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Light Chain (AL) AmyloidosisPhase 1NCT05692908

An Open-Label Study of the Safety of an Anti-CD38 Antibody Drug Conjugate (STI-6129) in Patients With AL Amyloidosis

A Phase 1 study testing STI-6129 in people with Light Chain (AL) Amyloidosis, run by Sorrento Therapeutics, Inc..

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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Trial summary

This is a Phase 1 open-label, dose escalation trial designed to identify the recommended phase 2 dose of STI-6129 by assessing the safety, preliminary efficacy, and immunogenicity in subjects with relapsed or refractory systemic AL Amyloidosis Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Light Chain (AL) Amyloidosis
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
0 participants
Where
No sites listed yet
Study dates
Sep 2023to Nov 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

  • 1. Age ≥ 18 years.
  • 2. Confirmed diagnosis of AL amyloidosis by tissue biopsy of an involved organ, or a surrogate site such as abdominal fat, demonstrating amyloid deposition by mass spectrometry
  • 3. The presence of a monoclonal light chain protein in serum and/or urine
  • 4. Relapsed or refractory (R/R) AL amyloidosis is patients who have exhausted standard of care treatment. Patients who have received prior CD38-directed monoclonal antibody (e.g. daratumumab, isatuximab) treatment or prior stem cell transplantation remain eligible. Patients may have relapsed with disease progression or have been refractory to their last prior line of treatment. Refractory systemic AL amyloidosis is defined as the development of disease progression during therapy with an anti-AL amyloidosis treatment regimen or within 60 days of the last dose of an anti-AL amyloidosis treatment regimen or the achievement of less than a PR after ≥ 2 cycles
  • 5. Measurable disease defined by the following: the finding by serum FLC assay that the difference between the involved and uninvolved FLC (dFLC) is ≥ 40 mg/L
  • 6. Pulse oximetry ≥ 92% on room air
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  • 7. ECOG performance status of 0, 1, or 2
  • 8. Be willing and able to comply with the study schedule and all other protocol requirements
  • 9. Willing to follow contraception guidelines: c. If a female, be sterile (surgically or biologically)* or at least one year post-menopausal, or have a monogamous partner who is surgically sterile, or have a same sex partner, or if in a heterosexual relationship, must agree to do the following during the study after completing IP dosing:
  • Practice abstinence (only considered an acceptable method of contraception when it is in line with the participants' usual and preferred lifestyle)
  • Use at least one of the following medically acceptable methods of birth control:
  • Hormonal methods as follows:
  • Combined estrogen and progestogen containing hormonal contraception associated with inhibition of ovulation (oral, intravaginal, transdermal)
  • Progestogen only hormonal contraception associated with inhibition of ovulation (oral, injectable, implantable)
  • Intrauterine devices
  • Intrauterine hormone-releasing systems
  • Vasectomized partner
  • Barrier contraception
  • Defined as having had a hysterectomy and/or bilateral oophorectomy, bilateral salpingectomy or bilateral tubal ligation/occlusion at least 6 weeks prior to screening; or having a congenital or acquired condition that prevents childbearing.
  • If a male of reproductive potential, unless he has a same sex partner, must agree to do the following during the study after completing IP dosing:
  • Refrain from donating sperm
  • Practice abstinence from heterosexual activity (only considered an acceptable method of contraception when it is in line with the participants' usual and preferred lifestyle), OR
  • Use (or have their partner use) acceptable contraception (see criterion above) during heterosexual activity, such as barrier contraception

Who cannot join

  • 1. Isolated vascular amyloid in a bone marrow biopsy or a plasmacytoma specimen or isolated soft tissue involvement (localized AL amyloidosis)
  • 2. Presence of non-AL amyloidosis
  • 3. A diagnosis of multiple myeloma
  • 4. A diagnosis of other malignancies if the malignancy has required 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
  • 5. Treatment with an allogeneic hematopoietic stem cell transplantation (HSCT) within 6 months prior to the planned infusion of STI-6129, or active graft-versus-host disease (GvHD) following the allogeneic transplant, or a requirement for currently receiving immunosuppressive therapy following the allogeneic transplant
  • 6. Revised Mayo Clinic AL amyloidosis stage > 3
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  • 7. New York Heart Association (NYHA) class > 3
  • 8. Left ventricular ejection fraction (LVEF) < 40%.
  • 9. Patients with mean left ventricular wall thickness ≥ 15 mm and/or intraventricular septal thickness > 25 mm by echocardiogram in the absence of hypertension or valvular heart disease
  • 10. Patients with NT-proBNP ≥ 1800 ng/L or BNP ≥ 400 ng/L, cTnT ≥ 0.025 mcg/L will be excluded in the dose-escalation stage of the study and can only be included in the PK and expansion stages after evaluation by cardiology and discussion with the principle investigator regarding the risk associated with the treatment
  • 11. The following baseline hematological laboratory results at Screening (these results must be independent of blood product or hematopoietic growth factor support):
  • Hemoglobin < 8.0 g/dL
  • Platelet count < 50,000/μL
  • Absolute neutrophil count (ANC) < 1000/ μL
  • 12. The following baseline chemistry laboratory results at Screening:
  • Serum creatinine > 2.0 x the upper limit of normal (ULN), or estimated creatinine clearance < 45 mL/min (using the Cockcroft-Gault equation).
  • Serum aspartate aminotransferase (AST) or alanine aminotransferase (ALT) > 3x ULN or serum total bilirubin > 1.5x ULN (except for patients in whom hyperbilirubinemia is attributed to Gilbert's Syndrome)
  • 13. INR or aPTT > 1.5x ULN within 1 week prior to the infusion of STI-6129, unless on a stable dose of an anticoagulant
  • 14. Are pregnant or breastfeeding
  • 15. Patients with ≥ Grade 3 neuropathy or Grade 2 neuropathy with associated pain
  • 16. Active bacterial, viral, or fungal infection within 72 hours of the infusion of STI-6129; patients with ongoing use of prophylactic antibiotics, antifungal agents, or antiviral agents remain eligible as long as there is no evidence of active infection, or the STI-6129 treatment would put the patient at risk for a meaningful safety event.
  • 17. Have a prolongation in QTcF (Fridericia correction formula) > 480 msec on a baseline ECG
  • 18. Any condition including the presence of laboratory abnormalities that places the patient at an unacceptable risk if the patient was to participate in the study

