GlioblastomaPhase 1/2NCT04478279
A Phase 1-2 Study of ST101 in Patients With Advanced Solid Tumors
A Phase 1/2 study testing ST101, Temozolomide and Radiation in people with Glioblastoma and Melanoma Stage IV, run by Sapience Therapeutics at 11 sites in 2 countries.
Trial summary
This is an open-label, two-part, phase 1-2 dose-finding study designed to determine the safety, tolerability, PK, PD, and proof-of-concept efficacy of ST101 administered IV in patients with advanced solid tumors. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Glioblastoma, Melanoma Stage IV, Breast Cancer
- What is being tested?
- ST101, Temozolomide and Radiation
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 125 participants
- Where
- 11 sitesin 2 countries
- Study dates
- 1 Jul 2020to Dec 2026
- Phase
- Phase 1/2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Able and willing to sign informed consent form (ICF) and comply with the protocol and the restrictions and assessments therein.
- Male or female ≥18 years of age.
- Eastern Cooperative Oncology Group (ECOG) performance status 0-1.
- Must have a locally advanced or metastatic inoperable tumor as follows:
- For the dose escalation/regimen exploration phase: melanoma, carcinoma, or sarcoma
- For the expansion phase: HR positive LA/MBC, melanoma, GBM, CRPC
Show all 15Show fewer
- Agrees to provide a newly obtained biopsy of an accessible lesion (if they can be biopsied based on the investigator's assessment) prior to the start of study treatment, and to repeat biopsy once during study treatment. Tissue obtained for the biopsy must not be previously irradiated (unless progressing following irradiation), but a new or progressing lesion in the radiation field is acceptable. Archived biopsies are acceptable for GBM patients.
- In the investigator's opinion, the patient may not derive clinical benefit from, or is ineligible for, a particular form of standard therapy on medical grounds, or the patient failed or did not tolerate one or more of other anti-cancer therapies:
- For the dose escalation/regimen exploration phase up to 3 previous lines of systemic anticancer therapies are allowed. Since this is a FIH study, it's important that patients are not refractory to therapeutic intervention due to multiple lines of prior therapies.
- For the expansion phase: i. HRpos LA/MBC must have progressed after prior 1-2 hormone-based therapies. Previous treatment with cyclin-dependent kinase 4/6 (CDK4/6) inhibitor, mammalian target of rapamycin (mTOR) inhibitor or chemotherapy is allowed as monotherapy or in combination ii. Melanoma that has progressed after or on treatment with a CPI and have received 1-2 prior lines of therapy for their advanced/metastatic disease. Patients that have BRAF mutated disease should also have received one line of appropriate targeted therapy iii. Primary (de novo) GBM that has recurred or progressed (per modified RANO criteria) after 1 standard treatment regimen (surgery, radiotherapy, and temozolomide therapy). Patients that undergo tumor treating fields as an adjuvant to first line therapy are allowed.
- CRPC that has progressed after previous treatment with taxanes, abiraterone and enzalutamide/apalutamide or that are intolerant to these treatments.
- Evaluable disease per RECIST 1.1, modified RANO or PCWG3 with at least one target lesion
- Disease that progressed on, or is non-responsive to, the previous line of therapy per RECIST 1.1, modified RANO or PCWG3.
- If not menopausal or surgically sterile, willing to practice at least one of the following highly effective methods of birth control for at least a (partner's) menstrual cycle before and for four months after ST101 administration: (1) total abstinence from sexual intercourse with a member of the opposite sex; (2) sexual intercourse with vasectomized male/sterilized female partner; (3) combined (estrogen and progestogen containing) or progestogen-only hormonal contraception associated with inhibition of ovulation (oral, parenteral, transvaginal or transdermal) for at least 3 consecutive months prior to investigational product administration; (4) other acceptable forms of birth control (condoms, contraceptive sponge, diaphragm or vaginal ring with spermicide or cream); (5) use of an intrauterine contraceptive device.
- All previous anti-cancer therapy-related adverse events should have resolved to grade 1 or baseline value with the exception of alopecia. Levothyroxine is allowed for patients that previously received a CPI and experienced thyroid dysfunction.
