A double blinded, placebo controlled, randomised trial to determine the minimum plasma penicillin concentration required to prevent Strep A pharyngitis in healthy volunteers

Start Date24 Aug 2022

Sponsor / Collaborator

Telethon Kids Institute

[+1]

NCT05202379

/ CompletedPhase 1

A Phase 1 Study in Healthy Participants to Evaluate the Safety, Tolerability, and Pharmacokinetics of Single-Ascending and Multiple-Ascending Doses of the Influenza A Virus Replication Inhibitor CC-42344

CC-42344 Phase 1 study with single-ascending dose (SAD) and multiple-ascending dose (MAD) parts.

Start Date11 Feb 2022

Sponsor / Collaborator

Cocrystal Pharma, Inc.

[+1]

ACTRN12621001455853

/ CompletedPhase 1

Investigating the safety of REVTx-99 in Participants With Allergic Rhinitis to Rye Grass Pollen

Start Date08 Dec 2021

Sponsor / Collaborator

Linear Clinical Research Ltd.

[+1]

100 Clinical Results associated with Linear Clinical Research Ltd.

0 Patents (Medical) associated with Linear Clinical Research Ltd.

Literatures (Medical) associated with Linear Clinical Research Ltd.

01 May 2025·Cancer Treatment Reviews

Primary testicular lymphoma

Review

Author: Cheah, Chan Y ; Grainger, Brian T

Primary testicular lymphoma (PTL) is a rare extranodal lymphoma. The majority of cases are of diffuse large B cell lymphoma (DLBCL) histology (PT-DLBCL) with an activated B-cell-like (ABC) gene expression profile. These are characterised clinically by a high risk of contralateral testis and central nervous system (CNS) relapse, representing an ongoing area of unmet clinical need. Here, we review the epidemiology, clinical presentation and diagnostic evaluation of PT-DLBCL along with the advances in molecular biology that have occurred in the last decade, concerning the now-recognised molecular subtypes of DLBCL and their role of immune escape and sustained signalling in disease pathophysiology. We also appraise the retrospective and prospective clinical trials underpinning modern treatment recommendations, including the updated guidance on the role of radiotherapy and the latest evidence regarding strategies for preventing CNS relapse.

25 Apr 2025·Cancer Research

Abstract CT045: A phase 1/2 trial of TAC-001 (TLR9 agonist-CD22 mAb) in advanced or metastatic solid tumors

Author: Wan, Hong I. ; Piha-Paul, Sarina A. ; Vaena, Daniel ; Jin, Feng ; Chow, Laura QM ; Gutierrez, Martin ; Kim, Sunnie ; Humphries, Timothy ; Sonpavde, Guru ; Perez, Cesar A. ; Sen, Shiraj ; Bollin, Sangeetha ; Pavlick, Anna C. ; Spira, Alexander ; Harrabi, Ons ; Henry, Jason T.

