Cancer clinical trial database.
Every new trial and trial result from New in Oncology, our weekly research briefing, since the first issue on . Search by NCT number, drug, or cancer type.
Spotlight picks
- Trial result Spotlight
Breast cancer
Sacituzumab govitecan (TROP2 ADC) + pembrolizumab extends PFS vs chemo+pembro across TROP2, tBRCA, and HER2-low mTNBC subgroups
Sacituzumab govitecan (SG) is a TROP2-directed antibody–drug conjugate delivering SN-38, combined here with pembrolizumab (PD-1 inhibitor) as first-line therapy in the Phase 3 ASCENT-04/KEYNOTE-D19 trial…
NCT05382286 - Trial result Spotlight
Breast cancer
ZN-A-1041 (BBB-permeable HER2 TKI) + T-DXd drives 65%–76% ORR in HER2+ mBC (incl CNS mets)
ZN-A-1041 is an oral, selective HER2 tyrosine kinase inhibitor designed for high intact blood–brain barrier permeability; in the Phase Ic ZN-A-1041-101-US trial (NCT05593094), it was combined with trastuzumab…
NCT05593094 - Trial result Spotlight
Breast cancer
Gedatolisib (pan-PI3K/mTORC1/2 inhibitor) + fulvestrant ± palbociclib doubles PFS vs alpelisib in PIK3CA-mut HR+/HER2− ABC
Gedatolisib (IV, comprehensive PI3Kα/β/δ/γ + mTORC1/2 inhibitor) was tested in the randomized, open-label Phase 3 VIKTORIA-1 Study 2 (NCT05501886) in HR+/HER2− PIK3CA-mutant advanced breast cancer after progression…
NCT05501886 - New trial Spotlight
Non-small cell lung cancer
Phase 3 calderasib (MK-1084) KRAS G12C inhibitor + durvalumab PD-L1 antibody after CCRT
Merck Sharp & Dohme (Merck/MSD) is running KANDLELIT-015 (MK-1084-015), a Phase 3 randomized, triple-blind, parallel-group trial in unresected stage II (node-positive) to stage III, predominantly nonsquamous NSCLC…
NCT07554339 Registrational - New trial Spotlight
Multiple myeloma
Phase 3 JNJ-79635322 BCMA/GPRC5D×CD3 trispecific antibody vs teclistamab BCMA×CD3 bispecific in RRMM
Janssen Research & Development (Johnson & Johnson) is running this Phase 3 randomized head-to-head study (TRIlogy-5) to compare JNJ-79635322 versus teclistamab in relapsed/refractory multiple myeloma after 1–3 prior…
NCT07518186 Registrational - New trial Spotlight
Chronic lymphocytic leukemia
Phase 3 sonrotoclax (BGB-11417) BCL2 inhibitor plus zanubrutinib BTK inhibitor in untreated CLL
BeOne Medicines’ Phase 3 open-label, randomized study (BGB-11417-304; CELESTIAL‑TNCLL‑2) tests whether fixed-duration sonrotoclax + zanubrutinib can improve outcomes versus a fixed-duration control of venetoclax +…
NCT07277231 Registrational - New trial Spotlight
Pancreatic cancer
Phase 3 zoldonrasib (RMC-9805) KRAS G12D-selective RAS(ON) inhibitor plus chemo in 1L metastatic PDAC.