Who cannot join
- <!-- -->
- Use of small molecule or tyrosine kinase inhibitor within 2 weeks or 5 half-lives (whichever is shorter) prior to the first dose of study drug; chemotherapy, investigational drug or biological cancer therapy within 3 weeks prior to the first dose of study therapy; nitrosourea or radioisotope within 6 weeks prior to first dose.
- Known hypersensitivity to ST101 or any of its excipients.
- Baseline corrected interval between q and t wave on electrocardiogram (ECG) (QTc) > 480 msec using Fredericia's formula.
- Symptomatic ascites or pleural effusion. A patient who is clinically stable following treatment for these conditions (including therapeutic thoraco- or paracentesis) is eligible.
- Known active central nervous system (CNS) metastases and/or carcinomatous meningitis. Patients with previously treated brain metastases may participate provided they are clinically stable for at least 4 weeks prior to study entry, have no evidence of new or enlarging brain metastases, and are off steroids for at least 14 days prior to first dose of study drug. This criterion does not apply to patients on the GBM cohort.
Show all 18Show fewer
- Presence of any other active malignancy requiring systemic therapy other than the disease under study.
- Active infection with human immunodeficiency virus (HIV) and CD4+ T-cell count <350/μL. Patients not on established ART for at least four weeks and having a detectable HIV viral load. Testing is not required for eligibility.
- Active infection with hepatitis B or hepatitis C, defined by a detectable viral load. Testing is not required for eligibility.
- Active autoimmune disease or a documented history of autoimmune disease or syndrome that requires systemic steroids or immunosuppressive agents. Vitiligo or resolved childhood asthma/atopy are exceptions to this rule. Patients requiring intermittent use of bronchodilators or topical steroids would not be excluded from the study. Patients with hypothyroidism that is stable on hormone replacement or controlled type 1 diabetes will not be excluded from the study.
- Use of systemic corticosteroids to treat inflammatory or autoimmune symptoms within 15 days or other immunosuppressive drugs within 30 days prior to the start of the study. Inhaled and topical corticosteroids are permitted. Up to 10 mg/day prednisone or equivalent is permitted as replacement therapy for adrenal insufficiency only.
- Active infection requiring systemic therapy.
- Active immune thrombocytopenic purpura or other chronic thrombocytopenic condition.
- Therapeutic anticoagulation that cannot be interrupted for a biopsy or had a thromboembolic event within the last 6 months.
- History or clinical evidence of any surgical or medical condition which the investigator judges as likely to interfere with the results of the study or pose an additional risk in participating, or makes the patient unlikely to comply with the study related visits and assessments particularly any pre-existing condition that would put the patient at additional risk should they experience an infusion-related reaction, e.g., rapidly progressive or uncontrolled disease involving a major organ system - vascular, cardiac, pulmonary, gastrointestinal, gynecologic, hematologic, neurologic, neoplastic, renal, endocrine, or an immunodeficiency
- Unable to comply with the visits and requirements of the protocol due to psychiatric condition or substance abuse. Pregnant or breastfeeding or planning to conceive or father children within the projected duration of the study.
- Exclusion Criteria for GBM Cohort:
- Any prior therapy for GBM other than that which is considered SOC for primary GBM, including but not limited to the following: i. more than one line of adjuvant temozolomide ii. prior treatment with another investigational drug iii. prior treatment with bevacizumab (Avastin) or other vascular-endothelial growth factor (VEGF) inhibitors or VEGF-receptor signaling inhibitors iv. prior treatment with nitrosoureas v. prior therapy that included interstitial brachytherapy or Gliadel® Wafers (carmustine implants) b) secondary GBM (i.e., GBM that progressed from low-grade diffuse astrocytoma or AA) c) tumor with a clinically significant mass effect (>5 mm midline shift) while on a stable corticosteroid dose d) prednisone or equivalent dose of >10mg per day e) known history of allergy
Trial locations and contacts
11 sites in 2 countries.
