Trial Title:
First-in-Human Study of STX-478 as Monotherapy and in Combination With Other Antineoplastic Agents in Participants With Advanced Solid Tumors
NCT ID:
NCT05768139
Condition:
Breast Cancer
Gynecologic Cancer
HNSCC
Solid Tumors, Adult
Conditions: Official terms:
Breast Neoplasms
Fulvestrant
Palbociclib
Conditions: Keywords:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
HER2-negative breast cancer
HR-positive breast cancer
Gynecologic cancer
Endometrial cancer
Ovarian cancer
Cervical cancer
Head and neck cancer
Head and neck squamous cell carcinoma
Fulvestrant
Antineoplastic Agents
PI3Kα
PI3K alpha
PI3Kα mutation
Alpelisib
STX-478
PI3Kα inhibitor
Estrogen Receptor Antagonists
Estrogen Antagonists
Hormone Receptor Antagonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Palbociclib
Ribociclib
PIK3CA
PIK3CA mutation
Study type:
Interventional
Study phase:
Phase 1/Phase 2
Overall status:
Recruiting
Study design:
Allocation:
Non-Randomized
Intervention model:
Sequential Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
STX-478
Description:
STX-478 is a mutant-selective PI3Kα inhibitor
Arm group label:
Dose Escalation (Advanced Solid Tumors)
Arm group label:
Dose Expansion
Arm group label:
Dose Selection/Expansion Combination STX-478 + fulvestrant + CDK4/6 inhibitor
Arm group label:
Dose Selection/Expansion: Combination STX-478 + fulvestrant
Intervention type:
Drug
Intervention name:
Fulvestrant
Description:
Fulvestrant
Arm group label:
Dose Selection/Expansion Combination STX-478 + fulvestrant + CDK4/6 inhibitor
Arm group label:
Dose Selection/Expansion: Combination STX-478 + fulvestrant
Other name:
Faslodex
Intervention type:
Drug
Intervention name:
Ribociclib
Description:
Ribociclib
Arm group label:
Dose Selection/Expansion Combination STX-478 + fulvestrant + CDK4/6 inhibitor
Other name:
Kisqali
Intervention type:
Drug
Intervention name:
Palbociclib
Description:
Palbociclib
Arm group label:
Dose Selection/Expansion Combination STX-478 + fulvestrant + CDK4/6 inhibitor
Other name:
Ibrance
Summary:
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 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 fulvestrant and a CDK4/6 Inhibitor (either Ribociclib
or Palbociclib) 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.
Criteria for eligibility:
Criteria:
Key Inclusion Criteria:
1. Has an advanced or refractory solid tumor malignancy that is metastatic or locally
advanced and unresectable (as specified by Cohort)
2. Has a new or recent tumor biopsy (collected at screening, if feasible) or archival
tumor specimen within 10 years prior to screening
3. Has a tumor that harbors a documented PI3Kα mutation (cohort specific criterion for
cohort-specific mutation types)
4. Is ≥18 years of age at the time of signing the ICF
5. Has an ECOG performance status score of 0 or 1 at screening
6. Has adequate organ function as defined per protocol
Key Exclusion Criteria:
1. Has history (within ≤2 years before screening) of a solid tumor or hematological
malignancy that is histologically distinct from the cancers being studied
2. Has symptomatic brain or spinal metastases
3. Has tumor with known mutations/deletions in PTEN, and activating mutations in AKT
(E17K) confirmed by a CLIA-certified or similarly certified laboratory
4. Has an established diagnosis of diabetes mellitus type 1 or has uncontrolled
diabetes mellitus type 2 (based on FPG and HbA1c thresholds defined in the inclusion
criteria) requiring antihyperglycemic medication
5. Cohorts A0, A1, A2, A3, A4, A5 and B: Has had prior treatment with PI3K/AKT/mTOR
inhibitor(s), except in certain circumstances
6. 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
7. 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
8. Has had radiotherapy within 14 days before the initiation of study treatment
9. Cohorts C1, C2, D1, and D2: Any prior systemic therapy for metastatic breast cancer,
prior treatment with fulvestrant or any selective estrogen-receptor degrader, with
