Solid TumorPhase 1NCT04242147
A Study to Investigate the Safety, Pharmacokinetics, Pharmacodynamics, and Preliminary Efficacy of KD033 (SAR445710) in Subjects With Metastatic or Locally Advanced Solid Tumors
A Phase 1 study testing KD033 (SAR445710) in people with Solid Tumor, run by Kadmon, a Sanofi Company at 5 sites in United States.
Trial summary
This is a Phase1, open-label, sequential dose-escalation and dose-expansion study of KD033 (SAR445710) in adult participants with advanced or metastatic solid tumors. The main purpose of this study is to test KD033 (SAR445710) at different dose levels to see if it is safe and well tolerated when given once every 2… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Solid Tumor
- What is being tested?
- KD033 (SAR445710)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 5 sitesUnited States
- Study dates
- 6 Mar 2023to 1 Dec 2023
- 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/documented advanced and/or metastatic solid tumor with at least one tumor lesion of location accessible to biopsy per clinical judgement of treating physician.
- Participants must be willing to provide a tumor biopsy at the following time points: Pre-treatment and at Cycle 4, Day 1. All other study eligibility criteria must be met before any biopsy sample is obtained.
- Measurable disease at baseline per RECIST v1.1 guidelines.
- Life expectancy of at least 3 months.
- Eastern Cooperative Oncology Group Performance Status (ECOG PS) score ≤ 1.
- Adequate organ and bone marrow functions.
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- All toxicities related to prior radiotherapy, chemotherapy, or surgical procedure must have recovered to baseline or Grade ≤ 1 based on NCI-CTCAE v5.0 except alopecia (any grade), Grade 2 peripheral neuropathy and adverse events that are clinically non-significant or stable on supportive care.
- All participants, male and female, who are not surgically sterilized or postmenopausal must agree to use 'highly effective methods of contraception' during the study and for at least 60 days after the last dose of KD033 (SAR445710).
- Women of childbearing potential must have a negative pregnancy test within 7 days prior to KD033 (SAR445710) treatment.
- Ability to understand the purpose of the study, provide signed and dated informed consent from the participant/legal representative prior to performing any protocol-related procedures and able to comply with the study procedures and any locally required authorization.
Who cannot join
- Use of immunotherapy, biological therapy, cytokine therapy < 21 days prior to the first dose of study drug.
- Use of immunomodulating agents < 21 days prior to the first dose of study drug.
- Use of chemotherapy and approved tyrosine kinase inhibitor (TKI) therapy < 14 days prior to the first dose of study drug.
- Anti PD-L1 or anti PD-1 therapy < 6 weeks prior to the first dose of study drug.
- Radiotherapy within 14 days before the start of trial treatment (prior diagnostic biopsy is permitted), with the exception of palliative radiation as described: patients assigned to radiotherapy require at least 1 additional lesion that can be safely irradiated while sparing the index lesion(s), and for which radiation at the limited, palliative doses contemplated would be considered medically appropriate; The lesion should be causing some signs or symptoms (e.g., tumor-related pain), for which radiation is indicated per the physician's standard clinical practice.
- Use of any investigational drug or have major surgery within 28 days before the start of trial treatment
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- Ongoing or recent (within 2 years) evidence of significant autoimmune disease that required systemic immunosuppressive treatments.
- Systemic therapy with immunosuppressive agents including corticosteroids within 14 days before the start of trial treatment with the exception of corticosteroid replacement therapy for adrenal insufficiency
- Rapidly progressive disease which, in the opinion of Investigator, may predispose to inability to tolerate treatment or trial procedure.
- History or clinical evidence of central nervous system primary tumors or metastases including leptomeningeal metastases unless they have been previously treated, demonstrated no progression at least 1 months, are asymptomatic and have had no requirement for steroids or enzyme inducing anticonvulsants in the last 14 days before Screening - Participants with suspected brain metastases at Screening should undergo a CT/MRI of the brain prior to study entry.
- Receipt of any organ transplantation including hematopoietic cell transplantation.
- Has a paraneoplastic syndrome of autoimmune nature.
- History of interstitial lung disease or severe obstructive pulmonary disease.
- Clinically significant cardiovascular/cerebrovascular disease.
- QTc(F) interval > 450 ms for men or > 470 ms for women)
- Left ventricular ejection fraction (LVEF) < 50% as measured by an echocardiogram (ECHO).
- Active infection requiring therapy.
- Any other diseases, metabolic dysfunction, physical examination finding, or clinical laboratory finding.
- Pregnant or breast-feeding women
- Known severe hypersensitivity reactions to monoclonal antibodies, any history of or recent (within 6 months) of anaphylaxis
- Vaccine administration within 4 weeks of investigational drug administration.
- Vaccination with live vaccines while on trial is prohibited. Administration of inactivated vaccines like inactivated influenza vaccines is allowed. COVID-19 vaccines are approved to be administered prior to KD033 (SAR445710) administration and during the treatment phase, however, it is preferred to not vaccinate during the 28-day DLT period.