AbstractBackground:TAC-001 is a novel next-generation antibody-drug conjugate designed for systemic delivery of a potent Toll-like Receptor (TLR)-9 agonist payload. It selectively targets TLR9 to CD22+ B cells, triggering their activation and inducing anti-tumor responses by harnessing the immunological functions of B cells. The mouse surrogate of TAC-001 induced tumor infiltration of activated B cells, effector T cells, and TLS-like structures, leading to sustained anti-tumor activity, including in models resistant to anti-PD-1 therapy.Methods:This Phase 1 trial (INCLINE 101; NCT05399654) evaluated the safety, tolerability, pharmacokinetics (PK), immunogenicity, tumor biopsy pharmacodynamic (PD) effects, and preliminary efficacy of TAC-001 across multiple solid tumors with ECOG-PS 0-1. Eligible patients (pts; ≥18 years) received TAC-001 IV Q2W at 3-fold escalating doses (0.1-12 mg/kg) with monitoring for 28-day dose-limiting toxicities (DLTs). Doses were reduced 2-fold or to the next lower tolerated dose level in the event of DLTs. TAC-001 was evaluated in select tumor types at two doses at and below the maximum tolerable dose (MTD).Results:As of September 11, 2024, 72 heavily pre-treated pts (median age 62, range 37-79) with a median of 6 (range 1 to 12) prior therapies were enrolled in the study, including 52 (72%) PD-(L)1 refractory/resistant pts. Treatment-related adverse events (TRAE) were reported in 66 (92%) pts, with 54 (75%) experiencing mild-moderate (Gr 1-2) events. The most frequent TRAEs included chills (61%), fatigue (35%), and pyrexia (35%). Gr ≥ 3 toxicities occurred in 12 (17%) pts, leading to treatment discontinuation in one pt (1.4%). DLTs occurred at 3 mg/kg (1 pt Gr ≥3 bilirubin and elevated ALT) and 12 mg/kg (1 pt transient Gr 3 transaminitis, and 1 pt Gr ≥3 bilirubin with Gr 4 acute kidney injury). The MTD was established at 6mg/kg, with 3mg/kg and 6mg/kg selected for dose expansion. TAC-001 PK exposures (Cmax and AUC) exhibited dose-dependent increases over the dose range tested. Preliminary PD assessment demonstrated dose-dependent CD22 engagement, with activation of circulating B cells observed across dose levels. Among 68 response-evaluable pts, 24 achieved stable disease (≥2 months), 2 (melanoma and cholangiocarcinoma) had confirmed durable partial responses, and 32 had progressive disease. Final results will be presented at the meeting.Conclusion:TAC-001 showed a favorable safety profile, dose-dependent PK/PD activity, and anti-tumor activity in PD- (L)1 refractory pts.Citation Format:Jason T. Henry, Anna C. Pavlick, Timothy Humphries, Sunnie Kim, Martin Gutierrez, Sarina A. Piha-Paul, Daniel Vaena, Shiraj Sen, Alexander Spira, Guru Sonpavde, Ons Harrabi, Feng Jin, Sangeetha Bollin, Laura QM Chow, Hong I. Wan, Cesar A. Perez. A phase 1/2 trial of TAC-001 (TLR9 agonist-CD22 mAb) in advanced or metastatic solid tumors [abstract]. In: Proceedings of the American Association for Cancer Research Annual Meeting 2025; Part 2 (Late-Breaking, Clinical Trial, and Invited Abstracts); 2025 Apr 25-30; Chicago, IL. Philadelphia (PA): AACR; Cancer Res 2025;85(8_Suppl_2):Abstract nr CT045.

25 Apr 2025·Cancer Research

Abstract CT266: D3S-001, a next generation GDP-bound KRAS G12C inhibitor, as monotherapy in KRAS G12C inhibitor resistant non-small cell lung cancer

Author: Zhao, Jun ; Loong, Herbert H. ; Chen, Zhi Jian ; Li, Ziming ; Cho, Byoung Chul ; Wang, Shaonan ; Chen, Cheng ; Lu, Shun ; Park, John ; Zhang, Jing ; Dong, Xiaorong ; Samantha, Bowyer ; Zhou, Jianya ; Chen, Qian ; Shen, Yandong ; Song, Zhengbo ; Liu, Yangbo ; Lee, Ki Hyeong ; Mok, Tony S. ; Wang, Hui ; Fan, Zifei

