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.
Latest entries
- Trial result Spotlight
Breast cancer
RLY-2608 Mutant-Selective PI3Kα Inhibitor Achieves 31% ORR and 9-Month mPFS with Minimal Grade 3 Hyperglycemia in Post-CDK4/6 HR+/HER2⁻ mBC
RLY-2608 is an oral, allosteric PI3Kα inhibitor that binds only oncogenic PIK3CA variants, sparing wild-type signaling to reduce metabolic toxicity. In the phase 1 ReDiscover trial, 52 heavily pre-treated HR+/HER2⁻…
- Trial result Spotlight
Breast cancer
T-DXd + Pyrotinib Hits 100% PR in Phase Ib First-Line HER2-Positive mBC (TROPHY)
Trastuzumab deruxtecan (T-DXd), a HER2-directed topoisomerase-I ADC, was paired with the irreversible pan-HER TKI pyrotinib in the TROPHY phase Ib dose-finding study (NCT06245824). Five previously untreated…
NCT06245824 - Trial result Spotlight
Breast cancer
Rezatapopt Restores Mutant p53, Yields 38% ORR in Heavily Pretreated TP53 Y220C-Mutated Metastatic Breast Cancer
Rezatapopt (PC14586) is an oral, first-in-class small-molecule that binds the p53 Y220C pocket, refolding the mutant protein into a wild-type conformation and reactivating tumor-suppressor function. In the Phase 1…
NCT04585750 - Trial result Spotlight
Breast cancer
Chemo-Free Durvalumab + Trastuzumab + Pertuzumab Yields 49% pCR (68% RCB0/1) in HER2-Enriched Early Breast Cancer
The single-arm Phase II DTP trial (NCT03820141) treated 39 stage I–III, ER/PR-negative, (by a BluePrint [BP] 80-gene molecular subtyping test that classifies early-stage breast cancer (EBC) into Basal, Luminal, and…
NCT03820141 - Trial result
Breast cancer
Real-World Endocrine-Resistant HR+/HER2- mBC Progresses in ≈8 mo on First-Line CDK4/6i, with 40% PIK3CA Mutations
A Flatiron Health EHR review (2015-2023) captured 7,096 U.S. patients starting first-line therapy for recurrent HR+/HER2- metastatic breast cancer. Among 922 who met INAVO120 endocrine-resistant criteria and still…
- Trial result
Breast cancer
Five-Fraction Ablative RT + Endocrine Therapy Achieves 53% pCR, Skips Surgery in Stage I HR+ Breast Cancer
A single-arm Phase II trial (NCT02945579) enrolled 20 women ≥ 50 y with unicentric, stage I HR+/HER2- tumors (Oncotype ≤25). After three months of endocrine therapy and hypofractionated ablative radiotherapy (37.5…
NCT02945579 - Trial result
Breast cancer
Olaparib + Durvalumab (PARP/PD-L1) Achieve 70% pCR, Early CD8+ Spike in TNBC
In the window-of-opportunity MEDIOLA Phase II trial (NCT03594396), 54 stage II/III triple-negative or ER-low breast-cancer patients received 4 weeks of olaparib (PARP inhibitor) with a single durvalumab dose before…
NCT03594396 - Trial result
Breast cancer
Ipatasertib Triplet Doubles PFS in PI3K/AKT/PTEN-Mutant HR+/HER2- Metastatic Breast Cancer After CDK4/6
Ipatasertib—the oral pan-AKT inhibitor—was tested in the Phase Ib TAKTIC trial (NCT03959891) alongside fulvestrant ± palbociclib in 77 pre-treated, CDK4/6-exposed HR+/HER2- MBC patients. In the 20-patient triplet…
NCT03959891 - Trial result
Breast cancer
Palazestrant + Ribociclib Shows 79% Clinical Benefit After Prior CDK4/6 Exposure in ER+/HER2- Metastatic Breast Cancer
Palazestrant (OP-1250), an oral complete ER antagonist/SERD that degrades both wild-type and mutant ESR1, was dose-escalated to 120 mg once daily alongside standard ribociclib 600 mg (3 weeks on/1 week off) in a…
- Trial result
Breast cancer
Zelenectide Pevedotin (Nectin-4 BTC) Delivers 50% ORR in NECTIN4-Amplified, Heavily Pretreated TNBC
Zelenectide pevedotin is a low-molecular-weight Bicycle® toxin conjugate that ferries MMAE to Nectin-4; in the Phase 1b DURAVELO-1 dose-expansion (5 mg/m² weekly), 32 triple-negative breast-cancer patients with a…
