Drugs / Zalifrelimab
Trials 13
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 12 trials | ||||||
| Phase 1 | NCT05375903 | Jun 2022 → Jan 2026 | bladder carcinoma in situ | UroGen Pharma Ltd. | Completed | No outcome recorded |
| Phase 1 | NCT04943848 | Jan 2022 → Sep 2026 overdue | diffuse midline glioma, H3 K27M-mutant | Ann & Robert H Lurie Children's Hospital of Chicago | Recruiting | No outcome recorded |
| Phase 1/24 trials | ||||||
| Phase 1/2 | NCT06782555 | Jan 2025 → Oct 2027 expected | head and neck squamous cell carcinoma, malignant pancreatic neoplasm, metastatic prostate carcinoma | ImmunoGenesis | Recruiting | No outcome recorded |
| Phase 1/2 | NCT04827953 | Sep 2021 → Apr 2025 overdue | pancreatic ductal adenocarcinoma | Nelum Corp | Active not recruiting | No outcome recorded |
| Phase 1/2 | NCT03495882 | Dec 2017 → Jul 2022 | cervical cancer | Agenus Inc. | Completed | No outcome recorded |
| Phase 1/2 | NCT02694822 | Apr 2016 → Mar 2022 | high grade malignant neoplasm, refractory malignant neoplasm | Agenus Inc. | Completed | No outcome recorded |
| Phase 26 trials | ||||||
| Phase 2 | NCT05033132 | Oct 2021 → Dec 2024 | cervical cancer | Agenus Inc. | Withdrawn | No outcome recorded |
| Phase 2 | NCT04607200 | Feb → Sep 2021 | angiosarcoma | Agenus Inc. | Withdrawn | No outcome recorded Stop: Business |
| Phase 2 | NCT04430036 | Oct 2020 → Oct 2021 | urinary bladder cancer | The University of Texas Health Science Center at San Antonio | Terminated | No outcome recorded |
| Phase 2 | NCT04028063 | Jan 2020 → Apr 2027 expected | soft tissue sarcoma | University of Colorado, Denver | Active not recruiting | No outcome recorded |
| Phase 2 | NCT03894215 | Jun 2019 → Mar 2025 | cervical cancer | Agenus Inc. | Terminated | No outcome recorded Stop: Business |
| Phase 2 | NCT03411473 | Oct 2017 → May 2018 | non-small cell lung carcinoma | Agenus Inc. | Terminated | No outcome recorded |
| Phase not stated1 trial | ||||||
| — | NCT05572970 | — | cancer | Agenus Inc. | Available | No outcome recorded |
News releases announcing trial results or a regulatory action · 29
| Date | Issuer | Release |
|---|---|---|
| 2025-04-26 | UroGen Pharma Ltd. | Results UroGen Pharma Announces Encouraging Results from a Phase 1 Dose-Escalation Study Evaluating UGN-301 in Non-Muscle Invasive Bladder Cancer urogen.com ↗
No dose-limiting toxicities and no treatment-emergent adverse events leading to treatment discontinuation were observed. |
| 2022-03-29 | UroGen Pharma Ltd. | Regulatory UroGen Announces FDA Clearance of IND Application for the Investigational Immunotherapy UGN-301 (zalifrelimab) Intravesical Solution in Recurrent Non-Muscle Invasive Bladder Cancer urogen.com ↗
UroGen Pharma Ltd. (Nasdaq: URGN), a biotech company dedicated to developing and commercializing innovative solutions that treat urothelial and specialty cancers, today announced that the U.S. Food and Drug Administration (FDA) has cleared UroGen’s Investigational New Drug (IND) application to begin a novel Phase 1 clinical study of the anti-CTLA-4 immunotherapy UGN-301 (zalifrelimab) in patients with recurrent NMIBC. |