AbstractBackground:Resistance mechanisms to first-generation (1G) KRAS G12C inhibitors (G12Ci) are diverse, with previous data revealing a heterogeneous pattern characterized by multiple subclonal events emerging after treatment (Tx). Incomplete G12C target engagement (TE) and G12Ci induced G12C amplification contributed to the resistance mechanisms against 1G G12Ci. D3S-001, a next-generation KRAS G12Ci, has demonstrated potent, faster and complete TE to effectively deplete active KRAS mutated protein. In pre-clinical studies, D3S-001 resulted in tumor regression in xenograft models that are resistant to sotorasib (soto) and adagrasib (ada). Phase 1 results demonstrated favorable safety and promising early efficacy across NSCLC, CRC and PDAC; Here, we present findings in G12Ci resistant NSCLC patients (pts) from the ongoing Phase 2 trial (NCT05410145).Methods:Pts of locally advanced or metastatic NSCLC with historically confirmed KRAS G12C mutation were eligible for inclusion if they had radiologically or clinically documented PD following TX of 1 prior KRAS G12Ci achieving CR/PR or SD for >= 6 months. In this cohort, D3S-001 was administered as monotherapy at 600mg once daily. The key objectives included safety, efficacy, and ctDNA kinetics by liquid biopsy.Results:As of 14 Feb 2024, a total of 20 pts were enrolled. Prior G12Ci Tx included FDA approved and experimental G12Cis. 7 pts had soto, 1 pt had ada and 12 pts had other experimental G12Cis. During their prior G12Ci Tx, 8 pts (40%) achieved PR, 7 pts (35%) achieved SD, and 5 pts (25%) were unknown as the BOR. 14 pts (70%) were enrolled into this study immediately after PD from prior G12Ci. Median study follow-up was 4.7 months (range: 1.3-12.8 months), and 9 pts (45%) remain on-study Tx. TRAE of any grade occurred in 18 pts (90%). Of which, 2 (10%) were Grade 3 (no >=G4). PR was achieved in 6 pts (30%). Median DOR was 8.2 months. DCR was 80% and tumor shrinkage was observed in 12 of the 20 (60%) pts. Of the 20 pts, 14 (70%) were KRAS G12C ctDNA positive at baseline [bG12C(+)]. Notable baseline co-mutations included secondary KRAS alterations (A146V, R68S and three G12C amplification), BRAF, EGFR, NTRK1/2/3, TP53, etc. Of the 14 bG12C(+) pts, 11 achieved >90% G12C MAF reduction including 8 with complete clearance. All 6 radiological responders were bG12C(+) and 5 of 6 had complete clearance of G12C MAF. Remarkably, of the 3 pts with KRAS amplification, 2 achieved PR and 1 SD with D3S-001 Tx. Conversely, pts who had immediate PD to D3S-001 carried baseline gene alterations of switch II pocket mutation (KRAS R68S), BRAF V600E, MYC amplification, NTRK2, CDKN2A and PIK3CG. These findings align with preclinical observation that D3S-001 was effective in G12Ci resistant xenograft model including those with KRAS G12C gene amplification.Conclusions:These findings highlight the potential of D3S-001 to overcome the limitations of earlier KRAS G12Ci and address unmet needs in G12Ci resistant NSCLC, offering a promising therapeutic option for pts with KRAS G12C-mutant cancers.Citation Format:Herbert H. Loong, Ziming Li, Byoung Chul Cho, Jun Zhao, John Park, Zhengbo Song, Bowyer Samantha, Ki Hyeong Lee, Xiaorong Dong, Jianya Zhou, Cheng Chen, Yangbo Liu, Yandong Shen, Shaonan Wang, Zifei Fan, Qian Chen, Hui Wang, Jing Zhang, Zhi Jian Chen, Tony S. Mok, Shun Lu. D3S-001, a next generation GDP-bound KRAS G12C inhibitor, as monotherapy in KRAS G12C inhibitor resistant non-small cell lung cancer [abstract]. In: Proceedings of the American Association for Cancer Research Annual Meeting 2025; Part 2 (Late-Breaking, Clinical Trial, and Invited Abstracts); 2025 Apr 25-30; Chicago, IL. Philadelphia (PA): AACR; Cancer Res 2025;85(8_Suppl_2):Abstract nr CT266.

100 Deals associated with Linear Clinical Research Ltd.

100 Translational Medicine associated with Linear Clinical Research Ltd.

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