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10 Trials |
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10 Trials |  |
233 News |  |
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- |||| Ziihera (zanidatamab-hrii) / Jazz
Trial completion date, Trial primary completion date: HERIZON-GEA-01: A Study of Zanidatamab in Combination With Chemotherapy Plus or Minus Tislelizumab in Patients With HER2-positive Advanced or Metastatic Gastric and Esophageal Cancers (clinicaltrials.gov) - Dec 26, 2024
P3, N=918, Recruiting, Sponsor: Jazz Pharmaceuticals
Trial completion date: Jul 2025 --> May 2026 | Trial primary completion date: Dec 2024 --> May 2025
- ||| Ziihera (zanidatamab-hrii) / Jazz
Enrollment open: A Phase 2 Study of Zanidatamab in Patients With HER2-expressing Tumors (clinicaltrials.gov) - Dec 20, 2024
P2, N=200, Recruiting, Sponsor: Jazz Pharmaceuticals
Trial completion date: Jul 2025 --> May 2026 | Trial primary completion date: Dec 2024 --> May 2025 Not yet recruiting --> Recruiting
- Ziihera (zanidatamab-hrii) / Jazz
HERIZON-BTC-302: A phase 3 study of zanidatamab with standard-of-care (SOC) therapy vs SOC alone for first-line treatment of human epidermal growth factor receptor 2 (HER2)-positive advanced/metastatic biliary tract cancer (BTC). (Level 1, West Hall; Poster Bd #: L6) - Dec 17, 2024 - Abstract #ASCOGI2025ASCO_GI_670;
P3
Clinical Trial Registration Number: NCT06282575. The abstract will be released to the public on January 21, 2025 at 10:00 PM UTC
- Ziihera (zanidatamab-hrii) / Jazz
Zanidatamab dose optimization in patients with HER2-positive biliary tract cancer (BTC). (Level 1, West Hall; Poster Bd #: A24) - Dec 17, 2024 - Abstract #ASCOGI2025ASCO_GI_456;
P1, P2
Clinical Trial Registration Number: NCT02892123, NCT04466891. The abstract will be released to the public on January 21, 2025 at 10:00 PM UTC
- ||| Tevimbra (tislelizumab-jsgr) / BeiGene, Ziihera (zanidatamab-hrii) / Jazz
Trial completion, Trial completion date, Combination therapy, Metastases: BGB-A317-ZW25-101: Anti-HER2 Bispecific Antibody Zanidatamab (ZW25) Activity in Combination With Chemotherapy With/Without Tislelizumab (clinicaltrials.gov) - Nov 25, 2024
P1/2, N=71, Completed, Sponsor: BeiGene
The abstract will be released to the public on January 21, 2025 at 10:00 PM UTC Active, not recruiting --> Completed | Trial completion date: Dec 2026 --> Oct 2024
- |||| Ziihera (zanidatamab-hrii) / Jazz
New P2 trial: A Phase 2 Study of Zanidatamab in Patients With HER2-expressing Tumors (clinicaltrials.gov) - Nov 19, 2024
P2, N=200, Not yet recruiting, Sponsor: Jazz Pharmaceuticals
- Ziihera (zanidatamab-hrii) / Jazz, Enhertu (fam-trastuzumab deruxtecan-nxki) / Daiichi Sankyo, AstraZeneca
EmpowHER 303: A phase 3 study to evaluate the efficacy and safety of zanidatamab vs trastuzumab with chemotherapy in patients (pts) with metastatic HER2-positive breast cancer who have progressed on, or are intolerant to, trastuzumab deruxtecan (Halls 2-3) - Nov 1, 2024 - Abstract #SABCS2024SABCS_1989;
