Multitude Therapeutics opens dosing in AMT-116 lung cancer combination with Ivonescimab
The Phase 1/2 trial pairs an unproven bispecific with the PD-1 x VEGF-A drug now advancing across dozens of NSCLC studies, with tolerability and response data due by mid-2027.
Executive Summary
- A Chinese Phase 1/2 trial testing a new PD-1/VEGF-A combination against non-small cell lung cancer began dosing patients, moving from not-yet-recruiting to active recruitment.
- The combination pairs an unproven bispecific antibody with a PD-1-targeted partner drug already deployed across a wide swath of active lung cancer trials, making this a test of whether the addition improves on an already-established profile rather than a first-in-class bet.
- The PD-1 target in NSCLC is heavily populated, with direct comparators spanning checkpoint monoclonal antibodies, antibody-drug conjugates, and other bispecifics from large sponsors already in Phase 3, so any signal from this trial will be read against a mature comparator field rather than an open one.
- The trial's primary completion is set for May 2027, when dose-limiting toxicity and objective response data will show whether the combination clears the tolerability and activity bar this stage of development requires.
The status change
NCT07590531 shifted from Not yet recruiting to Recruiting, with dosing starting June 29, 2026, and enrollment guidance holding at 118 patients. The move follows the trial's initial registration on May 15, 2026, and comes with no change to the anticipated enrollment figure, a routine early-stage operational step rather than a signal of trial distress. NCT07590531AMT-116 in Combination With Ivosidan in Patients With Lung CancerNCT07590531
Probability of SuccessBased on the AppliedXL Probability of Success model. For more information about the methodology, read the research here.
What the trial tests
The Phase 1 portion is designed to establish safety, tolerability, and a recommended Phase 2 dose for the AMT-116 and Ivonescimab combination in adults with advanced NSCLC, tracking adverse events and dose-limiting toxicities. The Phase 2 portion, enrolling separate cohorts defined by histology and EGFR mutation status, will measure objective response rate under RECIST v1.1 criteria. The primary completion date is set for May 30, 2027, roughly ten months after dosing begins for the Phase 1 safety readout and about twelve months for the Phase 2 response data. NCT07590531AMT-116 in Combination With Ivosidan in Patients With Lung CancerNCT07590531
The competitive field
Ivonescimab, the PD-1 x VEGF-A bispecific paired with AMT-116 in this trial, already appears across 32 active industry trials targeting PD-1 with over 11,600 patients enrolled, making it one of the more heavily deployed PD-1-directed assets in current development. The broader PD-1 field in NSCLC includes direct comparators at Phase 3, including Merck's pembrolizumab, sacituzumab tirumotecan, and intismeran autogene programs, alongside AbbVie's livmoniplimab and Roche's divarasib, all sharing the same target and modality class as either monoclonal antibodies or other PD-1-directed formats. AMT-116 in combination with Ivonescimab enters a target space where more than 60 industry peers are already at Phase 1 or beyond, so the combination's differentiation rests on whether the AMT-116 pairing improves tolerability or response rate over Ivonescimab's own single-agent or other combination data, not on mechanistic novelty.
Trial conduct
The trial has logged two registry events since its initial posting: the add-study entry on May 15, 2026, and the recruitment status change on July 14, 2026, with no amendments to eligibility criteria, endpoints, or the primary completion date in between. The enrollment target held at 118 patients across both entries, a change the operational risk model characterizes as within the routine band, not a cut or an expansion signal. NCT07590531AMT-116 in Combination With Ivosidan in Patients With Lung CancerNCT07590531
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.