| 2022-03-01 | UroGen Pharma Ltd. | Regulatory UroGen Submits Investigational New Drug Application Supporting Planned Phase 1 Clinical Study of UGN-301 (zalifrelimab) Intravesical Solution in Recurrent Non-Muscle Invasive Bladder Cancer urogen.com ↗
UroGen Pharma Ltd. (Nasdaq: URGN), a biotech company dedicated to developing and commercializing innovative solutions that treat urothelial and specialty cancers, today announced the submission of an Investigational New Drug application (IND) for UGN-301 (zalifrelimab) to the U.S. Food and Drug Administration (FDA) in support of the planned initiation of a multi-arm, Phase I clinical study for its anti-CTLA4 antibody. |
| 2021-12-22 | Agenus Inc. | Results Balstilimab Plus Zalifrelimab Data Published in Journal of Clinical Oncology (JCO) agenusbio.com ↗
The trial showed that in the 125 evaluable patients treated with Bal/Zal, ORR was 25.6%; among PD-L1+ patients, the ORR was 32.8%. |
| 2021-09-16 | Agenus Inc. | Results Combination of Balstilimab Plus Zalifrelimab Doubles Responses in 2L Cervical Cancer in Data to Be Presented at ESMO agenusbio.com ↗
With a median follow-up of almost 2 years, the Bal/Zal combination showed high response rates, durable clinical activity, and promising overall survival results |
| 2021-07-30 | Betta Pharmaceuticals Co., Ltd. | Regulatory 贝达药业CTLA-4抗体联合PD-1抗体治疗晚期宫颈癌获批开展临床试验 bettapharma.com ↗
治疗晚期宫颈癌的临床试验已获得国家药品监督管理局批准开展。 |
| 2021-07-15 | Betta Pharmaceuticals Co., Ltd. | Regulatory 贝达药业PD-1 抗体和CTLA-4 抗体联用治疗晚期实体瘤获批开展临床试验 bettapharma.com ↗
7月15日，贝达药业收到国家药品监督管理局签发的《药品临床试验批准通知书》 （通知书编号：2021LP01044、2021LP01052），由公 司和 Agenus Inc. (以下简称“Agenus”)共同申报的巴替利单抗注射液 (Balstilimab，PD-1 抗体)和泽弗利单抗注射液(Zalifrelimab，CTLA-4 抗体)联用治疗晚期实体瘤的两项药品临床试验已获得国家药品监督管理局批准开展。 |
| 2021-06-10 | Betta Pharmaceuticals Co., Ltd. | Regulatory 贝达药业巴替利单抗（PD-1抗体）注射液获批开展临床试验 bettapharma.com ↗
巴替利单抗注射液（Balstilimab，PD-1抗体）单独或联合泽弗利单抗注射液（Zalifrelimab，CTLA-4抗体）治疗晚期宫颈癌的临床试验已获得国家药品监督管理局批准。 |
| 2021-05-20 | Betta Pharmaceuticals Co., Ltd. | Regulatory 贝达药业CTLA-4抗体联合PD-1抗体治疗晚期宫颈癌药品临床试验申请获受理 bettapharma.com ↗
由公司和Agenus Inc.（以下简称“Agenus”）共同申报的泽弗利单抗注射液（Zalifrelimab，CTLA-4抗体）联合巴替利单抗注射液（Balstilimab，PD-1抗体）治疗晚期宫颈癌的药品临床试验申请已获得国家药品监督管理局受理。 |
| 2021-04-28 | Betta Pharmaceuticals Co., Ltd. | Regulatory 贝达药业PD-1抗体和CTLA-4抗体联用药品临床试验申请获受理 bettapharma.com ↗
由公司和 Agenus Inc. (以下简称“Agenus”)共同申报的巴替利单抗注射液 (Balstilimab，PD-1 抗体)和泽弗利单抗注射液(Zalifrelimab，CTLA-4 抗体)联用治疗晚期实体瘤的两项药品临床试验申请已获得国家药品监督管理局受理。 |
| 2020-11-09 | Agenus Inc. | Results Agenus Presents Additional Clinical Responses and Novel Biomarker Data at SITC2020 agenusbio.com ↗
Zalifrelimab (anti-CTLA-4) : 1 CR, 2 PRs, and 52% benefit in PD-1 refractory tumors |
| 2020-10-22 | Recepta Biopharma | Results Imunoterápicos Recepta / Agenus: opções promissoras para o tratamento de câncer uterino. receptabio.com.br ↗
Os resultados de dois ensaios de fase II independentes indicaram que o balstilimabe (AGEN2034, inibidor PD-1) em monoterapia ou em combinação com o zalifrelimabe (AGEN1884, inibidor CTLA-4) demonstrou taxas de resposta objetiva (TRO) promissoras, independentemente da expressão de PD-L1, e um perfil de segurança tolerável nesse perfil de pacientes. |
