Solid TumorPhase 1NCT04900519
Study of the Safety and Efficacy of STI-6643 in Subjects With Advanced Solid Tumors
A Phase 1 study testing STI-6643 in people with Solid Tumor and Relapsed Solid Neoplasm, run by Sorrento Therapeutics, Inc. at 5 sites in United States.
Trial summary
This is a first-in-human, phase 1, open-label, dose-escalation study of STI-6643 administered by intravenous infusion in subjects with a relapsed/refractory advanced solid tumor. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Solid Tumor, Relapsed Solid Neoplasm, Refractory Tumor
- What is being tested?
- STI-6643
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 5 sitesUnited States
- Study dates
- 24 Nov 2021to Mar 2025
- Phase
- Phase 1
- 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
- Signed informed consent
- Age ≥ 18 years
- ECOG Performance Status ≤ 2
- Histologically- or cytologically-confirmed solid tumor
- Patient has relapsed, is refractory to, or intolerant of standard of care therapy
- No available approved therapy that may provide clinical benefit (per Investigator)
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- Measurable or evaluable disease by RECISTv1.14
- Life expectancy of > 12 weeks (per Investigator)
- Adequate laboratory parameters including:
- Absolute neutrophil count (ANC) ≥ 1500/mm3
- Platelets ≥ 100,000/mm3
- Hemoglobin ≥ 12 g/dL (in the absence of transfusion over the prior 2 weeks)
- AST/SGOT ≤ 2.5 x ULN (≤ 5 x ULN if known liver involvement)
- ALT/SGPT ≤ 2.5 x ULN (≤ 5 x ULN if known liver involvement)
- Total bilirubin ≤ 2.0 x ULN (unless diagnosis of Gilbert's syndrome in which case < 3.0 times ULN)
- Serum creatinine ≤ 2.0 x ULN or estimated GFR ≥ 45 mL/min (per Cockcroft- Gault equation)
- If residual treatment related toxicity from prior therapy:
- Treatment related toxicity resolved to ≤ Grade 1 (alopecia excepted), or
- Treatment related toxicity resolved to ≤ Grade 2 with prior approval of the Medical Monitor
- Willingness to comply with the study schedule and all study requirements
- [Females] Must be postmenopausal, surgically sterile, or agree to use adequate contraception (per Investigator) throughout the study and for a least 30 days following the last dose
- [Males] Must be surgically sterile or must agree to use adequate contraception (per Investigator) throughout the study and for at least 30 days following the last dose
- [Males] Willingness to refrain from donating sperm throughout the study and for at least 30 days following the last dose
- [Females] If of child-bearing potential, must have a negative serum pregnancy test
Who cannot join
- Participating in any other interventional clinical study
- Previous exposure to an anti-CD47 or SIRPα antibody
- ≤ 28 days (or 5 half-lives if shorter) between of systemic anti-tumor treatment (e.g., chemotherapy, endocrine therapy, immunotherapy, cellular therapy) and the 1st dose of STI-6643
- ≤ 28 days from prior irradiation (≤ 7 days from limited field irradiation for control of symptoms) and the 1st dose of STI-6643
- ≤ 28 days between major surgery (≤ 7 days from minor surgical procedures, no waiting period following central catheter placement)
- ≤ 7 days between administration of G-CSF, GM-CSF, erythropoietin, thrombopoietin or IL11 and the 1st dose of STI-6643
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- ≤ 7 days between systemic immunosuppressive therapy in excess of 10 mg/day prednisone equivalent and the 1st dose of STI-6643 (topical or inhaled corticosteroids not restricted)
- ≤ 28 days between a live attenuated vaccine and the 1st dose of STI-6643
- Known central nervous system (CNS) involvement with tumor (e.g., metastases, meningeal carcinomatosis)
- Active second malignancy requiring ongoing systemic treatment
- History of primary immunodeficiency disorders
- History of active pulmonary tuberculosis
- History of COVID-19 symptoms unless COVID-19 test negative ≤ 72 hours of the 1st dose of STI-6643
- ≤ 12 weeks from an allogeneic hematopoietic stem cell transplant and C1D1 or active graft-versus-host disease (GvHD)
- Active infection (e.g., bacterial, viral, fungal) requiring systemic treatment ≤ 72 hours of the 1st dose of STI-6643
- Known HIV-positive with CD4+ cell counts < 350 cells/uL or a history of an AIDS defining opportunistic infection
