SOHO-01
First in Human Study of BAY2927088 in Participants Who Have Advanced Non-small Cell Lung Cancer (NSCLC) With Mutations in the Genes of Epidermal Growth Factor Receptor (EGFR) and/or Human Epidermal Growth Factor Receptor 2 (HER2)
- NCT05099172 ↗
- Recruiting
- Bayer
- Deep
We haven't built an HCP commentary report on SOHO-01 (BAY2927088_formulation A, BAY2927088_formulation B_1 and 2 more in Advanced Non-small Cell Lung Cancer) yet. This page shows the registry record and the public commentary we found that names the trial. A report reads that commentary and sets out what clinicians said about the trial, each point linked to its source. How reports are made.
Indexed commentary on SOHO-01 so far
Podcasts, YouTube videos and X posts we have indexed that name the trial. It is where a report starts, not where it ends: the build searches for more, so finished reports usually cover more than this.
| Channel | Indexed | |
|---|---|---|
| X threads | 89 | |
| YouTube | 22 | |
| Podcasts | 21 | |
| X videos | 4 | |
| Bluesky threads | 1 |
The trial
ClinicalTrials.gov- Official title
- An Open Label, First-in-human Study of BAY 2927088 in Participants With Advanced Non-small Cell Lung Cancer (NSCLC) Harboring an EGFR and/or HER2 Mutation
- Phase
- Phase 1/Phase 2
- Status
- Recruiting
- Conditions
- Advanced Non-small Cell Lung Cancer; EGFR Mutation; HER2 Mutation
- Interventions
- BAY2927088_formulation A; BAY2927088_formulation B_1; BAY2927088_formulation B_2; BAY2927088_formulation B_3
- Arms
- Dose escalation · Experimental
- Backfill · Experimental
- Dose expansion · Experimental
- Extension part · Experimental
- Enrollment
- 430 (estimated)
- Primary outcomes
- Number of participants with treatment-emergent adverse events (TEAEs)
- Number of participants with treatment-emergent serious adverse events (TESAEs)
- Severity of TEAEs
- Severity of TESAEs
- Number of participants who discontinue study treatment due to an AE
- Maximum tolerated dose (MTD) or maximum administered dose (MAD) of BAY2927088 within the DLT observation period in Dose Escalation (including participants from Backfill qualifying for the MTD population)
- Number of participants experiencing dose-limiting toxicities (DLTs) at each dose level associated with administration of BAY2927088 in the DLT observation period in Dose Escalation (including participants from Backfill)
- Cmax of BAY2927088
- AUC(0-24) of BAY2927088 for QD
- AUC(0-12) of BAY2927088 for BID
- Cmax,md of BAY2927088
- AUC(0-24)md of BAY2927088 for QD
- AUC(0-12)md of BAY2927088 for BID
- Overall response rate (ORR) per Response Evaluation Criteria in Solid Tumors, version 1.1 (RECIST v1.1) by blinded independent central review (BICR) in extension part
- Sponsor
- Bayer
- Start
- Oct 25, 2021
- Primary completion
- Dec 1, 2028 (estimated)
- Results posted
- No
- Registry record
- NCT05099172 · updated Oct 21, 2026
Publications
linked from the registry- Le X, Kim TM, Loong HH, Prelaj A, Goh BC, Li L, Fang Y, Lu S, Dong X, Wu L, Shinno Y, Daniele G, Yang TY, Kim HR, Ruiter G, Zhao J, Novello S, Miao L, Janne PA, Goto K, Ruttinger D, Descamps T, Brase JC, Bao W, Li R, Brega N, Grassi P, Girard N, Tan DS; SOHO-01 Investigators. Sevabertinib in Advanced HER2-Mutant Non-Small-Cell Lung Cancer. N Engl J Med. 2025 Nov 6;393(18):1819-1832. doi: 10.1056/NEJMoa2511065. Epub 2025 Oct 17. PubMed 41104928