SCLCPhase 1/2NCT04750239
Safety and Clinical Activity of Nivatrotamab in Relapsed/Recurrent Metastatic Small-cell Lung Cancer
A Phase 1/2 study testing Nivatrotamab in people with SCLC, run by Y-mAbs Therapeutics at 7 sites in United States.
Trial summary
Adult patients with small-cell lung cancer (SCLC) will be treated with nivatrotamab a monoclonal anti GD2×CD3 bispecific antibody to investigate the safety and tolerability of the drug. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- SCLC
- What is being tested?
- Nivatrotamab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3 participants
- Where
- 7 sitesUnited States
- Study dates
- 17 Aug 2021to 8 Apr 2022
- Phase
- Phase 1/2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 and dated informed consent has been provided prior to any trial-related procedures.
- Patient willing and able to comply with the trial protocol
- Age ≥18 years at the time of informed consent
- Histologically or cytologically proven SCLC. Radiographical relapse/progression after minimum 1 line of platinum-containing chemotherapy with partial response or complete response as the best response (only applicable for phase 2) and not more than 3 prior lines of therapy
- Measurable disease according to RECIST v1.1
- Eastern Cooperative Oncology Group (ECOG) performance status 0-1
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- Expected survival >3 months
- Platelet counts ≥100,000 cells/mm3
- Hemoglobin ≥9 g/dL
- Absolute neutrophil count (ANC) ≥1000 cells/mm3
- Adequate liver function defined by aspartate aminotransferase (AST), alanine aminotransferase (ALT), alkaline phosphatase (ALP) ≤3 × upper limit of normal (ULN), and serum bilirubin ≤1.5 × ULN with the following exceptions
- In patients with documented liver metastases, AST, ALT, and ALP ≤5 × ULN and serum bilirubin ≤1.5 × ULN
- Adequate renal function with serum creatinine ≤1.5 mg/dL or creatinine clearance ≥50 mL/min as calculated using the Cockcroft Gault equation
- Serum albumin >3.0 g/dL
- Women of child-bearing potential must agree to appropriate contraception during treatment and for a period of 30 days after the last dose of study drug.
Who cannot join
- Systemic chemotherapy, radiotherapy, immunotherapy, or major surgery administered within 3 weeks prior to the first planned dosing of the investigational Medicinal Product (IMP) per protocol
- Patients receiving any other investigational therapy for their cancer within 3 weeks prior to the first planned dosing of the IMP per protocol
- Patients who never received platinum-containing regimen for SCLC (defined as less than 2 cycles of platinum doublet)
- Persistent > grade 1 toxicity from previous treatment with checkpoint inhibitors
- Any immunosuppressive concomitant medication (i.e., salazopyrine, methotrexate, steroids etc.)
- Inability to wean off steroid, unless tapered to 0 mg/day minimum 10 days prior to the first treatment in case of prior use
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- Any active, uncontrolled viral, fungal, or bacterial infection
- Any medical history within 3 months prior to enrolment with need for anticonvulsant therapy
- Patients with diagnosis of autoimmune diseases or immunodeficiencies or documented infection with human immunodeficiency virus (HIV) or hepatitis B or C virus (active)
- Previous autologous stem cell transplantation or solid organ transplantation
- Active heart disease including myocardial infarction within the last 6 months before first dose. This includes cardiac insufficiency with left ventricular ejection fraction (LVEF) <50%
- Active CNS metastases. Patients with treated central nervous system (CNS) metastases are eligible if they are clinically stable without any new neurological symptoms and if there is no radiological evidence of new or enlarging CNS metastases. CNS-directed treatment (surgery, radiation) must be completed 4 weeks prior to the first IMP administration.
- Furthermore, patients are excluded if they have:
- Leptomeningeal carcinomatosis Uncontrolled seizures. Patients with known seizure are eligible if they are stable and have been without seizure 4 weeks prior to the first IMP administration
- Patients who experienced severe or recurrent (>grade 2) immune mediated adverse events (AEs) or infusion related reactions (IRRs), including those that lead to permanent discontinuation while on treatment with immune oncology agents
- Prior treatment with anti-GD2 antibody or bispecific antibodies
- Patients with Limited Disease (LD), who are candidates for local or regional therapy.
