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Tests treatment safety and results for Cancer
Official title Phase 1a and Phase 2 Study for Safety, Preliminary Efficacy, PK and PD of ST-067
ClinicalTrials.gov ID: NCT04787042
What this study is testing
What is ST-067?
ST-067 is an investigational medicine, given as an injection under the skin, being studied as a potential treatment for cancer.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This is a multiphase, multicenter study, which includes a Phase 1a open-label, dose escalation monotherapy study of ST-067 given as an SC injection with or without obinutuzumab [Gazyva®] pre-treatment, by IV infusion, and in combination with pembrolizumab. A Phase 2 monotherapy arm is also planned; the exact design of the Phase 2 study elements with respect to formulation and pre-treatment will be determined after completion of the Phase 1 study portion of the trial.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Male and female patients aged ≥18 years
- Must provide written informed consent and any authorizations required by local law
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- Have histologically or cytologically confirmed diagnosis of advanced/metastatic solid tumor For Phase 1a, the following solid tumors are allowed...
- For patients who have developed disease progression through standard therapy, or
You likely can't join if
- History of another malignancy
- Known symptomatic brain metastases requiring \>10 mg/day of prednisolone or equivalent
- Significant cardiovascular disease (MI, thrombotic events,) within 6 months prior to study treatmentSignificant ECG abnormalities (Phase 1a and 2...
- Any degree of respiratory compromise (from either malignant or non-malignant disease)
- Evidence of an ongoing systemic bacterial, fungal, or viral infection
- Has received a live vaccine within 30 days
See the full eligibility criteria
- Male and female patients aged ≥18 years
- Must provide written informed consent and any authorizations required by local law
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- Have histologically or cytologically confirmed diagnosis of advanced/metastatic solid tumor For Phase 1a, the following solid tumors are allowed: Melanoma, Merkel cell, RCC, urothelial, NSCLC,TNBC, SCCHN, microsatellite...
- For patients who have developed disease progression through standard therapy, or
- For patients whom standard of care therapy that prolongs survival is unavailable or unsuitable (according to the investigator and after consultation with the Medical Monitor) For Phase 1 combination therapy dose...
- TNBC is diagnosed in a tumor which does not express estrogen receptor or progesterone receptor, is not human epidermal growth factor receptor 2 (HER2) 3+ on IHC or is negative by fluorescence in situ hybridization...
- MSI high tumor should have mutations in 30% or more microsatellites by PCR or be negative for MSH1/2/6 or PMS-2 by IHC.
- Hi-TMB high tumor has 10 mut/Mb or greater calculated from whole genome sequencing or whole exome sequencing For Phase 2, the following solid tumors are allowed: Melanoma, RCC, TNBC, NSCLC, SCCHN, and MSI-Hi tumors
- Has at least 1 measurable lesion per RECIST 1.1 criteria which has not been biopsied or received prior irradiation
- Has an accessible tumor for biopsy pre- and on-treatment (mandatory).
- History of another malignancy
- Known symptomatic brain metastases requiring \>10 mg/day of prednisolone or equivalent
- Significant cardiovascular disease (MI, thrombotic events,) within 6 months prior to study treatmentSignificant ECG abnormalities (Phase 1a and 2 monotherapy only) including unstable cardiac arrhythmia requiring...
- Any degree of respiratory compromise (from either malignant or non-malignant disease)
- Evidence of an ongoing systemic bacterial, fungal, or viral infection
- Has received a live vaccine within 30 days
- Major surgery within 4 weeks
- Prior solid organ or bone marrow progenitor cell transplantation
- Prior high dose chemotherapy requiring stem cell rescue
- History of active autoimmune disorders
- Ongoing immunosuppressive therapy, including systemic or enteric corticosteroids.
- Treatment with an approved, systemic anticancer therapy or an investigational agent within 4 weeks of Day 1
- A positive severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) viral test within 28 days prior to dosing, unless there is Investigator-confirmed clinical recovery on or before C1D1
- people with adrenal insufficiency
- people with any chemistry or hematology laboratory values that are ≥Grade 2 Additional exclusion criteria for Phase 1 combination therapy only:
- Presence of known active CNS metastases and/or carcinomatous meningitis. people with previously treated brain metastases may participate provided they are radiologically stable, i.e., without evidence of progression for...
- Prior radiotherapy within 2 weeks of start of study treatment or history of radiation pneumonitis.
- Presence of an active documented autoimmune disease that has required systemic treatment in the past 2 years (i.e., with use of disease modifying agents, corticosteroids, or immunosuppressive drugs). Replacement therapy...
- Prior therapy with an anti-PD-1, anti-PD-L1, or anti-PD-L2 agent or with an agent directed to another stimulatory or co-inhibitory T-cell receptor (e.g., CTLA-4, OX40, CD137), and was discontinued from that treatment...
- Severe hypersensitivity (≥Grade 3) to pembrolizumab and/or any of its excipients. people who have been retreated after such a reaction may be allowed after discussion with the Simcha Medical Monitor
- History of (non-infectious) pneumonitis/interstitial lung disease that required steroids or has current pneumonitis/interstitial lung disease
- people that have received radiation therapy to the lung that is \>30Gy within 6 months of the first dose of study treatment
The study team makes the final eligibility decision.
Where it's taking place
- Scottsdale, Arizona, United States
- Denver, Colorado, United States
- New Haven, Connecticut, United States
- Tampa, Florida, United States
- Boston, Massachusetts, United States
- Buffalo, New York, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Scottsdale, Arizona, United States; Denver, Colorado, United States; New Haven, Connecticut, United States; Tampa, Florida, United States; Boston, Massachusetts, United States; Buffalo, New York, United States. Enter your location above to see the nearest site and check your eligibility.
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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.