Advanced Solid TumorPhase 1NCT05584709
Study to Access Anti-CD38 Anibody Drug in Patients With Advanced Solid Tumors
A Phase 1 study testing STI-6129 in people with Advanced Solid Tumor, run by Sorrento Therapeutics, Inc. at 1 site in United States.
Trial summary
This study is a Phase 1b, single-center, open-label, dose-finding trial designed to identify the Recommended Phase 2 Dose (RP2D) of STI 6129 by assessing the safety, preliminary efficacy, and immunogenicity in subjects with any advanced solid tumor. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Advanced Solid Tumor
- What is being tested?
- STI-6129
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2023to Oct 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
- Histologically confirmed advanced solid tumors, such as but not limited to:
- Lung squamous cell carcinoma (LSCC)
- Esophageal squamous cell carcinoma (ESCC)
- Head and neck squamous cell carcinoma (HNSCC)
- Microsatellite stable colorectal cancer (MSS-CRC) that are refractory to standard therapy (to include standard chemotherapy and anti-PD-L1 therapy concurrently or sequentially prior to enrollment) or for which standard or curative therapy does not exist or is not considered appropriate by the Investigator. Patients with MSS-CRC must have completed at least 2 lines of standard of care treatments prior to enrollment.
- Adequate hematologic (with no blood product or hematopoietic growth factor support during the prior 7 days), renal and hepatic function, as defined by the following laboratory values; test performed within 7 days prior to first dose of STI-6129:
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- Hematologic: i. Absolute neutrophil count (ANC) ≥ 1000 cells/μL ii. Platelet count ≥ 50,000 platelets/μL iii. Hemoglobin (Hgb) ≥ 8.0 g/dL b. Renal: creatine clearance (CrCl) ≥ 60 mL/min by Cockroft-Gault formula (Protocol Appendix 1) c. Hepatic: i. Serum aspartate aminotransferase (AST) or alanine aminotransferase (ALT) ˂ 3x the upper limit of normal (ULN) ii. serum total bilirubin ˂ 1.5x ULN (except for patients in whom hyperbilirubinemia is attributed to Gilbert's Syndrome) iii. Alkaline phosphatase times ˂ 3x ULN (˂ 5 times ULN if considered due to tumor)
- ECOG performance status of 0 or 1
- Be willing and able to comply with the study schedule and all other protocol requirements
- Willing to follow contraception guidelines
Who cannot join
- Use of systemic anti-tumor therapy or an investigational drug within 5 half-lives or 4 weeks of D1 whichever is shorter, preceding the first dose of study drug.
- Received any prior anti-CD38 treatment within 90 days.
- A diagnosis of other malignancies that have required systemic therapy within the last 3 years or is not in complete remission. Exceptions are non-metastatic basal cell or squamous cell carcinomas of the skin or prostate cancer or in situ cancer that does not require treatment or is well under control.
- A current history of CTCAE Grade 3 muscle paresis, eyelid conditions, glaucoma controlled with medication or watering eyes or any other ocular disorder that is CTCAE Grade 2.
- A history of a dose-limiting immune-related adverse event during PD-1 axis blockade.
- INR or aPTT > 1.5 times ULN within one week prior to the infusion of STI-6129, unless on a stable dose of an anticoagulant
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- Patients with ≥ Grade 3 neuropathy or Grade 2 neuropathy with associated pain.
- New York Heart Association (NYHA) Class > 2.
- QTcF > 470 msec on a 12-lead ECG.
- Treatment with potent inhibitors of cytochrome P450 systems: CYP3A4, CYP2B6 and CYP1A2, or strong inhibitors or transducers of transporter P-glycoprotein (Pgp or MDR1) or breast cancer resistance protein (BCRP or ABCG2) during the study. See https://www.fda.gov/drugs/drug-interactions-labeling/drug-development-and-drug-interactions-table-substrates-inhibitors-and-inducers for details.
- Symptomatic, untreated brain metastases. Patients with treated brain metastases may be treated at least 1 week after gamma knife stereotactic radiation or at least 2 weeks after whole brain radiation if symptoms have recovered with discontinuation of steroids. Patients with small, asymptomatic brain metastases may be considered for enrollment.
- Symptomatic CNS disease (i.e. cord compression)
Trial locations and contacts
1 site in 1 country.
