Hengrui completes Phase 1 SHR-7367 trial with enrollment cut to 22 from 182
The open-label dose-finding study closed with results not yet posted, leaving the tolerability and recommended Phase 2 dose of the intravenous therapy still to be established.
Executive Summary
- Hengrui's Phase 1 dose-escalation trial of SHR-7367 in advanced tumors has moved to Completed status, with its primary completion date recorded well before the update reached the registry.
- The trial was designed to find dose-limiting toxicities, adverse-event rates, and a recommended Phase 2 dose for the intravenous therapy, not to demonstrate efficacy.
- The registry's enrollment figure fell sharply versus an earlier planning estimate, but the change reflects a shift from an anticipated to an actual count rather than a shortfall against the trial's real target, which the final record shows was met in full.
- Hengrui is already advancing SHR-7367 into a larger combination study, positioning this Phase 1 safety and dosing work as a stepping stone rather than an endpoint in itself.
The completion
NCT05740202, a single-arm, open-label Phase 1 study of SHR-7367 in adults with advanced or metastatic tumors, moved to Completed status in the registry, with a primary completion date of August 4, 2025. The trial ran from its March 2023 start to that completion date, an 903-day span, and enrolled patients across sites in China. Enrollment closed at 22 patients, matching the trial's actual final target. NCT05740202A Trial of SHR-7367 in Subjects With Advanced Solid TumorsNCT05740202
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 study's three primary endpoints are dose-limiting toxicities assessed over three weeks, the incidence and severity of adverse and serious adverse events graded by CTCAE v5.0 over 12 months, and the recommended Phase 2 dose of intravenous SHR-7367. Fourteen secondary endpoints cover pharmacokinetics, immunogenicity, and an exploratory objective response rate using RECIST 1.1. This design, a single experimental arm with no comparator and no blinding, is built to establish a tolerable dose to carry forward, not to demonstrate a treatment effect. NCT05740202A Trial of SHR-7367 in Subjects With Advanced Solid TumorsNCT05740202
The enrollment figure
The registry's enrollment count changed from 182 to 22 patients on August 5, 2025, coinciding with the shift from an anticipated enrollment estimate to the trial's actual, final enrollment. The trial's own enrollment target for actual completion was 22, and the final record shows that target was met, not missed. A registry-derived operational read flagged the change as a large percentage swing against the earlier anticipated figure, but the earlier 182 figure was a projection rather than the trial's real recruitment goal, and the completed trial closed at its intended size. NCT05740202A Trial of SHR-7367 in Subjects With Advanced Solid TumorsNCT05740202
Where it sits in the pipeline
SHR-7367 has a second trial recruiting, a Phase 1/2 combination study pairing it with other anti-tumor agents in tumors, targeting an enrollment of 100 patients with a primary completion date in December 2027. That trial's continuation indicates Hengrui is moving SHR-7367 forward into combination testing. Hengrui's broader pipeline includes 58 trials, with 16 of 20 assessed trials completed and none of the resolved cohort showing extreme attrition.
The competitive frame
Tumors as a formal indication label draws a wide field, and the eight comparator programs surfaced in the same landscape, spanning KRAS G12C, HIF-2 alpha, PD-1, and CLPP-directed mechanisms from sponsors including Merck Sharp & Dohme, Hoffmann-La Roche, and OncoC4, none share SHR-7367's target or mechanism class. That leaves SHR-7367 without a direct comparator in the reviewed field, a reflection of how broadly the tumor label spans distinct biology rather than evidence of a validated or contested mechanism. The information this trial can supply is bounded to safety and dosing in a small, single-arm cohort, the basis on which any subsequent combination or expansion study would be justified.
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.