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Also known as Zimberelimab (ZIM), AB122, GS-0122
Zimberelimab · 3 trials · 7 indications
OS is defined as the time from the date of randomization to the date of death from any cause.
Progression free survival (PFS), as determined by RECIST v1.1, is defined as the time from study registration to the date of documented disease progression or death from any cause.
ORR is defined as the proportion of participants achieving a complete response (CR) or partial response (PR) as confirmed at least 4 weeks after the first detection of response.
pCR is defined as the percentage of participants having an absence of residual invasive cancer in resected lung specimens and lymph nodes as assessed by local pathology review.
| Arm | Type | Description |
|---|---|---|
| Zimberelimab (ZIM) +Domvanalimab (DOM) + Chemotherapy | EXPERIMENTAL | Participants will receive ZIM 360 mg + DOM 1200 mg (up to 35 doses) with chemotherapy every 3 weeks (Q3W) on Day 1 of each 21-day cycle. Choice of chemotherapy is dependent on histology. * Participants with nonsquamous histology will receive cisplatin 75 mg/m\^2 or carboplatin area under the concentration versus time curve (AUC)5 + pemetrexed 500 mg/m\^2 Q3W for first 4 cycles. After the completion of the first 4 cycles, participants with nonsquamous histology may continue with maintenance pemetrexed 500 mg/m\^2 Q3W until disease progression or intolerable toxicities. * Participants with squamous histology will receive carboplatin AUC 6 Q3W with paclitaxel 200 mg/m\^2 Q3W or nab-paclitaxel 100 mg/m\^2 weekly (QW) for first 4 cycles. |
| Pembrolizumab (PEMBRO) + Chemotherapy | ACTIVE_COMPARATOR | Participants will receive PEMBRO 200 mg (up to 35 doses) with chemotherapy Q3W on Day 1 of each 21-day cycle. Choice of chemotherapy is dependent on histology. * Participants with nonsquamous histology will receive cisplatin 75 mg/m\^2 or carboplatin AUC 5 + pemetrexed 500 mg/m\^2 Q3W for first 4 cycles. After the completion of the first 4 cycles, participants with nonsquamous histology may continue with maintenance pemetrexed 500 mg/m\^2 Q3W until disease progression or intolerable toxicities. * Participants with squamous histology will receive carboplatin AUC 6 Q3W with paclitaxel 200 mg/m\^2 Q3W or nab-paclitaxel 100 mg/m\^2 weekly (QW) for first 4 cycles. |
| Zimberelimab (ZIM) + Chemotherapy | EXPERIMENTAL | Participants will receive ZIM 360 mg (up to 35 doses) with chemotherapy Q3W on Day 1 of each 21-day cycle. Choice of chemotherapy is dependent on histology. * Participants with nonsquamous histology will receive cisplatin 75 mg/m\^2 or carboplatin AUC 5 + pemetrexed 500 mg/m\^2 Q3W for first 4 cycles After the completion of the first 4 cycles, participants with nonsquamous histology may continue with maintenance pemetrexed 500 mg/m\^2 Q3W until disease progression or intolerable toxicities. * Participants with squamous histology will receive carboplatin AUC 6 Q3W with paclitaxel 200 mg/m\^2 Q3W or nab-paclitaxel 100 mg/m\^2 weekly (QW) for first 4 cycles. |
| Arm A | EXPERIMENTAL | Quemliclustat (AB680), zimberelimab (AB122), gemcitabine, and cisplatin in subjects with untreated advanced BTC. Quemliclustat IV: Day 1, 15, and 29 of each cycle; Zimberelimab IV: Day 1 and 22 of each cycle; Gemcitabine IV: Day 1, 8, 22 and 29 of each cycle; Cisplatin IV: Day 1, 8, 22 and 29 of Cycles 1-4 only. |
| Substudy 01: Zimberelimab (ZIM) + Sacituzumab govitecan-hziy (SG) + Domvanalimab (DOM) | EXPERIMENTAL | Participants will receive ZIM, SG and DOM until disease progression (PD), unacceptable toxicity, or protocol specified discontinuation criteria are met. |
| Substudy 01: ZIM + DOM + Etrumadenant (ETRUMA) | EXPERIMENTAL | Participants will receive ZIM, DOM and ETRUMA until PD, unacceptable toxicity, or protocol specified discontinuation criteria are met. |
| Substudy 01: ZIM + ETRUMA | EXPERIMENTAL | Participants will receive ZIM and ETRUMA until PD, unacceptable toxicity, or protocol specified discontinuation criteria are met. |
| Substudy 01: Zimberelimab (ZIM) + Sacituzumab govitecan-hziy (SG) | EXPERIMENTAL | Participants will receive ZIM and SG until disease progression (PD), unacceptable toxicity, or protocol specified discontinuation criteria are met. |
| Substudy 01: ZIM + Platinum Based Chemotherapy | ACTIVE_COMPARATOR | Expansion Stage Only: Participants will receive ZIM plus any one of the chemotherapy (choice of chemotherapy is dependent on histology). Platinum Based Chemotherapy will be cisplatin or carboplatin and pemetrexed (non-squamous histology) or carboplatin, paclitaxel and nabpaclitaxel (squamous histology). |