United States1 site
Columbia University Medical Center
New York, New York, 10032
Brian Henick, MD
Brian Henick, MD
About this study
Official title: A Phase 1B, Open-Label, Dose-Escalation Study of the Safety and Efficacy of an Anti-CD38 Antibody Drug Conjugate (STI-6129) in Patients With Advanced Solid Tumors
This study is a Phase 1b, single-center, open-label, dose-finding trial designed to identify the Recommended Phase 2 Dose (RP2D) of STI 6129 by assessing the safety, preliminary efficacy, and immunogenicity in subjects with any advanced solid tumor.
The patients that will be treated with STI-6129 in this trial are advanced solid tumor patients who have received prior lines of treatment.
Read the detailed description
The study is a sequential cohort ascending dose (3+3 methodology after a sentinel at the 0,25 mg/kg level) study to confirm safety and identify DLTs in the study population and determine the maximum tolerated dose (MTD) and the RP2D.
The range of proposed doses includes optimal doses identified in parallel safety studies of STI-6129 for the treatment of relapsed/refractory systemic amyloid light chain (AL) amyloidosis that are currently ongoing (a three-stage, multicenter, open-label, dose -finding, Phase 1 trial to identify the RP2D). STI-6129 will be given as an intravenous (IV) infusion.
Each patient enrolled will received repeated 4-week cycles of STI-6129 (Q4W) Total duration will vary according to patient response. After the treatment period, patients will be monitored for up to 2 years.
- Conditions
- Advanced Solid Tumor
- Being tested
- STI-6129
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
STI-6129Biological
Also called Anti-CD38 antibody drug conjugate
Repeated 4-week intravenous infusion cycles of STI-6129 will be given. (one infusion every four weeks).
| Study group | Role | What they receive |
|---|---|---|
| STI-6129 infusion | Experimental | Intravenous infusion to be given with prophylaxis for infusion reactions if necessary. Receives: Biological: STI-6129 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of adverse events by type, frequency, severity, and causality (safety)
Safety as assessed by incidence of adverse events (AEs) by type, frequency, severity, and causality
Measured: Baseline through study completion at up to approximately 24 months
Incidence of serious adverse events by type, frequency, severity, and causality (safety)
Safety as assessed by incidence of serious AEs (SAEs) by type, frequency, severity, and causality
Measured: Baseline through study completion at up to approximately 24 months
Incidence of dose-limiting toxicities (safety)
Safety as assessed by incidence of dose-limiting toxicities
Measured: Baseline through study completion at up to approximately 24 months
Incidence of neurotoxicity (safety)
Safety as assessed by incidence of neurotoxicity
Measured: Baseline through study completion at up to approximately 24 months
Incidence of laboratory abnormalities (safety)
Safety as assessed by incidence of laboratory abnormalities using the Common Terminology Criteria for Adverse Events (CTCAE Version 5)
Measured: Baseline through study completion at up to approximately 24 months
Secondary outcomes (3)
Evaluation of response rate
Evaluation of response rate for advanced solid tumors using Response Evaluation Criteria in Solid Tumors, version 1.1 (RECIST v1.1)
Measured: Baseline through study completion at up to approximately 24 months
Overall response
Response assessed according to the Evaluation Criteria in Solid Tumors (RECIST v1.1)
Measured: Baseline through study completion at up to approximately 24 months
Overall duration
Duration assessed according to the Evaluation Criteria in Solid Tumors (RECIST v1.1)
Measured: Baseline through study completion at up to approximately 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Oct 2022
- Study startMar 2023 (estimated)
- Primary completionAug 2025 (estimated)
- Study completionOct 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced 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
- Sequential
- Masking
- None (open label)
- Enrolment
- 34 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sorrento Therapeutics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05584709
- Sponsor's protocol ID
- 38ADC-AST-101
- Status last verified
- Jan 2023
- First submitted
- 12 Oct 2022
- Last updated
- 30 Jan 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1B, Open-Label, Dose-Escalation Study of the Safety and Efficacy of an Anti-CD38 Antibody Drug Conjugate (STI-6129) in Patients With Advanced Solid Tumors
- ClinicalTrials.gov ID
- NCT05584709
- Acronym / sponsor ID
- 38ADC-AST-101
- Conditions
- Advanced Solid Tumor
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 34 participants (estimated)
- Lead sponsor
- Sorrento Therapeutics, Inc.Industry (pharma, biotech, devices)
- Study start
- Mar 2023 (estimated)
- Primary completion
- Aug 2025 (estimated)
- Study completion
- Oct 2025 (estimated)
- First posted
- 18 Oct 2022 (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 is a Phase 1b, single-center, open-label, dose-finding trial designed to identify the Recommended Phase 2 Dose (RP2D) of STI 6129 by assessing the safety, preliminary efficacy, and immunogenicity in subjects with any advanced solid tumor.
