Qilu registered a Phase 3 for its Claudin6 ADC. The trial has not started.

Chinese industry notes on 12 November treated Qilu’s QLS5132 as a finished step: the first Claudin6 antibody-drug conjugate in the world to reach Phase 3. The registry entry they are citing is a plan, not a started study.

ClinicalTrials.gov posted NCT07926048 on 9 November. Qilu Pharmaceutical is the sponsor. The design is a randomized, open-label comparison of QLS5132 alone against the physician’s choice of liposomal doxorubicin, paclitaxel, or topotecan, in platinum-resistant recurrent ovarian, fallopian-tube, or primary peritoneal cancer. Enrollment is set at 420. Progression-free survival and overall survival are both primary endpoints. The posted start date is December 2026. The status, as of the 9 November posting, is not yet recruiting, and the record lists no countries and no sites.

That is still a lead on the obvious rival. TORL Bio’s TORL-1-23 had looked like the faster Claudin6 ADC; its pivotal study in this setting, CATALINA-2, is a Phase 2, with topline results talked about for mid-2027. An ESMO-GI update put TORL-1-23’s response rate near 32% in an evaluable ovarian cohort. Qilu is ahead on the phase number. It is not ahead on patients treated in a registration study.

The response rate that will get copied into slides is older and smaller. At AACR in April, Qilu reported a Phase 1 cut in platinum-resistant ovarian cancer: 28 patients treated, 18 evaluable, a 50% response rate and 94% disease control; at 3.2 mg/kg and above, 17 patients showed a 52.9% response rate. That is a dose-finding poster. It is the wrong denominator for a 420-patient survival trial that has not opened a site.

For anyone looking at China ADC rights, the sentence to keep is the unglamorous one. Qilu is first to register a Claudin6 Phase 3. It will be first to run one only when a patient is dosed.

Industry information only—not medical or investment advice.