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Clinical trials
catalyst calendar across sponsors →Studies where AGEN is the lead sponsor, as filed with ClinicalTrials.gov. Completion dates are the sponsor's own projected windows and are revised as a study runs. Active studies first, then completed and stopped — newest readout first within each.
29 interventional · 2 expanded access · 5 with posted results
Held by 5 tracked-famous managers (MARSHALL WACE, LLP, Man Group plc, RENAISSANCE TECHNOLOGIES LLC, TWO SIGMA INVESTMENTS, LP, SUSQUEHANNA INTERNATIONAL GROUP, LLP) · FINRA short interest 3.0 days to cover (settled 2026-07-31) · government filings 180d: none disclosed
| Study | Phase | Status | Interventions | Conditions | Enrollment | Primary completion | Readout in | Updated |
|---|---|---|---|---|---|---|---|---|
| A Study of Botensilimab (AGEN1181) for the Treatment of Advanced MelanomaNCT05529316Objective Response RateRandomized · Open-label · Treatment | Phase 2 | Active, not recruiting | Drug: Botensilimab, Balstilimab | Advanced Melanoma | 150 | Feb 2028 | ≤ 558 d | 2026-01-16 |
| A Study of Botensilimab and Balstilimab for the Treatment of Colorectal CancerNCT05608044Objective Response RateRandomized · Open-label · Treatment | Phase 2 | Active, not recruiting | Drug: Botensilimab, Balstilimab, Standard of Care | Metastatic Colorectal Cancer | 234 | Sep 2027 | ≤ 406 d | 2025-09-04 |
| Fc-Engineered Anti-CTLA-4 Monoclonal Antibody in Advanced CancerNCT03860272Incidence Of Treatment-emergent Adverse Events (TEAEs)Non-randomized · Open-label · Treatment | Phase 1 | Active, not recruiting | Drug: Botensilimab, Balstilimab | Advanced Cancer, Angiosarcoma, Colorectal Cancer Without Liver Metastases, Endometrial Cancer, Fibrolamellar Carcinoma, Non-small-cell Lung Cancer, Ovarian Cancer, Prostate Cancer | 499 | 2025-01-13actual | — | 2026-03-30 |
| A Study of Botensilimab in Participants With Metastatic Pancreatic CancerNCT05630183Progression-free Survival as Assessed by InvestigatorRandomized · Open-label · Treatment | Phase 2 | Completed | Drug: Botensilimab, Gemcitabine, Nab-paclitaxel | Metastatic Pancreatic Ductal Adenocarcinoma | 81 | 2026-01-05actual | — | 2026-06-11 |
| RaPiDS- A Phase 2 Study of Anti-PD-1 Independently or in Combination With Anti-CTLA-4 in Second-Line Cervical CancerNCT03894215Objective Response RateRandomized · Quadruple-masked · Treatment | Phase 2 | Terminatedsponsor's stated reason: Sponsor strategic decision | Drug: AGEN2034, AGEN1884 | Cervical Cancer | 211 | 2025-03-26actual | — | 2026-03-27 |
| A Phase II Study of Balstilimab Independently or in Combination With Zalifrelimab in Advanced Cervical CancerNCT05033132Objective Response Rate (ORR) Of Balstilimab Monotherapy Per Independent Review Committee (IRC) Assessment Based Upon Response Evaluation Criteria In Solid Tumours (RECIST) 1.1Randomized · Open-label · Treatment | Phase 2 | Withdrawnsponsor's stated reason: Study was never initiated. | Drug: Balstilimab, Balstilimab + Zalifrelimab | Cervical Cancer | 0 | 2024-12-30 | — | 2024-03-28 |
| Study of AGEN1571 in Participants With Advanced Solid TumorsNCT05377528Number Of Participants With Dose-limiting ToxicitiesNon-randomized · Open-label · Treatment | Phase 1 | Completed | Drug: AGEN1571, Balstilimab, Botensilimab | Advanced Solid Tumor | 22 | 2024-12-23actual | — | 2025-04-30 |
| Anti-CD137 and Anti-CTLA-4 Monoclonal Antibody in Patients With Advanced CancerNCT04121676Occurrence of Dose Limiting Toxicity (DLT)Non-randomized · Open-label · Treatment | Phase 1 | Completed | Drug: AGEN2373, Botensilimab | Advanced Cancer | 91 | 2024-02-22actual | — | 2025-01-13 |
| A Study Investigating AGEN1777 in Participants With Advanced Solid TumorsNCT05025085Number of Participants with Dose-Limiting Toxicities (DLT) of AGEN1777 as a Single-Agent and in Combination with a PD-1 inhibitorRandomized · Open-label · Treatment | Phase 1 | Completed | Drug: AGEN1777, a PD-1 inhibitor | Advanced Cancer | 25 | 2023-07-11actual | — | 2025-10-15 |