- Impending need for palliative radiotherapy or surgery for pathological fractures and/or for medullary compression up to 3 weeks prior to the first planned dosing of the IMP per protocol (palliative radiation for other reasons within 2 weeks)
- History of other active malignancy within the past 3 years prior to the first planned dosing of the IMP per protocol (excluding non-melanoma skin cancers, carcinoma in situ of the cervix, ductal carcinoma in situ of the breast, incidental prostate cancer (T1a, Gleason score ≤ 6, prostate specific antigen (PSA) less than 0.5 ng/ml)
- Patients with a significant intercurrent illness (any ongoing serious medical problem unrelated to cancer or its treatment) that is not covered by the detailed exclusion criteria and that is expected to interfere with the action of the trial IMP or significantly increase the severity of the toxicities experienced from trial treatment
- Patients who are pregnant or breastfeeding
- Patients with a body weight of < 45 kg
- Patients with prior orthostatic hypotension
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
United States7 sites
Emory University
Atlanta, Georgia, 30332
Henry Ford Hospital
Detroit, Michigan, 48202
Sarah Cannon Research Institute - Tennessee Oncology
Nashville, Tennessee, 37203
Fox Chase Cancer Center
Philadelphia, Pennsylvania, 19111
UPMC Hillman Cancer Center
Pittsburgh, Pennsylvania, 15232
Washington University School of Medicine
St Louis, Missouri, 63110
Moffitt Cancer Center
Tampa, Florida, 33612
About this study
Official title: Safety and Clinical Activity of Nivatrotamab, an Anti GD2×CD3 Bispecific Antibody, in Relapsed/Recurrent Metastatic Small-cell Lung Cancer An Open-label, Single-arm, Multicenter, Phase 1/2 Trial
Adult patients with small-cell lung cancer (SCLC) will be treated with nivatrotamab a monoclonal anti GD2×CD3 bispecific antibody to investigate the safety and tolerability of the drug.
Read the detailed description
The study will include a phase 1 dose escalation part to determine the maximum tolerated dose (MTD) and the recommended phase 2 dose (RP2D). This will be conducted following a modified Bayesian Optimal Interval Design (mBOIN) design. For the purpose of dose escalation, dose-limiting toxicities (DLTs) will be collected and assessed for a period of 28 days (the DLT evaluation period).
A phase 2 dose expansion part will follow the phase 1 dose escalation. In phase 2, patients will be stratified according to whether they have platinum sensitive or platinum-resistant SCLC. Phase 2 will assess the long term safety and tolerability of nivatrotamab as well as the clinical activity of nivatrotamab when administered at the obtained MTD/RP2D in phase 1.
- Conditions
- SCLC
- Being tested
- Nivatrotamab
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NivatrotamabDrug
Anti GD2×CD3 monoclonal bi-specific antibody
| Study group | Role | What they receive |
|---|---|---|
| Nivatrotamab | Experimental | Subcutaneous administration of nivatrotamab up to 13 cycles Receives: Drug: Nivatrotamab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dose Limiting Toxicities (DLTs) Phase I
Summary of DLTs in DLT evaluable subjects.
Measured: Days 1 through 28
Number of Participants With Adverse Events (AEs) for Different Doses of Nivatrotamab in Phase I
Number of participants with adverse events as a measure of safety and tolerability.
