ImmunoGenesis pushes IMGS-001 tumor-trial readout a year to December 2027
The Phase 1 trial's primary completion date slipped 12 months as ImmunoGenesis widened its dose-expansion cohorts, without a change to its 105-patient enrollment target.
Executive Summary
- ImmunoGenesis pushed the primary completion date on its Phase 1 IMGS-001 trial in relapsed or refractory tumors back by a year, resetting when the safety and dosing readout will be available.
- The sponsor expanded and redefined its dose-expansion cohorts under the same protocol, adding tumor types and restructuring eligibility criteria rather than reporting a recruiting shortfall.
- The trial's enrollment target stayed flat even as the timeline moved, which points to a redesign of the expansion plan rather than a slower pace of patient recruitment.
- IMGS-001's mechanism is not established in the competitive landscape, so its position relative to other tumor programs cannot yet be benchmarked on target or pathway.
- The trial's Phase 1a and 1b design means the next disclosures will center on tolerability and a recommended dose, not on a tumor-shrinkage verdict.
The registry change
ImmunoGenesis updated the ClinicalTrials.gov record for NCT06014502 on July 17, 2026, moving the trial's primary completion date from December 1, 2026, to December 1, 2027, a 12-month shift. The update also revised the trial's summary language, formally re-describing Part 2 as a Phase 1b dose-expansion study spanning two cohort designs: four single-dose cohorts in ovarian cancer, 9p24.1 lymphomas, nasopharyngeal cancer, and HPV-positive head and neck cancer, plus a separate dose-optimization cohort in non-small cell lung cancer. That represents a change from the trial's prior tumor-cohort list, which had included colorectal, triple-negative breast, bladder, and gastric or esophageal cancer. NCT06014502Study to Evaluate IMGS-001 Treatment in Patients With Relapsed or Refractory Advanced Solid TumorsNCT06014502
Probability of SuccessBased on the AppliedXL Probability of Success model. For more information about the methodology, read the research here.
What stayed fixed
The trial's enrollment target held at 105 patients before and after the update, a 0% change. An enrollment level held flat alongside a cohort redesign is consistent with the sponsor reshaping how it plans to use its planned patient population, rather than running behind on recruitment. The trial remains open-label and non-randomized across six arms, testing IMGS-001 doses from 0.3 mg/kg up to 20 mg/kg every two weeks in Phase 1a before Phase 1b dose selection. NCT06014502Study to Evaluate IMGS-001 Treatment in Patients With Relapsed or Refractory Advanced Solid TumorsNCT06014502
What the readout will test
The trial's two primary endpoints are dose-limiting toxicities and adverse events in Phase 1a, and a recommended Phase 2 dose defined by pooling pharmacokinetic, pharmacodynamic, target-engagement, efficacy, and safety data in Phase 1b. Secondary measures include objective response rate, clinical benefit rate, and progression-free survival across the specified tumor cohorts, evaluated at 12 months. Because the design is open-label with no control arm, the coming data will establish tolerability and a workable dose rather than deliver a comparative efficacy verdict. The trial enrolls adults with ECOG performance status 0-1, measurable disease, and PD-L1-positive tumors in the third-line-or-later relapsed or refractory setting. NCT06014502Study to Evaluate IMGS-001 Treatment in Patients With Relapsed or Refractory Advanced Solid TumorsNCT06014502
Competitive position
IMGS-001's molecular target and modality are not established in trial registrations, so its position cannot be benchmarked against other tumor programs on mechanism. A July 2026 press release describes a partnership in which BostonGene's platform will help characterize patients for IMGS-001 response, aiming to target immunotherapy-resistant tumors, though registry data do not confirm the drug's specific molecular target. The broader competitive field around this indication includes late-stage, modality-diverse programs, including Merck's sacituzumab tirumotecan and patritumab deruxtecan, Daiichi Sankyo's trastuzumab deruxtecan, and AstraZeneca's saruparib, each running in different tumor types and different drug classes, none of which shares a confirmed target or mechanism with IMGS-001. NCT06014502+1Study to Evaluate IMGS-001 Treatment in Patients With Relapsed or Refractory Advanced Solid TumorsNCT06014502Study to Evaluate IMGS-001 Treatment in Patients With Relapsed or Refractory Advanced Solid TumorsJul 17, 2026
Sponsor track record
ImmunoGenesis has run eight trials, three completed and three terminated, alongside two currently recruiting, including this study. The completion-date change followed a pattern the sponsor has used before: the primary completion date has moved once since the trial began enrolling in September 2023, alongside four rounds of eligibility-criteria amendments as the sponsor refined its tumor-specific cohorts. NCT06014502Study to Evaluate IMGS-001 Treatment in Patients With Relapsed or Refractory Advanced Solid TumorsNCT06014502
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.