- Note: Other protocol-defined exclusion criteria could apply.
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites
Roswell Park Cancer Institute - 665 Elm St - Site 062
Buffalo, New York, 14263
Fox Chase Cancer Center - 333 Cottman Avenue - Site 141
Philadelphia, Pennsylvania, 19111
University of Pittsburgh Medical Center - Hillman Cancer Center - 5150 Centre Avenue, Suite 301 - Site 132
Pittsburgh, Pennsylvania, 15232
UCLA Hematology/Oncology, 2020 Santa Monica Boulevard, Suite 600 - Site 042
Santa Monica, California, 90404
Moffitt Cancer Center - Site 102
Tampa, Florida, 33612
About this study
Official title: A Phase 1, Open-label, Multiple-ascending Dose Study to Investigate the Safety, Pharmacokinetics, Pharmacodynamics, and Preliminary Efficacy of KD033 (SAR445710) in Subjects With Metastatic or Locally Advanced Solid Tumors
This is a Phase1, open-label, sequential dose-escalation and dose-expansion study of KD033 (SAR445710) in adult participants with advanced or metastatic solid tumors. The main purpose of this study is to test KD033 (SAR445710) at different dose levels to see if it is safe and well tolerated when given once every 2 weeks and when given weekly. Additional purposes of the study are to find out whether the study drug has anti-cancer effects and how the study drug is processed by the body.
Read the detailed description
The foreseen treatment duration is until disease progression, unacceptable toxicity, criterion for withdrawal or for a maximum of 2 years.
- Conditions
- Solid Tumor
- Being tested
- KD033 (SAR445710)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
KD033 (SAR445710)Drug
Pharmaceutical form: Solution for infusion Route of administration: intravenous (IV)
| Study group | Role | What they receive |
|---|---|---|
| Bi-weekly Monotherapy Dose Escalation (Q2W) | Experimental | KD033 (SAR445710) will be administered in sequential ascending doses as a monotherapy via intravenous (IV) administration every 2 weeks (Q2W). Receives: Drug: KD033 (SAR445710) |
| Weekly Monotherapy Dose Escalation (Q1W) | Experimental | KD033 (SAR445710) will be administered in sequential ascending doses as a monotherapy via intravenous (IV) administration once a week (QW) for 6 weeks and then every 2 week-dosing. Receives: Drug: KD033 (SAR445710) |
| Dose Expansion | Experimental | KD033 (SAR445710) will be administered at recommended dose/schedule for expansion Receives: Drug: KD033 (SAR445710) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Occurrence of Dose Limiting Toxicities (DLTs)
To evaluate the number of participants who experienced DLTs during the dose escalation phase
Measured: Up to 28 days
Treatment Emergent Adverse Events (TEAEs) and Treatment-related AEs by Severity
To evaluate the number of TEAEs and treatment-related AEs by severity for all dose groups/cohorts according to the National Cancer Institute Common Terminology Criteria for Adverse Events Version 5.0 (NCI CTCAE v5.0)
Measured: Up to 30 days after last treatment
Secondary outcomes (5)
Best Overall Response (BOR)
To evaluate the best overall response from study treatment according to Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) and Immune Response Evaluation Criteria in Solid Tumors (iRECIST) criteria per Investigator assessment
Measured: Through study completion, an expected average of 1 year
Duration Of Response (DOR)
To evaluate the duration of response from study treatment according to Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) and Immune Response Evaluation Criteria in Solid Tumors (iRECIST) criteria per Investigator assessment
Measured: Through study completion, an expected average of 1 year
Exploration of KD033 (SAR445710) Pharmacokinetic (PK) Profile - AUC
Area under the concentration versus time curve (AUC)
Measured: Through study completion, an expected average of 1 year
Exploration of KD033 (SAR445710) Pharmacokinetic (PK) Profile - Cmax
Maximum plasma concentration observed (Cmax)
Measured: Through study completion, an expected average of 1 year
Exploration of Anti-KD033 (SAR445710) Antibodies
To evaluate serum titers and assessment of neutralization of anti-KD033 (SAR445710) antibodies using blood samples collected during the dose escalation and dose expansion phases
Measured: Through study completion, an expected average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2020
- Study start6 Mar 2023
- Primary completion1 Dec 2023
- Study completion1 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kadmon, a Sanofi Company
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04242147
- Sponsor's protocol ID
- TED17644
- Other IDs
- KD033-101, U1111-1279-2406, 2022-503080-15, TED17644
- Status last verified
- Sep 2025
- First submitted
- 23 Jan 2020
- Last updated
- 16 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Open-label, Multiple-ascending Dose Study to Investigate the Safety, Pharmacokinetics, Pharmacodynamics, and Preliminary Efficacy of KD033 (SAR445710) in Subjects With Metastatic or Locally Advanced Solid Tumors
- ClinicalTrials.gov ID
- NCT04242147
- Acronym / sponsor ID
- TED17644
- Conditions
- Solid Tumor
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 45 participants (actual)
- Lead sponsor
- Kadmon, a Sanofi CompanyIndustry (pharma, biotech, devices)
- Study start
- 6 Mar 2023 (actual)
- Primary completion
- 1 Dec 2023 (actual)
- Study completion
- 1 Dec 2023 (actual)
- First posted
- 27 Jan 2020 (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 Phase1, open-label, sequential dose-escalation and dose-expansion study of KD033 (SAR445710) in adult participants with advanced or metastatic solid tumors. The main purpose of this study is to test KD033 (SAR445710) at different dose levels to see if it is safe and well tolerated when given once every 2 weeks and when given weekly. Additional purposes of the study are to find out whether the study drug has anti-cancer effects and how the study drug is processed by the body.
