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TLX007-CDx (TLX007 CDx / TLX007CDx)

✓ Approved

Telix Pharmaceuticals Limited · 影像药物 · 影像药物

什么是 TLX007-CDx？

TLX007-CDx 是一种影像药物，由Telix Pharmaceuticals Limited研发。该药已获批，用于治疗相关适应症，给药途径：Unknown。

药物档案

商品名TLX007 CDx, TLX007CDx
公司Telix Pharmaceuticals Limited
药物类别影像药物
给药途径Unknown
状态Approved
来源： ClinicalTrials.gov, Telix Pharmaceuticals Limited

治疗适应症

TLX007-CDx 针对 2 个适应症，涉及 1 个治疗领域。

治疗领域疾病/病症分期
Neoplasms benign, malignant and unspecified (incl cysts and polyps)Prostate cancer✓ Approved
Neoplasms benign, malignant and unspecified (incl cysts and polyps)Uterine cancerBLA/NDA

相关研究文献

PubMedWorld journal of surgical oncology2026-06-13

Intestinal SMARCA4-deficient undifferentiated carcinoma: a case series and systematic review of the literature.

Ma Wenjing W, Zhou Shenda S, Huang Yongta Y, Tang Xiaofeng X et al.

Intestinal SMARCA4-deficient undifferentiated carcinoma (SMARCA4-DUC) is a rare and highly aggressive malignancy. Its clinicopathological features remain poorly defined. No standardized treatment has been established. We report two new cases and review 18 previously published cases, providing a descriptive summary of clinicopathological, molecular, and therapeutic features. The aggregated 20 cases included 80% males, with a mean age of 56 years. The tumors exhibited diffuse sheet-like growth of epithelioid cells, with rhabdoid morphology observed in 81.25% (13/16) of cases. Necrosis and mitotic activity were frequent. Immunohistochemistry confirmed SMARCA4 loss and variable CK/CK7 expression, while CDX-2 and CK20 were consistently negative. Ki-67 was uniformly high. Although molecular profiling data in this study were limited, TP53 mutations were identified in all three cases with available NGS data. Distant metastasis was present in 41.2% of patients at initial diagnosis. The median overall survival was 11 months (range 1.5-29 months). Chemotherapy responses were poor, but responses to immune checkpoint inhibitors were heterogeneous: two patients achieved sustained complete remission (> 18 months) on pembrolizumab, while three others experienced no benefit. Intestinal SMARCA4-deficient carcinoma is a rare high-grade malignancy with a poor prognosis and currently no standard treatment regimen. In this small aggregated series, two patients achieved durable complete responses to pembrolizumab monotherapy, suggesting that a subset of these tumors may benefit from immune checkpoint inhibitors. However, given the inconsistent responses observed, these preliminary findings require validation in future multicenter, large-scale prospective studies.

PMID 42286625
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PubMedCancers2026-06-12

Observed RET-Positive Findings Across Routine Comprehensive Genomic Profiling Platforms in Japan: A Nationwide Descriptive Benchmark.

Kajiura Shinya S, Hayashi Ryuji R

Background: RET fusion is an actionable tumor-agnostic biomarker, but its observed frequency in routine comprehensive genomic profiling (CGP) may vary across testing platforms and clinical contexts. We conducted a nationwide descriptive analysis to benchmark observed RET fusion frequency in Japanese routine practice. Methods: This retrospective descriptive study used anonymized aggregated data from the Center for Cancer Genomics and Advanced Therapeutics (C-CAT), including CGP-tested cases through 31 March 2025. Observed RET fusion frequency was summarized overall, across five standardized CGP platforms, across 12 prespecified organ groups, and in pooled tissue-based versus liquid-based comparisons. Exact binomial 95% confidence intervals were calculated to provide descriptive precision for low-frequency estimates. Results: Among 97,343 cases, 257 were RET-positive, corresponding to an overall observed RET fusion frequency of 0.26%. Platform-specific frequencies were 0.29% (192/66,992) for FoundationOne CDx, 0.28% (42/14,878) for FoundationOne Liquid CDx, 0.14% (6/4235) for GenMineTOP, 0.16% (15/9196) for NCC oncopanel, and 0.10% (2/2042) for Guardant360. Thoracic tumors showed the highest observed frequency (1.39%, 94/6740), followed by head and neck/thyroid tumors (1.04%, 42/4030). In a crude pooled comparison not adjusted for organ mix or clinical context, tissue-based and liquid-based CGP yielded numerically similar crude pooled frequencies of 0.265% (213/80,423) and 0.260% (44/16,920), respectively. Conclusions: This nationwide analysis benchmarks how RET-positive findings are surfaced to clinicians across heterogeneous routine CGP implementations in Japan. The data support platform-aware interpretation of RET results in practice, but should not be construed as biologic prevalence estimates or comparative assay performance.

