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Virus Therapy
ST101 for Advanced Cancer
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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 30 months
Awards & highlights
Study 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 belowSelect...
All my side effects from cancer treatment have improved, except for hair loss.
Select...
My tumor cannot be removed by surgery and has spread.
Select...
I am 18 years old or older.
Select...
My cancer can be measured by scans and has at least one area that can be tracked over time.
Select...
I am fully active or can carry out light work.
Select...
My condition worsened or didn't respond to my last treatment.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 30 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~30 months
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 moreSide effects data
From 2016 Phase 2 trial • 175 Patients • NCT0105531436%
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
9%
Aspartate aminotransferase increased
9%
Anemia
9%
Mucositis oral
9%
Vomiting
9%
Constipation
9%
Dehydration
9%
Hypophosphatemia
8%
Platelet count decreased
8%
Sepsis
7%
Neoplasms benign, malignant and unspecified (incl cysts and polyps) - Other, specify
7%
Catheter related infection
7%
Colitis
7%
Abdominal pain
6%
Hypotension
6%
White blood cell decreased
6%
GGT increased
6%
Hypocalcemia
6%
Urinary retention
6%
Hypoalbuminemia
6%
Fever
5%
Anxiety
5%
Typhlitis
5%
Neutrophil count decreased
5%
Urinary tract infection
4%
Peripheral motor neuropathy
4%
Enterocolitis
4%
Lipase increased
4%
Pleural effusion
4%
Serum amylase increased
4%
Skin infection
4%
Epistaxis
4%
Urinary tract obstruction
3%
Lymphocyte count decreased
3%
Wound infection
3%
Blood bilirubin increased
3%
Syncope
3%
Dermatitis radiation
3%
Hypertension
3%
Sinus tachycardia
3%
Edema limbs
3%
Bone pain
3%
Dyspnea
3%
Hematuria
3%
Hypercalcemia
2%
Thromboembolic event
2%
Upper gastrointestinal hemorrhage
2%
Vulval infection
2%
Depressed level of consciousness
2%
Stridor
2%
Allergic reaction
2%
Back pain
2%
Lung infection
2%
Urticaria
2%
Acute kidney injury
2%
Muscle weakness lower limb
2%
Musculoskeletal and connective tissue disorder - Other, specify
2%
Pain in extremity
2%
Peripheral sensory neuropathy
2%
Proctitis
2%
Skin ulceration
2%
Apnea
2%
Stoma site infection
2%
Tumor pain
2%
Left ventricular systolic dysfunction
2%
Pancreatitis
2%
Portal hypertension
2%
Rectal hemorrhage
2%
Creatinine increased
2%
Enterocolitis infectious
2%
Hyperkalemia
2%
Investigations - Other, specify
2%
Abdominal distension
1%
Esophageal pain
1%
Gastrointestinal disorders - Other, specify
1%
Heart failure
1%
Hepatobiliary disorders - Other, specify
1%
Penile pain
1%
Vascular disorders - Other, specify
1%
Ascites
1%
Bone marrow hypocellular
1%
Anaphylaxis
1%
Delirium
1%
Sore throat
1%
Vasovagal reaction
1%
Anal hemorrhage
1%
Soft tissue infection
1%
Tracheitis
1%
Anal mucositis
1%
Seizure
1%
Menorrhagia
1%
Fracture
1%
Hydrocephalus
1%
Device related infection
1%
Tooth infection
1%
Gastric ulcer
1%
Sinusitis
1%
Skin and subcutaneous tissue disorders - Other, specify
1%
Pharyngitis
1%
Pyramidal tract syndrome
1%
Anal ulcer
1%
Depression
1%
Ejection fraction decreased
1%
Rash maculo-papular
1%
Pruritus
1%
Myositis
1%
Nail infection
1%
Pain of skin
1%
Pleuritic pain
1%
Pneumonitis
1%
Pneumothorax
1%
Postoperative hemorrhage
1%
Renal and urinary disorders - Other, specify
1%
Respiratory, thoracic and mediastinal disorders - Other, specify
1%
Salivary duct inflammation
1%
Small intestine infection
1%
Alkaline phosphatase increased
1%
Appendicitis
1%
Spinal fracture
1%
Disseminated intravascular coagulation
1%
Ear and labyrinth disorders - Other, specify
1%
Endocrine disorders - Other, specify
1%
Esophageal stenosis
1%
Esophagitis
1%
Gastric hemorrhage
1%
Gum infection
1%
Tumor lysis syndrome
1%
Upper respiratory infection
1%
Hypertriglyceridemia
1%
Hypoxia
1%
Ileus
1%
INR increased
1%
Laryngeal edema
1%
Multi-organ failure
1%
Myelodysplastic syndrome
1%
Oral hemorrhage
1%
Oral pain
1%
Pulmonary edema
1%
Rectal fistula
1%
Rectal pain
1%
Respiratory failure
1%
Bladder spasm
1%
Chest wall pain
1%
Confusion
1%
Congenital, familial and genetic disorders - Other, specify
1%
CPK increased
1%
Dizziness
1%
Encephalopathy
1%
Eye disorders - Other, specify
1%
Generalized muscle weakness
1%
Hoarseness
1%
Hypernatremia
1%
Hypoglycemia
1%
Hypomagnesemia
1%
Insomnia
1%
Irregular menstruation
1%
Irritability
1%
Joint range of motion decreased cervical spine
1%
Kyphosis
1%
Lethargy
1%
Headache
1%
Laryngeal mucositis
1%
Pelvic pain
1%
Esophageal infection
1%
Abdominal infection
1%
Acidosis
1%
Anal fistula
1%
Fall
1%
Fatigue
1%
Gait disturbance
100%
80%
60%
40%
20%
0%
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 3
~1020
Find a Location
Who is running the clinical trial?
