Multi-Cancer Studies
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Jun 01 – Jun 08, 2026
Targeting Fibroblast Activation Protein with [177Lu]Lu-FAP-2286 in Patients with Advanced Solid Tumors in the Phase I LuMIERE Trial.
CLIN CANCER RES · Q1 JOURNAL - RANK #29/326TOP-TIER
The LuMIERE trial is a prospective, open-label, non-randomized phase I/II clinical study evaluating the safety and efficacy of radiopharmaceutical therapy [177Lu]Lu-FAP-2286 in heavily pretreated patients with advanced solid tumors. Phase I employed a Bayesian optimal interval design to assess dosage-limiting toxicities (DLTs) across four dosage levels (3.70–9.25 GBq), administered intravenously every six weeks for up to six cycles. Two DLTs were reported, with one Grade 4 lymphopenia and one Grade 3 hemoptysis at doses of 5.55 GBq and 9.25 GBq, respectively, and the recommended phase II dose (RP2D) was identified as 9.25 GBq. Efficacy data showed one partial response and stable disease in 10 patients, warranting further investigation in phase II studies.
10.1158/1078-0432.CCR-25-4356
May 18 – May 25, 2026
Debio 0123, a WEE1 kinase inhibitor: Phase 1 results from dose escalation in patients with advanced solid tumors.
EUR J CANCER · Q1 JOURNAL - RANK #45/326
This phase 1 dose escalation clinical trial evaluated the WEE1 kinase inhibitor Debio 0123 in 27 patients with relapsed/refractory advanced solid tumors. The oral daily treatment was assessed for safety, pharmacokinetics, pharmacodynamics, and preliminary antitumor activity across doses from 30 to 350 mg. Key findings included any-grade treatment-related adverse events in 92.6% of patients, grade 3 events in 33.3% (most commonly QTcF prolongation at 11% and fatigue at 7%), and a maximum tolerated dose of 260 mg once daily. The study concluded that Debio 0123 has a manageable toxicity profile, linear pharmacokinetics, target engagement at ≥200 mg, and supports further investigation in selected indications.
10.1016/j.ejca.2026.116792
Biomarker study of pembrolizumab in patients with advanced rare cancers.
CELL REP MED · Q1 JOURNAL - RANK #15/195TOP-TIER
This prospective phase 2 clinical trial evaluated pembrolizumab in 154 patients (142 evaluable) with advanced rare cancers, aiming to identify predictive biomarkers of clinical benefit. Objective response rate was 14.8%, and overall clinical benefit (CB) was 26.8%. CB was strongly associated with MSI-H/TMB-H status (OR: 13.9, p=0.0013) and PD-L1 CPS ≥10 (p=0.0285), though some biomarker-negative tumors also responded; immune profiling revealed that CB tumors had higher baseline T cell infiltration and activation. The study concludes that immune microenvironment features may serve as predictive markers for pembrolizumab efficacy beyond genomic assays, highlighting the role of immune cell recruitment during therapy.
10.1016/j.xcrm.2026.102827
Lipid Nanoparticle-encapsulated mRNA-2752 Encoding Human OX40L, IL-23, and IL-36γ Plus Durvalumab Induces an Immunostimulatory Effect Within the Tumor Microenvironment in Patients with Advanced Solid Tumors.
CLIN CANCER RES · Q1 JOURNAL - RANK #29/326TOP-TIER
This phase 1 study (NCT03739931) evaluated intratumoral mRNA-2752 (encoding OX40L, IL-36γ, and IL-23) as monotherapy (Arm A) or combined with durvalumab (Arm B) in advanced solid tumors, with primary objectives of safety, tolerability, maximum tolerated dose (MTD), and objective response rate (ORR) per RECIST v1.1 in CPI-resistant melanoma. Among 134 patients (Arm A n=19; Arm B n=115), the MTD was not reached and a recommended dose for expansion ≤8 mg was selected; dose-limiting toxicities were two grade 2 cytokine-release syndrome events in Arm B. Treatment-related adverse events were mostly grade 1/2; grade 3 mRNA-2752–related events occurred in 1/19 (5.3%) in Arm A and 29/115 (25.2%) in Arm B, and confirmed ORR in CPI-resistant melanoma (n=28) was 17.9% (95% CI 6.1–36.9%) with disease control rate 42.9% (95% CI 24.5–62.8%). Biomarkers showed increased peripheral cytokines and sustained inflammatory tumor microenvironment responses, supporting antitumor activity and further development.
