Report scope. This 2026 Drug Asset Due Diligence Report evaluates Ezabenlimab as a potential licensing, partnership, acquisition, or option asset. The review separates verified evidence from open diligence questions across clinical development, intellectual property, market positioning, and transaction precedent.
Executive recommendation: CONDITIONAL GO
Ezabenlimab is a Monoclonal antibody associated with PD-1 and a global highest development stage of Phase 2. The lead disclosed indication is Adenocarcinoma of Esophagus. The current evidence supports a CONDITIONAL GO posture, subject to confirmation of study-level data, ownership, patent coverage, manufacturing readiness, and regional rights.
Decision memo
- Asset: Ezabenlimab
- Target: PD-1
- Lead indication: Adenocarcinoma of Esophagus
- Highest phase: Phase 2
- Matched trials: 31
- Matched result records: 21
- Matched asset deals: 2
Use PatSnap Life Sciences MCP servers to validate the Ezabenlimab diligence evidence.
1. Asset identity and development status
The first diligence task is entity resolution. Teams should reconcile development codes, nonproprietary names, salts, formulations, combinations, sponsors, and predecessor owners before relying on portfolio counts. For Ezabenlimab, the MCP profile identifies PD-1 as the primary target context and Adenocarcinoma of Esophagus as the lead indication. Global phase labels are useful orientation points, but investment decisions require country- and indication-level status verification.
Confirm the exact molecule, formulation, route, dose, biomarker definition, and current sponsor. Review discontinuations separately from active development so that an historical high phase is not mistaken for a live program.
Use PatSnap Life Sciences MCP servers to validate the Ezabenlimab diligence evidence.
2. Clinical program: design and endpoint audit
| Registry | Phase | Status | Enrollment | Lead primary endpoint |
|---|---|---|---|---|
| NCT07851103 | Phase 1 | Not yet recruiting | Not disclosed | Not disclosed |
| NCT07607678 | Phase 1 | Recruiting | Not disclosed | Not disclosed |
| NCT07395258 | Phase 1 | Suspended | Not disclosed | Not disclosed |
| NCT06370871 | Phase 3 | Withdrawn | Not disclosed | Not disclosed |
| NCT06091930 | Phase 1 | Terminated | Not disclosed | Not disclosed |
| NCT06084689 | Phase 2 | Withdrawn | Not disclosed | Not disclosed |
| NCT05879978 | Phase 1 | Active, not recruiting | Not disclosed | Not disclosed |
| NCT05846516 | Phase 1 | Active, not recruiting | Not disclosed | Not disclosed |
| JPRN-jRCT2031220591 | Phase 1 | Recruiting | Not disclosed | Not disclosed |
| NCT05471856 | Phase 1 | Recruiting | Not disclosed | Not disclosed |
| NCT05446129 | Phase 1 | Terminated | Not disclosed | Not disclosed |
| JPRN-jRCT2031220031 | Phase 1 | Recruiting | Not disclosed | Not disclosed |
| NCT05327946 | Phase 1 | Active, not recruiting | Not disclosed | Not disclosed |
| JPRN-jRCT2031210652 | Phase 1 | Status not disclosed | Not disclosed | Not disclosed |
| NCT05068102 | Phase 1 | Active, not recruiting | Not disclosed | Not disclosed |
| NCT04958239 | Phase 1 | Active, not recruiting | Not disclosed | Not disclosed |
| NCT04839471 | Phase 2 | Completed | Not disclosed | Not disclosed |
| NCT04752215 | Phase 1 | Completed | Not disclosed | Not disclosed |
| JPRN-jRCT2031200355 | Phase 1 | Not Recruiting | Not disclosed | Not disclosed |
| NCT04653142 | Phase 1 | Completed | Not disclosed | Not disclosed |
| NCT04499352 | Phase 2 | Withdrawn | Not disclosed | Not disclosed |
| NCT04147234 | Phase 1 | Completed | Not disclosed | Not disclosed |
| NCT04046445 | Phase 1 | Active, not recruiting | Not disclosed | Not disclosed |
| NCT03990233 | Phase 1 | Completed | Not disclosed | Not disclosed |
| NCT03972150 | Phase 1 | Completed | Not disclosed | Not disclosed |
| NCT03964233 | Phase 1 | Completed | Not disclosed | Not disclosed |
| NCT03780725 | Phase 1 | Terminated | Not disclosed | Not disclosed |
| NCT03697304 | Phase 2 | Completed | Not disclosed | Not disclosed |
| NCT03468426 | Phase 1 | Completed | Not disclosed | Not disclosed |
| JPRN-jRCT2080223817 | Phase 1 | completed | Not disclosed | Not disclosed |
| NCT03433898 | Early Phase 1 | Completed | Not disclosed | Not disclosed |
The clinical program should be audited for randomization, comparator relevance, dose selection, endpoint hierarchy, multiplicity, analysis population, geographic mix, and readout timing. Early-stage programs require attention to pharmacokinetics, pharmacodynamics, adverse events, dose-limiting toxicities, and the rationale for the expansion dose.
