GOG 3066) Read Moreabout STAR Ph2 ZN-c3 Tumor DNA Repair CCGA

Phase: II

Ph2 ONC-392 Pembro Ovarian PROC (PRESERVE-004)

Phase 2 Randomized Open-label Multicenter Study of Combination of ONC-392 and Pembrolizumab for the Treatment of Patients with Platinum Resistant Ovarian Cancer (PROC) (PRESERVE-004 MK-3475-E24 GOG-3081) Read Moreabout Ph2 ONC-392 Pembro Ovarian PROC (PRESERVE-004)

Phase: II

Ph2/3 CTX-009 + Paclitaxel vs. Paclitaxel in mBiliary Tract

A Phase 2/3 Randomized Controlled Study of CTX-009 in Combination with Paclitaxel versus Paclitaxel Alone in Adult Patients with Unresectable Advanced Metastatic or Recurrent Biliary Tract Cancers who have received One Prior Systemic Chemotherapy Regimen (CTX-009-002) Read Moreabout Ph2/3 CTX-009 + Paclitaxel vs. Paclitaxel in mBiliary Tract

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

Ph3b oral asciminib v. nilotinib in newly dx Phl. Chrom+ CML in Chronic phase

A phase IIIb multi-center open-label randomized study of tolerability and efficacy of oral asciminib versus nilotinib in patients with newly diagnosed Philadelphia Chromosome Positive Chronic Myelogenous Leukemia in Chronic Phase (CABL001J12302) Read Moreabout Ph3b oral asciminib v. nilotinib in newly dx Phl. Chrom+ CML in Chronic phase

Phase: III

STAR Ph3 Furmo v platinum chemo in EXON 20 NSCLC EGFR

(FURMO-004) 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 Locally Advanced or Metastatic Non-Small Cell Lung Cancer with Epidermal Growth Factor Receptor Exon 20 Insertion Mutations 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 (VS-6766) in Combination with Sotorasib 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

Ph3 Zimb Domv vs Pemb NSCLC Lymph Kinase geo Tumor

A Randomized Open-Label Phase 3 Study to Evaluate Zimberelimab and Domvanalimab in Combination with Chemotherapy Versus Pembrolizumab with Chemotherapy for the First-Line Treatment of Patients With Metastatic Non-Small Cell Lung Cancer With No Epidermal Growth Factor Receptor or Anaplastic Lymphoma Kinase Genomic Tumor Aberrations (GS-US-626-6216) Read Moreabout Ph3 Zimb Domv vs Pemb NSCLC Lymph Kinase geo Tumor

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

Ph 3 Durv vs. plbo SBRT NSCLC (PAC 4)

D9103C00001: A Phase III Randomized Placebo-controlled Double-blind Multi-center International Study of Durvalumab with Stereotactic Body Radiation Therapy (SBRT) for the Treatment of Patients with unresected Stage I/II lymph-node negative Non-small Cell Lung Cancer (PACIFIC-4/RTOG-3515) Read Moreabout Ph 3 Durv vs. plbo SBRT NSCLC (PAC 4)

Phase: 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

Ph2 SKB264 + Pembro in Select Solid Tumors

A multicenter open-label phase 2 basket study to evaluate the efficacy and safety of SKB264 in combination with pembrolizumab in subjects with selected solid tumors (SKB264-II-06) Read Moreabout Ph2 SKB264 + Pembro in Select Solid Tumors

Phase: II

STAR Ph2 ZN-c3 Tumor DNA Repair CCGA

A Phase 2 Open-Label Multicenter Study to Evaluate Efficacy and Safety of ZN-c3 in Subjects with High-Grade Serous Ovarian Fallopian Tube or Primary Peritoneal Cancer (ZN-c3-005 GOG 3066) Read Moreabout STAR Ph2 ZN-c3 Tumor DNA Repair CCGA

Phase: II

STAR Ph2 VS-6766 Fak-Inhib LGSOC (RAMP)

A Phase 2 Study of VS-6766 (Dual RAF/MEK Inhibitor) Alone and In Combination with Defactinib (FAK Inhibitor) in Recurrent Low-Grade Serous Ovarian Cancer (LGSOC)(VS-6766-201) (GOG 3052) Read Moreabout STAR Ph2 VS-6766 Fak-Inhib LGSOC (RAMP)