PMID 42279318
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PubMedDifferentiation; research in biological diversity2026-06-11

Validated CRISPR/Cas9 guide RNAs targeting neurodevelopmental genes in the tunicate Ciona robusta.

Popsuj Sydney S, Kalsang Tenzin T, Kim Kwantae K, Drummond Erica E et al.

The tunicate Ciona robusta provides a powerful and simplified model for dissecting the genetic control of developmental and cell biology. With a larval CNS composed of just over 200 neurons and sensory cells, it has also emerged as a model organism for neurobiology and the development of the nervous system. Although CRISPR/Cas9-mediated mutagenesis is now routinely used in Ciona as an important technique used to interrogate gene function in diverse biological processes, validated single-guide RNAs (sgRNAs) have yet to be validated for several key neural genes. Here, we report the design and experimental validation of 25 novel sgRNAs targeting eight conserved genes encoding conserved proteins involved in neurodevelopment and neural function, including six transcription factors (Cdx, Foxb, Sox1/2/3, Dmbx, Engrailed, and Mnx) and two neural effector genes (Tyrosinase and Slc18a3/VAChT). Candidate sgRNAs were selected and tested for mutagenesis efficiency using Illumina-based target site amplicon sequencing. All sgRNAs induced insertions or deletions at their target loci, with most genes yielding at least one sgRNA with mutagenesis efficacy exceeding 30%, with the exception of Dmbx, for which maximal efficacy reached 25%. We further compared measured mutagenesis rates to scores generated by different predictive algorithms, observing a modest but potentially improved correlation with predictions based on a newer algorithm. Based on these results, we recommend considering both scoring algorithms in combination, for improved predictive value for Ciona.

PMID 42269486
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PubMedIJU case reports2026-06-08

Significant Response to Nivolumab Plus Ipilimumab in Metastatic Mucinous Tubular and Spindle Cell Carcinoma: A Case Report.

Shimasaki Sho S, Yamamoto Shinkuro S, Iguchi Mitsuko M, Yamashita Erika E et al.

Mucinous tubular and spindle cell carcinoma (MTSCC) is a rare renal cell carcinoma subtype that is typically indolent but may exhibit aggressive behavior. No standard systemic therapy has been established for metastatic MTSCC. A 71-year-old woman underwent retroperitoneoscopic radical left nephrectomy for MTSCC (pT1b). Six months later, computed tomography (CT) and 18F-fluorodeoxyglucose positron emission tomography (PET)/CT revealed lung, bone, and adrenal metastases. Bone biopsy confirmed metastatic MTSCC, and the patient was classified as poor risk. Combination therapy with nivolumab and ipilimumab was initiated. After two cycles, PET/CT showed marked regression of metastatic lesions (SUVmax decreased from 21.7 to 4.3). RECIST evaluation demonstrated a partial response. Genomic profiling revealed microsatellite stability and a low tumor mutational burden, with no clinically actionable alterations identified on FoundationOne CDx. No disease progression was observed at 9 months. This case demonstrates the potential efficacy of combination immunotherapy in aggressive metastatic MTSCC.

PMID 42256331
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PubMedCell death & disease2026-06-06

The CDK4/6 inhibitor dalpiciclib augments the antitumor efficacy of enzalutamide in preclinical models of castration-resistant prostate cancer through inhibition of MCM4-mediated DNA replication.

Liu Yue Y, Ke Yuan Y, Yu Jingtian J, Chai Mengting M et al.

