Taibidi opens dosing in first-in-human trial of c-MET drug TPD3310
The Phase 1 trial moved to recruiting status, opening a multi-year dose-escalation and expansion study whose 2028 completion will test where TPD3310 fits among a crowded field of c-MET-targeted drugs.
Executive Summary
- A Phase 1 trial of TPD3310 shifted from not-yet-recruiting to actively enrolling patients, starting the human-dosing phase of the program.
- The study pairs a dose-escalation safety phase with a later expansion phase testing response rates across several tumor types selected for c-MET positivity, an open-label, single-arm approach typical for a first-in-human oncology trial.
- TPD3310 enters a c-MET-targeted field that already includes an approved antibody-drug conjugate and more than a dozen clinical-stage programs spanning small molecules, bispecific antibodies, and other modalities, placing the trial's differentiation on dosing and tolerability data still to come rather than on the target itself.
- The trial's enrollment and operational profile look unremarkable for this stage, leaving the dose-escalation safety readout, expected as the study progresses toward its 2028 primary completion date, as the next fact that will inform how the asset is read.
The status change
TPD3310, an investigational drug targeting c-MET, moved to Recruiting status on July 20, 2026, after the trial's start date shifted from an anticipated March 1, 2026 to an actual March 5, 2026. The trial, registered as NCT07368127, is titled 'A Study of TPD3310 in Patients With Advanced Malignant Tumors' and is sponsored by TAIBIDI PHARMACEUTICAL TECHNOLOGY(SHIJIAZHUANG) CO., LTD.. It is running exclusively at sites in China. NCT07368127A Study of TPD3310 in Patients With Advanced Malignant TumorsNCT07368127
Probability of SuccessBased on the AppliedXL Probability of Success model. For more information about the methodology, read the research here.
The design
The study is a single-arm, open-label Phase 1 program enrolling adults with ECOG performance status of 1 or better whose tumors test c-MET positive. Its Phase Ia primary endpoints are safety and toxicity, dose-limiting toxicity, and maximum tolerated dose, assessed using an accelerated titration plus 3+3 dose-escalation design; the Phase Ib portion adds objective response rate, measured by RECIST v1.1 (or mRECIST for hepatocellular carcinoma), as a primary endpoint across cohorts in lung, esophageal, gastric, liver and biliary tract, pancreatic, and renal cancers. The trial targets 112 patients, unchanged from its original anticipated enrollment, and carries a primary completion date of March 1, 2028. NCT07368127A Study of TPD3310 in Patients With Advanced Malignant TumorsNCT07368127
Trial health
The enrollment target held flat at 112 patients with no increase or reduction, which an operational risk model flags as typical for this design and stage. The trial's registry history shows a single status change since its initial posting in January 2026, with no protocol amendments to eligibility criteria or endpoints and no shift in the primary completion date. That pattern is consistent with a program moving through its planned startup sequence rather than one experiencing operational strain. NCT07368127A Study of TPD3310 in Patients With Advanced Malignant TumorsNCT07368127
Where it sits in the field
c-MET is an established oncology target: AbbVie's telisotuzumab vedotin, an antibody-drug conjugate, holds accelerated approval for c-Met-overexpressing non-squamous non-small cell lung cancer, a different indication than TPD3310's advanced -tumor population. Beyond that approval, the c-MET target field includes more than a dozen clinical-stage programs spanning small molecules, bispecific antibodies, antibody-drug conjugates, and other modalities from sponsors including AbbVie, AstraZeneca, Regeneron, Merus, and several China-based drugmakers, with c-MET-targeted trial activity down to roughly 71 recent trials from 500 in prior years. TPD3310 has no in-class peer trial registered specifically for its target-by-indication combination, but that reflects the pairing's narrow definition rather than a novel mechanism: the drug's target itself is precedented across the broader c-MET field.
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.