InventisBio's D-1553 trial pushes completion date out more than two years
The Phase 1/2 combination study with InxMed's ifebemtinib now targets December 2027, as a related cohort in the same program already reported an 82% response rate in lung cancer.
Executive Summary
- InventisBio moved the primary completion date on its Phase 1/2 combination trial out by more than two years, the second consecutive amendment to that date in under a year.
- The trial's enrollment target has not changed, and the study remains active but closed to new recruitment, so the delay does not reflect a shrinking or struggling patient pool.
- A companion cohort testing the same drug combination in first-line lung cancer patients already reported an 82% response rate and extended progression-free survival, publishing in a peer-reviewed journal, and that data now frames what this broader -tumor trial needs to show.
- The KRas G12C inhibitor field includes several approved and late-stage rivals targeting the same mutation, but InventisBio's asset is paired with a FAK inhibitor, a combination none of the approved single-agent options use.
The timing shift
The trial, registered as NCT05379946, tests D-1553 in combination with ifebemtinib (also known as IN10018) in patients with KRas G12C-mutated tumors who have exhausted standard treatment options. The primary completion date has moved three times since the trial's 2022 registration: from June 2024 to June 2025 in October 2024, to July 2025 in April 2025, and now to December 2027. The latest change extends the timeline by roughly two and a half years from the most recently stated date. NCT05379946+1Study to Evaluate D-1553 in Combination With IN10018 in Subjects With Solid TumorsNCT05379946Study to Evaluate D-1553 in Combination With IN10018 in Subjects With Solid TumorsJul 17, 2026
Probability of SuccessBased on the AppliedXL Probability of Success model. For more information about the methodology, read the research here.
Enrollment and status
The trial's target enrollment remains at 92 patients, unchanged from its prior anticipated count, and the study is listed as active but no longer recruiting, having closed enrollment in April 2025. That combination, a flat enrollment target alongside a multi-year completion-date extension, points to a trial that filled its planned cohort on schedule but needs more follow-up time to mature its response and survival data, rather than a trial that fell short of its patient target. NCT05379946Study to Evaluate D-1553 in Combination With IN10018 in Subjects With Solid TumorsNCT05379946
What the related cohort showed
A related cohort in the same clinical program, tracked under NCT06166836, reported results from a 33-patient group treated with the same D-1553 plus ifebemtinib combination in first-line KRAS G12C-mutant non-small cell lung cancer. That cohort recorded an 82% overall objective response rate, an 87% response rate among evaluable patients, and a median progression-free survival of 22.3 months, with no treatment-related deaths or discontinuations, published online in The Lancet Respiratory Medicine. InxMed, the co-developer, has since initiated a Phase 3 confirmatory trial (NCT07174908) testing ifebemtinib in combination with garsorasib in first-line KRAS G12C-mutant NSCLC, and has said ifebemtinib received Breakthrough Therapy Designation from China's National Medical Products Administration in that setting.
The competitive field
KRas G12C inhibitors are already an established mechanism class. Sotorasib and adagrasib both hold approvals for KRas G12C-mutated non-small cell lung cancer, and adagrasib is also approved in combination with cetuximab for KRas G12C-mutated colorectal cancer, though neither is approved in the broader -tumor, third-line-and-beyond population this trial enrolls. Roche's divarasib and Merck's calderasib are both advancing through Phase 2 and Phase 3 testing in the same target class. InventisBio's trial differs from those single-agent programs by pairing D-1553 with a FAK inhibitor, a combination intended to address resistance mechanisms that KRas inhibition alone does not fully block, a rationale supported by the response data already reported from the companion NSCLC cohort using the same combination.
Operational picture
The trial has changed its primary completion date three times and its recruitment status twice since 2022, a pace of amendment activity the registry itself characterizes as moderate. None of those changes touched the endpoint definition or the enrollment target, which have held constant throughout, so the amendment pattern reflects timeline recalibration rather than a redesign of what the trial measures. NCT05379946Study to Evaluate D-1553 in Combination With IN10018 in Subjects With Solid TumorsNCT05379946
This analysis was produced using AI-assisted reporting systems, AppliedXL data, and official public records. These systems undergo editorial review, quality checks, and regular audits by human experts. Errors may still occur, as with any automated system. Always consult the linked primary sources. Read our AI Editorial Policy.