Neoplasm MalignantPhase 1NCT02575781
A Study of SAR428926 in Patients With Advanced Solid Tumors
A Phase 1 study testing SAR428926 in people with Neoplasm Malignant, run by Sanofi at 3 sites in 3 countries.
Trial summary
Primary Objectives: To determine the maximum tolerated dose (MTD) of SAR428926 when administered as a single agent in patients with advanced solid tumors. To evaluate the anti-tumor response of SAR428926 when administered as a single agent in patients with advanced triple negative breast cancer (TNBC) positive for the… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Neoplasm Malignant
- What is being tested?
- SAR428926
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 3 sitesin 3 countries
- Study dates
- 5 Oct 2015to Jun 2018
- 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
- Patients with advanced solid tumor with no standard alternative treatment.
- Availability of archived tumor tissue for SAR428926 targeted antigen testing.
- For participants in the Escalation Phase: human epidermal growth factor receptor 2 (HER2) negative breast cancer (BC), gastric cancer, colorectal cancer (CRC), ovarian cancer, prostate cancer and non small-cell lung cancer (NSCLC).
- For participants in the Expansion Phase: patients with TNBC, prostate cancer, CRC, ovarian cancer or NSCLC and positive SAR428926 targeted antigen.
- At least one measurable lesion according to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 and one lesion amenable to biopsy in expansion cohort only (except for NSCLC patients).
Who cannot join
- Age less than 18 years old.
- Eastern Cooperative Oncology Group (ECOG) performance status more than 1.
- New or progressing brain metastases.
- Concurrent treatment with any other anticancer therapy or inadequate wash-out period for prior anticancer therapies, including other experimental anticancer treatment, before first administration of SAR428926, or non resolution of toxicities induced by these anticancer therapies.
- Women of reproductive potential and male subjects with female partners of childbearing potential who are not willing to avoid pregnancy.
- Pregnancy or breast feeding.
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- Prior maytansinoid treatments (DM1 or DM4 antibody drug conjugates [ADCs]).
- Unwillingness and inability to comply with scheduled visits, drug administration plan, laboratory tests, other study procedures, and study restrictions.
- Significant concomitant illness, including psychiatric condition that, in the opinion of the Investigator or Sponsor, would adversely affect the patient's participation in the study.
- Any surgery within the preceding 3 weeks.
- Known human immunodeficiency virus (HIV) infection or active hepatitis B or C viral infection.
- Poor bone marrow reserve.
- Poor kidney and liver function.
- Previous history of chronic corneal diseases (even if asymptomatic) or unresolved acute non-recurrent corneal conditions. Patients wearing contact lenses who are not willing to stop wearing them for the duration of the study.
- Unresolved signs and symptoms of peripheral neuropathy; Grade 1 is acceptable.
- Abnormal cardiac function defined by a left ventricular ejection fraction (LVEF) <50%.
- Known intolerance to infused protein products including other monoclonal antibodies and ADCs.
- Medical conditions requiring concomitant administration of medications with narrow therapeutic window, metabolized by CYPs and which a dose reduction cannot be considered.
- Medical conditions requiring concomitant administration of strong CYP3A inhibitors, unless it can be discontinued at least two weeks before first administration of SAR428926.
- Other prior neoplasm.
- Contraindications to the use of ophthalmic vasoconstrictor and/or corticosteroid as per package insert of each drug, including the following: increase intraocular pressure, prior or current glaucoma, narrow-angle glaucoma, ongoing eye infection, uncontrolled hypertension, known/suspected allergy to constituents of the preparation (such as sodium bisulfite).
- The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Trial locations and contacts
3 sites in 3 countries.
3 sites in 3 countries
About this study
Official title: A First-in-human Phase 1 Dose Escalation Study of SAR428926 in Patients With Advanced Solid Tumors
Primary Objectives:
To determine the maximum tolerated dose (MTD) of SAR428926 when administered as a single agent in patients with advanced solid tumors.
Read more
To evaluate the anti-tumor response of SAR428926 when administered as a single agent in patients with advanced triple negative breast cancer (TNBC) positive for the protein targeted by SAR428926 To assess the preliminary anti-tumor response of SAR428926 when administered as a single agent in patients with advanced solid tumors positive for the protein targeted by SAR428926
Secondary Objectives:
To determine the overall safety profile of SAR428926 as a single agent. To characterize the pharmacokinetics (PK) profile of SAR428926 and its metabolites.
To identify the recommended Phase 2 dose (RP2D) of SAR428926 as a single agent. To evaluate the immunogenicity of SAR428926. To assess the tumor response and duration of tumor response in all treated patients.
To evaluate the benefit of primary prophylaxis on the occurrence of corneal (keratopathy/keratitis) toxicity (Expansion cohorts).
