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- ||| ifinatamab deruxtecan (DS-7300) / Daiichi Sankyo, Merck (MSD), gocatamig (MK-6070) / Merck (MSD), Daiichi Sankyo
Enrollment open: A Study to Evaluate the Safety and Efficacy of Gocatamig (MK-6070) and Ifinatamab Deruxtecan (I-DXd) in Participants With Relapsed/Refractory Extensive-Stage Small Cell Lung Cancer (MK-6070-002) (clinicaltrials.gov) - Feb 21, 2025
P1/2, N=138, Recruiting, Sponsor: Merck Sharp & Dohme LLC
Not yet recruiting --> Recruiting
- || ifinatamab deruxtecan (DS-7300) / Daiichi Sankyo, Merck (MSD), gocatamig (MK-6070) / Merck (MSD), Daiichi Sankyo
Trial completion date, Trial primary completion date, Monotherapy: A Study in Participants With Advanced Cancers Associated With Expression of DLL3 (MK-6070-001/HPN328-4001) (clinicaltrials.gov) - Feb 19, 2025
P1/2, N=232, Recruiting, Sponsor: Harpoon Therapeutics, Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)
Not yet recruiting --> Recruiting Trial completion date: Feb 2026 --> Jun 2027 | Trial primary completion date: Feb 2026 --> Jun 2027
- |||| ifinatamab deruxtecan (DS-7300) / Daiichi Sankyo, Merck (MSD), gocatamig (MK-6070) / Merck (MSD), Daiichi Sankyo
New P1/2 trial: A Study to Evaluate the Safety and Efficacy of Gocatamig (MK-6070) and Ifinatamab Deruxtecan (I-DXd) in Participants With Relapsed/Refractory Extensive-Stage Small Cell Lung Cancer (MK-6070-002) (clinicaltrials.gov) - Jan 17, 2025
P1/2, N=138, Not yet recruiting, Sponsor: Merck Sharp & Dohme LLC
- MK-6070 / Merck (MSD), Daiichi Sankyo
A phase 1/2 trial in progress of MK-6070 (aka HPN328), a DLL3-targeting T cell engager, as monotherapy or combination therapy for advanced cancers associated with DLL3 expression (Exhibit Halls AB - George R. Brown Convention Center) - Oct 4, 2024 - Abstract #SITC2024SITC_1352;
P1/2
Cohorts combining the B7 homolog 3 ADC, ifinatamab deruxtecan, with MK-6070 will be enrolling to determine safety and preliminary efficacy in SCLC. Clinical trial information: NCT04471727.
- | ifinatamab deruxtecan (DS-7300) / Daiichi Sankyo, Merck (MSD), gocatamig (MK-6070) / Merck (MSD), Daiichi Sankyo
Enrollment change, Trial primary completion date, Monotherapy: A Study in Participants With Advanced Cancers Associated With Expression of DLL3 (MK-6070-001/HPN328-4001) (clinicaltrials.gov) - Aug 8, 2024
P1/2, N=232, Recruiting, Sponsor: Harpoon Therapeutics, Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)
Clinical trial information: NCT04471727. N=162 --> 232 | Trial primary completion date: Jul 2025 --> Jan 2026
- MK-6070 / Merck (MSD), Daiichi Sankyo
Impact of Brain Metastases on Safety and Efficacy of MK-6070, a DLL3-Targeting T Cell Engager, in Small Cell Lung Cancer (20A) - Jul 24, 2024 - Abstract #IASLCWCLC2024IASLC_WCLC_926;
P1/2
Introduction : MK-6070 (aka HPN328) is a DLL3-targeting T cell engager being studied in an ongoing phase 1/2 trial in patients (pts) with high grade neuroendocrine tumors associated with DLL3 expression, including small cell lung cancer (SCLC)...This trial is ongoing and data continue to mature. Updated safety and efficacy data including duration of response will be presented.
- || ifinatamab deruxtecan (DS-7300) / Daiichi Sankyo, Merck (MSD), gocatamig (MK-6070) / Merck (MSD), Daiichi Sankyo
Trial completion date, Trial primary completion date, Monotherapy, IO biomarker: A Study in Participants With Advanced Cancers Associated With Expression of DLL3 (MK-6070-001/HPN328-4001) (clinicaltrials.gov) - May 28, 2024
P1/2, N=162, Recruiting, Sponsor: Harpoon Therapeutics
Updated safety and efficacy data including duration of response will be presented. Trial completion date: Jun 2024 --> Dec 2025 | Trial primary completion date: Jan 2024 --> Jul 2025
- | MK-6070 / Merck (MSD)
Journal, Trispecific: HPN328, a Trispecific T Cell-activating Protein Construct Targeting DLL3-Expressing Solid Tumors. (Pubmed Central) - Apr 27, 2024
Preclinical and nonclinical characterization suggests that HPN328 is a highly efficacious, safe, and novel therapeutic candidate. A phase 1/2 clinical trial is currently underway testing safety and efficacy in patients with DLL3 expressing malignancies.