- Ziihera (zanidatamab-hrii) / Jazz, evorpacept (ALX148) / ALX Oncology
Zanidatamab in combination with evorpacept in HER2-positive and HER2-low metastatic breast cancer: Results from a phase 1b/2 study. (Stars at Night 1-2) - Nov 1, 2024 - Abstract #SABCS2024SABCS_1022;
- || Ziihera (zanidatamab-hrii) / Jazz
Trial primary completion date: ZWI-ZW25-201: A Safety and Efficacy Study of ZW25 (Zanidatamab) Plus Combination Chemotherapy in HER2-expressing Gastrointestinal Cancers, Including Gastroesophageal Adenocarcinoma, Biliary Tract Cancer, and Colorectal Cancer (clinicaltrials.gov) - Oct 17, 2024
P2, N=74, Active, not recruiting, Sponsor: Jazz Pharmaceuticals
Active, not recruiting --> Completed | Trial completion date: Dec 2026 --> Oct 2024 Trial primary completion date: Aug 2024 --> Jul 2025
- | Ziihera (zanidatamab-hrii) / Jazz
Trial completion date, Trial primary completion date: A Phase 2 Single-Arm Open-Label Pilot Trial Evaluating Zanidatamab (ZW25) in Patients With Early Stage HER2/Neu Positive (HER2+) Breast Cancer (BC) (clinicaltrials.gov) - Oct 8, 2024
P2, N=20, Active, not recruiting, Sponsor: M.D. Anderson Cancer Center
Trial primary completion date: Aug 2024 --> Jul 2025 Trial completion date: Dec 2024 --> Dec 2025 | Trial primary completion date: Dec 2024 --> Dec 2025
- || Ziihera (zanidatamab-hrii) / Jazz
Trial completion date, Trial primary completion date, Combination therapy, Metastases: ZWI-ZW25-204: A Study of Zanidatamab (ZW25) With Evorpacept (ALX148) in Patients With Advanced HER2-expressing Cancer (clinicaltrials.gov) - Sep 26, 2024
P1/2, N=52, Active, not recruiting, Sponsor: Jazz Pharmaceuticals
Trial completion date: Dec 2024 --> Dec 2025 | Trial primary completion date: Dec 2024 --> Dec 2025 Trial completion date: Apr 2025 --> Sep 2025 | Trial primary completion date: Oct 2024 --> Apr 2025
- Ziihera (zanidatamab-hrii) / Jazz
Asia subgroup overall survival and long-term follow-up results of the phase IIb HERIZON-BTC-01 study: Zanidatamab in previously treated human epidermal growth factor receptor 2 (HER2)-amplified biliary tract cancer (BTC) (Hall 406) - Sep 17, 2024 - Abstract #ESMOAsia2024ESMO_Asia_212;
P2
d Greenwood. CI, confidence interval.
- || Irene (pyrotinib) / Jiangsu Hengrui Pharma
Review, Journal: Advances in HER2-Targeted Therapies: From monoclonal antibodies to dual inhibitors developments in cancer treatment. (Pubmed Central) - Aug 31, 2024
Small molecules such as Lapatinib, Neratinib, and Pyrotinib were initially developed for treating breast cancer...This comprehensive review covers the structural characteristics of HER2, the HER family signaling pathway mechanism, recent findings regarding HER2 receptor involvement in various cancers, and diverse HER2-targeted therapies. This information provides a comprehensive understanding of HER2-targeted strategies in the evolving field of cancer treatment.
