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

Description

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.

Conditions

Breast Cancer, Gynecologic Cancer, HNSCC, Solid Tumors, Adult

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Study Overview

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Study Details

Study overview

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.

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

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

Condition
Breast Cancer
Intervention / Treatment

-

Contacts and Locations

Los Angeles

Angeles Clinic and Research Institute, Los Angeles, California, United States, 90025-6602

San Francisco

University of California, San Francisco, San Francisco, California, United States, 94158

Aurora

University of Colorado Anschutz Medical Center, Aurora, Colorado, United States, 80045

New Haven

Yale University, New Haven, Connecticut, United States, 06520

Lake Mary

Florida Cancer Specialists & Research Institute, Lake Mary, Florida, United States, 32746-2115

Tampa

Moffitt Cancer Center, Tampa, Florida, United States, 33612

Boston

Massachusetts General Hospital, Boston, Massachusetts, United States, 02114-2696

Boston

Dana Farber Cancer Center, Boston, Massachusetts, United States, 02215

Detroit

Karmanos Cancer Institute, Detroit, Michigan, United States, 48201

Kansas City

Saint Luke's Cancer Institute, Kansas City, Missouri, United States, 64111

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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
  • 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

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Scorpion Therapeutics, Inc.,

Amar Patel, MD, STUDY_DIRECTOR, Scorpion Therapeutics, Inc.

Study Record Dates

2029-02-28