Solid TumorPhase 2NCT04809012
Study of STI-3031 in Patients With Selected Relapsed or Refractory Solid Tumors
A Phase 2 study testing STI-3031 in people with Solid Tumor and Refractory Tumor, run by Sorrento Therapeutics, Inc..
Trial summary
This study evaluates the efficacy of STI-3031, an anti-PD-L1 antibody, in previously treated patients with selected solid tumors. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Solid Tumor, Refractory Tumor, Relapsed Solid Tumor
- What is being tested?
- STI-3031
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Jun 2021to Jun 2024
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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
- Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) score ≤ 2
- Has histologically- or cytologically-confirmed relapsing or refractory solid tumor and subject has exhausted all approved options that may, in the investigator's opinion, produce clinical benefit.
- Has at least one measurable disease per RECIST 1.1
- May have been treated with radiation therapy (RT) provided there is measurable disease outside the field of RT. Prior systemic RT must be completed at least 4 weeks before the first dose of study intervention. Prior focal radiotherapy must be completed at least 2 weeks before the first dose of study intervention. No radiopharmaceuticals are permitted within 8 weeks before the first dose of study intervention.
- Life expectancy of at least 16 weeks per investigator assessment
- Must have adequate hematologic, hepatic and renal function as assessed by specific laboratory criteria
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- Willing to sign the informed consent form and comply with the study schedule and all other protocol requirements
- Females of childbearing potential (FCBP) must have a negative pregnancy test during the Screening Period prior to treatment. All heterosexually active FCBP and all heterosexually active male patients must agree to use effective double barrier methods of birth control throughout the study.
- At time of the first dose of study intervention, at least 14 days or 5 half-lives, whichever is shorter, since the last chemotherapy, immunotherapy, biological or investigational therapy, and have recovered from toxicities associated with such treatment to < Grade 2.
Who cannot join
- Previously treated with an anti-PD-L1 or anti-PD-1 antibody
- Known presence of symptomatic central nervous system (CNS) metastases unless considered adequately treated and off corticosteroids and/or anticonvulsant therapy for at least 2 weeks prior to first dose of study intervention.
- Prior allogeneic hematopoietic stem cell transplantation (HSCT) or solid organ transplantation. Prior autologous HSCT is allowed.
- Any other malignancy, excluding basal or squamous cell carcinoma of the skin, cervical carcinoma in situ, or localized prostate cancer, from which the participant has not been disease-free for at least 2 years.
- Any active autoimmune disease requiring treatment within the past 3 months or a documented history of autoimmune disease, or history of syndrome that required systemic steroids or immunosuppressive medications, except for participants with vitiligo, hormone replacement therapy for stable thyroid diseases and Type 1 diabetes mellitus.
- Evidence of active or latent tuberculosis (TB) infection
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- Known viral infection with COVID-19, hepatitis B virus (HBV) hepatitis C virus (HCV), unless participant, as applicable, is negative on RT-PCR or rapid antigen tests, has been vaccinated, and has completed curative antiviral treatment and viral load is below the limit of quantification.
- Known active viral infection with human immunodeficiency virus (HIV)
- Active infection (viral, bacterial, or fungal) requiring intravenous (IV) systemic therapy within 14 days prior to the first dose of study intervention.
- Evidence of bleeding diathesis or coagulopathy.
- Conditions requiring chronic steroid use (> 10 mg/day of prednisone or equivalent).
- Recent history of attenuated viral vaccination within 30 days prior to the first dose of study intervention.
- Herbal preparations/medications are not allowed throughout the treatment period unless first discussed with and approved by the Medical Monitor.
- History of severe hypersensitivity reactions to other monoclonal antibodies or known hypersensitivity to the study intervention or its excipients.
- Known current drug or alcohol abuse
- Major surgical procedures ≤ 28 days prior to the first dose of study intervention, or minor surgical procedures ≤ 7 days prior to the first dose of study intervention. No waiting is required following port-a-catch placement or similar venous access device.