- ||| Ziihera (zanidatamab-hrii) / Jazz
Trial completion, Trial completion date, Monotherapy, Metastases: HERIZON-BTC-01: A Study of ZW25 (Zanidatamab) in Subjects With Advanced or Metastatic HER2-Amplified Biliary Tract Cancers (clinicaltrials.gov) - Aug 21, 2024
P2, N=87, Completed, Sponsor: Jazz Pharmaceuticals
This information provides a comprehensive understanding of HER2-targeted strategies in the evolving field of cancer treatment. Active, not recruiting --> Completed | Trial completion date: Oct 2024 --> Jul 2024
- || Ziihera (zanidatamab-hrii) / Jazz
Trial completion date, Trial primary completion date, Metastases: ZWI-ZW25-101: Trial of ZW25 (Zanidatamab) in Patients With Advanced HER2-expressing Cancers (clinicaltrials.gov) - Aug 15, 2024
P1, N=279, Active, not recruiting, Sponsor: Jazz Pharmaceuticals
Active, not recruiting --> Completed | Trial completion date: Oct 2024 --> Jul 2024 Trial completion date: Jul 2024 --> Oct 2024 | Trial primary completion date: Jun 2024 --> Oct 2024
- || Ziihera (zanidatamab-hrii) / Jazz
Trial completion date, Trial primary completion date: ZWI-ZW25-201: A Safety and Efficacy Study of ZW25 (Zanidatamab) Plus Combination Chemotherapy in HER2-expressing Gastrointestinal Cancers, Including Gastroesophageal Adenocarcinoma, Biliary Tract Cancer, and Colorectal Cancer (clinicaltrials.gov) - Aug 13, 2024
P2, N=74, Active, not recruiting, Sponsor: Jazz Pharmaceuticals
Trial completion date: Jul 2024 --> Oct 2024 | Trial primary completion date: Jun 2024 --> Oct 2024 Trial completion date: Oct 2026 --> Jul 2025 | Trial primary completion date: Nov 2025 --> Aug 2024
- || zanidatamab (ZW25) / Jazz
P2b data, Journal: A plain language summary of the results from the phase 2b HERIZON-BTC-01 study of zanidatamab in participants with HER2-amplified biliary tract cancer. (Pubmed Central) - Aug 8, 2024
P2
The results of this study support the potential for zanidatamab as a new therapy for people with HER2-positive biliary tract cancer after they had already received chemotherapy. More research is occurring to support these results.Clinical Trial Registration: NCT04466891 (HERIZON-BTC-01 study).
- |||||| Ziihera (zanidatamab-hrii) / Jazz
Enrollment open, Trial completion date, Trial primary completion date, Combination therapy, Metastases: JZP598-303: A Study Comparing the Efficacy and Safety of Zanidatamab to Trastuzumab, Each in Combination With Physician's Choice Chemotherapy, for the Treatment of Participants With Metastatic HER2-positive Breast Cancer (clinicaltrials.gov) - Aug 1, 2024
P3, N=550, Recruiting, Sponsor: Jazz Pharmaceuticals
More research is occurring to support these results.Clinical Trial Registration: NCT04466891 (HERIZON-BTC-01 study). Not yet recruiting --> Recruiting | Trial completion date: Apr 2031 --> Nov 2031 | Trial primary completion date: Apr 2031 --> Sep 2028
- zanidatamab (ZW25) / Jazz
HERIZON-BTC-302: A Phase 3 Study of Zanidatamab With Standard-of-Care (SOC) Therapy vs SOC Alone For First-Line (1L) Treatment of Human Epidermal Growth Factor Receptor 2 (HER2)-Positive Advanced/Metastatic Biliary Tract Cancer (BTC) (Hall 6 - Poster area) - Jul 18, 2024 - Abstract #ESMO2024ESMO_2013;
- ||| Ziihera (zanidatamab-hrii) / Jazz
Trial completion date: HERIZON-GEA-01: A Study of Zanidatamab in Combination With Chemotherapy Plus or Minus Tislelizumab in Patients With HER2-positive Advanced or Metastatic Gastric and Esophageal Cancers (clinicaltrials.gov) - Jun 21, 2024
P3, N=918, Recruiting, Sponsor: Jazz Pharmaceuticals
Not yet recruiting --> Recruiting | Trial completion date: Apr 2031 --> Nov 2031 | Trial primary completion date: Apr 2031 --> Sep 2028 Trial completion date: Feb 2026 --> Jul 2025