- Trial result
Breast cancer
KAT6 Inhibitor PF-07248144 + Fulvestrant Posts 37% ORR and 10.7-Month PFS After CDK4/6 Failure in ER+/HER2⁻ mBC
PF-07248144, an oral catalytic inhibitor of the histone acetyltransferases KAT6A/B, was given at 5 mg QD to 43 heavily pre-treated ER+/HER2⁻ metastatic breast-cancer patients alongside standard fulvestrant (Phase 1…
NCT04606446 - Trial result
Breast cancer
Zanidatamab + Evorpacept Delivers 56% ORR in Centrally-Confirmed HER2-Positive mBC After T-DXd
Zanidatamab is a bispecific antibody that dimerizes HER2 receptors and triggers ADCC/ADCP, while evorpacept is a “silent-Fc” CD47 blocker that augments macrophage phagocytosis. In the open-label phase 1b/2 trial…
NCT05027139 - Trial result
Breast cancer
Tucatinib + Alpelisib (HER2 TKI + PI3Kα) Nets 60% Partial Responses in Heavily Pretreated HER2-Positive, PIK3CA-Mutated mBC
In the phase Ib P5-03-10 “Time-to-Event” dose-escalation study (NCT05230810) post-menopausal women with HER2-positive metastatic breast cancer harboring activating PIK3CA mutations (median 2 prior metastatic lines;…
NCT05230810 - Trial result
Breast cancer
Taxane + SC Pertuzumab/Trastuzumab Scores 86% pCR in Node-Negative HER2+/HR⁻ Early Breast Cancer (DECRESCENDO)
Neoadjuvant weekly taxane plus fixed-dose subcutaneous pertuzumab-trastuzumab for 12 weeks yielded pCR (ypT0/Tis N0) in 113/131 patients (86%) with 15–50 mm, node-negative, hormone-receptor-negative HER2-positive…
- Trial result
Breast cancer
Bria-IMT Whole-Cell Vaccine plus PD-1 Blockade Extends Median OS to 13.4 mo in Heavily Pretreated HR+/HER2- mBC
Bria-IMT combines irradiated HER2/GM-CSF–secreting allogeneic breast-cancer cells with low-dose cyclophosphamide, peg-IFN-α, and pembrolizumab/retifanlimab; 54 metastatic-breast-cancer patients (median 6 prior lines)…
NCT03328026 - Trial result
Breast cancer
Elacestrant (oral SERD) + Everolimus mTOR Blockade Yields 81% 24-wk CBR in Pre-treated ER+/HER2- mBC
Elacestrant 258–345 mg QD combined with everolimus 5–10 mg (ELEVATE phase 1b; NCT05563220) enrolled 23 heavily pre-treated ER+/HER2- metastatic breast-cancer patients (all post-CDK4/6i); safety was dominated by…
NCT05563220 - Trial result
Breast cancer
Larotrectinib Delivers 53% ORR—and 83% in Secretory Subtype—with 73% 4-Year Durability in TRK-Fusion Breast Cancer
Larotrectinib, a highly selective CNS-penetrant TRK inhibitor, was evaluated across NAVIGATE and SCOUT (n = 16; TRK-fusion breast cancer). Notably, NTRK fusions are rare in breast cancer (0.4%) but are present in 90%…
- Trial result Spotlight
Non-small cell lung cancer
Perioperative PD-1 Blockade (Nivolumab) + Chemo Pushes 30-mo EFS to 61% in Resectable NSCLC
Nivolumab, an anti-PD-1 antibody, given with four neoadjuvant platinum-doublet cycles and up to a year of adjuvant monotherapy (CheckMate 77T, n = 461 stage IIA–IIIB) achieved median event-free survival of 46.6 mo vs…
- Trial result
Non-small cell lung cancer
RiskReveal 14-Gene Assay Guides Platinum Adjuvant to 96% 2-Year DFS in Stage IA–IIA NSCLC
RiskReveal, a 14-gene expression panel, stratified 421 resected stage IA–IIA non-squamous NSCLC patients; intermediate/high-risk cases (mITT n=194 [46%]) were randomized to 4 cycles of cisplatin-based adjuvant…
- Trial result Spotlight
Other blood cancers and transplant
Revumenib + AZA/VEN Hits 88% ORR and Universal MRD-Negativity in Older NPM1m/KMT2Ar AML
Revumenib, an oral menin inhibitor that disrupts the menin-KMT2A/NPM1 transcriptional axis, was added to frontline azacitidine + venetoclax in a phase I dose-escalation/expansion study (NCT03013998) enrolling 43…