- Known T-cell leukemia virus type 1 (HTLV1) infection, hepatitis B virus (HBV) or hepatitis C virus (HCV) viremia
- Significant risk for HBV reactivation (defined as HbsAg positive, HbcAb positive or HBV DNA positive)
- Detectable HCV RNA
- Pregnant or breast feeding
- History of clinically significant cardiovascular abnormalities including:
- Congestive heart failure (NYHA classification ≥ 3) within 6 months of the 1st dose of STI-6643
- Unstable angina pectoris
- ≤ 6 months from myocardial infarction and the 1st dose of STI-6643
- Arrhythmias (other than atrial fibrillation) requiring ongoing treatment
- QTcF interval > 480 msec (using Fridericia's formula)
- Uncontrolled hypertension (i.e., systolic BP > 180 mmHg or diastolic BP > 100
- Any condition, including the presence of laboratory abnormalities, that places the subject at an unacceptable risk if the subject was to participate in the study.
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites, 4 recruiting
- Completed
NEXT Oncology - Austin
Austin, Texas, 78758
- Recruiting
Mary Crowley Cancer Research
Dallas, Texas, 75230
Timothy Eamma, 214-658-1947, TEamma@marycrowley.org
Reva Schneider, MD
- Recruiting
Virginia Cancer Specialists
Fairfax, Virginia, 22031
Carrie Friedman, RN, carrie.friedman@usoncology.com
Alexander Spira, MD
- Not yet recruiting
University of California, San Diego
San Diego, California, 92093
Sandip Patel, MD
- Recruiting
Sanford Health
Sioux Falls, South Dakota, 57104
Staci Vogel, 605-328-1368, staci.vogel@sanfordhealth.org
Steven Powell, MD
About this study
Official title: A Phase 1, Open-Label, Dose-Escalation Study of the Safety and Efficacy of STI-6643, an Anti-CD47 Human Monoclonal Antibody, in Subjects With Advanced Solid Tumors
This is a first-in-human, phase 1, open-label, dose-escalation study of STI-6643 administered by intravenous infusion in subjects with a relapsed/refractory advanced solid tumor.
Read the detailed description
This is a first-in-human, phase 1, open-label, dose-escalation study of STI-6643 administered by intravenous infusion in subjects with a relapsed/refractory advanced solid tumor.
The study will determine an MTD and RP2D using a conventional 3+3 study design with priming dose identification (PDI) stage and therapeutic dose (TD) escalation (TDE) stage. Dose limiting toxicity evaluated over the initial 28 days of STI-6643 administration.
- Conditions
- Solid Tumor, Relapsed Solid Neoplasm, Refractory Tumor
- Being tested
- STI-6643
- Keywords
- solid tumor
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
STI-6643Biological
Anti-CD47 human monoclonal antibody
| Study group | Role | What they receive |
|---|---|---|
| STI-6643 | Experimental | STI-6643 will be provided in a single use 10-mL high borosilicate type 1 glass vial at a concentration of 500mg/10 mL (50 mg/mL) administered intravenously weekly for 4 weeks, then biweekly for Cycles 2 and up. Receives: Biological: STI-6643 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety of STI-6643
Safety as assessed by incidence of adverse events, SAEs, DLTs, and clinically significant changes in safety lab results
Measured: Baseline through study completion at up to approximately 31 months
Secondary outcomes (5)
Overall response rate
Overall response rate
Measured: Day 1 through study completion at up to approximately 31 months
Duration of response
Duration of response
Measured: Day 1 through study completion at up to approximately 31 months
STI-6643 receptor occupancy
STI-6643 receptor occupancy
Measured: Day 1 through Day 22
Anti-drug antibodies directed to STI-6643
Anti-drug antibodies directed to STI-6643
Measured: Day 1 through Day 15
PK parameters
Evaluate the pharmacokinetics of STI-6643
Measured: Day 1 through Day 22
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 May 2021
- Study start24 Nov 2021
- Primary completionDec 2024 (estimated)
- Study completionMar 2025 (estimated)
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 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
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, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04900519
- Sponsor's protocol ID
- 47MAB-ADVCA-101
- Status last verified
- Jan 2023
- First submitted
- 17 May 2021
- Last updated
- 17 Jan 2023