- |||||| Enrollment open: SAFIR-ABC10: Personalized Medicine for Advanced Biliary Cancer Patients (clinicaltrials.gov) - Jun 3, 2024
P3, N=800, Recruiting, Sponsor: UNICANCER
Trial completion date: Feb 2026 --> Jul 2025 Not yet recruiting --> Recruiting
- |||||||||| Ziihera (zanidatamab-hrii) / Jazz
New P3 trial, Combination therapy, Metastases: JZP598-303: A Study Comparing the Efficacy and Safety of Zanidatamab to Trastuzumab, Each in Combination With Physician's Choice Chemotherapy, for the Treatment of Participants With Metastatic HER2-positive Breast Cancer (clinicaltrials.gov) - May 29, 2024
P3, N=550, Not yet recruiting, Sponsor: Jazz Pharmaceuticals
- |||| Ziihera (zanidatamab-hrii) / Jazz
Trial completion date, Trial primary completion date: HERIZON-GEA-01: A Study of Zanidatamab in Combination With Chemotherapy Plus or Minus Tislelizumab in Patients With HER2-positive Advanced or Metastatic Gastric and Esophageal Cancers (clinicaltrials.gov) - May 20, 2024
P3, N=918, Recruiting, Sponsor: Jazz Pharmaceuticals
Not yet recruiting --> Recruiting Trial completion date: Jul 2025 --> Feb 2026 | Trial primary completion date: Jun 2024 --> Dec 2024
- |||| Tevimbra (tislelizumab-jsgr) / BeiGene, Partruvix (pamiparib) / EMD Serono
Trial completion date, Trial primary completion date, Metastases: BGB-A317-290-LTE1: Study of Tislelizumab, Pamiparib, and Other Investigational Agents in Participants With Advanced Malignancies (clinicaltrials.gov) - May 15, 2024
P3, N=300, Enrolling by invitation, Sponsor: BeiGene
Trial completion date: Jul 2025 --> Feb 2026 | Trial primary completion date: Jun 2024 --> Dec 2024 Trial completion date: Aug 2024 --> Dec 2026 | Trial primary completion date: Aug 2024 --> Dec 2026
- | zanidatamab (ZW25) / Jazz, Enhertu (fam-trastuzumab deruxtecan-nxki) / Daiichi Sankyo, AstraZeneca, evorpacept (ALX148) / ALX Oncology
Journal: State of the art and upcoming trends in HER2-directed therapies in gastrointestinal malignancies. (Pubmed Central) - May 10, 2024
The advancements in HER2-directed therapies underscore a pivotal era in the management of upper GI malignancies. These developments not only reflect the profound impact of integrating novel therapeutic combinations but also highlight the critical role of ongoing research in overcoming resistance mechanisms and tailoring treatment to individual disease profiles.
- ||| Ziihera (zanidatamab-hrii) / Jazz
Enrollment closed, Enrollment change, Trial primary completion date, Combination therapy, Metastases: ZWI-ZW25-204: A Study of Zanidatamab (ZW25) With Evorpacept (ALX148) in Patients With Advanced HER2-expressing Cancer (clinicaltrials.gov) - Apr 25, 2024
P1/2, N=52, Active, not recruiting, Sponsor: Jazz Pharmaceuticals
These developments not only reflect the profound impact of integrating novel therapeutic combinations but also highlight the critical role of ongoing research in overcoming resistance mechanisms and tailoring treatment to individual disease profiles. Recruiting --> Active, not recruiting | N=93 --> 52 | Trial primary completion date: Jul 2024 --> Oct 2024
- PRE-ISPY phase I/Ib oncology platform program (PRE-I-SPY-P1). () - Apr 24, 2024 - Abstract #ASCO2024ASCO_5186;
P1
2 or other phase 2/3 trials. The first patient was enrolled on 2/1/2023.
- zanidatamab (ZW25) / Jazz
Zanidatamab in previously-treated HER2-positive (HER2+) biliary tract cancer (BTC): Overall survival (OS) and longer follow-up from the phase 2b HERIZON-BTC-01 study. (Hall A; Poster Bd #: 71) - Apr 24, 2024 - Abstract #ASCO2024ASCO_3822;
P2
With additional follow-up, safety remained manageable. A phase 3 trial of zanidatamab in the first-line setting for patients with metastatic BTC is planned.
