Relapsed Solid NeoplasmPhase 1NCT05060276
Study to Assess an Anti-Trop2 Antibody Drug Conjugate in Relapsed or Refractory Solid Tumors
A Phase 1 study testing STI-3258 in people with Relapsed Solid Neoplasm and Refractory Cancer, run by Sorrento Therapeutics, Inc..
Trial summary
This is a phase 1b, open-label, dose-escalation study o STI-3258 administered intravenously in subjects with relapsed or refractory solid tumors. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Relapsed Solid Neoplasm, Refractory Cancer, Solid Tumor, Adult
- What is being tested?
- STI-3258
- 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
- Dec 2022to Dec 2024
- 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 or cytologically confirmed advanced cancer that is relapsing or refractory to at least one prior treatment and not a candidate for other treatments or is intolerant to established treatments.
- At least one measurable disease per Response Evaluation Criteria in Solid Tumors v. 1.1 (RECIST 1.1).
- Eastern Cooperative Oncology Group Performance Status ≤ 2.
- Must have a life expectancy of ≥ 6 months.
- Must have adequate bone marrow, hepatic and renal function as assessed by specific laboratory tests.
- Must be recovered ≤ Grade 1 from acute toxicities from previous therapies, excluding alopecia and vitiligo.
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- Has not had prior treatment within 2 weeks of screening with high dose corticosteroids.
- Be willing and able to comply with the study schedule and all study requirements.
- Willing to follow all contraception guidelines.
Who cannot join
- Previous treatment with any systemic therapy or investigational drug within 2 weeks of the first dose of study drug.
- Currently participating in any other interventional clinical study.
- Has a diagnosis of other malignancies if the malignancy has required therapy within the last 3 years or is not in complete remission.
- Has presence of bulky disease defined as any mass > 7 cm in greatest dimension will trigger a discussion with the medical monitor.
- Has left ventricular ejection fraction (LVEF) < 40%.
- New York Heart Association (NYHA) Class ≥ 3.
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- Has prolonged QTcF interval on an electrocardiogram.
- Has spinal cord compression or clinically active brain metastases.
- Has a history of Sacituzumab govitecan treatment.
- History of anaphylactic reaction to irinotecan or ≥ Grade 3 toxicity to prior irinotecan treatment.
- Has active or prior COVID-19 infection, with symptoms presenting within 4 weeks of the first dose of study drug.
- Has an active bacterial, viral, or fungal infection.
- Is currently pregnant or breast feeding or planning on either during the study.
- Has chronic or moderate chronic obstructive pulmonary disease or other chronic respiratory conditions unless receiving treatment and stable for 3 months prior to screening.
- Has known HIV or acquired immunodeficiency syndrome-related illness, acute or history of chronic hepatitis B or C.
- Has any significant medical condition, abnormality, or psychiatric illness that would prevent study participation.
About this study
Official title: A Phase 1B, Dose-Escalation Study of the Safety and Preliminary Efficacy of an Anti-Trop2 Antibody Drug Conjugate (STI-3258) in Patients With Relapsed or Refractory Solid Tumors
This is a phase 1b, open-label, dose-escalation study o STI-3258 administered intravenously in subjects with relapsed or refractory solid tumors.
Read the detailed description
This is a Phase 1b, open-label, dose-escalation study o STI-3258 administered intravenously in subjects with relapsed or refractory solid tumors including ovarian, breast, lung, esophageal, gastric, hepatocellular and urothelial cancers.
The study will determine any dose limiting toxicity (DLT), maximum tolerated dose (MTD) and recommended Phase 2 dose (RP2D), assessing safety and preliminary efficacy using ascending dose cohorts and a conventional 3+3 study design.
- Being tested
- STI-3258
- Keywords
- relapsed or refractory solid tumors
- Medical subject headings
- Neoplasms, Recurrence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
STI-3258Biological
Also called anti-Trop2-SN38 antibody drug conjugate (ADC)
Intravenous infusion of STI-3258 will be given (one infusion every three weeks).
| Study group | Role | What they receive |
|---|---|---|
| STI-3258 | Experimental | Intravenous infusion to be given with prophylaxis for infusion reactions, evaluating up to five dose cohorts including: 8 mg/kg, 12 mg/kg, 16 mg/kg, 20 mg/kg, and 24 mg/kg. Receives: Biological: STI-3258 |
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 treatment-emergent adverse events by type, frequency, severity, and causality (safety)
Safety as assessed by incidence of treatment-emergent AEs (TEAEs) 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 Infusion-related adverse events by type, frequency, severity, and causality (safety)
Safety as assessed by incidence of Infusion-related AEs (IrAEs) 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
Determine the MTD
Determine the MTD of STI-3258
Measured: Baseline through study completion at up to approximately 24 months
Determine the RP2D
To determine the RP2D of STI-3258
Measured: Baseline through study completion at up to approximately 24 months
Secondary outcomes (2)
Assess preliminary efficacy of STI-3258
To assess the preliminary efficacy of STI-3258 in the treatment of patients with RRSTs based upon Response evaluation criteria in solid tumors (RECIST).