Castration-resistant prostate cancer (CRPC) is a fatal malignancy often associated with alterations in cell cycle regulation, particularly within the Cyclin/CDK/RB axis. Despite ongoing clinical trials assessing CDK4/6 inhibitors in prostate cancer, clinical evidence remains limited. Although the androgen receptor (AR) inhibitor enzalutamide (ENZ) initially demonstrates therapeutic efficacy, resistance develops over time, and monotherapy offers limited antitumor benefits, highlighting the need for effective combination therapies. In this study, pharmacological profiling, genetic dependency analysis, RNA sequencing, and functional validation were conducted across various in vitro and in vivo preclinical CRPC models. The combination of ENZ and the CDK4/6 inhibitor dalpiciclib (DAL) exhibited potent antitumor activity in CRPC cell lines, a cell-derived xenograft (CDX) model, and a lymphatic metastatic model. Moreover, ENZ plus DAL inhibited cell cycle progression, migration, and DNA replication, while promoting apoptosis in CRPC cells. Mechanistically, ENZ blocked AR-mediated transcriptional activation of MCM4, a critical component of the DNA helicase complex, thereby enhancing the effect of CDK4/6 inhibition on DNA replication and inducing a pronounced synergistic antitumor response. These results suggest that the ENZ-DAL combination is a promising therapeutic approach that warrants further clinical evaluation in CRPC patients.

PMID 42248826
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PubMedbioRxiv : the preprint server for biology2026-06-04

Fast pairwise coalescence enables gene-resolution scans for recent selection in diverse human populations.

Korfmann Kevin K, Mathieson Sara S

Identifying the genetic changes that shaped recent human adaptation depends on our ability to detect selection from genomic data. Summary statistics from haplotype scans have been widely used for that purpose, aggregating genetic signal over windows, though resolution is limited by linkage and their power may diminish as sweeps approach fixation, as in the case of the integrated haplotype score (iHS). Ancient DNA based scans recover signal by analysing time-series trajectories, but the majority of human populations fall outside the geographic range of any existing ancient DNA dataset. Pairwise coalescence times provide a way to complement statistics and can be applied to any modern cohort, yet computing them densely enough at cohort scale poses a computational challenge due to the quadratic growth in the number of haplotype pairs. We introduce gamma_smc_cu , a GPU implementation of the Gamma-SMC algorithm (Schweiger and Durbin, 2023) for pairwise time-to-the-most-recent-common-ancestor (TMRCA) inference. Applied to the 1000 Genomes Project (3,202 phased samples, corresponding to 6,404 haplotypes; 829,638 within-population pairs across 26 populations and five different continental ancestries; ∼10 12 per-site posterior evaluations), it yields a gene-level TMRCA landscape of 17,823 autosomal protein-coding genes after masking for segmental duplications. The scan recovers well-known sweeps ( LCT, SLC24A5, EDAR, FADS1, HERC2, ABCC11 ) and, combined with a depleted-to-enriched variant-class profile, resolves haplotype-block signals down to the gene level. Of seven case studies, two are developed in the main text - GRK2 / ADRBK1 (chr11q13.2; SAS+EUR) and TREML1 / TREM2 (chr6p21.1) - and the remaining five ( IFIH1 chr2q24/IBS, CCDC92 chr12q24/CDX, SLC6A15 chr12q21/CHS, BPIFA2 chr20q11/GIH, CLEC6A chr12p13/CDX) are presented in the Supplementary Information (SI). Notably, TREML1 / TREM2 is a shared out-of-Africa signal - ranked below the within-population 1% tail in 16 of 19 non-African 1000 Genomes panels that PopHumanScan and five landmark haplotype-based scans miss. A previous 10 kb-windowed-mean iHS scan dilutes the cluster of extreme sites packed inside the ∼5 kb gene bodies, while our own gene-level iHS independently recovers the locus in three South Asian panels (BEB, STU, ITU; top 0.4% genome-wide). We cross-validate the seven cases against the 9.7 million per-variant selection posteriors from a recent West-Eurasian ancient DNA scan. BPIFA2 is detected concordantly ( s ≈ 1.8% per generation). GRK2 and CCDC92 reach detection threshold in flanking variants but not within their own gene bodies, while the TREML1 / TREM2 cluster falls below it. To calibrate novelty, we review the candidate landscape against an expanded eight-catalog set spanning curated haplotype scans, the largest current West-Eurasian ancient-DNA leads, and a recent 26-population iHS refinement; the vast majority of our loci overlap at least one prior entry, and only a handful - including TREML1 / TREM2 - remain unflagged. The contributions of this work are gene-level resolution, systematic ancient DNA cross-validation, and a reusable TMRCA landscape that complements aDNA panels.

PMID 42239206
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