11 sites in 2 countries
United States7 sites
Sarah Cannon Research Institute
Denver, Colorado, 80218
Duke University School of Medicine
Durham, North Carolina, 27708
START Midwest
Grand Rapids, Michigan, 49503
Sarah Cannon Research Institute
Nashville, Tennessee, 37203
Columbia University
New York, New York, 10032
University of California, San Francisco
San Francisco, California, 94143
Northwestern Medicine Cancer Centers
Warrenville, Illinois, 60555
United Kingdom4 sites
Edinburgh Cancer Centre
Edinburgh, EH4 2SP
The Beaston West of Scotland Cancer Centre
Glasgow, G12 0YN
University of Leeds
Leeds, LS9 7TF
Sarah Cannon Research Institute UK
London, W1G 6AD
About this study
Official title: A Phase 1-2 Dose-escalation and Expansion Study of ST101 in Patients With Advanced Unresectable and Metastatic Solid Tumors
This is an open-label, two-part, phase 1-2 dose-finding study designed to determine the safety, tolerability, PK, PD, and proof-of-concept efficacy of ST101 administered IV in patients with advanced solid tumors. The study consists of two phases: a phase 1 dose escalation/regimen exploration phase and a phase 2 expansion phase.
Read the detailed description
Dose escalation / regimen exploration phase During the dose escalation/regimen exploration phase, 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 that would impact survival will be enrolled.
ST101 will be administered intravenously (IV), initially once per week. The dose escalation cohorts will be recruited using a standard 3+3 design. At each new dosing cohort, there will be a 1-week observation period after dosing the first patient in order to assess safety prior to dosing the remainder of the patients in that cohort. The dose cohorts will be 0.5, 1, 2, 4, 8 and 16 mg/kg with once weekly (QW) dosing in all cohorts except for the highest dose level which will be dosed every other week (Q2W).
The expansion phase consists of 4 specific tumor-type cohorts, which each follow the same Simon 2-stage design. Fifteen (15) patients will be enrolled in each cohort and treated with the ST101 RP2D. If one or more responses is observed that cohort will be expanded to a total of 30 patients to further assess efficacy.
Responses will be graded using response evaluation criteria in solid tumors (RECIST) 1.1 (Eisenhauer 2009) for hormonal receptor positive (HRpos) locally advanced/metastatic breast cancer (LA/MBC) and melanoma, modified response assessment in neuro-oncology (RANO) (Ellingson 2017) for GBM and prostate cancer clinical trials working group 3 (PCWG3) (Scher 2016) for castration-resistant prostate cancer (CRPC).During the expansion phase, only patients diagnosed with the following tumor types will be allowed into this phase of the study:
- HRpos LA/MBC that has progressed after prior 1-2 hormone-based therapies. Previous treatment with cyclin-dependent kinase 4/6 (CDK4/6) inhibitor, mammalian target of rapamycin (mTOR) inhibitor or chemotherapy is allowed as monotherapy or in combination.
- 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. Patients that have BRAF mutated disease should also have received one line of appropriate targeted therapy.
- 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. Patients that undergo tumor treating fields as an adjuvant to first line therapy are allowed.
- CRPC that has progressed after previous treatment with taxanes, abiraterone and enzalutamide/apalutamide.
The tumor types in the expansion phase may change based on emerging data from the dose escalation phase of this study. Additional mini cohorts of 10 patients may be added to the expansion phase based on efficacy signals during the dose escalation phase.
- Conditions
- Glioblastoma, Melanoma Stage IV, Breast Cancer, Prostate Cancer, Glioblastoma Multiforme, GBM
- Being tested
- ST101, Temozolomide, Radiation
- Medical subject headings
- Glioblastoma, Melanoma, Breast Neoplasms, Prostatic Neoplasms, Brain Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ST101Drug
ST101 will be administered intravenously (IV), initially once per week with a flat dose on the schedule described for each study arm
TemozolomideDrug
Temozolomide
RadiationRadiation
Radiation
| Study group | Role | What they receive |
|---|---|---|
| Dose Escalation | Experimental | 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. Receives: Drug: ST101 |
| Dose Expansion HR+ Breast | Experimental | 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. Receives: Drug: ST101 |
| Dose Expansion Melanoma | Experimental | 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. Receives: Drug: ST101 |
| Dose Expansion GBM | Experimental | 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. Receives: Drug: ST101 |
| Dose Expansion CRPC | Experimental | 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. Receives: Drug: ST101 |
| Dose Expansion Recurrent Glioblastoma | Experimental | 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 Receives: Drug: ST101 |
| Newly Diagnosed Glioblastoma | Experimental | 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 Receives: Drug: ST101; Drug: Temozolomide; Radiation: Radiation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dose-Limiting Toxicity (DLT)
Number of Participants with a Dose-Limiting Toxicity (DLT)
Measured: 20 months
Adverse Events
Number of Participants with at Least One Adverse Event, Severity Graded According to the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 5.0 (NCI CTCAE v5.0)
Measured: 20 months
Secondary outcomes (7)
Area Under the Curve (AUC)
Area under the plasma concentration time curve of ST101
Measured: 30 Months
Cmax
Peak plasma concentration of ST101
Measured: 20 months
Terminal Half-Life (t1/2)
Elimination half-life of ST101
Measured: 20 months
Overall Response
Escalation and Expansion Evaluated using Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1.