Measured: From first dose until 30 days after last IMP, up to 26 weeks. Actual duration for treated patients were from 21 to 58 days.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Feb 2021
- Study start17 Aug 2021
- Primary completion8 Apr 2022
- Study completion8 Apr 2022
Why it stopped: Study terminated due to business priorities
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for SCLCStudies 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 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Model description
- open-label, single-arm, dose-escalation and expansion consisting of up to 13 cycles
- Masking
- None (open label)
- Enrolment
- 3 participants (actual)
Sponsor and investigators
- Lead sponsor
- Y-mAbs Therapeutics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04750239
- Sponsor's protocol ID
- 402
- Status last verified
- Jun 2023
- First submitted
- 6 Feb 2021
- Last updated
- 14 Aug 2023
- Results posted
- Yes, on ClinicalTrials.gov
- 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 14 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Clinical Activity of Nivatrotamab, an Anti GD2×CD3 Bispecific Antibody, in Relapsed/Recurrent Metastatic Small-cell Lung Cancer An Open-label, Single-arm, Multicenter, Phase 1/2 Trial
- ClinicalTrials.gov ID
- NCT04750239
- Acronym / sponsor ID
- 402
- Conditions
- SCLC
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Study terminated due to business priorities
- Enrolment
- 3 participants (actual)
- Lead sponsor
- Y-mAbs TherapeuticsIndustry (pharma, biotech, devices)
- Study start
- 17 Aug 2021 (actual)
- Primary completion
- 8 Apr 2022 (actual)
- Study completion
- 8 Apr 2022 (actual)
- First posted
- 11 Feb 2021 (actual)
- Results
- Posted 14 Aug 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Adult patients with small-cell lung cancer (SCLC) will be treated with nivatrotamab a monoclonal anti GD2×CD3 bispecific antibody to investigate the safety and tolerability of the drug.
Detailed description
The study will include a phase 1 dose escalation part to determine the maximum tolerated dose (MTD) and the recommended phase 2 dose (RP2D). This will be conducted following a modified Bayesian Optimal Interval Design (mBOIN) design. For the purpose of dose escalation, dose-limiting toxicities (DLTs) will be collected and assessed for a period of 28 days (the DLT evaluation period).
A phase 2 dose expansion part will follow the phase 1 dose escalation. In phase 2, patients will be stratified according to whether they have platinum sensitive or platinum-resistant SCLC. Phase 2 will assess the long term safety and tolerability of nivatrotamab as well as the clinical activity of nivatrotamab when administered at the obtained MTD/RP2D in phase 1.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- open-label, single-arm, dose-escalation and expansion consisting of up to 13 cycles
| Arm | Type | Receives |
|---|---|---|
| Nivatrotamab | Experimental | Drug: NivatrotamabSubcutaneous administration of nivatrotamab up to 13 cycles |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- Signed and dated informed consent has been provided prior to any trial-related procedures.
- Patient willing and able to comply with the trial protocol
- Age ≥18 years at the time of informed consent
- Histologically or cytologically proven SCLC. Radiographical relapse/progression after minimum 1 line of platinum-containing chemotherapy with partial response or complete response as the best response (only applicable for phase 2) and not more than 3 prior lines of therapy
- Measurable disease according to RECIST v1.1
Key exclusion criteria (23 listed)
- Systemic chemotherapy, radiotherapy, immunotherapy, or major surgery administered within 3 weeks prior to the first planned dosing of the investigational Medicinal Product (IMP) per protocol
- Patients receiving any other investigational therapy for their cancer within 3 weeks prior to the first planned dosing of the IMP per protocol
- Patients who never received platinum-containing regimen for SCLC (defined as less than 2 cycles of platinum doublet)
- Persistent > grade 1 toxicity from previous treatment with checkpoint inhibitors
- Any immunosuppressive concomitant medication (i.e., salazopyrine, methotrexate, steroids etc.)
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 |
|---|---|---|
| NivatrotamabAnti GD2×CD3 monoclonal bi-specific antibody | Drug | Nivatrotamab |
Primary outcome
Dose Limiting Toxicities (DLTs) Phase I
Time frame: Days 1 through 28
Summary of DLTs in DLT evaluable subjects.
Number of Participants With Adverse Events (AEs) for Different Doses of Nivatrotamab in Phase I
Time frame: From first dose until 30 days after last IMP, up to 26 weeks. Actual duration for treated patients were from 21 to 58 days.
Number of participants with adverse events as a measure of safety and tolerability.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Aug 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
The record lists no contact. Use the official record to reach the sponsor.
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Nivatrotamab in people with SCLC, run by Y-mAbs Therapeutics at 7 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 15 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: stopped early, as of the sponsor's last update on 14 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 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 combined 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.
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?
Yes. Results are posted in the registry (first posted 14 Aug 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Dose Limiting Toxicities (DLTs) Phase I (time frame: Days 1 through 28). The study lists 2 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 14 Aug 2023.