the exception of participants that have received fulvestrant or any selective
estrogen-receptor degrader as a part of neoadjuvant therapy only
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Angeles Clinic and Research Institute
Address:
City:
Los Angeles
Zip:
90025-6602
Country:
United States
Status:
Recruiting
Facility:
Name:
University of California, San Francisco
Address:
City:
San Francisco
Zip:
94158
Country:
United States
Status:
Recruiting
Facility:
Name:
University of Colorado Anschutz Medical Center
Address:
City:
Aurora
Zip:
80045
Country:
United States
Status:
Recruiting
Facility:
Name:
Yale University
Address:
City:
New Haven
Zip:
06520
Country:
United States
Status:
Recruiting
Facility:
Name:
Florida Cancer Specialists & Research Institute
Address:
City:
Lake Mary
Zip:
32746-2115
Country:
United States
Status:
Recruiting
Facility:
Name:
Moffitt Cancer Center
Address:
City:
Tampa
Zip:
33612
Country:
United States
Status:
Recruiting
Facility:
Name:
Massachusetts General Hospital
Address:
City:
Boston
Zip:
02114-2696
Country:
United States
Status:
Recruiting
Facility:
Name:
Dana Farber Cancer Center
Address:
City:
Boston
Zip:
02215
Country:
United States
Status:
Recruiting
Facility:
Name:
Karmanos Cancer Institute
Address:
City:
Detroit
Zip:
48201
Country:
United States
Status:
Recruiting
Facility:
Name:
Saint Luke's Cancer Institute
Address:
City:
Kansas City
Zip:
64111
Country:
United States
Status:
Recruiting
Facility:
Name:
Memorial Sloan Kettering Cancer Center
Address:
City:
New York
Zip:
10065
Country:
United States
Status:
Recruiting
Facility:
Name:
University Hospitals Cleveland Medical Center
Address:
City:
Cleveland
Zip:
44106
Country:
United States
Status:
Recruiting
Facility:
Name:
Stefanie Spielman Comprehensive Breast Cancer
Address:
City:
Columbus
Zip:
43212
Country:
United States
Status:
Recruiting
Facility:
Name:
University of Oklahoma
Address:
City:
Oklahoma City
Zip:
73104-5418
Country:
United States
Status:
Recruiting
Facility:
Name:
Mary Crowley Cancer Research
Address:
City:
Dallas
Zip:
75230
Country:
United States
Status:
Recruiting
Facility:
Name:
Texas Oncology - Baylor Charles A. Sammons Cancer Center
Address:
City:
Dallas
Zip:
75246
Country:
United States
Status:
Recruiting
Facility:
Name:
The University of Texas MD Anderson Cancer Center
Address:
City:
Houston
Zip:
77030
Country:
United States
Status:
Recruiting
Facility:
Name:
NEXT Virginia
Address:
City:
Fairfax
Zip:
22031
Country:
United States
Status:
Recruiting
Facility:
Name:
Institut Bergonie City: Bordeaux
Address:
City:
Bordeau
Zip:
33000
Country:
France
Status:
Recruiting
Facility:
Name:
Institut Gustave Roussy
Address:
City:
Villejuif
Zip:
94800
Country:
France
Status:
Recruiting
Facility:
Name:
Fondazione Policlinico Universitario A Gemelli-Rome
Address:
City:
Roma
Zip:
00168
Country:
Italy
Status:
Recruiting
Facility:
Name:
Istituto Europeo di Oncologia
Address:
City:
Milano
Zip:
20141
Country:
Italy
Status:
Recruiting
Facility:
Name:
NEXT Oncology - Hospital Quironsalud Madrid
Address:
City:
Pozuelo De Alarcón
Zip:
28223
Country:
Spain
Status:
Recruiting
Facility:
Name:
START Barcelona_HM Nou Delfos
Address:
City:
Barcelona
Zip:
08023
Country:
Spain
Status:
Recruiting
Facility:
Name:
Instituto de Investigacion Oncologica Vall d'Hebron
Address:
City:
Barcelona
Zip:
08035
Country:
Spain
Status:
Recruiting
Facility:
Name:
Hospital Clínico San Carlos
Address:
City:
Madrid
Zip:
28040
Country:
Spain
Status:
Recruiting
Facility:
Name:
START Madrid_Hospital Universitario Fundacion Jimenez Diaz
Address:
City:
Madrid
Zip:
28050
Country:
Spain
Status:
Recruiting
Facility:
Name:
START Madrid_Hospital Universitario HM Sanchinarro
Address:
City:
Madrid
Zip:
28050
Country:
Spain
Status:
Recruiting
Start date:
April 17, 2023
Completion date:
February 28, 2029
Lead sponsor:
Agency:
Scorpion Therapeutics, Inc.
Agency class:
Industry
Source:
Scorpion Therapeutics, Inc.
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05768139