Measured: 20 months
DCR
Expansion: Disease Control Rate, Assessed According to RECIST v1.1
Measured: 20 Months
Duration of Response
Expansion: Duration of Response, Assessed According to RECIST v1.1
Measured: 20 months
PFS
Expansion: Progression Free Survival, Assessed According to RECIST v1.1
Measured: 20 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2020
- Study start1 Jul 2020
- Primary completionDec 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GlioblastomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Model description
- The study consists of two phases: a phase 1 dose escalation/regimen exploration phase and a phase 2 expansion phase.
- Masking
- None (open label)
- Enrolment
- 125 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sapience Therapeutics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Abi Vainstein-Haras, MD, Study chair, CMO
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04478279
- Sponsor's protocol ID
- ST101-101
- Status last verified
- Feb 2026
- First submitted
- 2 Jul 2020
- Last updated
- 9 Feb 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1-2 Dose-escalation and Expansion Study of ST101 in Patients With Advanced Unresectable and Metastatic Solid Tumors
- ClinicalTrials.gov ID
- NCT04478279
- Acronym / sponsor ID
- ST101-101
- Conditions
- Glioblastoma, Melanoma Stage IV, Breast Cancer, Prostate Cancer, Glioblastoma Multiforme, GBM
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 125 participants (actual)
- Lead sponsor
- Sapience TherapeuticsIndustry (pharma, biotech, devices)
- Study start
- 1 Jul 2020 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 20 Jul 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is an open-label, two-part, phase 1-2 dose-finding study designed to determine the safety, tolerability, PK, PD, and proof-of-concept efficacy of ST101 administered IV in patients with advanced solid tumors. The study consists of two phases: a phase 1 dose escalation/regimen exploration phase and a phase 2 expansion phase.
Detailed description
Dose escalation / regimen exploration phase During the dose escalation/regimen exploration phase, 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 that would impact survival will be enrolled.
ST101 will be administered intravenously (IV), initially once per week. The dose escalation cohorts will be recruited using a standard 3+3 design. At each new dosing cohort, there will be a 1-week observation period after dosing the first patient in order to assess safety prior to dosing the remainder of the patients in that cohort. The dose cohorts will be 0.5, 1, 2, 4, 8 and 16 mg/kg with once weekly (QW) dosing in all cohorts except for the highest dose level which will be dosed every other week (Q2W).
The expansion phase consists of 4 specific tumor-type cohorts, which each follow the same Simon 2-stage design. Fifteen (15) patients will be enrolled in each cohort and treated with the ST101 RP2D. If one or more responses is observed that cohort will be expanded to a total of 30 patients to further assess efficacy.
Responses will be graded using response evaluation criteria in solid tumors (RECIST) 1.1 (Eisenhauer 2009) for hormonal receptor positive (HRpos) locally advanced/metastatic breast cancer (LA/MBC) and melanoma, modified response assessment in neuro-oncology (RANO) (Ellingson 2017) for GBM and prostate cancer clinical trials working group 3 (PCWG3) (Scher 2016) for castration-resistant prostate cancer (CRPC).During the expansion phase, only patients diagnosed with the following tumor types will be allowed into this phase of the study:
- HRpos LA/MBC that has progressed after prior 1-2 hormone-based therapies. Previous treatment with cyclin-dependent kinase 4/6 (CDK4/6) inhibitor, mammalian target of rapamycin (mTOR) inhibitor or chemotherapy is allowed as monotherapy or in combination.