NCT03013998 - Trial result
Other blood cancers and transplant
IDH Triplet (AZA/DEC + Venetoclax + Ivo/Enas) Delivers 92% CRc and 69% 2-Year OS in Intensive chemo-Ineligible AML
A single-center series (NCT03471260/NCT04774393) treated 60 newly diagnosed, intensive-chemo–ineligible IDH-mutated AML patients with a hypomethylating agent (HMA) azacitidine or oral decitabine plus venetoclax and…
NCT03471260 - Trial result Spotlight
Head and neck cancer
Ulevostinag (STING agonist) + Pembrolizumab Scores 50% ORR in First-Line R/M HNSCC
Ulevostinag, a cyclic-dinucleotide STING agonist given intratumorally at its RP2D 540 µg, was tested with pembrolizumab 200 mg Q3W in a phase 1 dose-escalation (n = 156) and a small randomized phase 2 head-to-head in…
- Trial result
Melanoma
Nivolumab + Relatlimab Posts 52% 4-Year OS in First-Line Advanced Melanoma
Nivolumab (PD-1) plus relatlimab (LAG-3) fixed-dose (Opdualag) outperformed nivolumab alone in the phase 2/3 RELATIVITY-047 trial (n = 714 treatment-naïve stage III/IV melanoma): 4-year PFS 30.6% vs 23.6%, OS 52.0%…
- Trial result
Lymphoma
Obinutuzumab + Lenalidomide Delivers 93% 2-Year PFS in First-Line High-Tumor-Burden FL
Obinutuzumab, a type II anti-CD20 antibody with enhanced ADCC, paired with the IMiD lenalidomide (G-Len) was tested in a single-center phase 2 trial (NCT02871219) in 90 untreated grade 1-3a, stage II–IV…
NCT02871219 - Trial result
Brain and CNS tumors
Anlotinib Adds ~4 Months PFS to STUPP in Newly Diagnosed GBM
Anlotinib, an oral VEGFR/FGFR/PDGFR multi-kinase inhibitor, was combined with standard chemoradiation (temozolomide + 54–60 Gy RT) in a double-blind, multicenter phase II trial (n = 153). Versus placebo, anlotinib…
- Trial result
Chronic lymphocytic leukemia
Zanubrutinib Holds a 72% 5-Year PFS in del(17p) Front-Line CLL/SLL
Zanubrutinib, a selective next-gen BTK inhibitor, was given as continuous monotherapy to 111 treatment-naïve CLL/SLL patients with high-risk del(17p) in the non-randomized SEQUOIA arm C (NCT03336333). After a median…
NCT03336333 - New trial
Breast cancer
Phase 1b Study of Axatilimab (CSF1R mAb) in Metastatic TNBC
This open-label, single-arm trial evaluates the combination of pembrolizumab, radiotherapy, and axatilimab for patients with metastatic or recurrent TNBC who have received prior immunotherapy. Conducted in Los…
NCT07015853 Exploratory - New trial
Breast cancer
Phase 1 trial of [68Ga]Ga DOTA-5G, somatostatin receptor-targeted PET/CT diagnostic agent.
This prospective trial at University of California, Davis evaluates [68Ga]Ga DOTA-5G PET/CT imaging after a 5 mCi injection in patients with advanced invasive lobular breast cancer. The study examines the safety and…
NCT07020806 First-in-human - New trial
Non-small cell lung cancer
Phase II: Durvalumab PD-L1 inhibitor with Tremelimumab CTLA-4 inhibitor and chemotherapy
This trial by Georgetown University evaluates the safety and efficacy of platinum-based chemotherapy combined with durvalumab and tremelimumab, followed by durvalumab maintenance, in HIV-positive patients with stage…
NCT04499053 Exploratory - New trial
Multiple solid tumors
Phase I NeoVax Personalized Neo-Antigen Vaccine Targeting Patient-Specific Tumor Mutations
This study evaluates the safety and immune response of NeoVax combined with poly ICLC and nivolumab in patients with metastatic or refractory melanoma, breast cancer, and non-small cell lung cancer. Conducted at Fred…
NCT05098210 Exploratory
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