| A Study of Zalifrelimab and Balstilimab for Treatment of Participants With Metastatic or Locally Advanced Solid Tumors, and Expansion Into Select Solid Tumors (Cervical)NCT03495882results2026-08-11Phase 2: Objective Response Rate (ORR) - Independent Endpoint Review Committee (IERC)Non-randomized · Open-label · TreatmentStudy Protocol ↗ · Statistical Analysis Plan ↗ | Phase 1/2 | Completed | Drug: Zalifrelimab, Balstilimab | Cervical Cancer | 175 | 2022-07-15actual | — | 2026-08-11 |
| A Study of AGEN2034 in Advanced Tumors and Cervical CancerNCT03104699results2025-07-30Phase 1: Number of Participants Experiencing Dose-limiting Toxicities (DLTs) for BalstilimabOpen-label · TreatmentStudy Protocol ↗ · Statistical Analysis Plan ↗ | Phase 1/2 | Completed | Drug: AGEN2034 | Advanced Cancer, Cervical Cancer | 211 | 2022-06-15actual | — | 2025-07-30 |
| AGEN1884, an Anti-CTLA-4 Human Monoclonal Antibody in Participants With Advanced or Refractory Cancer and Who Have Progressed With PD-1/PD-L1 Inhibitor as Their Most Recent TherapyNCT02694822results2025-03-17Phase 1: Number of Participants With Dose-limiting Toxicities (DLTs) of ZalifrelimabOpen-label · TreatmentStudy Protocol ↗ · Statistical Analysis Plan ↗ | Phase 1/2 | Completed | Drug: Zalifrelimab | Advanced Solid Cancers, Advanced Solid Cancers Refractory to PD-1 and PD-L1 Therapies | 89 | 2022-03-30actual | — | 2025-03-17 |
| Balstilimab Versus Investigator Choice Chemotherapy in Patients With Recurrent Cervical Cancer (BRAVA)NCT04943627Overall survival in patients with PD-L1 positive tumors randomized to BAL vs Investigator's Choice chemotherapyRandomized · Open-label · Treatment | Phase 3 | Withdrawnsponsor's stated reason: Strategic Business Decision | Drug: Balstilimab (BAL), Topotecan, Vinorelbine, Gemcitabine, Irinotecan, Pemetrexed | Advanced Cancer, Metastatic Cervical Cancer | 0 | 2021-10-22actual | — | 2022-10-05 |
| AGEN2034 & AGEN1884 in Patients With Recurrent, Inoperable AngiosarcomaNCT04607200Response rate of single-agent AGEN2034 and combination AGEN2034 + AGEN1884Non-randomized · Open-label · Treatment | Phase 2 | Withdrawnsponsor's stated reason: Strategic business decision | Drug: AGEN2034, AGEN1884 | Angiosarcoma | 0 | 2021-09-13actual | — | 2022-01-11 |
| A Study in Subjects With Advanced Solid TumorsNCT04156100Dose Limiting Toxicity (DLT)Non-randomized · Open-label · Treatment | Phase 1 | Terminatedsponsor's stated reason: Strategic business decision. | Drug: AGEN1223, AGEN1223 and balstilimab | Advanced Solid Tumor | 19 | 2021-04-08actual | — | 2022-03-03 |
| Phase 1a Study to Evaluate Immunogenicity of ASV®NCT03673020Incidence of Treatment-Emergence Adverse Events (Safety and Tolerability)Open-label · Treatment | Phase 1 | Completed | Biological: ASV® AGEN2017 + QS-21 Stimulon® adjuvant | Solid Tumor, Adult | 3 | 2021-02-03actual | — | 2021-12-02 |
| Safety and Tolerability Study of AutoSynVax™ Vaccine in Subjects With Advanced CancerNCT02992977Incidence of Treatment-Emergence Adverse Events (Safety and Tolerability)Open-label · Treatment | Phase 1 | Terminatedsponsor's stated reason: To enable development of an enhanced version of the vaccine. | Biological: AutoSynVax™ vaccine | Advanced Cancer | 3 | Dec 2018actual | — | 2020-06-02 |
| Study of AGEN1884 With Pembrolizumab in 1L NSCLCNCT03411473Occurrence of DLTs in subjects in the Safety Run-in Phase of the trialOpen-label · Treatment | Phase 2 | Terminatedsponsor's stated reason: Trial will not proceed due to changes in the treatment landscape. | Biological: AGEN1884 in combination with pembrolizumab | NSCLC Stage IV | 2 | 2018-05-01actual | — | 2020-06-02 |
| Biological Efficacy Study of HerpV Vaccine With QS-21 to Treat Participants With Recurrent Genital HerpesNCT01687595results2021-07-13Percent Change in Overall Viral Shedding Rate From Baseline (Week -7 to 0) to Post-treatment Period (Weeks 6 to 13)Randomized · Quadruple-masked · Treatment | Phase 2 | Completed | Drug: HerpV and QS-21, Placebo | Herpes Simplex Type 2 | 80 | Sep 2013actual | — | 2021-07-13 |
| Study of Vitespen (HSPPC-96, Oncophage ®) for Immune Response Assessment in Participants With Resectable Renal Cell Carcinoma at Intermediate Risk of RecurrenceNCT01147536results2021-06-03Number of Participants With Positive Immunological Response Using Enzyme Linked Immunosorbent Assay (ELISPOT) AssayOpen-label · Treatment | Phase 2 | Terminatedsponsor's stated reason: Sponsor's business decision | Biological: HSPPC-96 | Renal Cell Carcinoma | 12 | Jun 2012actual | — | 2021-06-03 |