- Pregnant or lactating or intending on either during the study
- Severe or uncontrolled cardiac disease requiring treatment, congestive heart failure NYHA III or IV, unstable angina pectoris even if medically controlled, history of myocardial infarction during the last 3 months, serious arrhythmias requiring medication (with exception of atrial fibrillation or paroxysmal supraventricular tachycardia).
- Underlying medical conditions that, in the Investigator's opinion, will make the administration of study intervention hazardous or obscure the interpretation of toxicity determination or AEs, including psychiatric illness or social situation that would preclude study compliance.
About this study
Official title: An Open-label, Multicenter, Phase 2 Basket Study to Investigate the Efficacy, Safety, Pharmacokinetics and Pharmacodynamics of STI-3031 in Patients With Selected Relapsed or Refractory Solid Tumors
This study evaluates the efficacy of STI-3031, an anti-PD-L1 antibody, in previously treated patients with selected solid tumors.
Read the detailed description
This is an open-label, multicenter, Phase 2 basket study to investigate the efficacy, safety, pharmacokinetics and pharmacodynamics of STI-3031, an anti-PD-L1 antibody, in patients with selected RRSTs. All participants will receive STI-3031 20 mg/kg every 2 weeks (Q2W) via IV infusion over approximately 60 minutes.
- Conditions
- Solid Tumor, Refractory Tumor, Relapsed Solid Tumor
- Being tested
- STI-3031
- Keywords
- PDL-1, RRST
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
STI-3031Biological
STI-3031 is an anti-PD-L1 antibody
| Study group | Role | What they receive |
|---|---|---|
| STI-3031 | Experimental | 20 mg/kg STI-3031 administered intravenously Q2W Receives: Biological: STI-3031 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective response rate
Objective response rate (ORR) as assessed using Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria
Measured: Baseline through study completion at up to approximately 3 years
Secondary outcomes (8)
Safety as assessed by incidence and severity of adverse events
Incidence of treatment-emergent adverse events and their relationships to STI-3031
Measured: Baseline through study completion at up to approximately 3 years
Duration of Response
Duration of response (DOR) as assessed using RECIST 1.1
Measured: Baseline through study completion at up to approximately 3 years
Complete response rate and duration
Complete response (CR) rate and duration of CR as assessed using RECIST 1.1
Measured: Baseline through study completion at up to approximately 3 years
Progression-Free Survival
Progression-free survival (PFS) and 12-month PFS as assessed using RECIST 1.1
Measured: Baseline through study completion at up to approximately 3 years
Event-free survival
Event-free survival (EFS) as assessed using RECIST 1.1
Measured: Baseline through study completion at up to approximately 3 years
Overall survival
Overall survival (OS) as assessed using RECIST 1.1
Measured: Baseline through study completion at up to approximately 3 years
Time to next treatment
Time to next treatment (TTNT)
Measured: Baseline through study completion at up to approximately 3 years
Incidence of anti-drug antibody
Incidence of anti-drug antibody (ADA) and correlation with exposure and activity as measured using serum titers of anti-STI-3031 antibodies
Measured: Baseline through study completion at up to approximately 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Mar 2021
- Study startJun 2021 (estimated)
- Primary completionJun 2024 (estimated)
- Study completionJun 2024 (estimated)
Why it stopped: Intended to be replaced with another Protocol
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Solid TumorStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sorrento Therapeutics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Mike Royal, MD, Study director, Sorrento Therapeutics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04809012
- Sponsor's protocol ID
- PDL1-RRST-201
- Status last verified
- Mar 2022
- First submitted
- 13 Mar 2021
- Last updated
- 25 Mar 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label, Multicenter, Phase 2 Basket Study to Investigate the Efficacy, Safety, Pharmacokinetics and Pharmacodynamics of STI-3031 in Patients With Selected Relapsed or Refractory Solid Tumors
- ClinicalTrials.gov ID
- NCT04809012
- Acronym / sponsor ID
- PDL1-RRST-201
- Conditions
- Solid Tumor, Refractory Tumor, Relapsed Solid Tumor
- Keywords
- PDL-1, RRST
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Intended to be replaced with another Protocol
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Sorrento Therapeutics, Inc.Industry (pharma, biotech, devices)
- Study start
- Jun 2021 (estimated)
- Primary completion
- Jun 2024 (estimated)
- Study completion
- Jun 2024 (estimated)
- First posted
- 22 Mar 2021 (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 study evaluates the efficacy of STI-3031, an anti-PD-L1 antibody, in previously treated patients with selected solid tumors.
