What side effects are associated with this type of intervention?

The most common treatments for Glioblastoma include chemotherapy with temozolomide, radiation therapy, and targeted therapies. Temozolomide can cause side effects such as nausea, vomiting, fatigue, and myelosuppression (decreased blood cell production). Radiation therapy often leads to fatigue, hair loss at the treatment site, and skin changes. Targeted therapies, which may be similar to ST101, can cause side effects like rash, diarrhea, liver enzyme abnormalities, and fatigue. These treatments aim to inhibit tumor growth and survival pathways but can also impact normal cells, leading to these adverse effects.

What prior FDA approvals exist?

The FDA has approved several treatments for Glioblastoma that target tumor growth and survival pathways. Temozolomide, an oral alkylating agent, is commonly used in combination with radiation therapy for newly diagnosed Glioblastoma and as monotherapy for recurrent cases. Bevacizumab, a monoclonal antibody targeting vascular endothelial growth factor (VEGF), is approved for recurrent Glioblastoma due to its ability to inhibit angiogenesis. These treatments aim to disrupt the tumor's ability to grow and survive, similar to the investigational agent ST101 being studied for advanced solid tumors.

What other types of research exist?

A promising novel alternative to ST101 for Glioblastoma patients is Sulforaphane (SFN). SFN has shown potential as an anti-glioblastoma agent by targeting multiple apoptosis and cell survival pathways. Further preclinical and clinical studies may validate its efficacy, either alone or in combination with other therapies.

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Virus Therapy

ST101 for Advanced Cancer

Q: What is the mechanism of action of this treatment?

Glioblastoma treatments primarily include surgery, radiation therapy, and chemotherapy with agents like temozolomide. Surgery aims to remove as much of the tumor as possible, while radiation therapy uses high-energy rays to kill remaining cancer cells. Temozolomide, an oral chemotherapy drug, works by damaging the DNA of cancer cells, preventing them from replicating. Targeted therapies, such as bevacizumab, inhibit angiogenesis by blocking vascular endothelial growth factor (VEGF), thereby starving the tumor of nutrients. Immunotherapies aim to boost the body's immune response against cancer cells. These treatments are crucial for Glioblastoma patients as they target the rapid growth and survival mechanisms of the tumor, aiming to prolong survival and improve quality of life. ST101, likely an anti-cancer agent, may work by interfering with specific pathways essential for tumor growth and survival, offering a potential new avenue for treatment.

Phase 1 & 2

Recruiting

Research Sponsored by Sapience Therapeutics

Eligibility Criteria Checklist

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

Must have

All previous anti-cancer therapy-related adverse events should have resolved to grade 1 or baseline value with the exception of alopecia

Must have a locally advanced or metastatic inoperable tumor as specified for the dose escalation/regimen exploration phase and the expansion phase

Must not have

Active infection with human immunodeficiency virus (HIV) and CD4+ T-cell count <350/μL

Symptomatic ascites or pleural effusion

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 30 months

Awards & highlights

Summary

This trial is testing a new cancer drug to see if it is safe and effective.

Who is the study for?

Adults with advanced solid tumors, including glioblastoma and certain types of breast, prostate, and melanoma cancers. Participants must have a measurable disease that's progressed after previous treatments, be willing to use birth control if necessary, and able to provide biopsy samples. They should not have other active cancers or infections like hepatitis B/C or HIV, nor should they be on certain medications that could affect the trial.Check my eligibility

What is being tested?

The study is testing ST101 given intravenously alongside Temozolomide and Radiation in two phases: first to find the safest dose (Phase 1) and then to see how well it works at that dose (Phase 2). Researchers want to learn about its safety, how the body processes it, and its preliminary effectiveness against cancer.See study design

What are the potential side effects?

Potential side effects may include typical reactions from chemotherapy such as nausea, fatigue, hair loss which might not recover during treatment (alopecia), blood disorders. Since this is an investigational drug there may also be unknown risks or side effects.

Eligibility Criteria

Inclusion Criteria

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

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All my side effects from cancer treatment have improved, except for hair loss.

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My tumor cannot be removed by surgery and has spread.

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I am 18 years old or older.

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My cancer can be measured by scans and has at least one area that can be tracked over time.

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I am fully active or can carry out light work.

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My condition worsened or didn't respond to my last treatment.

Exclusion Criteria

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

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I have HIV with a CD4+ T-cell count below 350.

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I have fluid buildup in my abdomen or around my lungs.