Phase: II

Ph2 ONC-392 Pembro Ovarian PROC (PRESERVE-004)

Phase 2 Randomized Open-label Multicenter Study of Combination of ONC-392 and Pembrolizumab for the Treatment of Patients with Platinum Resistant Ovarian Cancer (PROC) (PRESERVE-004 MK-3475-E24 GOG-3081) Read Moreabout Ph2 ONC-392 Pembro Ovarian PROC (PRESERVE-004)

Phase: 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 Ph2 ZN-c3 Tumor DNA Repair CCGA

A Phase 2 Open-Label Multicenter Study to Evaluate Efficacy and Safety of ZN-c3 in Subjects with High-Grade Serous Ovarian Fallopian Tube or Primary Peritoneal Cancer (ZN-c3-005 GOG 3066) Read Moreabout STAR Ph2 ZN-c3 Tumor DNA Repair CCGA

Phase: II

Ph2 ONC-392 Pembro Ovarian PROC (PRESERVE-004)

Phase 2 Randomized Open-label Multicenter Study of Combination of ONC-392 and Pembrolizumab for the Treatment of Patients with Platinum Resistant Ovarian Cancer (PROC) (PRESERVE-004 MK-3475-E24 GOG-3081) Read Moreabout Ph2 ONC-392 Pembro Ovarian PROC (PRESERVE-004)

Phase: II

Ph2 SKB264 + Pembro in Select Solid Tumors

A multicenter open-label phase 2 basket study to evaluate the efficacy and safety of SKB264 in combination with pembrolizumab in subjects with selected solid tumors (SKB264-II-06) Read Moreabout Ph2 SKB264 + Pembro in Select Solid Tumors

Phase: II

Ph3 Apalutamide Monotherapy Castration-Sensitive Prostate Cancer (mCSPC) LIBERTAS

A Phase 3 Open-label Randomized Prospective Study of Apalutamide with Continued Versus Intermittent Androgen-Deprivation Therapy (ADT) following PSA Response in Participants with Metastatic Castration-Sensitive Prostate Cancer (mCSPC) (56021927PCR3020) Read Moreabout Ph3 Apalutamide Monotherapy Castration-Sensitive Prostate Cancer (mCSPC) LIBERTAS

Phase: III

STAR PH3 Abi+/-Capi mHSPC CAPItello-281

A Phase III Double-Blind Randomised Placebo-Controlled Study Assessing the Efficacy and Safety of Capivasertib + Abiraterone Versus Placebo + Abiraterone as Treatment for Patients with De Novo Metastatic Hormone Sensitive Prostate Cancer(mHSPC) Characterised by PTEN deficiency (CAPItello-281) D361BC00001 Read Moreabout STAR PH3 Abi+/-Capi mHSPC CAPItello-281

Phase: III

Ph3 Abema +Abira +Predn mHSPC (Cyclone3)

CYCLONE 3: A Phase 3 Randomized Double-Blind Placebo-Controlled Study of Abemaciclib in Combination with Abiraterone plus Prednisone in Men with High-Risk Metastatic Hormone-Sensitive Prostate Cancer (I3Y-MC-JPEG) Read Moreabout Ph3 Abema +Abira +Predn mHSPC (Cyclone3)

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 Ph2 Basket nab-siro Solids TSC1 or TSC2 genes

A Phase 2 multi-center open-label basket trial of nab-sirolimus for adult and adolescent patients with malignant solid tumors harboring pathogenic inactivating alterations in TSC1 or TSC2 genes (TSC-007) Read Moreabout STAR Ph2 Basket nab-siro Solids TSC1 or TSC2 genes

Phase: II

Ph2 Tumor-Agnostic Precision TAPISTRY

TUMOR-AGNOSTIC PRECISION IMMUNO-ONCOLOGY AND SOMATIC TARGETING RATIONAL FOR YOU (TAPISTRY) PHASE II PLATFORM TRIAL (BO41932) Read Moreabout Ph2 Tumor-Agnostic Precision TAPISTRY

Phase: II

Ph2 SKB264 + Pembro in Select Solid Tumors

A multicenter open-label phase 2 basket study to evaluate the efficacy and safety of SKB264 in combination with pembrolizumab in subjects with selected solid tumors (SKB264-II-06) Read Moreabout Ph2 SKB264 + Pembro in Select Solid Tumors

Phase: 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