| 2020-09-18 | Betta Pharmaceuticals Co., Ltd. | Results 贝达药业携手Agenus守护宫颈癌患者：PD-1+CTLA-4联合治疗宫颈癌获最优数据 bettapharma.com ↗
155例balstilimab (PD-1)+zalifrelimab(CTLA-4)的患者联合治疗的缓解率达到所有患者中22%,PD-L1阳性患者中27%。 |
| 2020-09-18 | Agenus Inc. | Results Agenus Presents Results from Two Large Cervical Cancer Trials at ESMO agenusbio.com ↗
Furthermore, we have also shown important expansion in response rates, to near doubling in PD-L1 positive patients, and durability of response when patients receive zalifrelimab in combination with balstilimab. |
| 2020-08-06 | Agenus Inc. | Results Agenus Provides R&D Update & Second Quarter Financial Report agenusbio.com ↗
Zalifrelimab achieves responses in PD-1 failures (1CR, 3PRs) |
| 2020-05-07 | Agenus Inc. | Results Agenus First Quarter Results and Update agenusbio.com ↗
Balstilimab + Zalifrelimab (anti-CTLA-4) achieve 26% response rates in a cohort of 55 patients with advanced cervical cancer |
| 2020-04-07 | Agenus Inc. | Regulatory Agenus Receives Fast Track Designation for Balstilimab in Advanced Cervical Cancer agenusbio.com ↗ |
| 2020-03-21 | Recepta Biopharma | Results Balstilimab e zalifrelimab são promissores para o tratamento de câncer de colo do útero. receptabio.com.br ↗
Agenus announced early data supporting its two lead immunotherapy candidates — balstilimab and zalifrelimab — for the second-line treatment of advanced cervical cancer that responded poorly to platinum chemotherapy. |
| 2020-03-12 | Agenus Inc. | Results Agenus Reports Fourth Quarter and Full Year 2019 Financial Results and Provides Corporate Update agenusbio.com ↗
Updated data of balstilimab & zalifrelimab show 26.5% objective response rates which are durable in an all-comer, non-biomarker selected population of patients with refractory cervical cancer |
| 2020-03-12 | Agenus Inc. | Regulatory Agenus Receives Fast Track Designation for Balstilimab & Zalifrelimab in Advanced Cervical Cancer agenusbio.com ↗
today announced that the U.S. Food and Drug Administration (FDA) has granted Agenus Fast Track designation for investigation of balstilimab [PD-1] in combination with zalifrelimab [CTLA-4] for the treatment of patients with relapsed or refractory metastatic cervical cancer. |
| 2020-02-20 | Agenus Inc. | Results Agenus Announces Positive Interim Data from Balstilimab and Zalifrelimab Clinical Trials in Second-Line Cervical Cancer agenusbio.com ↗
The interim analysis from 34 evaluable patients treated with the combination of balstilimab (anti-PD-1) and zalifrelimab (anti-CTLA-4) demonstrated a 20.6% overall response rate (ORR), which included a complete response (CR) rate of 8.8% in second-line cervical cancer. |
| 2018-10-20 | Agenus Inc. | Results Agenus Presents Clinical Data on Its PD-1 & CTLA-4 at ESMO 2018 agenusbio.com ↗
Data from combination AGEN2034 plus AGEN1884 show similar trends; early clinical benefit observed in 7 of 16 evaluable patients with ovarian, breast, and soft tissue sarcoma, including a durable response in a patient with ovarian cancer. |