- 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. Patients that have BRAF mutated disease should also have received one line of appropriate targeted therapy.
- 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. Patients that undergo tumor treating fields as an adjuvant to first line therapy are allowed.
- CRPC that has progressed after previous treatment with taxanes, abiraterone and enzalutamide/apalutamide.
The tumor types in the expansion phase may change based on emerging data from the dose escalation phase of this study. Additional mini cohorts of 10 patients may be added to the expansion phase based on efficacy signals during the dose escalation phase.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 7
- Model description
- The study consists of two phases: a phase 1 dose escalation/regimen exploration phase and a phase 2 expansion phase.
| Arm | Type | Receives |
|---|---|---|
| Dose Escalation | Experimental | Drug: ST101This 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. |
| Dose Expansion HR+ Breast | Experimental | Drug: ST101This 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. |
| Dose Expansion Melanoma | Experimental | Drug: ST101This 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. |
| Dose Expansion GBM | Experimental | Drug: ST101Primary (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. |
| Dose Expansion CRPC | Experimental | Drug: ST101CRPC 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. |
| Dose Expansion Recurrent Glioblastoma | Experimental | Drug: ST101Recurrent 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 |
| Newly Diagnosed Glioblastoma | Experimental | Drug: ST101, Drug: Temozolomide, Radiation: RadiationNewly 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
Key exclusion criteria (18 listed)
- <!-- -->
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ST101ST101 will be administered intravenously (IV), initially once per week with a flat dose on the schedule described for each study arm | Drug | Dose Escalation, Dose Expansion CRPC, Dose Expansion GBM, Dose Expansion HR+ Breast, Dose Expansion Melanoma, Dose Expansion Recurrent Glioblastoma, Newly Diagnosed Glioblastoma |
| TemozolomideTemozolomide | Drug | Newly Diagnosed Glioblastoma |
| RadiationRadiation | Radiation | Newly Diagnosed Glioblastoma |
Primary outcome
Dose-Limiting Toxicity (DLT)
Time frame: 20 months
Number of Participants with a Dose-Limiting Toxicity (DLT)
Adverse Events
Time frame: 20 months
Number of Participants with at Least One Adverse Event, Severity Graded According to the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 5.0 (NCI CTCAE v5.0)
7 secondary outcomes
Area Under the Curve (AUC)
Time frame: 30 Months
Cmax
Time frame: 20 months
Terminal Half-Life (t1/2)
Time frame: 20 months
Overall Response
Time frame: 20 months
DCR
Time frame: 20 Months
Duration of Response
Time frame: 20 months
PFS
Time frame: 20 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Feb 2026.
- Individual participant dataSharing planned: No
Related trials for Glioblastoma
Active, not recruitingPhase 3
EF-41/KEYNOTE D58: Phase 3 Study of Optune Concomitant With Temozolomide Plus Pembrolizumab in Newly Diagnosed Glioblastoma
Glioblastoma
RecruitingPhase 3
Beginning Radiation Immediately With GammaTile at GBM Excision Versus Standard of Care
Glioblastoma
RecruitingPhase 1/2
Testing the Addition of an Anti-cancer Drug, Selinexor, to the Usual Chemotherapy Treatment (Temozolomide) for Brain Tumors That Have Returned After Previous Treatment
Recurrent Glioblastoma, IDH-Wildtype, Recurrent MGMT-Methylated Glioblastoma
Active, not recruitingPhase 1
Oral Gallium Maltolate for the Treatment of Relapsed and Refractory Glioblastoma
Glioblastoma
RecruitingPhase 1/2
PLX038 in Primary Central Nervous System Tumors Containing MYC or MYCN Amplifications
Glioma, Medulloblastoma
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Abi Vainstein-Haras, MD study chair
CMO
11 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing ST101, Temozolomide and Radiation in people with Glioblastoma and Melanoma Stage IV, run by Sapience Therapeutics at 11 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 15 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 9 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 sites in United States, United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dose-Limiting Toxicity (DLT) (time frame: 20 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Feb 2026.