- MK-6070 / Merck (MSD)
Updated results from a phase 1/2 study of HPN328, a tri-specific, half-life (T1/2) extended DLL3-targeting T-cell engager in patients (pts) with small cell lung cancer (SCLC) and other neuroendocrine cancers (NEC). (Hall A; Poster Bd #: 352) - Apr 24, 2024 - Abstract #ASCO2024ASCO_3348;
P1/2
Current dose optimization cohorts have completed enrollment and data continue to mature; selection of a recommended phase 2 dose will be made based upon complete mature data. Updated safety and efficacy results will be presented.
- HPN328 / Harpoon Therap
Interim results from a phase 1/2 study of HPN328, a tri-specific, half-life (T1/2) extended DLL3-targeting T-cell engager, in patients (pts) with neuroendocrine prostate cancer (NEPC) and other neuroendocrine neoplasms (NEN). (Level 3, Ballroom) - Dec 13, 2023 - Abstract #ASCOGU2024ASCO_GU_153;
P1/2
MTD determination, dose escalation, and dose optimization are ongoing. Updated safety and efficacy results including recently enrolled NEPC and SCBC pts will be presented.
- HPN328 / Harpoon Therap
Interim results from a phase I/II study of HPN328, a tri-specific, half-life (T1/2) extended DLL3-targeting T cell engager in patients (pts) with small cell lung cancer (SCLC) and other neuroendocrine neoplasms (NEN) () - Jul 27, 2023 - Abstract #ESMO2023ESMO_2271;
P1/2
Future planned cohorts include every other week dosing and HPN328 + atezolizumab. Updated safety and efficacy results including pts recently enrolled in backfill cohorts will be presented.
- ||||| tarlatamab (AMG 757) / Amgen, BI 764532 / Boehringer Ingelheim, HPN328 / Harpoon Therap
BI 764532 A NOVEL DLL3/CD3 IgG- like bispecific T-cell (BiTE) engager in DLL3 positive SCLC, similar results to tarlatamab and HPN328 #ASCO2023 #LCSM @OncoAlert (Twitter) - Jun 3, 2023
- ||| ifinatamab deruxtecan (DS-7300) / Daiichi Sankyo, Merck (MSD), gocatamig (MK-6070) / Merck (MSD), Daiichi Sankyo
Enrollment change, Trial completion date, Trial primary completion date, Monotherapy, IO biomarker: A Study in Participants With Advanced Cancers Associated With Expression of DLL3 (MK-6070-001/HPN328-4001) (clinicaltrials.gov) - Mar 24, 2023
P1/2, N=162, Recruiting, Sponsor: Harpoon Therapeutics
Updated safety and efficacy results including pts recently enrolled in backfill cohorts will be presented. N=57 --> 162 | Trial completion date: Mar 2023 --> Jun 2024 | Trial primary completion date: Dec 2022 --> Jan 2024
- HPN328 / Harpoon Therap
Anti-tumor activity of HPN328, a DLL3-targeting tri-specific, half-life extended T cell engager, is enhanced by combining with an anti-PD-L1 antibody in an immunocompetent mouse model (Section 21; Poster Board #4) - Mar 14, 2023 - Abstract #AACR2023AACR_7410;
P1/2
These results demonstrate the utility of combining anti-PD-L1 antibodies to enhance the anti-tumor activity of HPN328 and further supports investigation of this combinatorial approach in patients. Clinical studies of HPN328 in combination with atezolizumab are planned.
- HPN328 / Harpoon Therap
Long-term anti-tumor immunity induced by of HPN328, a DLL3-targeting trispecific, half-life extended T cell engager, in a preclinical immunocompetent mouse model (Section 24; Poster Board #20) - Mar 14, 2023 - Abstract #AACR2023AACR_6342;
P1/2
Concomitant with anti-tumor immune response, we detected increases in memory T cells in the spleens of mice previously treated with HPN328. Together these results indicate that HPN328 can induce epitope spreading and prolonged anti-tumor immunity, suggest a novel mechanism for its activity and efficacy in vivo.
