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  • GILEAD and the GILEAD logo are trademarks of Gilead Sciences, Inc. KITE and the KITE logo are trademarks of Kite Pharma, Inc. © 2024 Gilead Sciences, Inc. All rights reserved. IHQ-UNB-5659 May 2024

Our pipeline.

Active and planned clinical trials

Click row, filter menu or scientific focus key color to view available clinical trial study designs.

The safety and efficacy of these investigational agents or investigational uses of marketed products have not been established. These uses have not been approved by regulatory authorities. There is no guarantee that these therapies or uses will be commercialized.

Our scientific focus areas target:
Tumor-intrinsic cell death Immune-mediated tumor killing Tumor-permissive microenvironment
TUMOR TYPE RESEARCH AREA Molecule(s)
PHASE 1 PHASE 2 PHASE 3
Hematological malignancies 2L+ high-risk FL (ZUMA-22) axicabtagene ciloleucel NCT05371093
1L high-risk LBCL (ZUMA-23) axicabtagene ciloleucel NCT05605899
2L LBCL outpatient (ZUMA-24) axicabtagene ciloleucel NCT05459571
R/R Pediatric ALL/NHL (ZUMA-4) brexucabtagene autoleucel NCT02625480
R/R MM (iMMagine-3)a anitocabtagene autoleucel NCT06413498
R/R MM (iMMagine-1)a anitocabtagene autoleucel NCT05396885
R/R DLBCL KITE-363 (CD19/20 bicistronic) NCT04989803
R/R DLBCL KITE-753 (CD19/20 bicistronic) NCT04989803
R/R DLBCL KITE-197 (next-gen CD19 CAR-T) NCT06079164
Breast 1L mTNBC, PD-L1- (ASCENT-03) sacituzumab govitecan (SG) NCT05382299
1L mTNBC, PD-L1+ (ASCENT-04)b sacituzumab govitecan + pembrolizumab NCT05382286
Adjuvant TNBC (ASCENT-05)c sacituzumab govitecan + pembrolizumab NCT05633654
1L HR+/HER2- chemo-naïve mBC (ASCENT-07) sacituzumab govitecan NCT05840211
2L+ HR+/HER2- mBC (EVER-132-002)d sacituzumab govitecan NCT04639986
2L+ mTNBC (ASCENT-J02) sacituzumab govitecan NCT05101096 1/2
GU 2L+ mUC (TROPiCS-04) sacituzumab govitecan NCT04527991
1L/2L+ mUC (TROPHY U-01, multicohort) sacituzumab govitecan + combinations NCT03547973
gastrointestinal 1L upper GI (STAR-221)e,f domvanalimab + zimberelimab + chemotherapy NCT05568095
1-2L upper GI (EDGE-Gastric)e,g domvanalimab + zimberelimab + chemotherapy NCT05329766
2L+ mCRC (ARC-9)e,h etrumadenant + zimberelimab combinations NCT04660812 1b/2
1-2L mPDAC (ARC-8)e,i quemliclustat + zimberelimab + chemo NCT04104672
GYN 2L+ mEC (ASCENT-GYN-01) sacituzumab govitecan
Planned
Thoracic 2-3L mNSCLC (EVOKE-01) sacituzumab govitecan NCT05089734
1L mNSCLC, PD-L1+, TPS≥50% (EVOKE-03)b sacituzumab govitecan + pembrolizumab NCT05609968
1L mNSCLC (STAR-121)e domvanalimab + zimberelimab + chemotherapy NCT05502237
Early NSCLC (STAR-131)e Dom + zim + chemo → dom + zim
Planned
1L mNSCLC (EVOKE-02)b sacituzumab govitecan ± pembrolizumab ± chemo NCT05186974
1L mNSCLC (ARC-7)e,j domvanalimab + zimberelimab + etrumadenant NCT04262856
1-2L mNSCLC (VELOCITY-Lung)e dom + zim + etruma + SG combinations NCT05633667
1-2L mNSCLC (EDGE-Lung)e dom + zim + quemli + chemotherapy combinations NCT05676931
Other solid tumors Solid tumors (EVER-132-003) sacituzumab govitecan NCT05119907
Solid tumor basket study (TROPiCS-03)k sacituzumab govitecan NCT03964727
Advanced/metastatic solid tumor (hepatic impairment)l sacituzumab govitecan NCT04617522
Solid tumors GS-9716 (MCL-1) + chemo or SG NCT05006794
Solid tumors GS-1811 (CCR8) + zim NCT05007782
Solid tumors GS-4528 (IL2 variant) + zim NCT05840224
Solid tumors GS-0201 (PARPi) ± SG NCT06167317
Solid tumors GS-9911 (DGKα) ± zim NCT06082960
Solid tumors XTX301 (masked IL-12)m NCT05684965