| 2018-06-04 | Agenus Inc. | Results Agenus Presents Clinical Responses of AGEN1884 (anti-CTLA-4) and AGEN2034 (anti-PD-1) at ASCO 2018 agenusbio.com ↗
Clinical benefit was observed in 31% and 42% of evaluable patients, respectively. |
| 2018-05-17 | Agenus Inc. | Results Agenus to Present Clinical Data on Lead Programs at ASCO 2018 agenusbio.com ↗
AGEN1884 (CTLA-4) and AGEN2034 (PD-1) show objective clinical responses |
| 2017-11-09 | Agenus Inc. | Results Agenus To Present on Lead Antibody Programs AGEN1884 (CTLA-4) and AGEN2034 (PD-1) at SITC 2017 agenusbio.com ↗ |
| 2017-06-05 | Agenus Inc. | Results Agenus' anti-CTLA-4 antibody shows strong safety and tolerability agenusbio.com ↗
A partial response was observed for a patient with angiosarcoma at week 33, with a 92% reduction in tumor volume upon treatment with 0.1 mg/kg of AGEN1884. |
| 2017-03-07 | Agenus Inc. | Results Four Agenus Abstracts Accepted for Presentation at the American Association for Cancer Research (AACR) 2017 Annual Meeting agenusbio.com ↗
Data presentations will highlight how Agenus' clinical-stage CTLA-4 antagonist (AGEN1884) effectively combines with its PD-1 antagonist (AGEN2034) and other antibodies targeting the PD-1/PD-L1 axis to promote superior T cell immune responses compared to monotherapy approaches. |
| 2016-01-21 | Agenus Inc. | Regulatory Agenus Announces Clearance of Investigational New Drug Applications by the FDA for anti-CTLA-4 and anti-GITR Antibodies agenusbio.com ↗
Agenus Inc. (NASDAQ: AGEN), an immuno-oncology company developing checkpoint modulator antibodies and cancer vaccines, announced today that the U.S. Food and Drug Administration (FDA) cleared the company's investigational new drug (IND) application for AGEN1884, an immune checkpoint modulator (CPM) antibody that binds to cytotoxic T-lymphocyte antigen-4 (CTLA-4). |
| 2016-01-21 | Recepta Biopharma | Regulatory FDA autoriza testes clínicos com anticorpo imunoterápico da Agenus-Recepta. receptabio.com.br ↗ |
All press releases naming this drug 35 releases
Evidence & citations 7 cited values
Every value below carries the sentence it was read from. 13 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | zalifrelimab | “UGN-301 (zalifrelimab) administered intravesically as monotherapy and in combination with other agents in patients with recurrent NMIBC.” NCT05375903 ↗ |
| Known as | AGEN1884 | “Expanded Access for Cancer Treatment With Balstilimab (AGEN2034) and Zalifrelimab (AGEN1884)” NCT05572970 ↗ |
| Known as | UGN-301 | “UGN-301 (zalifrelimab) administered intravesically as monotherapy and in combination with other agents in patients with recurrent NMIBC.” NCT05375903 ↗ |
| Action | Inhibit | “An anti-CTLA-4 monoclonal antibody.” NCT02694822 ↗ |
| Modality | Monoclonal antibody | “An anti-CTLA-4 monoclonal antibody.” NCT02694822 ↗ |
| Route | Intravenous | “Participants received zalifrelimab intravenously.” NCT02694822 ↗ |
| Target | CTLA4 | “An anti-CTLA-4 monoclonal antibody.” NCT02694822 ↗ |