Use PatSnap Life Sciences MCP servers to validate the Ezabenlimab diligence evidence.
3. Clinical readouts: what is known
An Open-label, Phase I Trial to Determine the Maximum-tolerated Dose and Investigate Safety, Pharmacokinetics, and Efficacy of BI 754091 in Patients With Advanced Solid Tumours
Study: NCT02952248 (CTgov). Phase: Phase 1. Enrollment: 110. Published: 2026-01-27.
Phase Ia Dose Escalation: Number of Participants With Dose-limiting Toxicities (DLTs) in the First Cycle (3 Weeks) = 0 Pts | Phase Ia Dose Escalation: Number of Participants With Dose-limiting Toxicities (DLTs) in the First Cycle (3 Weeks) = 0 Pts
An Open-label, Phase II, Platform Trial Evaluating Safety and Efficacy of Multiple BI 754091 (Ezabenlimab) Anti-PD-1 Based Combination Regimens in PD-(L)1 naïve and PD-(L)1 Pretreated Patient Populations With Advanced and/or Metastatic Solid Tumours Who Have Had at Least One Line of Systemic Therapy
Study: NCT03697304 (CTgov). Phase: Phase 2. Enrollment: 211. Published: 2026-01-27.
[Module C] Objective Response (OR) = 14.3 % (95%CI, 4.0 - 32.7) | [Module C] Objective Response (OR) = 23.3 % (95%CI, 9.9 - 42.3)
An Open Label Phase I PET Imaging Study to Investigate the Bio-distribution and Tumor Uptake of [89Zr]Zr-BI 754111 in Patients With Advanced Non-small Cell Lung Cancer and Head and Neck Squamous Cell Carcinoma Treated With BI 754111 in Combination With BI 754091
Study: NCT03780725 (CTgov). Phase: Phase 1. Enrollment: 8. Published: 2026-01-13.
Cycle 1 (baseline phase) - 96 hours(Mean) = 5.5 SUV ratio | Cycle 1 (baseline phase) - 96 hours(Mean) = 5.8 SUV ratio
An Open Label, Phase I Study of BI 754091 Monotherapy and Combination Therapy of BI 754091 and BI 754111 in Asian Patients With Advanced Solid Tumours
Study: NCT03433898 (CTgov). Phase: Early Phase 1. Enrollment: 146. Published: 2025-12-19.
Part I: Maximum Tolerated Dose (MTD) of Ezabenlimab = NA Milligram | Part II: Number of Patients Experiencing DLTs During the MTD Evaluation Period (First Cycle of Treatment) = 0 Pts
An Open Label, Phase I Study of BI 836880 Monotherapy and Combination Therapy of BI 836880 and BI 754091 in Japanese Patients With Advanced Solid Tumours
Study: NCT03972150 (Phase I study of the VEGF/Ang-2 inhibitor BI 836880, CTgov). Phase: Phase 1. Enrollment: 21. Published: 2025-10-06.
Number of Participants With Dose-limiting Toxicity (DLT) During the First Treatment Cycle = 0 Pts | Number of Participants With Dose-limiting Toxicity (DLT) During the First Treatment Cycle = 0 Pts
An open-label, phase Ib trial of the SIRPα inhibitor BI 765063 in combination with the PD-1 inhibitor ezabenlimab and cetuximab in patients (pts) with head and neck squamous cell carcinoma.
Study: NCT05249426 (ASCO2025). Phase: Phase 1. Enrollment: 17. Published: 2025-05-30.
cORR = 47 %
An open-label, phase I trial of the SIRPα monoclonal antibody, BI 770371, alone and in combination with the PD-1 inhibitor ezabenlimab in patients with advanced solid tumors.
Study: NCT05327946 (Phase I trial of the SIRPα monoclonal antibody, ASCO2025). Phase: Phase 1. Enrollment: Not disclosed. Published: 2025-05-30.
