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TLX007-CDx (TLX007 CDx / TLX007CDx)

✓ Approved

Telix Pharmaceuticals Limited · Imaging Agents · Imaging Agents

What is TLX007-CDx?

TLX007-CDx is a imaging agents developed by Telix Pharmaceuticals Limited. It is approved for therapeutic indications via unknown.

Drug Profile

Brand NamesTLX007 CDx, TLX007CDx
CompanyTelix Pharmaceuticals Limited
Drug ClassImaging Agents
RouteUnknown
StatusApproved
Sources: ClinicalTrials.gov, Telix Pharmaceuticals Limited

Therapeutic Indications

TLX007-CDx is developed for 2 unique indications across 1 therapeutic area.

Therapeutic AreaConditionPhase
Neoplasms benign, malignant and unspecified (incl cysts and polyps)Prostate cancer✓ Approved
Neoplasms benign, malignant and unspecified (incl cysts and polyps)Uterine cancerBLA/NDA

Related Research Articles

PubMedDiscover nano2026-10-14

Development of 99mTc-cefadroxil loaded chitosan nanoparticles as a novel radiotracer for detection of septic and aseptic foci.

El Refaye Marwa S MS, Challan Safaa B SB, Ramadan H E HE, Khater S I SI

Early detection of inflammation is critical for preventing disease progression, and nuclear medicine plays a pivotal role in this context. Imaging modalities such as single-photon emission computed tomography (SPECT) enable the early identification of functional abnormalities through the use of targeted radiotracers that specifically localize inflammatory processes. In this regard, antibiotic-loaded nanoparticles have emerged as a promising platform for inflammation imaging, integrating diagnostic capabilities with potential therapeutic functionality. Among these systems, chitosan-based nanocarriers (CS-NPs), a nano-polymeric pharmaceutical excipient, were employed for the encapsulation of the antibiotic cefadroxil (CDX). The formulation was prepared via a simple ionic gelation (cross-linking) technique. The physicochemical properties of the resulting nanoparticles were characterized using transmission electron microscopy (TEM), Fourier-transform infrared spectroscopy (FT-IR), zeta potential analysis, and X-ray diffraction (XRD). Drug encapsulation efficiency and loading capacity were subsequently quantified by UV-visible spectrophotometry. For imaging applications, CDX-loaded CS-NPs (400 µg) were radiolabeled with technetium-99m in the presence of stannous chloride (50 µg) as a reducing agent, yielding a complex with a radiochemical efficiency of 94 ± 1.3%. The resulting 99mTc-CDX-CS-NPs demonstrated excellent in vitro stability in fresh serum for up to 6 hours, which is suitable for diagnostic imaging applications. In vivo biodistribution studies in murine models of both septic and aseptic inflammation revealed significant tracer accumulation at infected and inflamed sites, with high target-to-non-target (T/NT) ratios of 8.55 and 6.02 after 2 hours post-injection, respectively. These findings suggest the developed radiotracer's ability to effectually localize septic and aseptic foci, irrespective of their underlying etiology.

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PubMedThe Journal of molecular diagnostics : JMD2026-10-14

Pre-submission Pathological Quality Control for FoundationOne CDx Comprehensive Genomic Profiling.

Natori Yume Y, Hirotsu Yosuke Y, Shibusawa Masahiro M, Nakamura Kaito K et al.

Comprehensive genomic profiling (CGP) using FoundationOne CDx (F1CDx) requires formalin-fixed paraffin-embedded specimens with sufficient tumor area and DNA yield. Pre-submission pathological assessment is critical but has not been systematically evaluated in real-world practice. This study analyzed 371 consecutive F1CDx requests at a cancer genomic medicine designated hospital in Japan. Pre-submission quality checks assessed tumor surface area, estimated section numbers and residual specimen volume. Assay outcomes were classified as pre-submission cancellation, temporary suspension (insufficient DNA, suspected contamination, or technical issues), Qualified, or Pass. Of 371 requests, 52 (14.0%) were cancelled before submission, mainly due to insufficient specimen volume or clinical decision. Among 319 submitted cases, 22 (6.9%) were temporarily suspended. Among 297 cases with returned results, 256 (86.2%) achieved Pass quality and 41 (13.8%) were Qualified. Tumor content-related parameters including institutional tumor content, laboratory-assessed tumor content, and sequencing-estimated tumor content were all significantly lower in Qualified than in Pass case. In Qualified cases, evaluation of tumor mutational burden and microsatellite instability was successful in only 31.7% and 19.5%, respectively. In multivariable analysis, lower tumor content was the only independent predictor of QC failure. These findings indicate most F1CDx assay failures are attributable to insufficient tumor content or specimen volume. Strengthened pre-submission QC and coordinated workflows can meaningfully improve CGP success. Limitations include the retrospective single-institution design and lack of external validation.