- |||||| HPN328 / Harpoon Therap
Clinical: HPN328, a DLL3-targeting T-cell engager, demonstrated clinical activity and tolerability in patients with pretreated SCLC and other neuroendocrine tumors, according to findings from a phase 1/2 study. @MLJohnsonMD2 @SarahCannonDocs @ASCO #ASCO22 https://t.co/xH9c9z0GCu (Twitter) - Jul 25, 2022
- |||||| HPN328 / Harpoon Therap
Clinical: Results from a phase 1/2 study demonstrated that 39% of patients with neuroendocrine tumors who received HPN328 experienced a reduction in the sum of their target lesion diameter, including 5 patients with SCLC. @MLJohnsonMD2 @SarahCannonDocs @ASCO #ASCO22 https://t.co/wVCbaXEUgL (Twitter) - Jul 23, 2022
- |||||| HPN328 / Harpoon Therap
Clinical: Dr. @MLJohnsonMD2 describes the interim results of an ongoing phase I/IIa study (NCT04471727) of HPN328, a tri-specific, DLL3-targeting T-cell engager, in patients with small cell lung cancer (SCLC) and other neuroendocrine cancers. https://t.co/O9lOt6iw0T (Twitter) - Jun 30, 2022
P1/2
- ||| HPN328 / Harpoon Therap
HPN328 Elicits Antitumor Activity in Small Cell Lung Cancer and Other NETs @MLJohnsonMD2 @SarahCannonDocs #lcsm https://t.co/0SIHF2rUcc (Twitter) - Jun 23, 2022
- ||| HPN328 / Harpoon Therap
$HARP HPN328 (anti-DLL3 T-cell engager) update, vs earlier Dec 2021 cutoff. The earlier unconfirmed PR now appears to be a SD #ASCO22 (Twitter) - Jun 6, 2022
- HPN328 / Harpoon Therap
Interim results of an ongoing phase 1/2a study of HPN328, a tri-specific, half-life extended, DLL3-targeting, T-cell engager, in patients with small cell lung cancer and other neuroendocrine cancers. (Available On Demand; 193) - Apr 28, 2022 - Abstract #ASCO2022ASCO_5640;
P1/2
AEs have been transient, manageable, and consistent with class. No ≥ Grade-3 CRS occurred.
- HPN328 / Harpoon Therap
DLL3-targeted T cell engager therapy (HPN328) for neuroendocrine prostate cancer (Section 38) - Mar 9, 2022 - Abstract #AACR2022AACR_4827;
The DLL3-targeted TriTAC HPN328 demonstrates robust and specific anti-tumor activity in DLL3-positive NEPC preclinical models in vitro and in vivo. T cell engagers targeting DLL3 represent a promising therapeutic strategy for NEPC.Acknowledgements: This research is funded by a Helen Trailblazers Award from the Helen Gurley Brown Foundation /DFCI Presidential Initiative (H.B.).
- |||||| HPN328 / Harpoon Therap
Clinical: DLL3-targeted therapy – recruiting HPN328 - tri-specific recombinant protein construct (Tri-specific T Cell Activating Construct [TriTAC®]) Ongoing open-label trial evaluating safety, tolerability, & PK of HPN328 in patients w/ advanced cancers including relapsed SCLC #SCLCchat (Twitter) - Dec 6, 2021
- HPN424 / AbbVie, Harpoon Therap
[VIRTUAL] Combinatorial antitumor effects of CD3-based trispecific T cell activating constructs (TriTACs) and checkpoint inhibitors in preclinical models () - Mar 11, 2021 - Abstract #AACR2021AACR_1398;
P1/2
In addition, in the MSLN-expressing NCI-H292 lung cancer model that co-expresses constitutive, high levels of PD-L1, both anti-PD1 and anti-PDL1 antibodies significantly enhanced the antitumor effects of the MSLN-targeting TriTAC HPN536 in vivo. Together these results demonstrate the potential utility of PD1/PDL1 blockade to enhance the potency of TriTAC-mediated tumor cell killing, supporting further investigation of these combinatorial approaches in patients.
- ||| ifinatamab deruxtecan (DS-7300) / Daiichi Sankyo, Merck (MSD), gocatamig (MK-6070) / Merck (MSD), Daiichi Sankyo
Enrollment open, Monotherapy, IO biomarker: A Study in Participants With Advanced Cancers Associated With Expression of DLL3 (MK-6070-001/HPN328-4001) (clinicaltrials.gov) - Nov 24, 2020
P1/2, N=52, Recruiting, Sponsor: Harpoon Therapeutics
Together these results demonstrate the potential utility of PD1/PDL1 blockade to enhance the potency of TriTAC-mediated tumor cell killing, supporting further investigation of these combinatorial approaches in patients. Not yet recruiting --> Recruiting
- |||| ifinatamab deruxtecan (DS-7300) / Daiichi Sankyo, Merck (MSD), gocatamig (MK-6070) / Merck (MSD), Daiichi Sankyo
New P1/2 trial, Monotherapy, IO biomarker: A Study in Participants With Advanced Cancers Associated With Expression of DLL3 (MK-6070-001/HPN328-4001) (clinicaltrials.gov) - Jul 14, 2020
P1/2, N=52, Not yet recruiting, Sponsor: Harpoon Therapeutics