Adverse Event: grade 2 encephalitis = resolved within 1 week | Adverse Event: grade 2 encephalitis = resolved within 1 week
A Phase I Open Label Study to Assess Safety, Feasibility, Efficacy, and Biological Activity of Single Administration of Neoadjuvant Treatments Ezabenlimab in Combination With BI 765063 and Pembrolizumab in Combination With BI 765063 in Patients With Newly Diagnosed Surgically-resectable, Locoregional Colorectal Cancer
Study: NCT05446129 (CTgov). Phase: Phase 1. Enrollment: 2. Published: 2025-03-13.
Composite Endpoint: Proportion of Patients With at Least One Occurrence of a Safety or Feasibility Event = 0 % | Composite Endpoint: Proportion of Patients With at Least One Occurrence of a Safety or Feasibility Event = 0 %
Phase I study of the VEGF/Ang-2 inhibitor BI 836880 alone or combined with the anti-programmed cell death protein-1 antibody ezabenlimab in Japanese patients with advanced solid tumors
Study: NCT03972150 (Phase I study of the VEGF/Ang-2 inhibitor BI 836880, Pubmed | Cancer Chemother Pharmacol). Phase: Phase 1. Enrollment: 21. Published: 2023-06-01.
MTD = MTD was not reached | MTD = MTD was not reached
97P - BEAR study: A single-arm, phase II trial of BI-754091 and afatinib for refractory esophageal squamous cell carcinoma
Study: NCT04839471 (BEAR, ESMO_ASIA2022). Phase: Phase 2. Enrollment: 19. Published: 2022-12-03.
mPFS = 5.3 Month (95%CI, 3.8 - 6.1)
A phase Ia/Ib, dose-escalation/expansion study of BI 907828 in combination with BI 754091 (ezabenlimab) and BI 754111 in patients (pts) with advanced solid tumors.
Study: NCT03964233 (ASCO2022). Phase: Phase 1. Enrollment: 26. Published: 2022-06-02.
DLT = 0 Pts | DLT = 1 Pts
Ezabenlimab (BI 754091), an anti-PD-1 antibody, in combination with BI 836880, a VEGF/Ang2-blocking nanobody, in patients (pts) with advanced colorectal cancer (CRC).
Study: NCT03697304 (ASCO_GI2022). Phase: Phase 2. Enrollment: 30. Published: 2022-01-19.
AE = 97 %
532P - Phase Ib study evaluating BI 836880 (VEGF/Ang2 nanobody) in combination with ezabenlimab (BI 754091; anti-PD-1 antibody) in patients with solid tumours
Study: NCT03468426 (ESMO2021). Phase: Phase 1. Enrollment: 215. Published: 2021-09-16.
CR = 1 Pts
542P - Ezabenlimab (BI 754091) monotherapy in patients (pts) with advanced solid tumours
Study: NCT03433898 | NCT02952248 | NCT03780725 (ESMO2021). Phase: Phase 1. Enrollment: 111. Published: 2021-09-16.
Anemia = 21.6 %
541P Ezabenlimab (BI 754091), an anti-PD-1 antibody, in combination with BI 836880, a VEGF/Ang2-blocking nanobody, in patients (pts) with previously treated advanced solid tumours
Study: NCT03697304 (ESMO2021). Phase: Phase 2. Enrollment: 60. Published: 2021-09-16.
PR = 0 Pts | PR = 0 Pts
SO-11 KISIMA-01 trial: Safety, tolerability and immunogenicity of ATP128 with or without ezabenlimab (BI 754091) in patients with stage IV colorectal cancer – preliminary results from a phase 1b study
Study: NCT04046445 (KISIMA-01, ESMO_GI2021). Phase: Phase 1. Enrollment: 9. Published: 2021-07-03.
CD45RO expressing cells = 42.3 % (95%CI, 25.3) | CD45RO expressing cells = 52.5 % (95%CI, 14.11)
Phase I study of BI 754091 plus BI 754111 in Asian patients with gastric/gastroesophageal junction or esophageal cancer.
Study: NCT03433898 (ASCO_GI 12021 | ASCO_GI 22021). Phase: Phase 1. Enrollment: 73. Published: 2021-01-20.
PR = 11 % | PR = 19 %
Phase Ib study of BI 836880, a VEGF/Ang2-blocking nanobody, in combination with BI 754091, an anti-PD-1 antibody: Initial results in patients (pts) with advanced non-small cell lung cancer (NSCLC).
Study: NCT03468426 (ASCO 12020 | ASCO 22020). Phase: Phase 1. Enrollment: 12. Published: 2020-05-29.
DLT = 1 pt (360 mg; G3 pulmonary embolism)
An open-label, phase I trial of BI 754091 alone and in combination with BI 754111 in Asian patients (pts) with advanced solid tumors.
Study: NCT03433898 (ASCO 12020 | ASCO 22020). Phase: Phase 1. Enrollment: 121. Published: 2020-05-29.