10.1158/1078-0432.CCR-25-4643
May 11 – May 18, 2026
Five-year follow-up of the SABR-5 trial: primary toxicity analysis of stereotactic ablative radiotherapy for up to five oligometastases.
RADIOTHER ONCOL · Q1 JOURNAL - RANK #22/212
This provincially coordinated single-arm phase II trial (SABR-5; NCT02933242) prospectively evaluated long-term toxicity of stereotactic ablative radiotherapy (SABR) for up to five extracranial oligometastases. Adults with oligometastatic/oligoprogressive disease (≤5 lesions) were enrolled across six BC Cancer centres (2016–2020) and treated with SABR; toxicities were centrally reviewed and analyzed using crude rates, cumulative incidence, annual landmarks to 5 years, and duration analyses, with median follow-up 54.2 months. Among 380 treated patients (median age 69; 32% female; 91% with 1–2 lesions), crude per-patient toxicity rates were grade 2: 18.9%, grade 3: 5.8%, grade 4: 0.0%, grade 5: 0.3%; 5-year cumulative incidence was 24% (grade 2) and 7% (grade ≥3), with most grade 3 events resolving within <12 months; fractures (2.9%) and pain (1.8%) were most frequent grade ≥3. SABR showed a low incidence of late high-grade toxicity and no new treatment-related deaths.
10.1016/j.radonc.2026.111532
Fully intravenous split-dose administration of the oncolytic adenovirus TILT-123 in advanced solid tumors.
MOL THER · Q1 JOURNAL - RANK #5/191TOP-TIER
This phase I, open-label, prospective clinical trial enrolled six patients with advanced solid tumors refractory to standard therapy to evaluate the safety and exploratory efficacy of the chimeric oncolytic adenovirus TILT-123 delivered intravenously in a split-dose schedule across seven cycles. Safety was the primary endpoint; chills, fever, fatigue, and transient lymphopenia were the most common treatment-related adverse events, with no dose-limiting toxicities observed. Efficacy assessment showed a disease-control rate of 83.3 % by PET and 33.3 % by RECIST 1.1, and the median overall survival was 198 days; split-dosing enhanced TILT-123 exposure and systemic cytokine responses, while stronger humoral immunity correlated with shorter survival. Post-treatment biopsies confirmed intratumoral virus and immune cell alterations, supporting continued investigation of intravenous TILT-123 for advanced solid tumors.
10.1016/j.ymthe.2026.05.007
Prospective evaluation of genomics-guided off-label treatment.
NATURE · Q1 JOURNAL - RANK #2/135TOP-TIER
This prospective clinical trial (DRUP; NCT02925234) examined the off-label use of 37 anticancer drugs in 1,610 patients with advanced solid tumors carrying actionable genomic alterations in the Netherlands. Of the 1,363 response-evaluable patients (39.1% with rare cancers), the clinical benefit rate was 34.9% (95% CI, 32.2-37.6) and the objective response rate was 15.7% (95% CI, 13.7-17.9), with median progression-free and overall survival of 3.4 and 8.2 months, respectively. Grade 3 or higher treatment-related adverse events occurred in 28.4% of patients, and 7.0% were exceptional responders. The authors conclude that genomics-guided off-label drug use can confer clinical benefit but recommend restricting such use to systematic frameworks for ongoing evaluation.
10.1038/s41586-026-10405-x
Benefits of Electronic Symptom Monitoring During Cancer Treatment by Age, Sex, Race, and Education (Alliance AFT-39).