- ||| Ziihera (zanidatamab-hrii) / Jazz, Cyramza (ramucirumab) / Eli Lilly
Enrollment open, Metastases: Paclitaxel and Ramucirumab +/- Zanidatamab in HER2 Postive Advanced Gastroesophageal Adenocarcinoma (clinicaltrials.gov) - Apr 18, 2024
P2, N=168, Recruiting, Sponsor: Canadian Cancer Trials Group
A phase 3 trial of zanidatamab in the first-line setting for patients with metastatic BTC is planned. Not yet recruiting --> Recruiting
- || Ziihera (zanidatamab-hrii) / Jazz
Trial completion, Trial completion date, Trial primary completion date: ZW25-IST-2: ZW25 in Women With Endometrial Cancers (clinicaltrials.gov) - Mar 11, 2024
P2, N=17, Completed, Sponsor: Memorial Sloan Kettering Cancer Center
Not yet recruiting --> Recruiting Active, not recruiting --> Completed | Trial completion date: Feb 2025 --> Mar 2024 | Trial primary completion date: Feb 2025 --> Mar 2024
- ||| Ziihera (zanidatamab-hrii) / Jazz
Enrollment closed, Enrollment change: ZWI-ZW25-201: A Safety and Efficacy Study of ZW25 (Zanidatamab) Plus Combination Chemotherapy in HER2-expressing Gastrointestinal Cancers, Including Gastroesophageal Adenocarcinoma, Biliary Tract Cancer, and Colorectal Cancer (clinicaltrials.gov) - Mar 5, 2024
P2, N=74, Active, not recruiting, Sponsor: Jazz Pharmaceuticals
Active, not recruiting --> Completed | Trial completion date: Feb 2025 --> Mar 2024 | Trial primary completion date: Feb 2025 --> Mar 2024 Recruiting --> Active, not recruiting | N=362 --> 74
- | Ziihera (zanidatamab-hrii) / Jazz
Trial completion date, Trial primary completion date: ZW25-IST-2: ZW25 in Women With Endometrial Cancers (clinicaltrials.gov) - Mar 3, 2024
P2, N=17, Active, not recruiting, Sponsor: Memorial Sloan Kettering Cancer Center
Recruiting --> Active, not recruiting | N=362 --> 74 Trial completion date: Feb 2024 --> Feb 2025 | Trial primary completion date: Feb 2024 --> Feb 2025
- |||||||||| Ziihera (zanidatamab-hrii) / Jazz
New P3 trial, Metastases: HERIZON-BTC-302: Efficacy and Safety of Zanidatamab With Standard-of-care Therapy Against Standard-of-care Therapy for Advanced HER2-positive Biliary Tract Cancer (clinicaltrials.gov) - Feb 28, 2024
P3, N=286, Recruiting, Sponsor: Jazz Pharmaceuticals
- | zanidatamab (ZW25) / Jazz
Journal: Co-Clinical Trial of Novel Bispecific Anti-HER2 Antibody Zanidatamab in Patient-Derived Xenografts. (Pubmed Central) - Feb 15, 2024
P1
We also identified amplification of MET as a potential mechanism of acquired resistance to zanidatamab and demonstrated that MET inhibitors have single agent activity and can enhance zanidatamab activity in vitro and in vivo. These findings provide evidence that PDXs can be developed from pre-treatment biopsies in clinical trials and may provide insight into mechanisms of resistance.
- || Review, Journal, Metastases: New developments and standard of care in the management of advanced gastric cancer. (Pubmed Central) - Jan 15, 2024
Based on phase 2 studies, trastuzumab-deruxtecan was approved in 2022 by the EMA for HER2-positive pretreated patients. This agent is currently evaluated in phase 3 study (DESTINY-Gastric04 trial), as are several other anti-HER2 (zanidatamab, margetuximab, tucatinib), immune checkpoint inhibitors, or targeted therapies (anti-FGFR2b).
