- |||||||||| Yutuo (zimberelimab) / Arcus Biosci, Gilead, domvanalimab (AB154) / Arcus Biosci, Gilead, Keytruda (pembrolizumab) / Merck (MSD)
P3 data, Journal, Combination therapy, PD(L)-1 Biomarker, IO biomarker, Metastases: STAR-121: A Phase III Randomized Study of Domvanalimab and Zimberelimab in Combination With Chemotherapy Versus Pembrolizumab With Chemotherapy in Untreated Metastatic Non-Small Cell Lung Cancer With No Actionable Gene Alterations. (Pubmed Central) - May 16, 2024
P3
Enrollment in the STAR-121 study commenced on October 12, 2022, and is currently ongoing with completion planned by September 2024. The study completion is expected by December 2027.
- |||||||||| Yutuo (zimberelimab) / Arcus Biosci, Gilead, domvanalimab (AB154) / Arcus Biosci, Gilead
Trial completion date, Combination therapy: AB154 Combined With AB122 for Recurrent Glioblastoma (clinicaltrials.gov) - Apr 12, 2024
P1, N=46, Recruiting,
The study is currently recruiting. Trial completion date: Dec 2025 --> Feb 2025
- |||||||||| Yutuo (zimberelimab) / Arcus Biosci, Gilead, etrumadenant (AB928) / Arcus Biosci, Gilead, domvanalimab (AB154) / Arcus Biosci, Gilead
Enrollment closed, Combination therapy: Safety and Efficacy of Zimberelimab (AB122) in Combination With Domvanalimab (AB154) and Etrumadenant (AB928) in Patients With Previously Treated Non-Small Cell Lung Cancer (clinicaltrials.gov) - Apr 8, 2024
P2, N=30, Active, not recruiting,
Trial completion date: Dec 2025 --> Feb 2025 Recruiting --> Active, not recruiting
- |||||||||| Yutuo (zimberelimab) / Arcus Biosci, Gilead, domvanalimab (AB154) / Arcus Biosci, Gilead
Trial completion date, Trial primary completion date, Combination therapy, Metastases: STAR-121: Zimberelimab and Domvanalimab in Combination With Chemotherapy Versus Pembrolizumab With Chemotherapy in Patients With Untreated Metastatic Non-Small Cell Lung Cancer (clinicaltrials.gov) - Apr 8, 2024
P3, N=720, Recruiting,
Recruiting --> Active, not recruiting Trial completion date: Dec 2027 --> Sep 2027 | Trial primary completion date: Dec 2027 --> Sep 2027
- |||||||||| Yutuo (zimberelimab) / Arcus Biosci, Gilead, domvanalimab (AB154) / Arcus Biosci, Gilead
Enrollment closed, Enrollment change, Metastases: Study Comparing the Combination Domvanalimab and Zimberelimab With Pembrolizumab in Untreated Locally Advanced or Metastatic PD-L1-High Non-Small Cell Lung Cancer (clinicaltrials.gov) - Mar 15, 2024
P3, N=169, Active, not recruiting,
Trial completion date: Jan 2028 --> Jan 2027 Recruiting --> Active, not recruiting | N=750 --> 169
- |||||||||| domvanalimab (AB154) / Arcus Biosci, Gilead
Trial completion date, Trial primary completion date, Combination therapy, Monotherapy, Metastases: A Study to Evaluate the Safety and Tolerability of AB154 in Participants With Advanced Malignancies (clinicaltrials.gov) - Mar 2, 2024
P1, N=75, Active, not recruiting,
Recruiting --> Active, not recruiting | N=750 --> 169 Trial completion date: Feb 2024 --> Nov 2024 | Trial primary completion date: Feb 2024 --> Nov 2024
- |||||||||| Yutuo (zimberelimab) / Arcus Biosci, Gilead, domvanalimab (AB154) / Arcus Biosci, Gilead
Trial primary completion date, Pan tumor, Metastases: Domvanalimab and Zimberelimab in Advanced Liver Cancers (clinicaltrials.gov) - Jan 16, 2024
P2, N=58, Recruiting,
Trial completion date: Sep 2029 --> Aug 2030 | Trial primary completion date: Jun 2027 --> Jun 2028 Trial primary completion date: Jul 2025 --> Jul 2026
- |||||||||| Yutuo (zimberelimab) / Arcus Biosci, Otsuka, Gilead, domvanalimab (AB154) / Arcus Biosci, Gilead, Otsuka, Trodelvy (sacituzumab govitecan-hziy) / Everest Medicines, Gilead
Trial completion date, Trial initiation date, Trial primary completion date, Combination therapy: PeRioperative Immunotherapy Combined With Sacituzumab Govitecan in Muscle Invasive blAdder Cancer (clinicaltrials.gov) - Dec 31, 2023
