Biliary
22033 STAR
A Phase II, Open Label, Multicenter Study to Evaluate the Efficacy and Safety of TT-00420 Tablet in Adult Patients with Advanced Cholangiocarcinoma (TT420C1206)
- TX Line(s) – 2nd line or More
- Biomarker – FGFR-Documentation of status required. Eligibility includes both FGFR positive and wild-type.
Breast
22101 STAR
Phase 3 Study of adjuvant imlunestrant (LY3484356, an oral selective estrogen receptor degrader (SERD)) vs Standard Adjuvant endocrine therapy in patients who have previously received 2-5 years of adjuvant Endocrine Therapy for ER positive Her2 negative Early Breast Cancer with and increased Risk of Recurrence.
22159 STAR
A Phase 3, Comparing Gedatolisib (IV potential first-in-class pan-PI3K and mTOR inhibitor) 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.
Colon
19151 STAR
A Phase 1/2 Multiple Expansion Cohort Trial of MRTX849 in Patients with Advanced Solid Tumors with KRAS G12C Mutation (849-001) For all solid tumor designations with a G12C mutation.
- TX Line(s) – 2nd line/Metastatic – Cohorts A and B, patients must have previous treatment with at least a platinum & checkpoint inhibitor therapy.
- Biomarker – Genomic testing for KRAS if not previously performed, KRAS G12C
20318 STAR
A Randomized Phase 3 Study of MRTX849 in Combination with Cetuximab Versus Chemotherapy in Patients with Advanced Colorectal Cancer with KRAS G12C Mutation with Disease Progression On or After Standard First-Line Therapy (849-010)
- TX Line(s) – 2nd line
- Biomarker – KRAS G12C mutation
Head and Neck
21459 STAR
Ph1 FIH CUE101 Mono/Combo w/Pembro HNSCC (available to non Phase 1 sites)
- TX Line(s) – Recurrent/Mets
- Biomarker – HPV16 positive and express p16INK4A
Leukemia/Lymphoma
18263 STAR
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)
- TX Line(s) – Minimum of 1 prior line of standard chemotherapy
18263 STAR
A Phase 2, Multicenter, Single-Arm Study Of Zanubrutinib( oral brukinsa a BTK inhibitor) (Bgb-3111) In Patients With Previously Treated B-Cell Lymphoma Intolerant Of Prior Treatment With Acalabrutinib (CALQUENCE) (Bgb-3111-215)
Lung
21239 STAR
A Phase 3, Open-Label, Randomized Study of Amivantamab and Lazertinib in Combination with Platinum-Based Chemotherapy Compared with Platinum-Based Chemotherapy in Patients with EGFR-Mutated Locally Advanced or Metastatic Non-Small Cell Lung Cancer After Osimertinib Failure (61186372NSC3002)
- TX Line(s) – Locally advanced or metastatic 2nd or 3rd line with most recent treatment being Osimertinib
- Biomarker – EGFR Exon 19del or Exon 21 L858R mutation
19151 STAR
A Phase 1/2 Multiple Expansion Cohort Trial of MRTX849 in Patients with Advanced Solid Tumors with KRAS G12C Mutation (849-001). All Sites can participate in the Ph1b & Ph2
- TX Line(s) – Treatment Naïve, 2nd line
- Biomarker – KRAS G12C, KRAS G12C and STK11
21498 STAR
Ph1/2 VS-6766 + Soto KRAS G12C NSCLC-A Phase 1/2 Study of VS-6766 in Combination with Sotorasib in Patients with KRAS G12C mutant Non-Small Cell Lung Cancer (NSCLC) (RAMP 203) (VS-6766-203) **2 slots re-opened for the dose level VS-6766 4.0 mg VIW + sotorasib 960 mg QD
- TX Line(s) – 2nd or 3rd line
- Biomarker – KRAS G12C
20139 STAR
A Phase III, Randomised, Controlled, Multi-centre, 3-Arm Study of Neoadjuvant Osimertinib as Monotherapy or in Combination with Chemotherapy versus Standard of Care Chemotherapy Alone for the Treatment of Patients with Epidermal Growth Factor Receptor Mutation Positive, Resectable Non-small Cell Lung Cancer (NeoADAURA) (D516AC00001)
- TX Line(s) – Neoadjuvant
- Biomarker – Mutation in EGFR-TKI sensitivity (Ex19del, L858R), either alone or in combination with other EGFR mutations (ie, T790M, G719X, Exon20 insertions, S7681 and L861Q).