The patients that will be treated with STI-6129 in this trial are advanced solid tumor patients who have received prior lines of treatment.
Detailed description
The study is a sequential cohort ascending dose (3+3 methodology after a sentinel at the 0,25 mg/kg level) study to confirm safety and identify DLTs in the study population and determine the maximum tolerated dose (MTD) and the RP2D.
The range of proposed doses includes optimal doses identified in parallel safety studies of STI-6129 for the treatment of relapsed/refractory systemic amyloid light chain (AL) amyloidosis that are currently ongoing (a three-stage, multicenter, open-label, dose -finding, Phase 1 trial to identify the RP2D). STI-6129 will be given as an intravenous (IV) infusion.
Each patient enrolled will received repeated 4-week cycles of STI-6129 (Q4W) Total duration will vary according to patient response. After the treatment period, patients will be monitored for up to 2 years.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| STI-6129 infusion | Experimental | Biological: STI-6129Intravenous infusion to be given with prophylaxis for infusion reactions if necessary. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Histologically confirmed advanced solid tumors, such as but not limited to:
- Adequate hematologic (with no blood product or hematopoietic growth factor support during the prior 7 days), renal and hepatic function, as defined by the following laboratory values; test performed within 7 days prior to first dose of STI-6129:
- ECOG performance status of 0 or 1
- Be willing and able to comply with the study schedule and all other protocol requirements
- Willing to follow contraception guidelines
Key exclusion criteria (12 listed)
- Use of systemic anti-tumor therapy or an investigational drug within 5 half-lives or 4 weeks of D1 whichever is shorter, preceding the first dose of study drug.
- Received any prior anti-CD38 treatment within 90 days.
- A diagnosis of other malignancies that have required systemic therapy within the last 3 years or is not in complete remission. Exceptions are non-metastatic basal cell or squamous cell carcinomas of the skin or prostate cancer or in situ cancer that does not require treatment or is well under control.
- A current history of CTCAE Grade 3 muscle paresis, eyelid conditions, glaucoma controlled with medication or watering eyes or any other ocular disorder that is CTCAE Grade 2.
- A history of a dose-limiting immune-related adverse event during PD-1 axis blockade.
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-6129Also: Anti-CD38 antibody drug conjugateRepeated 4-week intravenous infusion cycles of STI-6129 will be given. (one infusion every four weeks). | Biological | STI-6129 infusion |
Primary outcome
Incidence of adverse events by type, frequency, severity, and causality (safety)
Time frame: Baseline through study completion at up to approximately 24 months
Safety as assessed by incidence of adverse events (AEs) by type, frequency, severity, and causality
Incidence of serious adverse events by type, frequency, severity, and causality (safety)
Time frame: Baseline through study completion at up to approximately 24 months
Safety as assessed by incidence of serious AEs (SAEs) by type, frequency, severity, and causality
Incidence of dose-limiting toxicities (safety)
Time frame: Baseline through study completion at up to approximately 24 months
Safety as assessed by incidence of dose-limiting toxicities
Incidence of neurotoxicity (safety)
Time frame: Baseline through study completion at up to approximately 24 months
Safety as assessed by incidence of neurotoxicity
Incidence of laboratory abnormalities (safety)
Time frame: Baseline through study completion at up to approximately 24 months
Safety as assessed by incidence of laboratory abnormalities using the Common Terminology Criteria for Adverse Events (CTCAE Version 5)
3 secondary outcomes
Evaluation of response rate
Time frame: Baseline through study completion at up to approximately 24 months
Overall response
Time frame: Baseline through study completion at up to approximately 24 months
Overall duration
Time frame: Baseline through study completion at up to approximately 24 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 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.
1 site 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-6129 in people with Advanced Solid Tumor, run by Sorrento Therapeutics, Inc. at 1 site 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 10 inclusion and 12 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 30 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 1 site 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 Ying Yan, MD, MS (858-203-4100 ext. 4183, yyan@sorrentotherapeutics.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of adverse events by type, frequency, severity, and causality (safety) (time frame: Baseline through study completion at up to approximately 24 months). The study lists 5 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 30 Jan 2023.