About this study

Official title: An Open-Label, Dose-Escalation Study of the Safety of an Anti-CD38 Antibody Drug Conjugate (STI-6129) in Patients With Relapsed or Refractory Systemic AL Amyloidosis

This is a Phase 1 open-label, dose escalation trial designed to identify the recommended phase 2 dose of STI-6129 by assessing the safety, preliminary efficacy, and immunogenicity in subjects with relapsed or refractory systemic AL Amyloidosis

Read the detailed description

This study is an open-label, dose-finding, to identify the recommended phase 2 dose (RP2D) of STI-6129 by assessing the safety, and pharmacokinetics for the treatment of RRAL which is defined as the development of disease progression during therapy with an anti-AL amyloidosis treatment regimen or within 60 days of the last dose of an anti-AL amyloidosis treatment regimen or the achievement of less than a PR after ≥ 2 cycles.

The trial is the dose-escalation study. A standard dose escalation 3+3 will be utilized to identify dose-limiting toxiticy (DLTs) and a safe maximum tolerated dose (MTD) of STI-6129 in patients with R/R systemic AL amyloidosis. A total of 6 dosing cohorts are planned from 0.88 mg/kg to 3.68 mg/kg. Approximate dosing increments between cohorts are 1.33x up to the maximum planned dose level.

Being tested
STI-6129
Medical subject headings
Amyloidosis

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-Duostatin 5.2 antibody-drug conjugate (ADC)

    Four cycles of intravenous infusion of STI-6129 will be given (one infusion every four weeks).

Study groups in NCT05692908
Study groupRoleWhat they receive
STI-6129 infusionExperimentalIntravenous 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.

  1. Safety of STI-6129

    Safety as assessed by incidence of adverse events (AEs), severe AEs (SAEs), DLTs, neurotoxicity and 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 (4)

  1. Overall hematological response rate according to the 2012 Consensus Round Table response criteria

    Proportion of subjects with Complete Response (CR), Very Good Partial Response (VGPR), Partial Response (PR), No Response (NR) and Progressive Disease (PD)

    Measured: Baseline through study completion at up to approximately 24 months

  2. Organ response rates (cardiac, renal, hepatic, peripheral nervous system) according to the 2012 Consensus Round Table response criteria

    Organ response rates (cardiac, renal, hepatic, peripheral nervous system) according to the 2012 Consensus Round Table response criteria

    Measured: Baseline through study completion at up to approximately 24 months

  3. Correlation of treatment response (organ responses and hematological response) with disease severity based on the 2012 revised Mayo Clinic staging system for AL amyloidosis

    Correlation of treatment response (organ responses and hematological response) with disease severity based on the 2012 revised Mayo Clinic staging system for AL amyloidosis

    Measured: Baseline through study completion at up to approximately 24 months

  4. Plasma levels of the total antibody plus conjugated toxin (STI-6129) and the free toxin (Duostatin 5.2)

    Plasma levels of the total antibody plus conjugated toxin (STI-6129) and the free toxin (Duostatin 5.2) by ELISA and mass spectrophotometry assays, respectively, at pre-dose and various time points post-dose

    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.

  1. First posted20 Jan 2023
  2. Study startSep 2023 (estimated)
  3. Primary completionSep 2024 (estimated)
  4. Study completionNov 2024 (estimated)

Why it stopped: Sorrento Therapeutics filed for chapter 11 bankruptcy.

Resources

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
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05692908
Sponsor's protocol ID
38ADC-RRAL-102-SWE
Status last verified
Apr 2023
First submitted
11 Jan 2023
Last updated
28 Apr 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing STI-6129 in people with Light Chain (AL) Amyloidosis, 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 23 inclusion and 23 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 28 Apr 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?

Safety of STI-6129 (time frame: Baseline through study completion at up to approximately 24 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05692908.

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 28 Apr 2023.

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