A Study of BI 4015092, Alone or in Combination With Other Cancer Treatment, in Patients With Advanced Cancer That Has a KRAS G12D Mutation
NCT07926334, Phase 1, Not yet recruiting, Boehringer Ingelheim
Trial 10
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
| Field | Value | Source |
|---|---|---|
| Title | A Study of BI 4015092, Alone or in Combination With Other Cancer Treatment, in Patients With Advanced Cancer That Has a KRAS G12D Mutation | ClinicalTrials.gov |
| NCT number | NCT07926334 | ClinicalTrials.gov |
| Status | Not yet recruiting | ClinicalTrials.gov |
| Phases | Phase 1 | ClinicalTrials.gov |
| Enrollment | 200 participants, estimated | ClinicalTrials.gov |
| Lead sponsor | Boehringer Ingelheim | ClinicalTrials.gov |
| Conditions | Advanced or Metastatic Solid Tumors With KRAS G12D Mutation | ClinicalTrials.gov |
| Interventions | BI 4015092, Cetuximab | ClinicalTrials.gov |
| First posted | 2026-11-09 | ClinicalTrials.gov |
| Last updated | 2026-11-09 | ClinicalTrials.gov |
Registered outcomes 16
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description | Source |
|---|---|---|---|---|
| Primary | Dose escalation (DE) parts: Occurrence of dose limiting toxicities (DLTs) during the primary DLT evaluation period | Up to 3 weeks | ClinicalTrials.gov | |
| Primary | Monotherapy expansion part: Objective response (OR) | Up to 36 months | OR defined as the best overall response (BOR) of confirmed complete response (CR) or confirmed partial response (PR), where BOR is determined by the investigator's assessment according to Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 from the first treatment administration until the earliest of disease progression, death or last evaluable tumor assessment before start of subsequent anticancer therapy, lost to follow-up, or withdrawal of consent, whichever occurs first. | ClinicalTrials.gov |
| Primary | Combination therapy randomized dose optimization (Combi RDO) part: OR | Up to 36 months | as defined above | ClinicalTrials.gov |
| Secondary | All trial parts: Occurrence of treatment-emergent adverse events (AEs) | Up to 36 months | ClinicalTrials.gov | |
| Secondary | All trial parts: Occurrence of DLTs | Up to 36 months | ClinicalTrials.gov | |
| Secondary | All trial parts: Occurrence of drug-related AEs | Up to 36 months | ClinicalTrials.gov | |
| Secondary | All trial parts: Occurrence of treatment-emergent serious adverse events (SAEs) | Up to 36 months | ClinicalTrials.gov | |
| Secondary | DE part: OR | Up to 36 months | as defined above | ClinicalTrials.gov |
| Secondary | Mono expansion part and Combi RDO part: Duration of response (DoR), based on RECIST v1.1 | Up to 36 months | DoR defined as the time from first complete response (CR) or partial response (PR) until the earliest of progressive disease (PD) or death among patients with an OR, as defined above. | ClinicalTrials.gov |
| Secondary | Mono expansion part and Combi RDO part: Progression free survival (PFS) | Up to 36 months | PFS defined as the time from first treatment administration until tumor progression according to RECIST v1.1 or death from any cause, whichever occurs first. | ClinicalTrials.gov |
| Secondary | Mono expansion part and Combi RDO part: PFS at 6 months (PFS6) | At 6 months | PFS6 defined as being alive and without tumor progression at 6 months from first trial treatment. | ClinicalTrials.gov |
| Secondary | Mono expansion part and Combi RDO part: Clinical benefit (CB) | At 6 months | CB defined as achievement of best overall response (BOR) of CR or PR of any duration, or stable disease (SD) of at least 6 months according to RECIST v1.1 from the first administration of trial medication until the earliest of PD, death, last evaluable tumor assessment before the start of subsequent anticancer therapy, loss to follow-up, or withdrawal of consent, whichever occurs first. | ClinicalTrials.gov |
| Secondary | All trial parts: Disease control (DC), based on RECIST v1.1 | Up to 36 months | DC defined as the best overall response of CR, PR, or SD from the first administration of trial medication until the earliest of PD, death, last evaluable tumor assessment before the start of subsequent anticancer therapy, loss to follow-up, or withdrawal of consent, whichever occurs first. | ClinicalTrials.gov |
| Secondary | All trial parts: Maximum measured concentration of the analyte in plasma (Cmax) (after the first dose in Cycle 1 and 2) | Up to 36 months | ClinicalTrials.gov | |
| Secondary | All trial parts: Area under the concentration-time curve over a uniform dosing interval 0 - 24 h (AUC0-24) (Cycle 1) or τ (AUCτ) (Cycle 2) (after first administration in Cycle 1 or Cycle 2) | Up to 36 months | ClinicalTrials.gov | |
| Secondary | DE part back fill cohorts: Changes from baseline in the transcript levels of genes controlled by the mitogen-activated protein kinase (MAPK) pathway, such as dual specificity phosphatase 6 (DUSP6) | At baseline and between Cycle 1 Day 15 and Cycle 2 Day 1 or Day 2 (Treatment cycles are 21 days) | ClinicalTrials.gov |
Outcomes 0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as | Source |
|---|
Results by group 0
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units | Source |
|---|
Participant flow 0
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted | Source |
|---|
Adverse events 0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events | Source |
|---|
Adverse event totals 0
The totals the trial posted for each group.
| Total | Group | Affected | At risk | Source |
|---|
Papers 0
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as | Source |
|---|
Grants 0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years | Source |
|---|
Trial comparisons 0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|
Tests 0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
| Test | Named as | Source |
|---|
Source 5
| Field | Value | Source |
|---|---|---|
| Release | trials-2026-11-12-0.4.0 | ClinicalTrials.gov |
| Release manifest SHA-256 | 0f4a8d8c48aee2a7573ae0fa94ecbeab70c1adbe449bbc95c424bc7d3e97b9d4 | ClinicalTrials.gov |
| Registry capture | 2026-11-12 | ClinicalTrials.gov |
| Results copy, AACT | 2026-03-23 | ClinicalTrials.gov |
| NIH clinical studies file | 2026-11-13 | ClinicalTrials.gov |
Release trials-2026-11-12-0.4.0
ClinicalTrials.gov's posted results, through CTTI's AACT: ClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299 ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
ClinicalTrials.gov: none stated ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
NIH RePORTER's clinical studies and project files: Public domain (NIH RePORTER)