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I do not have any other cancer needing treatment besides the one being studied.

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I have a long-term condition that causes low platelet counts.

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I haven't taken any cancer drugs or undergone certain treatments recently.

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I have an autoimmune disease that needs steroids or immunosuppressants.

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I have cancer that has spread to my brain or spinal cord.

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I do not have an active hepatitis B or C infection.

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I am on blood thinners that can't be stopped for a biopsy or had a clotting event recently.

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I am currently on medication for an infection.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 30 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~30 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 30 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

Adverse Events

Dose-Limiting Toxicity (DLT)

Secondary outcome measures

Area Under the Curve (AUC)

Cmax

DCR

+4 more

Side effects data

From 2016 Phase 2 trial • 175 Patients • NCT01055314

36%

Febrile neutropenia

31%

Death NOS

30%

Diarrhea

22%

Pain

21%

Hyperglycemia

16%

Anorexia

16%

Infections and infestations - Other, specify

16%

Alanine aminotransferase increased

14%

Hypokalemia

13%

Nausea

11%

Hyponatremia

10%

Weight loss

Anemia

Aspartate aminotransferase increased

Vomiting

Mucositis oral

Constipation

Dehydration

Hypophosphatemia

Platelet count decreased

Sepsis

Neoplasms benign, malignant and unspecified (incl cysts and polyps) - Other, specify

Catheter related infection

Colitis

Abdominal pain

White blood cell decreased

Hypotension

GGT increased

Hypocalcemia

Urinary retention

Hypoalbuminemia

Fever

Typhlitis

Anxiety

Neutrophil count decreased

Urinary tract infection

Peripheral motor neuropathy

Enterocolitis

Lipase increased

Pleural effusion

Serum amylase increased

Skin infection

Epistaxis

Urinary tract obstruction

Syncope

Lymphocyte count decreased

Wound infection

Blood bilirubin increased

Dermatitis radiation

Hypertension

Sinus tachycardia

Edema limbs

Bone pain

Dyspnea

Hematuria

Hypercalcemia

Upper gastrointestinal hemorrhage

Vulval infection

Depressed level of consciousness

Thromboembolic event

Stridor

Allergic reaction

Back pain

Lung infection

Urticaria

Acute kidney injury

Muscle weakness lower limb

Musculoskeletal and connective tissue disorder - Other, specify

Pain in extremity

Peripheral sensory neuropathy

Proctitis

Skin ulceration

Apnea

Stoma site infection

Tumor pain

Left ventricular systolic dysfunction

Pancreatitis

Portal hypertension

Rectal hemorrhage

Creatinine increased

Enterocolitis infectious

Hyperkalemia

Investigations - Other, specify

Abdominal distension

Anaphylaxis

Soft tissue infection

Ascites

Vascular disorders - Other, specify

Vasovagal reaction

Esophageal pain

Seizure

Heart failure

Penile pain

Gastrointestinal disorders - Other, specify

Bone marrow hypocellular

Delirium

Sore throat

Tracheitis

Menorrhagia

Hepatobiliary disorders - Other, specify

Anal mucositis

Anal hemorrhage

Fracture

Hydrocephalus

Device related infection

Tooth infection

Gastric ulcer

Sinusitis

Skin and subcutaneous tissue disorders - Other, specify

Pharyngitis

Pyramidal tract syndrome

Anal ulcer

Depression

Ejection fraction decreased

Rash maculo-papular

Pruritus

Myositis

Nail infection

Pain of skin

Pleuritic pain

Pneumonitis

Pneumothorax

Postoperative hemorrhage

Renal and urinary disorders - Other, specify

Respiratory, thoracic and mediastinal disorders - Other, specify

Salivary duct inflammation

Small intestine infection

Alkaline phosphatase increased

Appendicitis

Spinal fracture

Disseminated intravascular coagulation

Ear and labyrinth disorders - Other, specify

Endocrine disorders - Other, specify

Esophageal stenosis

Esophagitis

Gastric hemorrhage

Gum infection

Tumor lysis syndrome

Upper respiratory infection

Hypertriglyceridemia

Hypoxia

Ileus

INR increased

Laryngeal edema

Multi-organ failure

Myelodysplastic syndrome

Oral hemorrhage

Oral pain

Pulmonary edema

Rectal fistula

Rectal pain

Respiratory failure

Bladder spasm

Chest wall pain

Confusion

Congenital, familial and genetic disorders - Other, specify

CPK increased

Dizziness

Encephalopathy

Eye disorders - Other, specify

Generalized muscle weakness

Hoarseness

Hypernatremia

Hypoglycemia

Hypomagnesemia

Insomnia

Irregular menstruation

Irritability

Joint range of motion decreased cervical spine

Kyphosis

Lethargy

Headache

Laryngeal mucositis

Pelvic pain

Esophageal infection

Abdominal infection

Acidosis

Anal fistula

Fall

Fatigue

Gait disturbance

100%

80%

60%

40%

20%

Study treatment Arm

Group 1 (Chemotherapy, Radiation Therapy, Cixutumumab)