Optionable Partner Programs 1,n

Agenus

1 clinical stage program
Solid tumors

Arcus

1 clinical stage program
PK study

MacroGenics

1 clinical stage program
Advanced cancers


Targets

GS-9716 GS-0201 sacituzumab govitecan anito-cel axi-cel, brexu-cel KITE-197 KITE-363, KITE-753 GS-9911 GS-4528 XTX301 zimberelimab domvanalimab etrumadenant GS-1811 quemliclustat
MCL-1 PARPi TROP2 BCMA CD19 CD19
Next-gen CAR-T		 CD19/20
bicistronic		 DGKα IL2 variant IL12 PD-1 TIGIT A2AR/A2BR CCR8 CD73

The safety and efficacy of these investigational agents or investigational uses of marketed products have not been established. These uses have not been approved by regulatory authorities. There is no guarantee that these therapies or uses will be commercialized.

aIn collaboration with Arcellx, Inc. bIn collaboration with Merck. cIn collaboration with Alliance Foundation Trials, LLC and National Surgical Adjuvant Breast and Bowel Project Foundation, Inc. dA Phase 3 Asian Study of Sacituzumab Govitecan Versus Treatment of Physician's Choice (TPC) in Subjects With Hormonal Receptor-positive (HR+)/Human Epidermal Growth Factor Receptor 2 Negative (HER2-) Metastatic Breast Cancer (MBC) Who Have Failed at Least 2 Prior Chemotherapy Regimens. eIn collaboration with Arcus Biosciences. fSTAR-221: Dom + Zim + FOLFOX vs Nivo + FOLFOX. gEDGE-Gastric: (1L) Dom + Zim + chemo, Zim + chemo and (2L) Dom + Zim, Zim + Quemli. hARC-9: Etruma + Zim + FOLFOX vs FOLFOX, Etruma + Zim + FOLFOX vs Rego, and Etruma + Zim + Quemli. iARC-8: Quemli + Zim + Gem/Nab-pac. jARC-7: Zim ± Dom ± Etruma. kmNSCLC, mSCLC, mHNSCC, mEC. lPatient population includes those with moderate hepatic impairment. mOperationalized by Xilio Development, Inc. nSelected programs listed are optionable partner programs. Gilead has not opted into these programs unless otherwise noted.

1L, first line; 2L, second line; 3L, third line; A2aR/A2bR, adenosine 2a receptor/adenosine 2b receptor; ALL, acute lymphoblastic leukemia; AML, acute myeloid leukemia; anito-cel, anitocabtagene autoleucel; axi-cel, axicabtagene ciloleucel; BC, breast cancer; BCMA, B-cell maturation antigen; brexu-cel, brexucabtagene autoleucel; CCR8, chemokine receptor 8; CD19/20/73, cluster of differentiation 19/20/73; chemo, chemotherapy; CRC, colorectal cancer; DGKα, diacylglycerol kinase alpha; DLBCL, diffuse large B-cell lymphoma;doce, docetaxel; dom, domvanalimab; durva, durvalumab; EC, endometrial cancer; etruma, etrumadenant; FL, follicular lymphoma; FOLFIRI, FOLinic acid-Fluorouracil-IRInotecan regimen; gem/nab-pac, gemcitabine/nab-paclitaxel; GI, gastrointestinal; GU, genitourinary; GYN, gynecologic; HER2, human epidermal growth factor receptor 2; HNSCC, head and neck squamous cell carcinoma; HR, hormone receptor; ITIM, immunoreceptor tyrosine-based inhibitory motif; LBCL, large B-cell lymphoma; m, metastatic; MCL-1, myeloid cell leukemia-1; MM, multiple myeloma; NCT, national clinical trial; nivo, nivolumab; NHL, non-Hodgkin lymphoma; NSCLC, non-small cell lung cancer; PARPi, poly (adenosine diphosphate [ADP]) ribose polymerase (PARP) inhibitor; pembro, pembrolizumab; PD-1, programmed cell death protein 1; PD-L1, programmed death-ligand 1; PDAC, pancreatic ductal adenocarcinoma; PK, pharmacokinetics; Quemli, quemliclustat; rego, regorafenib; R/R, relapsed/refractory; SG, sacituzumab govitecan; TIGIT, T cell immunoreceptor with immunoglobulin and ITIM domains; TNBC, triple-negative breast cancer; TPS, tumor proportion score; TROP2, trophoblast cell-surface antigen 2; UC, urothelial cancer; zim, zimberelimab.

Last updated May 2024