Neoplasms

Urinary Tract, Sexual Organs, and Pregnancy Conditions

All Conditions

Skin and Connective Tissue Diseases

Gland and Hormone Related Diseases

Rare Diseases

Uterine Cervical Neoplasms

Carcinoma

Breast Neoplasms

Carcinoma, Squamous Cell

Head and Neck Neoplasms

Ovarian Neoplasms

Carcinoma, Ovarian Epithelial

Breast Diseases

Skin Diseases

Ovarian Cancer

Ovarian Epithelial Cancer

All Drugs and Chemicals

Antineoplastic Agents

Hormones

Fulvestrant

Estrogens

Hormone Antagonists

Estrogen Antagonists

Estrogen Receptor Antagonists

Antineoplastic Agents, Hormonal

* Cohort A0: Advanced Solid tumors expressing PI3Kα mutations.
* Cohort A1: HR+/HER2- breast cancer expressing PI3Kα H1047X mutations or other kinase domain mutations.

* Cohort A2: Gynecologic cancers
* Cohort A3: HNSCC
* Cohort A4: Other solid tumors not included in Cohorts A0, A1, or A2
* Mutations for Cohorts A2, A3, and A4: PI3Kα H1047X mutations or other kinase domain mutations
* Cohort A5: Solid tumors expressing PI3Kα helical domain mutations (E542/E545)

Recommended Phase 2 dose (RP2D)

Cohort A1: HR+/HER2- breast cancer expressing PI3Kα H1047X mutations or other kinase domain mutations.

Cohort A1: HR+/HER2- breast cancer expressing PI3Kα H1047X mutations or other kinase domain mutations.

Cohort B: HR+/HER2- breast cancer expressing PI3Kα H1047X mutations or other kinase domain mutations.

STX-478 is a second generation, mutant-selective, oral PI3Kα small molecule allosteric inhibitor.

STX-478

Fulvestrant will be administered according to local labeling.

For questions concerning enrollment

Mark Chao, MD, PhD

Study STX-478-101 is a multipart, open-label, phase 1/2 study evaluating the safety, tolerability, pharmacokinetics (PK), and preliminary antitumor activity of STX-478 in participants with advanced solid tumors with certain mutations.

Part 1 will evaluate STX-478 as monotherapy in participants with advanced solid tumors and breast cancer; Part 2 will evaluate STX-478 therapy as combination therapy with fulvestrant in participants with breast cancer.

Each study part will include a 28-day screening period, followed by treatment with STX-478 monotherapy or combination therapy.

First-in-Human Study of STX-478 as Monotherapy and in Combination With Other Antineoplastic Agents in Participants With Advanced Solid Tumors

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

Scorpion Therapeutics, Inc.

Spots Global Cancer Trial Database for pi3kα

Every month we try and update this database with for pi3kα cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for pi3kα

Every month we try and update this database with for pi3kα cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for pi3kα cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.