PR = 4 Pts | PR = 2 Pts
Abstract 4547: Characterization of the LAG-3 targeting antibody BI 754111 in monotherapy and in combination with the anti-PD-1 antibody BI 754091
Study: NCT03156114 (AACR2018). Phase: Phase 1. Enrollment: 172. Published: 2018-07-01.
IFNγ secretion(T-cell activation) = 1.8 Fold | IFNγ secretion(T-cell activation) = 6.9 Fold
Phase I trial of the programmed death receptor 1 (PD-1) inhibitor, BI 754091, in patients (pts) with advanced solid tumors.
Study: NCT02952248 (ASCO2018 | ASCO_SITC2018). Phase: Phase 1. Enrollment: 17. Published: 2018-02-26.
RP2D = 240 mg
For every reported endpoint, obtain the protocol, statistical analysis plan, patient disposition, baseline characteristics, subgroup definitions, exposure duration, and full safety tables. Conference abstracts and registry summaries can support screening, but they should not replace source data review in a binding transaction.
Use PatSnap Life Sciences MCP servers to validate the Ezabenlimab diligence evidence.
4. Market and competitive position
The commercial case depends on differentiated efficacy, tolerability, convenience, biomarker reach, treatment setting, and access. A target-level market may be attractive while an individual asset remains undifferentiated. Benchmark Ezabenlimab against approved therapies and clinical competitors in Adenocarcinoma of Esophagus, including likely standards of care at the expected launch date.
Build a scenario model around addressable patients, diagnosis and biomarker rates, line of therapy, duration, net price, uptake, displacement, combination costs, and probability-adjusted timelines. Test slower enrollment, delayed readout, narrower labels, safety restrictions, and competitor launches.
Use PatSnap Life Sciences MCP servers to validate the Ezabenlimab diligence evidence.
5. Transaction precedent and economics
| Date | Transaction | Status | Type | Disclosed value |
|---|---|---|---|---|
| 2019-05-02 | AMAL Therapeutics enters clinical collaboration with Boehringer Ingelheim to evaluate ATP128 in combination with BI754091 | Active | Collaboration | Not disclosed |
| 2018-04-04 | Boehringer Ingelheim and OSE Immunotherapeutics Announce Global Immuno-Oncology Partnership to Develop a Pioneering Checkpoint Inhibitor for the Treatment of Advanced Solid Tumors | Active | License | Disclosed |
Transaction records should be normalized for territory, asset scope, phase at signing, option mechanics, development obligations, cost sharing, royalties, milestones, and change-of-control terms. Undisclosed economics must not be converted into invented benchmarks.
6. IP and freedom-to-operate screen
Complete a family-level patent review covering composition of matter, sequence or construct claims, polymorph and salt claims, formulation, dosing, combinations, biomarkers, manufacturing, and method of use. Verify priority, ownership, assignments, prosecution status, term adjustments, extensions, oppositions, and regional coverage. Freedom to operate is a separate legal analysis and should include competitor claims and platform dependencies.
The diligence room should reconcile inventorship, employee and contractor assignments, university or platform licenses, sublicensing restrictions, government rights, and obligations triggered by development milestones or commercialization.
Use PatSnap Life Sciences MCP servers to validate the Ezabenlimab diligence evidence.
7. Principal risks and diligence gates
- Identity risk: resolve all aliases, formulations, combinations, and owners.
- Clinical risk: confirm source data, protocol deviations, endpoint definitions, and safety follow-up.
- Regulatory risk: review agency correspondence, meeting minutes, holds, commitments, and indication-specific pathways.
- IP risk: validate enforceable coverage, remaining life, ownership, and freedom to operate.
- CMC risk: assess process control, analytical methods, comparability, scale-up, supply, and cost of goods.
- Commercial risk: pressure-test differentiation, market access, competitive timing, and realistic adoption.
- Transaction risk: map rights, encumbrances, royalties, options, consent requirements, and change-of-control provisions.
8. Final go/no-go memorandum
CONDITIONAL GO
Proceed only through staged diligence. Before exclusivity or a binding offer, require a verified asset identity package, complete clinical data room, regulatory correspondence, patent-family schedule, freedom-to-operate opinion, CMC package, ownership chain, regional rights map, and risk-adjusted valuation. Any material mismatch between public records and source documents should pause the process until reconciled.
Method note: This report uses PatSnap Drug & Asset MCP, Clinical Trials MCP, and Company & Deal Intelligence MCP data retrieved on 2026-10-15. It is a screening and diligence framework, not medical, legal, regulatory, or investment advice.