Read the detailed description
The study duration for an individual patient will include a screening period for inclusion of up to 28 days, a treatment period, an end-of-treatment (EOT) visit around 30 days following the last administration of SAR428926, and at least one follow-up visit around 30 days after the EOT visit. The treatment period may continue until disease progression, intolerable toxicity, or investigator, Sponsor, or patient decision to discontinue therapy. Patients who discontinue treatment for reasons other than progression of disease will be followed every 3 months until progression, initiation of subsequent therapy, or until the primary analysis cutoff date, whichever comes first.
- Conditions
- Neoplasm Malignant
- Being tested
- SAR428926
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SAR428926Drug
Pharmaceutical form:concentrate for solution for infusion Route of administration: intravenous
| Study group | Role | What they receive |
|---|---|---|
| SAR428926-Escalating cohort | Experimental | SAR428926 will be administered intravenously up to disease progression or dose limiting toxicities Receives: Drug: SAR428926 |
| SAR428926 in triple negative breast cancer-Expansion Cohort 1 | Experimental | SAR428926 will be administered intravenously at maximum tolerated dose (MTD) up to disease progression or unacceptable toxicity Receives: Drug: SAR428926 |
| SAR428926 in solid tumors-Expansion Cohort 2 | Experimental | SAR428926 will be administered intravenously at the MTD up to disease progression or unacceptable toxicity Receives: Drug: SAR428926 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patients with dose limiting adverse events (Escalation cohort)
Measured: 4 weeks
Number of patients with corneal adverse events impacting study treatment (Escalation cohort)
Measured: 8 weeks
Assessment of overall response rate using standard imaging and RECIST v1.1 criteria (Expansion cohort)
Measured: Tumor assessment every 2 months until disease progression or up to 36 months, whichever came first
Secondary outcomes (11)
Number of treatment emergent adverse events
Measured: Up to 3 years
Assessment of PK parameter: maximum concentration (Cmax)
Measured: 2 months
Assessment of PK parameter: time to reach maximum concentration (tmax)
Measured: 2 months
Assessment of PK parameter: trough plasma concentration (Ctrough)
Measured: Every 2 weeks until approximately 14 weeks
Assessment of PK parameter: area under the plasma concentration curve versus time curve between 1 and 14 days (AUC0-14 day)
Measured: 2 months
Assessment of PK parameter: mean systemic clearance (CL)
Measured: 2 months
Assessment of PK parameter: clearance at steady state (CLss)
Measured: 2 months
Assessment of PK parameter: accumulation ratio on AUC0-14
Measured: 2 months
Assessment of PK parameter: accumulation ratio on Cmax
Measured: 2 months
Preliminary tumor response by RECIST v1.1 (Escalation)
Measured: 2 months
Number of corneal events according to the presence or not of preventive measures
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Oct 2015 (estimated)
- Study start5 Oct 2015
- Primary completionJun 2018
- Study completionJun 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neoplasm MalignantStudies of the same condition, open and under way.
- More trials run by SanofiThe sponsor's other registered studies.
- 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sanofi
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Sciences & Operations, Study director, Sanofi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02575781
- Sponsor's protocol ID
- TED14147
- Other IDs
- 2015-001441-92, U1111-1168-4706, 2015
- Status last verified
- Aug 2018
- First submitted
- 8 Oct 2015
- Last updated
- 22 Aug 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A First-in-human Phase 1 Dose Escalation Study of SAR428926 in Patients With Advanced Solid Tumors
- ClinicalTrials.gov ID
- NCT02575781
- Acronym / sponsor ID
- TED14147
- Conditions
- Neoplasm Malignant
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- SanofiIndustry (pharma, biotech, devices)
- Study start
- 5 Oct 2015 (actual)
- Primary completion
- Jun 2018 (actual)
- Study completion
- Jun 2018 (actual)
- First posted
- 15 Oct 2015 (estimated)
- 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.
Primary Objectives:
To determine the maximum tolerated dose (MTD) of SAR428926 when administered as a single agent in patients with advanced solid tumors.
To evaluate the anti-tumor response of SAR428926 when administered as a single agent in patients with advanced triple negative breast cancer (TNBC) positive for the protein targeted by SAR428926 To assess the preliminary anti-tumor response of SAR428926 when administered as a single agent in patients with advanced solid tumors positive for the protein targeted by SAR428926
Secondary Objectives:
To determine the overall safety profile of SAR428926 as a single agent. To characterize the pharmacokinetics (PK) profile of SAR428926 and its metabolites.
To identify the recommended Phase 2 dose (RP2D) of SAR428926 as a single agent. To evaluate the immunogenicity of SAR428926. To assess the tumor response and duration of tumor response in all treated patients.