P2, N=70, Not yet recruiting,
- |||||||||| Yutuo (zimberelimab) / Arcus Biosci, Gilead, domvanalimab (AB154) / Arcus Biosci, Gilead
Trial completion date, Trial primary completion date, Surgery, Metastases: STAR-221: A Clinical Trial of a New Combination Treatment, Domvanalimab and Zimberelimab, Plus Chemotherapy, for People With an Upper Gastrointestinal Tract Cancer That Cannot be Removed With Surgery That Has Spread to Other Parts of the Body (clinicaltrials.gov) - Dec 15, 2023
P3, N=970, Recruiting,
- |||||||||| Yutuo (zimberelimab) / Arcus Biosci, Otsuka, Gilead, domvanalimab (AB154) / Arcus Biosci, Gilead, Otsuka, Trodelvy (sacituzumab govitecan-hziy) / Everest Medicines, Gilead
New P2 trial, Combination therapy: PeRioperative Immunotherapy Combined With Sacituzumab Govitecan in Muscle Invasive blAdder Cancer (clinicaltrials.gov) - Nov 15, 2023
P2, N=70, Not yet recruiting,
- |||||||||| Yutuo (zimberelimab) / Arcus Biosci, Gilead, etrumadenant (AB928) / Arcus Biosci, Gilead, domvanalimab (AB154) / Arcus Biosci, Gilead
Trial completion date, Trial primary completion date, Combination therapy, Monotherapy: ARC-7: Study to Evaluate Monotherapy and Combination Immunotherapies in Participants With PD-L1 Positive Non-small Cell Lung Cancer (clinicaltrials.gov) - Nov 3, 2023
P2, N=151, Active, not recruiting,
NCT05329766 Trial completion date: Feb 2024 --> Feb 2025 | Trial primary completion date: Feb 2024 --> Feb 2025
- |||||||||| ralzapastotug (AB308) / Arcus Biosci, Gilead, Otsuka
Fc-silent anti-TIGIT antibodies potentiate anti-tumor immunity without depleting regulatory T cells (Exhibit Hall B) - Sep 27, 2023 - Abstract #SITC2023SITC_831;
P1
Anecdotal clinical outcomes in two patients from NCT03628677 receiving domvanalimab in combination with an anti-PD-1 antibody, zimberelimab, are also reported...Conclusions We demonstrate that Fc-silent anti-TIGIT antibodies potentiate activation of tumor-specific T cells and anti-tumor efficacy without depleting Treg (figure 1). These data provide critical insights related to activity of anti-TIGIT antibodies lacking Fc functionality, such as domvanalimab.
- |||||||||| zimberelimab (AB122) / Arcus Biosci, Otsuka, Gilead, etrumadenant (AB928) / Arcus Biosci, Otsuka, Gilead, domvanalimab (AB154) / Arcus Biosci, Gilead, Otsuka
Clinical, Metastases: ICYMI: The TIGIT inhibitor domvanalimab & the A2R antagonist etrumadenant enhances the clinical activity of the PD-1 inhibitor zimberelimab when administered as triplet therapy in pts w/ PD-L1–high, metastatic NSCLC. @MLJohnsonMD2 @SarahCannonDocs #lcsm https://t.co/z5dxHeQf1S (Twitter) - Jul 28, 2023
- |||||||||| zimberelimab (AB122) / Arcus Biosci, Otsuka, Gilead, domvanalimab (AB154) / Arcus Biosci, Gilead, Otsuka, quemliclustat (AB680) / Arcus Biosci, Gilead
EDGE-Lung: A Phase 2 Open-Label Platform Study to Evaluate Immunotherapy-Based Combinations in Patients with Metastatic NSCLC (Exhibit Hall) - Jul 25, 2023 - Abstract #IASLCWCLC2023IASLC_WCLC_2259;
P2
Zimberelimab (zim) is a mAb that binds PD-1 on T/NK cells, preventing PD-L1-mediated immunosuppressive effects and resulting in increased immune-mediated tumor cell death...In substudy C, patients with metastatic NSCLC who have progressed after prior platinum-based chemotherapy and anti-PD-L1 therapy will receive docetaxel (75 mg/m2 IV Q3W) in combination with either quemli (300 mg IV Q3W) or dom (1200 mg IV Q3W) in combination with zim (360 mg IV Q3W)...Other endpoints include disease control rate, progression-free survival, duration of response, overall survival, and pharmacokinetics. EDGE-Lung is currently enrolling patients in Asia-Pacific, Europe, and North America.