This registrational, randomized, double-blind, placebo-controlled Phase 3 study (RASolute 305) tests whether adding zoldonrasib (RMC-9805)—Revolution Medicines’ oral KRAS G12D-selective “RAS(ON)” inhibitor that…
NCT07621718 Registrational - New trial Spotlight
Multiple solid tumors
Phase 1/2 BLU-924 (SAR449336) pan-KRAS inhibitor in KRAS-mutant PDAC/NSCLC/CRC
This first-in-human, open-label Phase 1/2 trial tests BLU-924 (SAR449336), an oral pan-KRAS small-molecule inhibitor, as monotherapy and in combination therapy in people with metastatic, KRAS-mutant pancreatic ductal…
NCT07629960 First-in-human - Trial result Spotlight
Non-small cell lung cancer
Sevabertinib (HER2 TKI) sustains 67–75% ORR in HER2-mutant NSCLC with no ILD signal
Sevabertinib is a potent, reversible, oral HER2 (ERBB2) tyrosine kinase inhibitor evaluated at 20mg BID in the open-label Phase I/II SOHO-01 trial (NCT05099172) in advanced HER2–tyrosine kinase domain–mutant NSCLC…
NCT05099172 - Trial result Spotlight
Non-small cell lung cancer
Neladalkib (next-gen ALK TKI; TRK-sparing) posts 31% ORR post–multiple ALK TKIs, with 68% ORR in G1202R ALK+ NSCLC
Neladalkib is an investigational, brain-penetrant ALK tyrosine kinase inhibitor designed to cover single/compound ALK resistance mutations (including G1202R) while sparing TRK, evaluated in the global single-arm…
NCT05384626 - Trial result Spotlight
Non-small cell lung cancer
Lunbotinib (A400/EP0031) selective RET inhibitor posts 81–87% ORR and 27.5-mo mPFS in RET-fusion NSCLC
Lunbotinib is an oral, brain-penetrant next-generation selective RET inhibitor designed to inhibit RET fusion and mutant proteins, evaluated in a pivotal Phase II, two-cohort, single-arm study in China (NCT05265091)…
NCT05265091 - Trial result Spotlight
Non-small cell lung cancer
Divarasib (KRAS G12C inhibitor) + pembrolizumab drives 73% ORR and 19.3-mo PFS in 1L KRAS G12C+ NSCLC
Divarasib is an oral, next-generation covalent KRAS G12C inhibitor combined with pembrolizumab (PD-1) in the open-label Phase Ib/II Krascendo-170 dose-finding/expansion study (NCT05789082) in untreated…
NCT05789082 - Trial result Spotlight
Non-small cell lung cancer
BH-30643 (OMNI‑EGFR mutant‑selective macrocyclic TKI) shows 59% ORR in post‑osimertinib C797S NSCLC (incl CNS)
BH-30643 is a first-in-class macrocyclic, non-covalent “OMNI‑EGFR” inhibitor engineered to selectively hit EGFR driver mutations while largely sparing WT EGFR and retaining activity against C797S with or without…
NCT06706076 - Trial result Spotlight
Non-small cell lung cancer
SSGJ-707 (PF-08634404) PD-1×VEGF Bispecific Delivers 67.6% ORR and 12.4-mo mPFS in 1L PD-L1+ NSCLC
SSGJ-707 is a fully human IgG4 bispecific antibody that simultaneously binds PD-1 and VEGF, aiming to pair checkpoint blockade with anti-angiogenic activity in a single agent. In the Phase 2 NCT06361927 dose-finding…
NCT06361927 - Trial result Spotlight
Non-small cell lung cancer
Lattice SF-SBRT + Toripalimab/Chemo Drives 95% MPR in Resectable NSCLC
Lattice spatially fractionated SBRT delivers a single preoperative radiation fraction with a 12 Gy peak and <4 Gy valley, here combined with toripalimab, a PD-1 antibody, plus platinum-doublet chemotherapy in a…
NCT06293690 - New trial Spotlight
Prostate cancer
Phase 3 AZD2265 (FPI-2265) Actinium-225 PSMA-targeted alpha radioconjugate vs physician’s-choice SOC in mCRPC
AstraZeneca’s VECTRA-01 is a randomized, multicenter Phase 3 study testing AZD2265 (FPI-2265), a PSMA-binding small-molecule radioconjugate labeled with actinium-225 that delivers high–linear energy transfer alpha…
NCT07611110 Registrational - New trial Spotlight
Breast cancer
Phase 2 BETTER trial tests pembrolizumab PD-1 blockade with taxane/platinum chemo de-escalation.
MD Anderson Cancer Center is running this Phase 2 neoadjuvant study in high-risk, early-stage triple-negative breast cancer (clinical stage T1cN1-2 or T2-4N0-2) to see whether blood-based ctDNA and breast MRI can…
NCT07610525 Exploratory - New trial Spotlight
Ovarian cancer
Phase 3 azenosertib WEE1 inhibitor vs chemotherapy in Cyclin E1+ platinum-resistant HGS ovarian cancer.
This global, randomized, open-label Phase 3 study (ASPENOVA; also referenced as GOG-3147/ENGOT-ov109/APGOT-OV27) tests whether azenosertib (ZN-c3)—a first-in-class, oral WEE1 kinase inhibitor from Zentalis…
NCT07546500 Registrational - New trial Spotlight
Acute myeloid leukemia and MDS
Phase 2 revumenib menin inhibitor triplet with azacitidine + venetoclax in KMT2A-rearranged AML.