To evaluate the benefit of primary prophylaxis on the occurrence of corneal (keratopathy/keratitis) toxicity (Expansion cohorts).
Detailed description
The study duration for an individual patient will include a screening period for inclusion of up to 28 days, a treatment period, an end-of-treatment (EOT) visit around 30 days following the last administration of SAR428926, and at least one follow-up visit around 30 days after the EOT visit. The treatment period may continue until disease progression, intolerable toxicity, or investigator, Sponsor, or patient decision to discontinue therapy. Patients who discontinue treatment for reasons other than progression of disease will be followed every 3 months until progression, initiation of subsequent therapy, or until the primary analysis cutoff date, whichever comes first.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| SAR428926-Escalating cohort | Experimental | Drug: SAR428926SAR428926 will be administered intravenously up to disease progression or dose limiting toxicities |
| SAR428926 in triple negative breast cancer-Expansion Cohort 1 | Experimental | Drug: SAR428926SAR428926 will be administered intravenously at maximum tolerated dose (MTD) up to disease progression or unacceptable toxicity |
| SAR428926 in solid tumors-Expansion Cohort 2 | Experimental | Drug: SAR428926SAR428926 will be administered intravenously at the MTD up to disease progression or unacceptable toxicity |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patients with advanced solid tumor with no standard alternative treatment.
- Availability of archived tumor tissue for SAR428926 targeted antigen testing.
- For participants in the Escalation Phase: human epidermal growth factor receptor 2 (HER2) negative breast cancer (BC), gastric cancer, colorectal cancer (CRC), ovarian cancer, prostate cancer and non small-cell lung cancer (NSCLC).
- For participants in the Expansion Phase: patients with TNBC, prostate cancer, CRC, ovarian cancer or NSCLC and positive SAR428926 targeted antigen.
- At least one measurable lesion according to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 and one lesion amenable to biopsy in expansion cohort only (except for NSCLC patients).
Key exclusion criteria (22 listed)
- Age less than 18 years old.
- Eastern Cooperative Oncology Group (ECOG) performance status more than 1.
- New or progressing brain metastases.
- Concurrent treatment with any other anticancer therapy or inadequate wash-out period for prior anticancer therapies, including other experimental anticancer treatment, before first administration of SAR428926, or non resolution of toxicities induced by these anticancer therapies.
- Women of reproductive potential and male subjects with female partners of childbearing potential who are not willing to avoid pregnancy.
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 |
|---|---|---|
| SAR428926Pharmaceutical form:concentrate for solution for infusion Route of administration: intravenous | Drug | SAR428926 in solid tumors-Expansion Cohort 2, SAR428926 in triple negative breast cancer-Expansion Cohort 1, SAR428926-Escalating cohort |
Primary outcome
Number of patients with dose limiting adverse events (Escalation cohort)
Time frame: 4 weeks
Number of patients with corneal adverse events impacting study treatment (Escalation cohort)
Time frame: 8 weeks
Assessment of overall response rate using standard imaging and RECIST v1.1 criteria (Expansion cohort)
Time frame: Tumor assessment every 2 months until disease progression or up to 36 months, whichever came first
11 secondary outcomes
Number of treatment emergent adverse events
Time frame: Up to 3 years
Assessment of PK parameter: maximum concentration (Cmax)
Time frame: 2 months
Assessment of PK parameter: time to reach maximum concentration (tmax)
Time frame: 2 months
Assessment of PK parameter: trough plasma concentration (Ctrough)
Time frame: Every 2 weeks until approximately 14 weeks
Assessment of PK parameter: area under the plasma concentration curve versus time curve between 1 and 14 days (AUC0-14 day)
Time frame: 2 months
Assessment of PK parameter: mean systemic clearance (CL)
Time frame: 2 months
Assessment of PK parameter: clearance at steady state (CLss)
Time frame: 2 months
Assessment of PK parameter: accumulation ratio on AUC0-14
Time frame: 2 months
Assessment of PK parameter: accumulation ratio on Cmax
Time frame: 2 months
Preliminary tumor response by RECIST v1.1 (Escalation)
Time frame: 2 months
Number of corneal events according to the presence or not of preventive measures
Time frame: 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Aug 2018.
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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.
Clinical Sciences & Operations study director
Sanofi
3 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing SAR428926 in people with Neoplasm Malignant, run by Sanofi at 3 sites in 3 countries.
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 5 inclusion and 22 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: finished, as of the sponsor's last update on 22 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Denmark, France, Spain. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Number of patients with dose limiting adverse events (Escalation cohort) (time frame: 4 weeks). The study lists 3 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 22 Aug 2018.