Sapience TherapeuticsLead Sponsor
1 Previous Clinical Trials
156 Total Patients Enrolled
Yasser Kamel, MDStudy DirectorSapience Medical Monitor
Alice Bexon, MDStudy ChairCMO
6 Previous Clinical Trials
323 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have HIV with a CD4+ T-cell count below 350.I have fluid buildup in my abdomen or around my lungs.I do not have any other cancer needing treatment besides the one being studied.I have a long-term condition that causes low platelet counts.You are allergic to ST101 or any of its ingredients.I agree to have two biopsies: one before and one during the study.All my side effects from cancer treatment have improved, except for hair loss.I haven't taken any cancer drugs or undergone certain treatments recently.My tumor cannot be removed by surgery and has spread.I am 18 years old or older.I haven't taken steroids for inflammation or autoimmune issues, or immunosuppressants in the last 30 days.I have an autoimmune disease that needs steroids or immunosuppressants.I have cancer that has spread to my brain or spinal cord.My cancer can be measured by scans and has at least one area that can be tracked over time.I do not have an active hepatitis B or C infection.I am on blood thinners that can't be stopped for a biopsy or had a clotting event recently.My doctor thinks standard treatments won't work for me or I've had bad reactions to cancer treatments.Your heart's electrical activity, as shown on an ECG, takes too long between two specific waves.I am currently on medication for an infection.I am fully active or can carry out light work.My condition worsened or didn't respond to my last treatment.
Research Study Groups:
This trial has the following groups:- Group 1: Dose Expansion CRPC
- Group 2: Dose Expansion Recurrent Glioblastoma
- Group 3: Newly Diagnosed Glioblastoma
- Group 4: Dose Escalation
- Group 5: Dose Expansion HR+ Breast
- Group 6: Dose Expansion Melanoma
- Group 7: Dose Expansion GBM
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
How many participants have joined this research endeavor?
"This clinical trial requires 162 participants who possess the specified inclusion criteria. Those interested in joining this medical research can visit Texas Oncology - Baylor Charles A. Sammons Cancer Center in Dallas, Texas and Northwestern Medicine Cancer Centers in Warrenville, Illinois for enrollment."
Answered by AI
Does this experiment bring anything new to the scientific community?
"Since 2020, ST101 has been under investigative scrutiny. Sapience Therapeutics sponsored the first study of 162 participants and then followed it up with successful Phase 1 & 2 drug approvals. Currently, there is one active trial for this product ran by Sapience Therapeutics."
Answered by AI
Has ST101 been subject to any other scientific investigations?
"The first instance of research on ST101 was conducted in 2020 by the University of Leeds. To date, there are 3 concluded studies and 1 still ongoing clinical trial based mostly out of Dallas, Texas."
Answered by AI
What are the projected outcomes of this investigation?
"This 20-month trial's primary objective is to measure Dose-Limiting Toxicity (DLT). Secondary objectives encompass Area Under the Curve (AUC), Duration of Response, and Cmax."
Answered by AI
Are there still vacancies available in this research venture?
"Affirmative. The clinical trial is accepting volunteers as per the data available on clinicaltrials.gov. It was originally listed in July of 2020, with updates made up until November 15th 2022; 162 individuals will be recruited from 8 different medical institutions."
Answered by AI
How many healthcare facilities are administering this clinical trial?
"Texas Oncology - Baylor Charles A. Sammons Cancer Center in Dallas, Texas, Northwestern Medicine Cancer Centers in Warrenville, Illinois and Columbia University in New york City are amongst the 8 additional medical centres involved with this test."
Answered by AI
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