Detailed description
This is an open-label, multicenter, Phase 2 basket study to investigate the efficacy, safety, pharmacokinetics and pharmacodynamics of STI-3031, an anti-PD-L1 antibody, in patients with selected RRSTs. All participants will receive STI-3031 20 mg/kg every 2 weeks (Q2W) via IV infusion over approximately 60 minutes.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| STI-3031 | Experimental | Biological: STI-303120 mg/kg STI-3031 administered intravenously Q2W |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) score ≤ 2
- Has histologically- or cytologically-confirmed relapsing or refractory solid tumor and subject has exhausted all approved options that may, in the investigator's opinion, produce clinical benefit.
- Has at least one measurable disease per RECIST 1.1
- May have been treated with radiation therapy (RT) provided there is measurable disease outside the field of RT. Prior systemic RT must be completed at least 4 weeks before the first dose of study intervention. Prior focal radiotherapy must be completed at least 2 weeks before the first dose of study intervention. No radiopharmaceuticals are permitted within 8 weeks before the first dose of study intervention.
- Life expectancy of at least 16 weeks per investigator assessment
Key exclusion criteria (19 listed)
- Previously treated with an anti-PD-L1 or anti-PD-1 antibody
- Known presence of symptomatic central nervous system (CNS) metastases unless considered adequately treated and off corticosteroids and/or anticonvulsant therapy for at least 2 weeks prior to first dose of study intervention.
- Prior allogeneic hematopoietic stem cell transplantation (HSCT) or solid organ transplantation. Prior autologous HSCT is allowed.
- Any other malignancy, excluding basal or squamous cell carcinoma of the skin, cervical carcinoma in situ, or localized prostate cancer, from which the participant has not been disease-free for at least 2 years.
- Any active autoimmune disease requiring treatment within the past 3 months or a documented history of autoimmune disease, or history of syndrome that required systemic steroids or immunosuppressive medications, except for participants with vitiligo, hormone replacement therapy for stable thyroid diseases and Type 1 diabetes mellitus.
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 |
|---|---|---|
| STI-3031STI-3031 is an anti-PD-L1 antibody | Biological | STI-3031 |
Primary outcome
Objective response rate
Time frame: Baseline through study completion at up to approximately 3 years
Objective response rate (ORR) as assessed using Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria
8 secondary outcomes
Safety as assessed by incidence and severity of adverse events
Time frame: Baseline through study completion at up to approximately 3 years
Duration of Response
Time frame: Baseline through study completion at up to approximately 3 years
Complete response rate and duration
Time frame: Baseline through study completion at up to approximately 3 years
Progression-Free Survival
Time frame: Baseline through study completion at up to approximately 3 years
Event-free survival
Time frame: Baseline through study completion at up to approximately 3 years
Overall survival
Time frame: Baseline through study completion at up to approximately 3 years
Time to next treatment
Time frame: Baseline through study completion at up to approximately 3 years
Incidence of anti-drug antibody
Time frame: Baseline through study completion at up to approximately 3 years
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Mar 2022.
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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.
Mike Royal, MD study director
Sorrento Therapeutics
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing STI-3031 in people with Solid Tumor and Refractory Tumor, run by Sorrento Therapeutics, Inc..
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 9 inclusion and 19 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: withdrawn, as of the sponsor's last update on 25 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
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 phase mean?
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?
The study was withdrawn before enrolling participants, so there are no results.
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?
Objective response rate (time frame: Baseline through study completion at up to approximately 3 years). 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 25 Mar 2022.