Group 2 (Chemotherapy, Radiation Therapy, Temozolomide)

Trial Design

7Treatment groups

Experimental Treatment

Group I: Newly Diagnosed GlioblastomaExperimental Treatment3 Interventions

Newly diagnosed patients with a suboptimal resection or biopsy must be candidates for another surgical resection as determined by neurosurgical evaluation or multidisciplinary team based on the current standard of care that suggests that maximal safe resection is beneficial. Recurrent GBM patients must be candidates for tumor resection

Group II: Dose Expansion Recurrent GlioblastomaExperimental Treatment1 Intervention

Recurrent GBM patients must have completed radiation at least 3 months prior to minimize the inclusion of patients with pseudoprogression. Recurrent GBM patients must have unequivocal radiographic evidence of tumor progression by contrast-enhanced magnetic resonance imaging (MRI) scan within 21 days prior to registration. Patients must be able to delay surgery for 2 - 4 weeks per investigator decision

Group III: Dose Expansion MelanomaExperimental Treatment1 Intervention

This cohort must have Melanoma that has progressed after/or on treatment with an immune checkpoint inhibitor (CPI) and have received 1-2 prior lines of therapy for their advanced/metastatic disease. The starting dose of ST101 for Expansion will be derived from the maximum tolerated dose (MTD)/recommended dose for expansion (RDE) and the best dosing schedule determined during Dose Escalation.

Group IV: Dose Expansion HR+ BreastExperimental Treatment1 Intervention

This cohort must have progressed after 1-2 hormone based therapies. The starting dose of ST101 for Expansion will be derived from the maximum tolerated dose (MTD)/recommended dose for expansion (RDE) and the best dosing schedule determined during Dose Escalation.

Group V: Dose Expansion GBMExperimental Treatment1 Intervention

Primary (de novo) GBM that has recurred or progressed (per modified RANO criteria) after 1 standard treatment regimen. Standard therapy is defined as maximal surgical resection, radiotherapy, and concomitant temozolomide with radiotherapy or adjuvant chemotherapy with temozolomide. The starting dose of ST101 for Expansion will be derived from the maximum tolerated dose (MTD)/recommended dose for expansion (RDE) and the best dosing schedule determined during Dose Escalation.

Group VI: Dose Expansion CRPCExperimental Treatment1 Intervention

CRPC that has progressed after previous treatment with taxanes, abiraterone and enzalutamide/apalutamide. The starting dose of ST101 for Expansion will be derived from the maximum tolerated dose (MTD)/recommended dose for expansion (RDE) and the best dosing schedule determined during Dose Escalation.

Group VII: Dose EscalationExperimental Treatment1 Intervention

This cohort only patients diagnosed with locally advanced or metastatic melanoma, carcinoma or sarcoma of any tumor type who are refractory or intolerant to all available therapies. ST101 will be administered intravenously (IV), initially once per week.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

ST101

2011

Completed Phase 2

~410

Temozolomide

2010

Completed Phase 3

~1930

Radiation

2003

Completed Phase 2

~780

0 / 16Eligibility 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

Glioblastoma treatments primarily include surgery, radiation therapy, and chemotherapy with agents like temozolomide. Surgery aims to remove as much of the tumor as possible, while radiation therapy uses high-energy rays to kill remaining cancer cells. Temozolomide, an oral chemotherapy drug, works by damaging the DNA of cancer cells, preventing them from replicating. Targeted therapies, such as bevacizumab, inhibit angiogenesis by blocking vascular endothelial growth factor (VEGF), thereby starving the tumor of nutrients. Immunotherapies aim to boost the body's immune response against cancer cells. These treatments are crucial for Glioblastoma patients as they target the rapid growth and survival mechanisms of the tumor, aiming to prolong survival and improve quality of life. ST101, likely an anti-cancer agent, may work by interfering with specific pathways essential for tumor growth and survival, offering a potential new avenue for treatment.