What side effects are associated with this type of intervention?

Common treatments for breast cancer, including chemotherapy, hormone therapy, and targeted therapy, have a range of side effects. Chemotherapy often causes nausea, vomiting, hair loss, fatigue, and increased infection risk. Hormone therapies like tamoxifen and aromatase inhibitors can lead to hot flashes, joint pain, bone density loss, and cardiovascular risks. Targeted therapies, such as monoclonal antibodies like trastuzumab, may cause infusion reactions, cardiotoxicity, and skin rashes. The severity and frequency of these side effects can vary among patients.

What prior FDA approvals exist?

The FDA has approved several drugs for the treatment of breast cancer that exhibit antitumor activity, similar to the investigational drug STX-478. Notable examples include fulvestrant, an estrogen receptor antagonist used in hormone receptor-positive metastatic breast cancer, often in combination with other agents. Additionally, CDK4/6 inhibitors like palbociclib, ribociclib, and abemaciclib are approved for use in combination with endocrine therapy, such as letrozole or fulvestrant, to enhance antitumor efficacy. These treatments aim to inhibit cancer cell proliferation and improve patient outcomes in advanced breast cancer.

What other types of research exist?

Promising novel alternatives to STX-478 for breast cancer patients include TAK-285, which has shown greater inhibition of brain tumor growth in a breast cancer brain metastasis model compared to lapatinib, and STX140, which demonstrated superior efficacy to docetaxel in a prostate hormone-independent PC-3 xenograft model and significant inhibition of tumor growth in breast cancer models.

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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

Must not have

Has a tumor with known mutations/deletions in PTEN and activating mutations in AKT (E17K) confirmed by a CLIA-certified or similarly certified laboratory

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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a new drug called STX-478 to see if it can help treat advanced solid tumors and breast cancer. The study will look at how safe the drug is, how it behaves in the body, and if it can stop or slow down cancer growth. Some patients will receive just STX-478, while others will get it combined with another drug called fulvestrant, which is often used to treat advanced breast cancer.

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.

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.

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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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My tumor has specific genetic changes in PTEN and AKT.

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I haven't had cancer treatment or experimental drugs in the last 14 days to 28 days.

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I have type 1 diabetes or uncontrolled type 2 diabetes and need medication.

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I have cancer that has spread to my brain or spine and is causing symptoms.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

4Treatment groups

Experimental Treatment

Group I: Dose Selection/Expansion: Combination STX-478 + fulvestrantExperimental Treatment2 Interventions

Cohort B: HR+/HER2- or HR+/HER2low breast cancer expressing PI3Kα mutations

Group II: Dose Selection/Expansion Combination STX-478 + fulvestrant + CDK4/6 inhibitorExperimental Treatment4 Interventions

Cohort C/D: HR+/HER2- or HR+/HER2low breast cancer expressing PI3Ka mutations

Group III: Dose ExpansionExperimental Treatment1 Intervention

* Cohort A1: HR+/HER2- breast cancer expressing PI3Ka mutations * Cohort A2: Gynecologic cancers * Cohort A3: Head and Neck Squamous Cell Carcinoma * Cohorts A4/A5: Other solid tumors not included in Cohorts A1, A2, or A3 expressing PI3Kα mutations

Group IV: Dose Escalation (Advanced Solid Tumors)Experimental Treatment1 Intervention

* Cohort A0: Advanced Solid tumors expressing PI3Kα mutations * Cohort A1: HR+ breast cancer expressing PI3Kα mutations

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Ribociclib

2018

Completed Phase 3

~2420

Palbociclib

2017

Completed Phase 3

~3880

Fulvestrant

2011

Completed Phase 3

~3520

0 / 8Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for breast cancer, particularly hormone receptor-positive types, include endocrine therapies like tamoxifen and fulvestrant, and targeted therapies such as those inhibiting specific mutations (e.g., PIK3CA). Endocrine therapies work by blocking estrogen receptors or reducing estrogen production, thereby slowing the growth of hormone-sensitive tumors. Targeted therapies, on the other hand, inhibit specific molecular pathways that are crucial for cancer cell survival and proliferation. For instance, STX-478 is being studied for its antitumor activity in combination with fulvestrant, which highlights the importance of targeting both hormone receptors and specific mutations. These mechanisms are crucial as they offer more personalized and effective treatment options, potentially leading to better outcomes and fewer side effects for breast cancer patients.

Exploring the Molecular Mechanism of the Drug-Treated Breast Cancer Based on Gene Expression Microarray.Implementing neoadjuvant endocrine strategies in ER-positive, HER2-negative breast cancer.