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STX-478 + Fulvestrant for Advanced Breast Cancer

Phase 1 & 2

Recruiting

Research Sponsored by Scorpion Therapeutics, Inc.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Has an advanced or refractory solid tumor malignancy that is metastatic or locally advanced and unresectable (as specified by Cohort)

Is ≥18 years of age at the time of signing the ICF

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 12 months

Awards & highlights

Study Summary

This trial is testing a drug to see if it can safely and effectively treat advanced solid tumors. Participants will receive either the drug alone or with another drug.

Who is the study for?

This trial is for adults with advanced solid tumors, including breast and gynecologic cancers, that have a specific mutation (PI3Kα). Participants must be in good physical condition (ECOG score of 0 or 1) and not have uncontrolled diabetes or recent treatments with certain inhibitors. They should not have other cancer types within the last two years or brain/spinal metastases.Check my eligibility

What is being tested?

The study tests STX-478 alone and combined with Fulvestrant on patients with advanced solid tumors. It's divided into parts: one for STX-478 as monotherapy, another for combination therapy. The treatment follows a screening period and aims to assess safety, tolerability, and anti-tumor effects.See study design

What are the potential side effects?

While the side effects are not explicitly listed here, common ones from similar therapies may include nausea, fatigue, skin reactions at injection sites, hormonal imbalances due to Fulvestrant in combination therapy, and potential liver function changes.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My cancer has spread or can't be removed by surgery.

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I am 18 years old or older.

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I am fully active or restricted in physically strenuous activity but can do light work.

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My tumor has a PI3Kα mutation confirmed by an approved test.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 12 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~12 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Part 1.1 (Dose Escalation): AUC(0-inf) of STX-478

Part 1.1 (Dose Escalation): AUC(0-t) of STX-478

Part 1.1 (Dose Escalation): AUC(0-τ) of STX-478

+23 more

Trial Design

6Treatment groups

Experimental Treatment

Group I: Part 2.2: RP2D ExpansionExperimental Treatment2 Interventions

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

Group II: Part 2.1: RP2D SelectionExperimental Treatment2 Interventions

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

Group III: Part 1.3: RP2D Expansion (Breast)Experimental Treatment1 Intervention

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

Group IV: Part 1.2-DS: RP2D Selection (Breast)Experimental Treatment1 Intervention

Recommended Phase 2 dose (RP2D) Cohort A1: HR+/HER2- breast cancer expressing PI3Kα H1047X mutations or other kinase domain mutations.

Group V: Part 1.2-DE: Dose expansion at MTDExperimental Treatment1 Intervention

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)

Group VI: Part 1.1: Dose Escalation (Advanced Solid Tumors and Breast)Experimental Treatment1 Intervention

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

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Fulvestrant

2011

Completed Phase 3

~3690

0 / 4Eligibility criteria met

Find a Location

Who is running the clinical trial?

Scorpion Therapeutics, Inc.Lead Sponsor

1 Previous Clinical Trials

120 Total Patients Enrolled

Carlos Amaya-Chanaga, MDStudy DirectorScorpion Therapeutics, Inc.

Michael Streit, MDStudy DirectorScorpion Therapeutics, Inc.

Media Library

STX-478 (Other) Clinical Trial Eligibility Overview. Trial Name: NCT05768139 — Phase 1 & 2

Breast Cancer Research Study Groups: Part 1.1: Dose Escalation (Advanced Solid Tumors and Breast), Part 1.2-DE: Dose expansion at MTD, Part 2.1: RP2D Selection, Part 1.2-DS: RP2D Selection (Breast), Part 1.3: RP2D Expansion (Breast), Part 2.2: RP2D Expansion

Breast Cancer Clinical Trial 2023: STX-478 Highlights & Side Effects. Trial Name: NCT05768139 — Phase 1 & 2

STX-478 (Other) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05768139 — Phase 1 & 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any available vacancies in this clinical experiment?

"Affirmative. Clinicaltrials.gov's records demonstrate that this clinical trial is actively seeking enrollees, as initially posted on March 1st 2023 and recently modified on the 13th of the same month. They require 160 participants from a single location to participate."

Answered by AI

How many participants have been enlisted for this clinical trial?

"Verified. The clinicaltrials.gov portal indicates that this trial is presently recruiting patients, with the initial posting occuring on March 1st 2023 and being last updated on March 13th 2023. Around 160 participants are expected to be recruited from a single site for enrolment in this study."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

2023. "First-in-Human Study of STX-478 as Monotherapy and in Combination With Other Antineoplastic Agents in Participants With Advanced Solid Tumors". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05768139.

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