JCO ONCOL PRACT · Q1 JOURNAL - RANK #81/326
This exploratory analysis of the PRO-TECT cluster randomized trial examined whether electronic symptom monitoring benefits varied by age, sex, race, and education among 1,191 adults with metastatic solid tumors receiving systemic therapy across 52 US community oncology practices. Participants were assigned to weekly electronic symptom monitoring with alerts to care teams or usual care. From baseline to 3 months, the PRO group showed greater improvements in symptom control (+2.37 vs. -0.20, p=0.002) and physical function (+1.54 vs. -0.93, p=0.02) versus usual care, with benefits most pronounced among younger, female, Black, and less educated participants. The authors conclude that remote symptom monitoring is an equitable strategy to enhance cancer care delivery.
10.1200/OP-26-00015
Preoperative Stereotactic Body Radiotherapy for Metastatic Bone Disease With Impending Fracture: A Nonrandomized Clinical Trial.
J NATL COMPR CANC NE · Q1 JOURNAL - RANK #17/326TOP-TIER
The study aimed to assess the safety and efficacy of preoperative stereotactic body radiotherapy (SBRT) for metastatic bone disease with impending fracture, using a phase I nonrandomized clinical trial design at a cancer center. Thirty-eight eligible patients with pelvic or long bone metastases received preoperative SBRT (27-30 Gy in 3 fractions or 18-24 Gy in 1 fraction), followed by surgical stabilization within one week. Among 31 patients evaluated postoperatively, 2 (6.5%) experienced wound complications at 6 weeks, 1 (3.8%) had grade ≥3 treatment-related toxicity at 3 months, and 1 (6.3%) had tumor recurrence at 12 months. The principal conclusion is that preoperative SBRT demonstrates a low risk of wound complications and durable local tumor control, justifying further randomized research.
10.6004/jnccn.2025.7478
Rice Bran Arabinoxylan Compound and Tryptophan Metabolism on Quality of Life of Cancer Patients: A Secondary Analysis of the RBAC-QoL Study.
INT J TRYPTOPHAN RES · Q1 JOURNAL - RANK #75/314
This study conducted a secondary analysis of serum tryptophan and kynurenine from a double-blind, placebo-controlled trial (RBAC-QoL) to assess the role of tryptophan metabolism in quality of life (QoL) of cancer patients receiving systemic cancer treatment. A validated liquid chromatography method with ultraviolet and fluorescence detection was used, and data were analyzed with repeated-measures ANOVA, Spearman’s correlation, and linear mixed models. RBAC supplementation had no statistically significant effect on tryptophan metabolism compared to placebo; however, tryptophan significantly correlated positively with global QoL, physical and social functioning, and negatively with fatigue, dyspnoea, appetite loss, and diarrhoea (p ≤ .05). The authors concluded that RBAC and tryptophan appeared to have an additive effect on QoL, warranting further investigation into potential synergy.
10.1177/11786469261441904
May 04 – May 11, 2026
Efficacy of olaparib in advanced cancers with somatic or germline mutations in BAP1, BARD1, BRIP1 and PALB2.
ESMO OPEN · Q1 JOURNAL - RANK #36/326
This investigator-initiated, open-label, basket phase II trial assessed the efficacy of olaparib in patients with advanced tumors harboring somatic or germline mutations in homologous recombination (HR)-related genes, following progression on standard-of-care therapies. Stratified cohorts were formed based on specific gene mutations, and a case series examined cohorts with rare gene alterations. Objective responses were observed in patients with mutations in BAP1, BARD1, BRIP1, and PALB2, while no responses were identified in mutations affecting other HR-related genes like ARID1A, ATR, and RAD50. These findings suggest that olaparib has meaningful clinical activity in treating advanced cancers with certain HR-related gene mutations.
10.1016/j.esmoop.2026.107693
Megestrol acetate in the management of cancer cachexia: a prospective quasi-experimental study focusing on body composition and patient-reported outcomes.
FRONT NUTR · Q1 JOURNAL - RANK #16/112
This prospective, non-randomized study assessed megestrol acetate (MA) in 97 cancer cachexia patients (33 control vs. 64 intervention) over two months. Nutritional indices, inflammatory markers, immune parameters, fatigue, and quality of life were measured at baseline and post intervention. MA treatment significantly improved body weight (+3.2 kg), BMI, fat mass (+2.5 kg), albumin, hemoglobin, and reduced IL-6 levels and fatigue across all domains, while preserving skeletal muscle mass. No serious drug-related adverse events were observed, and the authors conclude that MA exerts multi-dimensional benefits, including enhanced nutritional status, reduced fatigue, and improved quality of life in patients with cancer cachexia.