| Substudy 02: SG + ZIM + ETRUMA | EXPERIMENTAL | Participants will receive SG, ZIM and ETRUMA until PD, unacceptable toxicity, or protocol specified discontinuation criteria are met. |
| Substudy 02: Either Docetaxel or SG (Monotherapy Only) | ACTIVE_COMPARATOR | Participants will receive either Docetaxel or SG until PD, unacceptable toxicity, or protocol specified discontinuation criteria are met. |
| Substudy 03 - ZIM + DOM + Platinum-based Chemotherapy | EXPERIMENTAL | Participants will receive ZIM plus DOM and any one of the chemotherapy (choice of chemotherapy is dependent on histology). Platinum Based Chemotherapy will be carboplatin and pemetrexed (non-squamous histology) or carboplatin and paclitaxel (squamous histology). |
| Substudy 03 - ZIM + Platinum-based Chemotherapy | EXPERIMENTAL | Participants will receive ZIM plus any one of the chemotherapy (choice of chemotherapy is dependent on histology). Platinum Based Chemotherapy will be carboplatin and pemetrexed (non-squamous histology) or carboplatin and paclitaxel (squamous histology). |
| Substudy 03: Nivolumab + Platinum-based Chemotherapy | ACTIVE_COMPARATOR | Participants will receive nivolumab plus any one of the chemotherapy (choice of chemotherapy is dependent on histology). Platinum Based Chemotherapy will be carboplatin and pemetrexed (non-squamous histology) or carboplatin and paclitaxel (squamous histology). |
| Name | Type | Description |
|---|---|---|
| Zimberelimab | DRUG | Administered intravenously |
| Domvanalimab | DRUG | Administered intravenously |
| Pembrolizumab | DRUG | Administered intravenously |
| Carboplatin | DRUG | Administered intravenously |
| Cisplatin | DRUG | Administered intravenously |
| Paclitaxel | DRUG | Administered intravenously |
| Nab-paclitaxel | DRUG | Administered intravenously |
| Pemetrexed | DRUG | Administered intravenously |
| Gemcitabine | DRUG | Gemcitabine IV: Day 1, 8, 22, and 29 every 42 days |
| Quemliclustat | DRUG | Quemliclustat IV: Day 1, 15, 29 every 42 days |
| Zimberelimab (ZIM) | DRUG | Administered intravenously |
| Domvanalimab (DOM) | DRUG | Administered intravenously |
| Sacituzumab govitecan-hziy (SG) | DRUG | Administered intravenously |
| Etrumadenant (ETRUMA) | DRUG | Administered orally |
| Docetaxel | DRUG | Administered intravenously |
| Nivolumab | DRUG | Administered intravenously |
Key Inclusion Criteria: * Life expectancy ≥ 3 months. * Pathologically documented NSCLC that meets both of the criteria below: * Have documented evidence of Stage IV NSCLC disease at the time of enrollment (based on American Joint Committee on Cancer (AJCC), Eighth Edition). * Have documented ...
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Zimberelimab is an investigational monoclonal antibody being studied in oncology for biliary tract carcinoma, cholangiocarcinoma, bile duct cancer, and non-small cell lung cancer. It is being evaluated in Phase 2 and Phase 3 clinical trials, both as a single agent and in combination with other therapies such as domvanalimab and chemotherapy.
Zimberelimab targets PDCD1, also known as PD-1, and functions as an inhibitor. By binding to PDCD1, it is designed to block a checkpoint pathway that cancer cells use to suppress immune responses, thereby aiming to restore T-cell activity against tumor cells.
Zimberelimab is being developed by Gilead Sciences, Inc., which trades on the Nasdaq under the ticker GILD. The company is sponsoring clinical trials of zimberelimab in multiple cancer types, including biliary tract cancers and non-small cell lung cancer.
Zimberelimab is in Phase 2 and Phase 3 clinical development. It is investigational and has not been approved by the FDA. The Phase 3 trial NCT05502237 is evaluating zimberelimab and domvanalimab with chemotherapy versus pembrolizumab with chemotherapy in untreated metastatic non-small cell lung cancer.
Zimberelimab is being studied in three registered clinical trials. NCT06048133 is a Phase 2 study in advanced biliary tract cancers. NCT05633667 is a Phase 2 study in lung cancer. NCT05502237 is a Phase 3 study in untreated metastatic non-small cell lung cancer. All three trials are active but not recruiting.
Yes, Zimberelimab is also known as ZIM. ZIM is an abbreviation for zimberelimab used in some study titles and publications. Both names refer to the same investigational monoclonal antibody targeting PDCD1 being developed by Gilead Sciences.