Clinical Trials Watch — 2026-06-01

TITLE: Clinical Trials Watch — Phase II oncology readouts, NIH biomarker pushes, and a Telix EAP shuttered

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This Week's Signal

A quieter tape with no Phase III readouts crossing the wire, but several NIH-sponsored biomarker programs remain active and one Telix expanded-access program has gone dark. Phase II oncology and rare-disease assets dominate the completed/active column.

Phase II

• Sidney Kimmel/Jefferson wrapped its NCT02583893 Phase II of sirolimus plus chemotherapy in high-risk and secondary AML (n=39), with biochemical response as the primary endpoint — small dataset, but a biomarker-stratified mTOR readout in a population with few options.
• NHGRI's NCT04316546 Phase II of MK-7075 (miransertib) in Proteus syndrome (n=38) is active but no longer recruiting, with CCTN as primary — a key AKT-inhibitor readout to watch for the broader PROS/overgrowth class.

Phase III

No Phase III readouts or initiations in this week's tape.

Phase IV / Real-World & Stewardship

• Althaia Manresa completed NCT07604597, a digital stewardship intervention for reported penicillin allergy (n=182), measuring uptake of empirical beta-lactam therapy — a small but pragmatic antimicrobial-stewardship signal relevant to hospital formulary decisions.

Non-Phased / Observational & Biomarker Programs

NIH institutes continue to anchor the long-tail biomarker and registry work this week:

• NINDS is still recruiting NCT02639325 in tumor-related epilepsy (n=100), tracking seizure-frequency change on the Engel scale — a relatively rare prospective dataset bridging neuro-oncology and epileptology.
• Centre Antoine Lacassagne's NCT06851975 is enrolling an ambitious n=40,000 pan-cancer biomarker cohort for survival and treatment-response prediction — scale here is the story; expect downstream signature papers rather than near-term readouts.
• NHLBI's NCT02423070 "Genome Transplant Dynamics" (n=991) continues validating donor-derived cell-free DNA as a rejection biomarker in thoracic transplant — a space where commercial dd-cfDNA assays are already pressuring clinical practice.
• NCI's NCT00342654 Linxian nutrition-intervention follow-up (n=32,902) reported completion status this week — a legacy cohort still generating esophageal/gastric cancer incidence and mortality data decades on.

Terminations & Access Changes

• NCT06090331, Telix's expanded-access program for 89Zr-DFO-girentuximab in clear cell RCC, is now listed NO_LONGER_AVAILABLE. With the diagnostic (Zircaix) on a commercial trajectory, the EAP closure likely reflects a transition to approved/commercial supply rather than a safety signal — worth confirming with sponsor commentary.

Also Noted

• Two small mechanistic/device studies completed without commercial relevance: NCT07612969 (PNF coupled with dry needling vs. acupuncture vs. sham in healthy males, n=65) and Bordeaux's NCT01254474 monophasic action potential catheter evaluation in AF/VF (n=42).

Bottom Line

A maintenance week: no pivotal readouts, but the Telix EAP delisting is the single item worth a follow-up call, and the miransertib Proteus readout (NCT04316546) remains the most interesting near-term rare-disease catalyst on this list.