10.3389/fnut.2026.1780653
Benralizumab relieves Eosinophil-Related Cutaneous Adverse Events from Cancer Therapy: A Nonrandomized Phase 2 Trial.
CLIN CANCER RES · Q1 JOURNAL - RANK #29/326TOP-TIER
This single-arm, open-label phase 2 trial evaluated benralizumab 30 mg subcutaneously for eosinophil-related cutaneous adverse events (ercAEs) in patients with cancer receiving systemic therapy. Forty-seven patients were enrolled, with ercAEs related to PI3K inhibitors (47%), checkpoint inhibitors (21%), tyrosine kinase inhibitors (9%), and antibody-drug conjugates (9%), and 49%/51% presenting grade 2/3 ercAEs. Among 42 evaluable patients, 76% (32/42) responded by Week 4 with a median reduction of ercAE grade from 2 to 1 (P < .0001), improved HRQoL, reduced rash-BSA, and decreased eosinophils; all patients with ercAEs due to alpelisib (n=18) or enfortumab vedotin (n=4) had complete responses (P < .05). Most adverse events were mild to moderate, and benralizumab had favorable efficacy and safety, supporting further placebo-controlled investigation.
10.1158/1078-0432.CCR-25-2764
Apr 27 – May 04, 2026
Tumor-localized CD40 agonism with MP0317, a FAP x CD40 DARPin, reprograms the tumor microenvironment in patients with advanced solid tumors: an open-label, nonrandomized, dose-escalation phase 1 study.
NAT CANCER · Q1 JOURNAL - RANK #11/326TOP-TIER
This phase 1, open-label, nonrandomized, dose-escalation study evaluated MP0317 (FAP x CD40 DARPin) in 46 adults with advanced solid tumors across nine dose cohorts (0.03–10 mg/kg IV weekly or every 3 weeks). The primary outcome was safety; secondary outcomes included antitumor activity, pharmacokinetics, and pharmacodynamics. Most treatment-related adverse events were grade 1–2 (95%), no maximum tolerated dose was reached, one patient had an unconfirmed partial response, and 14 had stable disease. The study concluded MP0317 has a favorable safety profile and supports further evaluation with complementary immunotherapies.
10.1038/s43018-026-01150-1
Safety and activity of RO7300490, a bispecific CD40 agonist targeted to fibroblast activation protein, in patients with advanced solid tumors: a single-arm, multicenter, first-in-human, phase 1 trial.
NAT CANCER · Q1 JOURNAL - RANK #11/326TOP-TIER
This single-arm, multicenter, phase 1 trial evaluated the safety, tolerability, and activity of RO7300490, a fibroblast activation protein (FAP)-targeted CD40 agonist antibody, in 80 patients with advanced/metastatic solid tumors treated biweekly with doses ranging from 16 to 1,100 mg. The primary objective assessed safety, with 53 patients (66.3%) experiencing treatment-related adverse events (TRAEs), mostly grade 1-2; grade 3-4 TRAEs occurred in 3.8%, and no grade 5 TRAEs were reported. Key findings revealed a disease control rate of 42.5% with no objective tumor responses and an immunomodulatory effect evidenced by increased DC-LAMP+ dendritic cell density, B cell density, and pretertiary lymphoid structures in the tumor microenvironment. The study concludes that RO7300490 is feasible, well-tolerated, and capable of inducing tumor-specific immunomodulation, though clinical activity was limited.
10.1038/s43018-026-01157-8
Nivolumab Plus Ipilimumab in Patients With Solid Tumors With High Tumor Mutation Burden: Results From the Targeted Agent and Profiling Utilization Registry Study.
JCO PRECIS ONCOL · Q1 JOURNAL - RANK #57/326
This phase II basket trial (TAPUR) evaluated nivolumab plus ipilimumab in advanced cancer patients with high tumor mutation burden (≥10 mut/Mb). Three cohorts were enrolled: colorectal cancer (CRC, N=12), breast cancer (BC, N=13), and other solid tumors (HP, N=26). Disease control (DC) at ≥16 weeks was the primary endpoint; DC rates were 33% (BC) and 32% (HP), significantly exceeding the null rate of 15%, while the CRC cohort failed to meet the threshold. The authors conclude N+I demonstrated antitumor activity in BC and HP cohorts but not CRC.