| Study of L-NDDP (Aroplatin) in Patients With Advanced Solid Malignancies or B-Cell LymphomaNCT00316511Determine the maximum tolerated dose and dose-limiting toxicity of L-NDDPNon-randomized · Open-label · Treatment | Phase 1 | Completed | Drug: Aroplatin | Malignancies, B-Cell Lymphoma | 21 | Jun 2008actual | — | 2008-10-27 |
| Study of the Feasibility to Derive Vaccine From Tumor Tissue in Patients With Non-Small Cell Lung CancerNCT00098085The primary goal of this trial is to determine if HSPPC-96 can be made from the tumor tissue of patients with resectable non-small cell lung cancer.Non-randomized · Open-label | Phase 2 | Completed | Biological: HSPPC-96 | Non-Small-Cell Lung Carcinoma, Lung Cancer, Pulmonary Cancer | 20 | Nov 2007actual | — | 2009-03-09 |
| Survival Study Of Oncophage® vs. Observation In Patients With Kidney CancerNCT00033904Randomized · Open-label · Treatment | Phase 3 | Completed | Drug: autologous human tumor-derived HSPPC-96 | Renal Cell Carcinoma | 650 | Apr 2007actual | — | 2012-09-07 |
| AG-858 in Patients Who Are Cytogenetically Positive After Treatment With Gleevec™NCT00058747Non-randomized · Open-label · Treatment | Phase 2 | Terminatedsponsor's stated reason: Business decision of the sponsor | Drug: Autologous HSP-70 Protein-Peptide Complex (AG-858) Plus Gleevec™. | Leukemia, Myeloid, Chronic | 40 | Apr 2006actual | — | 2012-09-07 |
| Clinical Trial Studying a Personalized Cancer Vaccine in Patients With Non-metastatic Kidney CancerNCT00126178To determine whether patients randomized to receive adjuvant HSPPC-96 (treatment) after surgical resection of the kidney cancer have improved recurrence-free survival as compared to patients who did not receive adjuvant treatment (observation)Randomized · Open-label · Treatment | Phase 3 | Terminated | Biological: HSPPC-96 | Kidney Cancer, Renal Cell Carcinoma | 600 | Mar 2006actual | — | 2012-09-07 |
| Study of Heat Shock Protein-Peptide Complex (HSPPC-96) Versus IL-2/DTIC for Stage IV MelanomaNCT00039000Randomized · Open-label · Treatment | Phase 3 | Completed | Drug: HSPPC-96 or Oncophage | Malignant Melanoma | 350 | Dec 2005actual | — | 2012-09-07 |
| Trial to Compare the Routes of Administration of an Investigational, Personalized, Therapeutic Cancer Vaccine Oncophage (HSPPC-96) in Patients With Metastatic Renal Cell CarcinomaNCT00082459Randomized · Open-label · Treatment | Phase 2 | Terminatedsponsor's stated reason: Lack of enrollment | Biological: autologous human tumor-derived HSPPC-96 | Renal Cell Carcinoma | 40 | Dec 2005actual | — | 2012-09-07 |
| A Safety and Effectiveness Study of Vaccine Therapy in Patients With Indolent LymphomaNCT00081809Non-randomized · Open-label · Treatment | Phase 2 | Completed | Drug: autologous human tumor-derived HSPPC-96 | Lymphoma, Follicular, Lymphoma, Small Lymphocytic | 35 | Jun 2005actual | — | 2023-09-28 |
| Trial Evaluating Safety, Tolerability and Immune Response of AG-707NCT00231049Determine the overall safety profile of three different dose levels of AG-707 vaccination (with and without an adjuvant, QS-21) at 80, 240 and 400 µg compared to placebo and QS-21 alone in herpes simplex virus-2 (HSV-2) seropositive adultsRandomized · Single-masked · Treatment | Phase 1 | Completed | Drug: AG-707 | Genital Herpes | 35 | — | — | 2008-10-27 |
| Expanded Access for Cancer Treatment With Balstilimab (AGEN2034) and Zalifrelimab (AGEN1884)NCT05572970expanded access | — | Available | Drug: Balstilimab, Zalifrelimab | Cancer | — | — | — | 2026-05-06 |
| Expanded Access Program (EAP) Designed to Provide Access to Botensilimab and Balstilimab Before Regulatory ApprovalNCT06751524expanded access | — | Available | Drug: Botensilimab, Balstililmab | Colorectal Cancer (CRC), Pancreatic Cancer, Non-Small Cell Lung Cancer (NSCLC), Hepatocellular Carcinoma (HCC), Melanoma, Sarcoma, Ovarian Cancer, Prostate Cancer | — | — | — | 2026-05-15 |
Primary completion is the date the sponsor filed with the registry — their own projection, revised whenever they revise it, unless the row is marked actual.
Source: ClinicalTrials.gov, retrieved 2026-08-19