- |||||||||| Keytruda (pembrolizumab) / Merck (MSD)
STAR-121: Phase 3 Study of DOM and ZIM plus Chemo vs Pembro plus Chemo in 1L mNSCLC with No Actionable Gene Alterations (Exhibit Hall) - Jul 25, 2023 - Abstract #IASLCWCLC2023IASLC_WCLC_2254;
Zimberelimab (ZIM) is an anti-PD-1 IgG4 monoclonal antibody with demonstrated antitumor activity in vivo and preliminary clinical activity in multiple tumor types...PT will be chosen by investigators based on tumor histology and administered for the first 4 cycles, after which, pemetrexed can be continued for patients with nonsquamous histology until PD or intolerable toxicities...Key secondary endpoints are ORR and duration of response by BICR, safety, and quality of life. As of April 10, 2023, the study has 239 planned sites and is currently enrolling globally in North America, South America, Europe, and Asia.
- |||||||||| zimberelimab (AB122) / Arcus Biosci, Otsuka, Gilead, domvanalimab (AB154) / Arcus Biosci, Gilead, Otsuka, Opdivo (nivolumab) / Ono Pharma, BMS
Metastases: Check out Dr. Samuel Klempner @KlempnerSam @MGHMedicine discussing #ASCO23 STAR-221 Phase 3 Trial - Domvanalimab, Zimberelimab, & Chemo vs. Nivo & Chemo in Previously Untreated, Locally Advanced, Unresectable or Metastatic GC/GEJC/EC #gicsm #gastriccancer https://t.co/m4MJfNFJlk (Twitter) - Jun 16, 2023
- |||||||||| Yutuo (zimberelimab) / Arcus Biosci, Gilead, domvanalimab (AB154) / Arcus Biosci, Gilead
Enrollment open, Pan tumor, Metastases: Domvanalimab and Zimberelimab in Advanced Liver Cancers (clinicaltrials.gov) - Jun 6, 2023
P2, N=58, Recruiting,
As of April 10, 2023, the study has 239 planned sites and is currently enrolling globally in North America, South America, Europe, and Asia. Not yet recruiting --> Recruiting
- |||||||||| zimberelimab (AB122) / Arcus Biosci, Otsuka, Gilead, domvanalimab (AB154) / Arcus Biosci, Gilead, Otsuka, Keytruda (pembrolizumab) / Merck (MSD)
ARC-10: A phase 3 study to evaluate zimberelimab + domvanalimab versus pembrolizumab in front-line, PD-L1-high, locally advanced or metastatic non (On Demand | Hall A; Poster Bd # 131b) - Apr 26, 2023 - Abstract #ASCO2023ASCO_3556;
P3
Study recruitment is planned in Asia, North and South America, Africa, and Europe. Clinical trial information: NCT04736173.
- |||||||||| zimberelimab (AB122) / Arcus Biosci, Otsuka, Gilead, domvanalimab (AB154) / Arcus Biosci, Gilead, Otsuka, Opdivo (nivolumab) / Ono Pharma, BMS
STAR-221: A randomized, open-label, multicenter, phase 3 trial of domvanalimab, zimberelimab, and chemotherapy versus nivolumab and chemotherapy in previously untreated, locally advanced, unresectable or metastatic gastric, gastroesophageal junction, and esophageal adenocarcinoma. (On Demand | Hall A; Poster Bd # 509b) - Apr 26, 2023 - Abstract #ASCO2023ASCO_1330;
P3
STAR-221 is currently enrolling globally. Clinical trial information: NCT05568095.