10.1200/PO-25-01205
Apr 20 – Apr 27, 2026
Long-acting IL-7 induces distinct transcriptomic features in peripheral T cells of patients with solid tumors.
JCI INSIGHT · Q1 JOURNAL - RANK #34/195
The study aimed to assess the effects of long-acting recombinant human interleukin-7 (rhIL-7-hyFc) on peripheral T cells in patients with advanced solid tumors using a prospective design. Blood samples were collected pre- and post-treatment, analyzed by single-cell transcriptomics and flow cytometry, revealing rhIL-7-hyFc induced marked T-cell proliferation, immune activation, cell cycle progression, and anti-apoptotic transcriptional shifts. A second dose after three weeks resulted in diminished proliferation and minimal transcriptomic change, with intact proximal IL-7 signaling but downregulation of distal pathway elements such as PIM-1 kinase and c-Myc. The findings support rhIL-7-hyFc’s potential utility in lymphopenic cancer patients receiving immunotherapy.
10.1172/jci.insight.203629
Apr 13 – Apr 20, 2026
DART (NCI/SWOG S1609): Comprehensive Final Results from Dual Checkpoint Inhibition with CTLA-4 and PD-1 Blockade in Rare Cancers.
ANN ONCOL · Q1 JOURNAL - RANK #4/326TOP-TIER
The NCI/SWOG S1609 trial was a prospective, open-label, multicenter phase 2 study evaluating the efficacy of dual CTLA-4 and PD-1 inhibition (ipilimumab plus nivolumab) in 53 refractory rare cancer cohorts, enrolling 798 previously treated patients with 727 receiving treatment. Key findings included a median objective response rate (ORR) of 12% (range 0-75%), clinical benefit rate (CBR) of 27% (range 0-75%), 2-year progression-free survival (PFS) of 10% (range 0-75%), and 3-year overall survival (OS) of 23% (range 0-100%), with 11% of patients achieving an immune-related PFS of ≥2 years. The study concluded that patients with multiple refractory rare cancer types derived meaningful responses to the treatment, though immune-related toxicity led to discontinuation in 14% of cases. Further research is needed to optimize therapeutic selection for biologically defined subsets.
10.1016/j.annonc.2026.04.004
Apr 06 – Apr 13, 2026
Predictors of Skeletal-Related Events and Quality-of-Life Dimensions Among Patients With High-Risk Asymptomatic Bone Metastases With or Without Early Radiation Therapy: Secondary Analysis of a Multicenter Randomized Phase II Clinical Trial.
J NATL COMPR CANC NE · Q1 JOURNAL - RANK #17/326TOP-TIER
This secondary analysis of a multicenter randomized phase II clinical trial (NCT03523351) evaluated whether early radiation therapy (RT) to asymptomatic, high-risk bone metastases reduces skeletal-related events (SREs) and affects specific EuroQol 5-Dimension 5-Level (EQ-5D-5L) quality-of-life domains using competing risks analysis and linear mixed models. Among 78 enrolled patients (122 bone metastases), 71 were evaluable for SREs (35 early RT vs 36 control), with 15 SREs occurring in 11 patients over one year; early RT was associated with a markedly lower SRE risk (hazard ratio 0.09, 95% CI 0.01-0.66, P=0.018). The time-by-arm interaction for the EQ-5D-5L self-care dimension was significant (P=0.022), showing a decline at 6 months in the control arm and improvement in the RT arm, while anxiety/depression was worse at 3 months in the RT arm but not statistically significant (P=0.120). The study concludes that SRE rates are high and that early RT can prevent SREs and preserve self-care, with longer survival potentially needed to observe broader QoL benefits; a phase III trial (NRG CC014; NCT06745024) is ongoing.
10.6004/jnccn.2025.7126
The role of the molecular tumor board: learnings from the ROME trial.
