Informations générales (source: ClinicalTrials.gov)
First-in-Human Study of STX-478, a Mutant-Selective PI3Kα Inhibitor as Monotherapy and in Combination With Other Antineoplastic Agents in Participants With Advanced Solid Tumors
Interventional
Phase 1/Phase 2
Eli Lilly and Company (Voir sur ClinicalTrials)
avril 2023
juillet 2030
02 décembre 2025
Study STX-478-101 (LY4064809) is a multipart, open-label, phase 1/2 study evaluating the
safety, tolerability, pharmacokinetics (PK), and preliminary antitumor activity of
STX-478 (LY4064809) in participants with advanced solid tumors with P13Ka mutations.
Part 1 will evaluate STX-478 as monotherapy in participants with advanced solid tumors.
Part 2 will evaluate STX-478 therapy as combination therapy with fulvestrant in
participants with hormone receptor positive (HR+) breast cancer. Part 3 will evaluate
STX-478 as combination therapy with endocrine therapy (aromatase inhibitors, fulvestrant
or imlunestrant) and a CDK4/6 Inhibitor (either Ribociclib, Palbociclib or Abemaciclib)
in participants with HR+ breast cancer.
Each study part will include a 28-day screening period, followed by treatment with
STX-478 monotherapy or combination therapy.
Etablissements
| Les établissements d'Île-de-France ayant mis à jour leurs données Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| CLCC INSTITUT GUSTAVE ROUSSY | Barbara PISTILLI | 25/06/2024 12:41:28 | Contacter | ||
Critères
Tous
- Has an advanced or refractory solid tumor malignancy that is metastatic or locally
advanced and unresectable (as specified by Cohort)
- Has a new or recent tumor biopsy (collected at screening, if feasible) or will
provide an adequate tissue sample prior to screening
- Has a tumor that harbors a documented PI3Kα mutation (cohort specific criterion for
cohort-specific mutation types)
- Is ≥18 years of age at the time of signing the ICF
- Has an ECOG performance status score of 0 or 1 at screening
- Has adequate organ function as defined per protocol
Key Exclusion Criteria:
- Has history (within ≤2 years before screening) of a solid tumor or hematological
malignancy that is histologically distinct from the cancers being studied
- Has symptomatic brain or spinal metastases
- Has an established diagnosis of uncontrolled diabetes mellitus (defined as HbA1c ≥8%
and/or FBG ≥140 mg/dL [7.7 mmol/L] and/or requiring or required insulin).
- Has had prior treatment with PI3K/AKT/mTOR inhibitor(s), except in certain
circumstances
- Has had treatment with any local or systemic antineoplastic therapy or
investigational anticancer agent within 14 days or 4 half-lives, whichever is
longer, prior to the initiation of study treatment up to a maximum washout period of
28 days. Endocrine therapy does not require a washout period if the patient is
enrolling in a cohort with the same combination endocrine therapy.
- Has toxicities from previous anticancer therapies that have not resolved to baseline
levels or CTCAE grade ≤1, with the exception of alopecia and peripheral neuropathy.
- Has had radiotherapy within 14 days before the initiation of study treatment