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Open-Label, Dose-Escalation Study of the Safety and Efficacy of STI-6643, an Anti-CD47 Human Monoclonal Antibody, in Subjects With Advanced Solid Tumors
- ClinicalTrials.gov ID
- NCT04900519
- Acronym / sponsor ID
- 47MAB-ADVCA-101
- Conditions
- Solid Tumor, Relapsed Solid Neoplasm, Refractory Tumor
- Keywords
- solid tumor
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Sorrento Therapeutics, Inc.Industry (pharma, biotech, devices)
- Study start
- 24 Nov 2021 (actual)
- Primary completion
- Dec 2024 (estimated)
- Study completion
- Mar 2025 (estimated)
- First posted
- 25 May 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 is a first-in-human, phase 1, open-label, dose-escalation study of STI-6643 administered by intravenous infusion in subjects with a relapsed/refractory advanced solid tumor.
Detailed description
This is a first-in-human, phase 1, open-label, dose-escalation study of STI-6643 administered by intravenous infusion in subjects with a relapsed/refractory advanced solid tumor.
The study will determine an MTD and RP2D using a conventional 3+3 study design with priming dose identification (PDI) stage and therapeutic dose (TD) escalation (TDE) stage. Dose limiting toxicity evaluated over the initial 28 days of STI-6643 administration.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| STI-6643 | Experimental | Biological: STI-6643STI-6643 will be provided in a single use 10-mL high borosilicate type 1 glass vial at a concentration of 500mg/10 mL (50 mg/mL) administered intravenously weekly for 4 weeks, then biweekly for Cycles 2 and up. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (24 listed)
- Signed informed consent
- Age ≥ 18 years
- ECOG Performance Status ≤ 2
- Histologically- or cytologically-confirmed solid tumor
- Patient has relapsed, is refractory to, or intolerant of standard of care therapy
Key exclusion criteria (28 listed)
- Participating in any other interventional clinical study
- Previous exposure to an anti-CD47 or SIRPα antibody
- ≤ 28 days (or 5 half-lives if shorter) between of systemic anti-tumor treatment (e.g., chemotherapy, endocrine therapy, immunotherapy, cellular therapy) and the 1st dose of STI-6643
- ≤ 28 days from prior irradiation (≤ 7 days from limited field irradiation for control of symptoms) and the 1st dose of STI-6643
- ≤ 28 days between major surgery (≤ 7 days from minor surgical procedures, no waiting period following central catheter placement)
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-6643Anti-CD47 human monoclonal antibody | Biological | STI-6643 |
Primary outcome
Safety of STI-6643
Time frame: Baseline through study completion at up to approximately 31 months
Safety as assessed by incidence of adverse events, SAEs, DLTs, and clinically significant changes in safety lab results
5 secondary outcomes
Overall response rate
Time frame: Day 1 through study completion at up to approximately 31 months
Duration of response
Time frame: Day 1 through study completion at up to approximately 31 months
STI-6643 receptor occupancy
Time frame: Day 1 through Day 22
Anti-drug antibodies directed to STI-6643
Time frame: Day 1 through Day 15
PK parameters
Time frame: Day 1 through Day 22
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jan 2023.
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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, Inc.
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing STI-6643 in people with Solid Tumor and Relapsed Solid Neoplasm, run by Sorrento Therapeutics, Inc. at 5 sites in United States.
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 24 inclusion and 28 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: status not confirmed, as of the sponsor's last update on 17 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in United States. 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 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.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mike Royal, MD ((858) 203-4100 ext. 4146, mroyal@sorrentotherapeutics.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety of STI-6643 (time frame: Baseline through study completion at up to approximately 31 months). 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 17 Jan 2023.