- | Tevimbra (tislelizumab-jsgr) / BeiGene, Ziihera (zanidatamab-hrii) / Jazz
Phase classification, Combination therapy, Metastases: BGB-A317-ZW25-101: Anti-HER2 Bispecific Antibody Zanidatamab (ZW25) Activity in Combination With Chemotherapy With/Without Tislelizumab (clinicaltrials.gov) - Jan 11, 2024
P1/2, N=71, Active, not recruiting, Sponsor: BeiGene
This agent is currently evaluated in phase 3 study (DESTINY-Gastric04 trial), as are several other anti-HER2 (zanidatamab, margetuximab, tucatinib), immune checkpoint inhibitors, or targeted therapies (anti-FGFR2b). Phase classification: P1b/2 --> P1/2
- MODULE 4: Current Considerations in the Care of Patients with HER2-Positive Gastroesophageal Cancers (Golden Gate Ballroom ) - Jan 2, 2024 - Abstract #ASCOGI2024ASCO_GI_907;
This activity is supported by educational grants from Astellas, BeiGene Ltd, Bristol Myers Squibb, and Lilly. Available data from the Phase III KEYNOTE-811 trial evaluating the addition of pembrolizumab to chemotherapy and trastuzumab for previously untreated HER2-positive advanced gastric/GEJ adenocarcinoma Efficacy and safety findings from the DESTINY-Gastric01 and DESTINY-Gastric02 studies evaluating trastuzumab deruxtecan (T-DXd) for patients with progressive HER2- positive gastric/GEJ cancer; optimal integration into clinical practice Ongoing clinical trials attempting to further define the role of T-DXd in gastric/GEJ cancers, such as DESTINY-Gastric03 and DESTINY-Gastric04 Mechanism of action of the novel HER2-targeted bispecific antibody zanidatamab; published findings with zanidatamab/chemotherapy as first-line treatment for advanced HER2-positive gastroesophageal adenocarcinoma Design, eligibility criteria and key efficacy and safety endpoints of the Phase III HERIZON-GEA-01 trial of up-front zanidatamab and chemotherapy with or without tislelizumab for HER2-positive gastroesophageal adenocarcinoma; estimated completion date
- |||| Trial completion date, Trial primary completion date: SAFIR-ABC10: Personalized Medicine for Advanced Biliary Cancer Patients (clinicaltrials.gov) - Dec 31, 2023
P3, N=800, Not yet recruiting, Sponsor: UNICANCER
- The role of tumor molecular profiling in patients with advanced biliary tract cancer receiving systemic treatment (ePoster Area) - Dec 26, 2023 - Abstract #LCS2024LCS_203;
mOS was numerically longer in pts receiving targeted therapy, and in those with IDH1 mutated or FGFR2 rearranged tumors, but failed to reach statistical significance, probably due to the small sample size. Larger studies could provide additional information regarding the prognostic and predictive value of pivotal molecular alterations in BTC.
- || Ziihera (zanidatamab-hrii) / Jazz, Cyramza (ramucirumab) / Eli Lilly
Trial initiation date, Metastases: Paclitaxel and Ramucirumab +/- Zanidatamab in HER2 Postive Advanced Gastroesophageal Adenocarcinoma (clinicaltrials.gov) - Dec 15, 2023
P2, N=168, Not yet recruiting, Sponsor: Canadian Cancer Trials Group
Larger studies could provide additional information regarding the prognostic and predictive value of pivotal molecular alterations in BTC. Initiation date: Oct 2023 --> Jan 2024
- zanidatamab (ZW25) / Jazz
Zanidatamab (zani) in previously treated HER2+ biliary tract cancer (BTC): Impact on patient-reported pain outcomes in the phase 2b HERIZON-BTC-01 study. (Poster Bd # A15) - Dec 6, 2023 - Abstract #ASCOGI2024ASCO_GI_394;
P2
Clinical trial information: NCT04466891. >Change from BL for each patient is post-BL value minus BL value; negative values for change from BL indicate better outcomes and positive indicate worse.