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PubMedCureus2026-10-11

Cerebellar Metastasis From Radioiodine-Refractory Widely Invasive Oncocytic (Hurthle Cell) Carcinoma of the Thyroid in a Young Adult.

Davuluri Meera M, Bhasin Maansi M, Cheema Ahmed A, Miller James J

Oncocytic (Hurthle cell) carcinoma is an uncommon thyroid malignancy that tends to spread through the bloodstream and often concentrates radioactive iodine poorly. Spread to the brain is rare, and a solitary cerebellar deposit is rarer still. We describe a 44-year-old man who presented with neck swelling and was found to have a widely invasive oncocytic carcinoma with extensive vascular invasion and a minor classic papillary component (5%). He underwent total thyroidectomy with central neck dissection followed by radioactive iodine ablation with 150 mCi of iodine-131. The post-therapy scan showed uptake confined to the thyroid bed. Over the next 18 months, his serum thyroglobulin climbed steadily from 1.5 µg/L to 11.6 µg/L even though the thyroid-stimulating hormone (TSH)-stimulated diagnostic whole-body iodine scan remained negative. Fluorodeoxyglucose positron emission tomography/computed tomography then showed multiple hypermetabolic bilateral pulmonary nodules suspicious for metastases. Roughly 22 months after thyroidectomy, he developed progressive dizziness and headache. Magnetic resonance imaging (MRI) revealed a 3.3 × 3.2 × 3.1 cm mixed cystic and solid left cerebellar mass with surrounding vasogenic edema and mass effect on the brainstem. The mass was resected through a left suboccipital craniotomy. Histology showed a malignant epithelioid neoplasm with nested and trabecular growth, abundant granular eosinophilic cytoplasm, prominent nucleoli, scattered bizarre giant nuclei, and 8 mitoses per 2 mm2 without necrosis. The tumor cells expressed cytokeratin AE1/AE3, CK7, TTF-1, and PAX-8 and were negative for CK20, CDX-2, synaptophysin, chromogranin, and S100, confirming thyroid origin. The metastasis fulfilled criteria for high-grade differentiated thyroid carcinoma with oncocytic features. His symptoms resolved after surgery, and stereotactic radiosurgery for the resection cavity was recommended. A rising thyroglobulin with negative iodine imaging represents a biochemical incomplete response and should prompt a search for structural disease recurrence. Because the brain lesion in our patient came to light only when symptoms appeared, brain MRI may be worth considering in patients with radiodiodine-refractory distant metastases.

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PubMedESMO open2026-10-09

Nivolumab in patients with advanced solid tumors with ctDNA-defined high blood tumor mutational burden: a phase II trial.

Nakamura Y Y, Esaki T T, Nishina T T, Shinozaki E E et al.

Tissue-based tumor mutational burden (TMB) is a biomarker for immune checkpoint inhibitors; however, data on circulating tumor DNA (ctDNA)-based blood TMB (bTMB) are limited. We conducted an amended phase II basket study enrolling patients with gastrointestinal (GI) cancers with high bTMB identified using Guardant360® CDx (cohorts 1 and 2) and patients with GI cancers with ultrahigh bTMB identified using Guardant360® CDx (Ultrahigh TMB GI cohort; top 2% within each GI tumor type). After early discontinuation of the Ultrahigh TMB GI cohort, the bTMB-High cohort enrolled patients with solid tumors across cancer types with bTMB score ≥14, as measured by FoundationOne® Liquid CDx. Nivolumab 360 mg was administered intravenously every 3 weeks until progression or unacceptable toxicity. The primary endpoint was objective response rate (ORR) and hypothesis testing was prespecified for the bTMB-High cohort. Seventy patients were treated (cohort 1, n = 28; cohort 2, n = 4; Ultrahigh TMB GI cohort, n = 19; bTMB-High cohort, n = 19). The ORR was 14.3%, 0%, 21.1%, and 21.1%, respectively. In the bTMB-High cohort, the lower bound of the 90% confidence interval (CI) exceeded the prespecified 5% threshold, meeting the primary endpoint. Treatment-related grade ≥3 adverse events occurred in 8.6% of patients. Early ctDNA decline at week 3 was associated with longer progression-free survival (hazard ratio 0.51, 95% CI 0.29-0.87). Baseline bTMB did not clearly distinguish responders from nonresponders, whereas higher baseline ctDNA concentrations were associated with a lower ORR. Nivolumab showed activity in patients with ctDNA-defined bTMB-High cancers. Absolute bTMB alone did not reliably identify benefits, whereas baseline ctDNA concentrations and early ctDNA decline provided additional insight into response. These findings provide a preliminary signal supporting the prospective evaluation of ctDNA-based bTMB selection in a tumor-agnostic setting and warrant further validation in larger, randomized trials.