NPJ PRECIS ONCOL · Q1 JOURNAL - RANK #39/326
The Phase II ROME trial was a prospective randomized clinical trial comparing personalized therapy guided by genomic profiling and Molecular Tumor Board review versus standard-of-care in 400 randomized patients with advanced solid tumors. Between November 2020 and August 2023, 897 patients were discussed by the MTB, with randomization driven by high TMB, MSI, or actionable alterations in pathways like PIK3CA/AKT/PTEN, while exclusions occurred due to lack of actionable alterations or unavailable drugs. The trial demonstrates that MTBs play a substantial role in interpreting complex molecular data, refining patient selection, and optimizing therapy use in precision oncology. The study concludes that standardization and implementation of MTBs are crucial for improving patient outcomes in cancer treatment.
10.1038/s41698-026-01386-1
Post-Hoc Analysis of the Phase II DESTINY-PanTumor02 Study: Local and Central HER2 IHC Concordance and Trastuzumab Deruxtecan Efficacy by HER2 IHC Status in HER2-Expressing Solid Tumors.
CLIN CANCER RES · Q1 JOURNAL - RANK #29/326TOP-TIER
This post-hoc analysis of the open-label, Phase 2 DESTINY-PanTumor02 trial assessed concordance between local and central HER2 immunohistochemistry (IHC) testing and explored trastuzumab deruxtecan (T-DXd) efficacy by HER2 status in patients with HER2-expressing, locally advanced, unresectable, or metastatic solid tumors. Methods included administering T-DXd 5.4 mg/kg every 3 weeks to 267 patients, 75.7% of whom were enrolled based on local test results, after at least one prior systemic therapy or when no alternatives were available. Key findings reported moderate concordance between local and central testing: 58.6% for IHC 3+, 54.5% for IHC 2+, and 73.4% when combining IHC 3+ and 2+; efficacy data by HER2 status are referenced but not numerically detailed in the abstract. The authors conclude that the moderate concordance underscores the need for validated diagnostics and standardized algorithms to accurately identify candidates for HER2-directed therapies.
10.1158/1078-0432.CCR-25-4702
A first-in-human phase 1 clinical trial evaluating clinical activity and proof-of-mechanism of tobemstomig, a PD1-LAG3 bispecific antibody, in patients with CPI-experienced melanoma.
CLIN CANCER RES · Q1 JOURNAL - RANK #29/326TOP-TIER
This study is a first-in-human, open-label, phase 1 clinical trial evaluating the safety, tolerability, pharmacokinetics, and preliminary antitumor activity of the PD1-LAG3 bispecific antibody, tobemstomig, in patients with advanced and/or metastatic solid tumors. The study included 35 patients in the dose-escalation phase and 69 patients in the expansion phase, across various tumor types. Partial responses were observed in 15% (6/41) of CPI-experienced melanoma patients and proof-of-mechanism was demonstrated by increased CD8+ T cell activity, among other immunological effects. Tobemstomig demonstrated a tolerable safety profile with a recommended dose established at 2100 mg Q2W, supporting further investigation in earlier disease settings.
10.1158/1078-0432.CCR-25-4478
Intratympanic Dexamethasone Efficacy in Preventing Cisplatin-induced Tinnitus: A Randomized Controlled Phase IIIB Clinical Trial.
EAR HEARING · Q1 JOURNAL - RANK #3/35
This randomized controlled phase IIIB clinical trial aimed to assess whether intratympanic dexamethasone can prevent cisplatin-induced tinnitus. Researchers recruited 34 cancer patients whose treatment protocol included cisplatin, excluded 11, and analyzed data from 23 patients with randomly selected ears for dexamethasone administration using a Microwick device, while the contralateral ear served as a control and an additional group of 10 remained untreated. Results showed no tinnitus in dexamethasone-treated ears, while 90% of the untreated controls experienced bilateral tinnitus with a mean worsening of 20.2 points on the Tinnitus Handicap Inventory, 8.69% infection complications, and 34.8% permanent perforation at 6 months. The authors concluded that high-dose, extended-duration intratympanic dexamethasone prevents cisplatin-induced tinnitus without affecting hearing thresholds.
10.1097/AUD.0000000000001818