- | Ziihera (zanidatamab-hrii) / Jazz
Phase classification, Combination therapy, Metastases: ZWI-ZW25-202: A Study of ZW25 (Zanidatamab) With Palbociclib Plus Fulvestrant in Patients With HER2+/HR+ Advanced Breast Cancer (clinicaltrials.gov) - Dec 6, 2023
P2, N=51, Active, not recruiting, Sponsor: Jazz Pharmaceuticals
>Change from BL for each patient is post-BL value minus BL value; negative values for change from BL indicate better outcomes and positive indicate worse. Phase classification: P2a --> P2
- | Ziihera (zanidatamab-hrii) / Jazz
Phase classification, Monotherapy, Metastases: HERIZON-BTC-01: A Study of ZW25 (Zanidatamab) in Subjects With Advanced or Metastatic HER2-Amplified Biliary Tract Cancers (clinicaltrials.gov) - Nov 18, 2023
P2, N=87, Active, not recruiting, Sponsor: Jazz Pharmaceuticals
Phase classification: P2a --> P2 Phase classification: P2b --> P2
- || Ziihera (zanidatamab-hrii) / Jazz
Phase classification, Trial completion date, Trial primary completion date, Combination therapy, Metastases: ZWI-ZW25-204: A Study of Zanidatamab (ZW25) With Evorpacept (ALX148) in Patients With Advanced HER2-expressing Cancer (clinicaltrials.gov) - Nov 18, 2023
P1/2, N=93, Recruiting, Sponsor: Jazz Pharmaceuticals
Phase classification: P2b --> P2 Phase classification: P1b/2 --> P1/2 | Trial completion date: Oct 2024 --> Jan 2025 | Trial primary completion date: Apr 2024 --> Jul 2024
- | Biomarker, Enrollment change: PRE-I-SPY-PI: PRE-I-SPY Phase I/Ib Oncology Platform Program (clinicaltrials.gov) - Nov 18, 2023
P1, N=54, Recruiting, Sponsor: QuantumLeap Healthcare Collaborative
Phase classification: P1b/2 --> P1/2 | Trial completion date: Oct 2024 --> Jan 2025 | Trial primary completion date: Apr 2024 --> Jul 2024 N=40 --> 54
- || zanidatamab (ZW25) / Jazz, Enhertu (fam-trastuzumab deruxtecan-nxki) / Daiichi Sankyo, AstraZeneca, Margenza (margetuximab) / MacroGenics, ZAI Lab
Review, Journal: Human Epidermal Growth Factor Receptor-2 Gastric Adenocarcinoma: Expanding Therapy of a Recognized Target. (Pubmed Central) - Nov 14, 2023
Trastuzumab deruxtecan, an antibody drug conjugate of trastuzumab with a topoisomerase inhibitor, was recently approved for the treatment of refractory HER2-positive advanced GAC patients...Here we review the current status of HER2-targeted therapy in GACs. We additionally review newer therapies under investigation and their potential role in HER2 GACs.
- zanidatamab (ZW25) / Jazz
Neoadjuvant zanidatamab for stage I node negative HER2 positive breast cancer (Stars at Night Ballroom 1-2) - Nov 4, 2023 - Abstract #SABCS2023SABCS_351;
Neoadjuvant zanidatamab demonstrates significant preliminary efficacy, (pCR/RCB-1 64%) with a good safety profile in patients with stage I node negative HER2+ BC. An update of efficacy and safety of all patients will be presented at the time of meeting
- Ibrance (palbociclib) / Pfizer, zanidatamab (ZW25) / Jazz
Primary results from a phase 2a study of zanidatamab (zani) + palbociclib (palbo) + fulvestrant (fulv) in HER2+/HR+ metastatic breast cancer (mBC) (Stars at Night Ballroom 1-2) - Nov 4, 2023 - Abstract #SABCS2023SABCS_282;
P2a
The safety profile was manageable. These results support further development of a novel chemotherapy-free treatment regimen for heavily pretreated pts with HER2+/HR+ mBC.
- | Ziihera (zanidatamab-hrii) / Jazz
Enrollment closed: A Phase 2 Single-Arm Open-Label Pilot Trial Evaluating Zanidatamab (ZW25) in Patients With Early Stage HER2/Neu Positive (HER2+) Breast Cancer (BC) (clinicaltrials.gov) - Oct 30, 2023
P2, N=20, Active, not recruiting, Sponsor: M.D. Anderson Cancer Center
These results support further development of a novel chemotherapy-free treatment regimen for heavily pretreated pts with HER2+/HR+ mBC. Recruiting --> Active, not recruiting
- zanidatamab (ZW25) / Jazz
Zanidatamab (ZW25; Zani) in patients (pts) with previously treated advanced human epidermal growth factor receptor 2 (HER2)-amplified biliary tract cancer (BTC): Asia subgroup analysis of the phase IIb HERIZON-BTC-01 study (Hall 405) - Oct 6, 2023 - Abstract #ESMOAsia2023ESMO_Asia_409;
P2
Lancet Oncol. 2023).