- |||||||||| domvanalimab (AB154) / Arcus Biosci, Gilead
Trial completion date, Trial primary completion date, Combination therapy, Monotherapy, Metastases: A Study to Evaluate the Safety and Tolerability of AB154 in Participants With Advanced Malignancies (clinicaltrials.gov) - Apr 20, 2023
P1, N=75, Active, not recruiting,
Clinical trial information: NCT05568095. Trial completion date: Aug 2023 --> Feb 2024 | Trial primary completion date: Aug 2023 --> Feb 2024
- |||||||||| domvanalimab (AB154) / Arcus Biosci, Gilead
Trial completion date, Trial primary completion date, Combination therapy, Monotherapy, Metastases: A Study to Evaluate the Safety and Tolerability of AB154 in Participants With Advanced Malignancies (clinicaltrials.gov) - Mar 7, 2023
P1, N=75, Active, not recruiting,
Trial completion date: Jun 2026 --> Jul 2027 | Trial primary completion date: Dec 2025 --> Aug 2024 Trial completion date: Feb 2023 --> Aug 2023 | Trial primary completion date: Feb 2023 --> Aug 2023
- |||||||||| Yutuo (zimberelimab) / Arcus Biosci, Gilead, domvanalimab (AB154) / Arcus Biosci, Gilead, quemliclustat (AB680) / Arcus Biosci, Gilead
Enrollment change, Trial completion date, Trial primary completion date, Combination therapy, IO biomarker, Metastases: EDGE-Gastric: A Safety and Efficacy Study of Treatment Combinations With and Without Chemotherapy in Adult Participants With Advanced Upper Gastrointestinal Tract Malignancies (clinicaltrials.gov) - Jan 23, 2023
P2, N=200, Recruiting,
Trial completion date: Feb 2023 --> Aug 2023 | Trial primary completion date: Feb 2023 --> Aug 2023 N=120 --> 200 | Trial completion date: May 2024 --> Nov 2025 | Trial primary completion date: Mar 2024 --> Sep 2025
- |||||||||| Yutuo (zimberelimab) / Arcus Biosci, Gilead, domvanalimab (AB154) / Arcus Biosci, Gilead, sotigalimab (PYX-107) / Pyxis Oncology
Enrollment open, Metastases: Switch Maintenance in Pancreatic (clinicaltrials.gov) - Jan 11, 2023
P1/2, N=46, Recruiting,
N=120 --> 200 | Trial completion date: May 2024 --> Nov 2025 | Trial primary completion date: Mar 2024 --> Sep 2025 Not yet recruiting --> Recruiting
- |||||||||| zimberelimab (AB122) / Arcus Biosci, Otsuka, Gilead, domvanalimab (AB154) / Arcus Biosci, Gilead, Otsuka, Trodelvy (sacituzumab govitecan-hziy) / Everest Medicines, Gilead
TROPHY-U-01 cohort 6: Sacituzumab govitecan (SG), SG plus zimberelimab (ZIM), SG plus ZIM plus domvanalimab (DOM), or carboplatin (CARBO) + gemcitabine (GEM) in cisplatin-ineligible patients (pts) with treatment-naive metastatic urothelial cancer (mUC). (On Demand | Level 1, West Hall; Poster Board No. P15) - Jan 10, 2023 - Abstract #ASCOGU2023ASCO_GU_686;
P2
of 0.05 to demonstrate an improvement in ORR, with a null hypothesis of ORR 40% for Arms 2-3 and an alternative hypothesis of ORR at 65% for Arms 2-4. Clinical trial information: NCT03547973.
- |||||||||| zimberelimab (AB122) / Arcus Biosci, Otsuka, Gilead, etrumadenant (AB928) / Arcus Biosci, Otsuka, Gilead, domvanalimab (AB154) / Arcus Biosci, Gilead, Otsuka
Clinical, Metastases: Results from the phase 2 ARC-7 trial found that zimberelimab, etrumadenant, and domvanalimab enhanced efficacy outcomes in patients with advanced non–small cell lung cancer. #NSCLC | @MLJohnsonMD2 https://t.co/KTabgSGZGr (Twitter) - Dec 28, 2022
- |||||||||| Yutuo (zimberelimab) / Arcus Biosci, Gilead, domvanalimab (AB154) / Arcus Biosci, Gilead
Trial completion date, Trial primary completion date, Combination therapy: AB154 Combined With AB122 for Recurrent Glioblastoma (clinicaltrials.gov) - Dec 22, 2022
P1, N=46, Recruiting,
Clinical trial information: NCT03547973. Trial completion date: Jul 2023 --> Dec 2025 | Trial primary completion date: Dec 2022 --> Feb 2025
- |||||||||| zimberelimab (AB122) / Arcus Biosci, Otsuka, Gilead, etrumadenant (AB928) / Arcus Biosci, Otsuka, Gilead, domvanalimab (AB154) / Arcus Biosci, Gilead, Otsuka
Clinical: Patients with PDL1 high NSCLC (EGFR/ALK wild type) randomized to zimberelimab (PD-1) alone, zim + domvanalimab (TIGIT), or zim + dom + etrumadenant (A2R). Co-primary endpoints of RR and PFS. About 50 pts per arm. (Twitter) - Dec 20, 2022
- |||||||||| zimberelimab (AB122) / Arcus Biosci, Otsuka, Gilead, etrumadenant (AB928) / Arcus Biosci, Otsuka, Gilead, domvanalimab (AB154) / Arcus Biosci, Gilead, Otsuka
ARC-7: Randomized phase 2 study of domvanalimab + zimberelimab ± etrumadenant versus zimberelimab in first-line, metastatic, PD-L1-high non-small cell lung cancer (NSCLC). (Live Stream) - Dec 12, 2022 - Abstract #ASCOPlenaryDec2022ASCO Plenary Dec_3;
P2
Trial completion date: Jul 2023 --> Dec 2025 | Trial primary completion date: Dec 2022 --> Feb 2025 NCT04262856
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