20331 STAR
A Phase 2 Study of VS-6766 (Dual RAF/MEK Inhibitor) as a Single Agent and in Combination with Defactinib (FAK Inhibitor) in Recurrent KRAS-Mutant (KRAS-MT) Non-Small Cell Lung Cancer (NSCLC)(VS-6766-202). Part B Status: Not Moving Forward – Part A Status: Reopen for Enrollment.
- TX Line(s) – Metastatic
- Biomarker – In Part A of the study, subjects must have either a KRAS-G12V mutation or ANY other KRAS mutation (KRAS-other, including KRAS-G12C & G12D).
20412 STAR
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)
- TX Line(s) – Adjuvant
- Biomarker – Central labs for RET testing
21318 STAR
A Phase I-III Multicenter Study Evaluating the Efficacy and Safety of Multiple Therapies in Cohorts of Biomarker-selected Patients with Locally Advanced Stage III Non-Small Cell Lung Cancer
- TX Line(s) – Prior receipt of at least two prior cycles of platinum-based chemot given with radiotherapy (cCRT); or at least two prior
- Biomarker – ALK, ROS-1, RET
22198 STAR
(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
23074 STAR
A randomized, phase 3, open-label study to evaluate SGN-B6A ( integrin beta-6-directed monoclonal antibody)compared with docetaxel in adult subjects with previously treated non-small cell lung cancer with or without actionable genomic alterations
Ovarian
21270 STAR
A Phase 2 Study Open-Label, Multicenter Study to Evaluate Efficacy and Safety of ZN-c3 in Subjects with High-Grade Serious Ovarian, Fallopian Tube, or Primary Peritoneal Cancer (ZN-c3-005 | GOG 3066)
- TX Line(s) – One to 3 prior lines or regiments for advanced/metastatic disease are allowed, must have documented progressive disease ≤6 months (183 days) from last dose of platinum therapy, and must not have platinum refractory disease.
- Biomarker – Must have copy number amplification in the CCNE1 gene
21270 STAR
A Phase 2 Study To Evaluate Efficacy And Safety Of Zn-C3 (oral WEE1 kinase is a serine-threonine kinase that regulates G2/M checkpoint transition) In Subjects With High-Grade Serous Ovarian, Fallopian Tube, Or Primary Peritoneal Cancer (Zn-C3-005| Gog 3066)
Prostate
20138 STAR
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
- TX Line(s) – 1st line Metastatic
- Biomarker – PTEN mutation
20248 STAR
A Phase 3 Randomized, Placebo-controlled, Double-blind Study of Niraparib in Combination with Abiraterone Acetate and Prednisone Versus Abiraterone Acetate and Prednisone for the Treatment of Participants with Deleterious Germline or Somatic Homologous Recombination Repair (HRR) Gene-Mutated Metastatic Castration-Sensitive Prostate Cancer (mCSPC)(67652000PCR3002)
- TX Line(s) – 2nd line metastatic
- Biomarker – one of the following: BRCA1, BRCA2, BRIP1, CDK12, CHEK2, FANCA, PALB2, RAD51B, RAD54L
Solid Tumors
19151 STAR
A Phase 1/2 Multiple Expansion Cohort Trial of MRTX849 in Patients with Advanced Solid Tumors with KRAS G12C Mutation (849-001) Refer to CTMS for open COHORTS
- TX Line(s) – Other solid tumors see Amend 9 flyer
- Biomarker – KRAS G12C- other mutations when no other treatment options- Phas2 portion
22052 STAR
Ph2 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)
- TX Line(s) – Received all SOC therapies appropriate for their tumor type OR investigator determines no clinical benefit from SOC and no satisfactory alternative treatments
- Biomarker – TSCI1 or TSC2 genes alterations
20186 STAR
Tumor-Agnostic Precision Immuno-Oncology And Somatic Targeting Rational For You (Tapistry) Phase 2 Platform Trial (Bo41932)
- Biomarker arms:
ROS1-Entrectinib PO (Rozlytrek) (oral TKI- Tyrosine kinase inhibitor- targeted therapy)
NTRK-1/2/3-Entrectinib PO (Rozlytrek) (oral TKI- Tyrosine kinase inhibitor- targeted therapy)
ALK-Alectinib PO (Alcensa) (oral TKI- Tyrosine kinase inhibitor- targeted therapy)
RET- Pralsetinib P (Gavreto) (oral TKI- Tyrosine kinase inhibitor- targeted therapy)