Measured: Baseline through study completion at up to approximately 24 months
Assess the area under the curve (AUC) pharmacokinetic profile of STI-3258
To assess the AUC of STI-3258 in plasma as a measure of exposure to the ADC, STI-3258.
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 posted29 Sep 2021
- Study startDec 2022 (estimated)
- Primary completionMay 2024 (estimated)
- Study completionDec 2024 (estimated)
Why it stopped: Protocol changed to Phase 2
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Relapsed Solid NeoplasmStudies 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
- Model description
- To determine DLT and MTD, the design uses a 3+3 ascending dose cohort design evaluating up to five dose cohorts including: 8 mg/kg, 12 mg/kg, 16 mg/kg, 20 mg/kg, 24 mg/kg.
- 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, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05060276
- Sponsor's protocol ID
- T2ADC-RRST-101
- Status last verified
- Jan 2023
- First submitted
- 20 Aug 2021
- Last updated
- 26 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 26 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1B, Dose-Escalation Study of the Safety and Preliminary Efficacy of an Anti-Trop2 Antibody Drug Conjugate (STI-3258) in Patients With Relapsed or Refractory Solid Tumors
- ClinicalTrials.gov ID
- NCT05060276
- Acronym / sponsor ID
- T2ADC-RRST-101
- Keywords
- relapsed or refractory solid tumors
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Protocol changed to Phase 2
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Sorrento Therapeutics, Inc.Industry (pharma, biotech, devices)
- Study start
- Dec 2022 (estimated)
- Primary completion
- May 2024 (estimated)
- Study completion
- Dec 2024 (estimated)
- First posted
- 29 Sep 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 phase 1b, open-label, dose-escalation study o STI-3258 administered intravenously in subjects with relapsed or refractory solid tumors.
Detailed description
This is a Phase 1b, open-label, dose-escalation study o STI-3258 administered intravenously in subjects with relapsed or refractory solid tumors including ovarian, breast, lung, esophageal, gastric, hepatocellular and urothelial cancers.
The study will determine any dose limiting toxicity (DLT), maximum tolerated dose (MTD) and recommended Phase 2 dose (RP2D), assessing safety and preliminary efficacy using ascending dose cohorts and a conventional 3+3 study design.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- To determine DLT and MTD, the design uses a 3+3 ascending dose cohort design evaluating up to five dose cohorts including: 8 mg/kg, 12 mg/kg, 16 mg/kg, 20 mg/kg, 24 mg/kg.
| Arm | Type | Receives |
|---|---|---|
| STI-3258 | Experimental | Biological: STI-3258Intravenous infusion to be given with prophylaxis for infusion reactions, evaluating up to five dose cohorts including: 8 mg/kg, 12 mg/kg, 16 mg/kg, 20 mg/kg, and 24 mg/kg. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Histologically or cytologically confirmed advanced cancer that is relapsing or refractory to at least one prior treatment and not a candidate for other treatments or is intolerant to established treatments.
- At least one measurable disease per Response Evaluation Criteria in Solid Tumors v. 1.1 (RECIST 1.1).
- Eastern Cooperative Oncology Group Performance Status ≤ 2.
- Must have a life expectancy of ≥ 6 months.
- Must have adequate bone marrow, hepatic and renal function as assessed by specific laboratory tests.
Key exclusion criteria (16 listed)
- Previous treatment with any systemic therapy or investigational drug within 2 weeks of the first dose of study drug.
- Currently participating in any other interventional clinical study.
- Has a diagnosis of other malignancies if the malignancy has required therapy within the last 3 years or is not in complete remission.
- Has presence of bulky disease defined as any mass > 7 cm in greatest dimension will trigger a discussion with the medical monitor.
- Has left ventricular ejection fraction (LVEF) < 40%.
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-3258Also: anti-Trop2-SN38 antibody drug conjugate (ADC)Intravenous infusion of STI-3258 will be given (one infusion every three weeks). | Biological | STI-3258 |
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 treatment-emergent 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 treatment-emergent AEs (TEAEs) 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 Infusion-related 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 Infusion-related AEs (IrAEs) 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
Determine the MTD
Time frame: Baseline through study completion at up to approximately 24 months
Determine the MTD of STI-3258
Determine the RP2D
Time frame: Baseline through study completion at up to approximately 24 months
To determine the RP2D of STI-3258
2 secondary outcomes
Assess preliminary efficacy of STI-3258
Time frame: Baseline through study completion at up to approximately 24 months
Assess the area under the curve (AUC) pharmacokinetic profile of STI-3258
Time frame: Baseline through study completion at up to approximately 24 months
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 26 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.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing STI-3258 in people with Relapsed Solid Neoplasm and Refractory Cancer, 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 16 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 26 Jan 2023. 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 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?
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?
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 7 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 26 Jan 2023; AzTrials last refreshed its copy on 8 Nov 2026.