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PubMedGastroenterology report2026-10-08

Synergistic effects of sacituzumab govitecan and radiotherapy in preclinical models of colorectal cancer.

Wang Ruowei R, Situ Yingting Y, Wang Weifeng W, Liao Yuanbin Y et al.

Although radiotherapy (RT) remains the standard of care for locally advanced colorectal cancer (CRC), intrinsic and acquired resistance frequently compromise long-term outcomes. Sacituzumab govitecan (SG)-a TROP2-directed antibody-drug conjugate-offers a targeted platform for intracellular SN-38 delivery. The aim of the present preclinical study was to investigate whether SG enhances radiosensitivity in CRC, thereby providing a preclinical rationale for the clinical evaluation of SG-based combination strategies. We evaluated SG-RT synergy across CRC cell lines with differential TROP2 expression (SW480, DLD-1 vs SW620, HCT116). In mechanistic studies, clonogenic assays, flow cytometry, cell counting kit-8, Western blot, and comet assays were utilized to assess cell survival, apoptosis, and DNA damage. TROP2 was knocked down or overexpressed to validate its role in radiosensitization. In vivo efficacy was evaluated by using cell-line-derived xenograft (CDX) and patient-derived xenograft (PDX) mouse models. Immunohistochemistry for cleaved caspase-3 (CASP3), phosphorylated histone H2AX (γ-H2AX), and Ki-67 were used to assess treatment-induced biological effects. In TROP2-high CRC cell lines (SW480, DLD-1), combined SG and RT markedly inhibited proliferation, increased apoptosis, and amplified DNA double-strand breaks, as evidenced by elevated γ-H2AX expression and comet assay tail moments. Knockdown of TROP2 abrogated this synergy, whereas TROP2 overexpression restored it. In CDX and PDX models, SG combined with RT significantly suppressed tumor growth, increased cleaved CASP3 and γ-H2AX expression, and reduced Ki-67 without exacerbating systemic weight loss. Our findings identify SG as a potent radiosensitizer, providing a strong rationale for integrating SG into neoadjuvant RT regimens for locally advanced CRC.

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PubMedEuropean journal of cancer (Oxford, England : 1990)2026-10-08

Exploration of tumor genomics associated with prolonged benefit from or resistance to talazoparib monotherapy in patients with metastatic castration-resistant prostate cancer.

Castro Elena E, Douglas Laird A A, Mehra Niven N, Dorff Tanya T et al.

Poly(ADP-ribose) polymerase (PARP) inhibition is synthetically lethal in cells with deleterious alterations in DNA damage response genes involved in homologous recombination repair (HRR). Alterations in HRR genes, including BRCA1/2, have been identified in ~25% of prostate cancer samples and linked with worse clinical outcomes. We explored relationships between tumor genetics and prolonged benefit with talazoparib in TALAPRO-1. The phase II TALAPRO-1 trial evaluated talazoparib monotherapy in pretreated patients with metastatic castration-resistant prostate cancer with HRR gene alterations. Tumor genetics were retrospectively assessed in subgroups in the efficacy population (n = 104) based on radiographic progression-free survival (rPFS: ≥12 months; ≥2 to <12 months; <2 months). Serial circulating tumor DNA samples from weeks 1, 9, and 25 and the safety follow-up visit (SFUV) were assessed for emergent changes in mutational profiles using FoundationOne®Liquid CDx. Among 16 patients with rPFS ≥ 12 months, 15 (94%) exhibited tumor BRCA2 alterations vs. 6/27 (22%) patients with rPFS < 2 months (p < 0.00001). HRR gene reversions predicted to restore HRR gene function were detected in 7/27 patients (BRCA1 [n = 1], BRCA2 [n = 5], PALB2 [n = 1]) evaluable for emergent variants at week 25 and/or the SFUV. Emergent PARP1 variants predicted to truncate PARP1 and/or inhibit talazoparib binding were evident in 5/27 evaluable patients. Patients experiencing prolonged benefit typically exhibited tumor BRCA2 copy number loss. Reversion mutations of HRR genes and emergent PARP1 variants likely reflect selective pressure to escape talazoparib synthetic lethality and/or PARP trapping. NCT03148795.

PMID 42849324
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