UNC Lineberger’s RAVEN study (NCT07605949) evaluates an all-oral/SC intensive-lower regimen combining revumenib (a menin–KMT2A/MLL interaction inhibitor that downregulates leukemogenic HOX/MEIS programs) with…
NCT07605949 Exploratory - Trial result Spotlight
Breast cancer
Dato-DXd (TROP2 ADC) + durvalumab (PD-L1) drives ~80% ORR and 14-mo mPFS in 1L metastatic TNBC (BEGONIA)
Dato-DXd is a TROP2-directed antibody–drug conjugate delivering a topoisomerase I inhibitor payload (deruxtecan), combined here with durvalumab (anti–PD-L1) as first-line therapy in unresectable locally…
NCT03742102 - Trial result Spotlight
Non-small cell lung cancer
Zoldonrasib (RMC-9805) RAS(ON) KRAS G12D inhibitor drives 52% ORR and 11.1-mo PFS in pretreated NSCLC
Zoldonrasib (RMC-9805) is an oral, covalent, KRAS G12D-selective “RAS(ON)” tri-complex inhibitor that targets the active (GTP-bound) state; updated monotherapy data come from an ongoing Phase 1/1b dose-escalation…
NCT06040541 - Trial result Spotlight
Non-small cell lung cancer
Elisrasib (D3S-001) GDP-bound KRAS G12C inhibitor posts 56% ORR in 2L+ NSCLC and 32% post–G12Ci
Elisrasib is an oral, next-generation KRAS G12C inhibitor designed to bind the GDP-bound state and sustain target engagement despite growth factor–driven nucleotide exchange (a hypothesized resistance lever for…
NCT05410145 - Trial result Spotlight
Bladder and urothelial cancer
EV-103: Enfortumab vedotin (Nectin-4 ADC) + pembrolizumab (PD-1) sustains 41.5% 5-year survival in 1L cisplatin-ineligible la/mUC
Enfortumab vedotin is a Nectin-4–directed antibody–drug conjugate delivering MMAE, combined here with pembrolizumab (anti–PD-1) as first-line therapy in EV-103 dose escalation/cohort A (Phase Ib/II; NCT03288545) for…
NCT03288545 - New trial Spotlight
Bladder and urothelial cancer
Phase 3 EV-309 tests enfortumab vedotin Nectin-4 ADC + pembrolizumab PD-1 inhibitor
This Phase 3, open-label, randomized, multicenter study (EV-309) evaluates bladder-preserving enfortumab vedotin plus pembrolizumab versus concurrent chemoradiotherapy (cCRT) in adults with non-metastatic…
NCT07566156 Registrational - New trial Spotlight
Prostate cancer
Phase 3 BNT324 (DB-1311) B7-H3–targeted topoisomerase I–payload ADC vs docetaxel in mCRPC.
This randomized, open-label Phase 3 BioNTech SE study compares BNT324 (also known as DB-1311) with docetaxel plus prednisone/prednisolone in men with progressive metastatic castration-resistant prostate cancer who…
NCT07365995 Registrational - New trial Spotlight
Ovarian cancer
Phase 1 XmAb541 CLDN6×CD3 T‑cell–engaging bispecific + XmAb808 B7‑H3×CD28 costimulatory bispecific
Xencor’s open-label Phase 1 study (sequential assignment) dose-escalates then dose-expands XmAb541 with XmAb808 to define safety, dose-limiting toxicities, PK, and early antitumor activity (RECIST 1.1) in CLDN6+…
NCT07593092 Exploratory - New trial Spotlight
Non-small cell lung cancer
Phase 2/3 EIK1001 TLR7/8 agonist + pembrolizumab chemo in 1L stage 4 NSCLC
This global, multicenter, randomized, double-blind, placebo-controlled adaptive Phase 2/3 trial (TeLuRide-008) tests whether adding Eikon Therapeutics’ EIK1001—an IV Toll-like receptor 7/8 (TLR7/8) innate immune…
NCT07365319 Exploratory - New trial Spotlight
Small cell lung cancer
Phase 1b tarlatamab DLL3×CD3 T‑cell engager + ZL‑1310 DLL3 Topo‑I ADC ± durvalumab
Amgen’s open-label Phase 1b study tests whether dual DLL3 targeting can deepen responses in relapsed/recurrent small cell lung cancer: tarlatamab (a DLL3×CD3 bispecific antibody that redirects T cells to…
NCT07531095 Exploratory - New trial Spotlight
Lymphoma
Phase 1 CART-45 anti-CD45 CAR T + CD45 base-edited HSPC epitope shield
University of Pennsylvania’s Phase 1 open-label, dose-finding study evaluates a two-step, autologous cell-therapy strategy: infusion of CD45 base-edited hematopoietic stem and progenitor cells (CD45BE-HSPC) followed…
NCT07451054 First-in-human - New trial Spotlight
Multiple solid tumors
Phase 1 TCR1188-ABC KRAS G12V TCR + ILT4 (LILRB2)–redirected base-edited T cells
This University of Pennsylvania first-in-human, Phase 1, open-label 3+3 dose-escalation study tests TCR1188-ABC: autologous CD4+ and CD8+ T cells that are base-edited and engineered to (1) express a high-affinity,…
NCT07594067 First-in-human
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