Detailed description
The foreseen treatment duration is until disease progression, unacceptable toxicity, criterion for withdrawal or for a maximum of 2 years.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Bi-weekly Monotherapy Dose Escalation (Q2W) | Experimental | Drug: KD033 (SAR445710)KD033 (SAR445710) will be administered in sequential ascending doses as a monotherapy via intravenous (IV) administration every 2 weeks (Q2W). |
| Weekly Monotherapy Dose Escalation (Q1W) | Experimental | Drug: KD033 (SAR445710)KD033 (SAR445710) will be administered in sequential ascending doses as a monotherapy via intravenous (IV) administration once a week (QW) for 6 weeks and then every 2 week-dosing. |
| Dose Expansion | Experimental | Drug: KD033 (SAR445710)KD033 (SAR445710) will be administered at recommended dose/schedule for expansion |
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 or cytologically confirmed/documented advanced and/or metastatic solid tumor with at least one tumor lesion of location accessible to biopsy per clinical judgement of treating physician.
- Participants must be willing to provide a tumor biopsy at the following time points: Pre-treatment and at Cycle 4, Day 1. All other study eligibility criteria must be met before any biopsy sample is obtained.
- Measurable disease at baseline per RECIST v1.1 guidelines.
- Life expectancy of at least 3 months.
- Eastern Cooperative Oncology Group Performance Status (ECOG PS) score ≤ 1.
Key exclusion criteria (23 listed)
- Use of immunotherapy, biological therapy, cytokine therapy < 21 days prior to the first dose of study drug.
- Use of immunomodulating agents < 21 days prior to the first dose of study drug.
- Use of chemotherapy and approved tyrosine kinase inhibitor (TKI) therapy < 14 days prior to the first dose of study drug.
- Anti PD-L1 or anti PD-1 therapy < 6 weeks prior to the first dose of study drug.
- Radiotherapy within 14 days before the start of trial treatment (prior diagnostic biopsy is permitted), with the exception of palliative radiation as described: patients assigned to radiotherapy require at least 1 additional lesion that can be safely irradiated while sparing the index lesion(s), and for which radiation at the limited, palliative doses contemplated would be considered medically appropriate; The lesion should be causing some signs or symptoms (e.g., tumor-related pain), for which radiation is indicated per the physician's standard clinical practice.
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 |
|---|---|---|
| KD033 (SAR445710)Pharmaceutical form: Solution for infusion Route of administration: intravenous (IV) | Drug | Bi-weekly Monotherapy Dose Escalation (Q2W), Dose Expansion, Weekly Monotherapy Dose Escalation (Q1W) |
Primary outcome
Occurrence of Dose Limiting Toxicities (DLTs)
Time frame: Up to 28 days
To evaluate the number of participants who experienced DLTs during the dose escalation phase
Treatment Emergent Adverse Events (TEAEs) and Treatment-related AEs by Severity
Time frame: Up to 30 days after last treatment
To evaluate the number of TEAEs and treatment-related AEs by severity for all dose groups/cohorts according to the National Cancer Institute Common Terminology Criteria for Adverse Events Version 5.0 (NCI CTCAE v5.0)
5 secondary outcomes
Best Overall Response (BOR)
Time frame: Through study completion, an expected average of 1 year
Duration Of Response (DOR)
Time frame: Through study completion, an expected average of 1 year
Exploration of KD033 (SAR445710) Pharmacokinetic (PK) Profile - AUC
Time frame: Through study completion, an expected average of 1 year
Exploration of KD033 (SAR445710) Pharmacokinetic (PK) Profile - Cmax
Time frame: Through study completion, an expected average of 1 year
Exploration of Anti-KD033 (SAR445710) Antibodies
Time frame: Through study completion, an expected average of 1 year
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Sep 2025.
- TED17644 Plain Language Results SummaryLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org
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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.
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing KD033 (SAR445710) in people with Solid Tumor, run by Kadmon, a Sanofi Company at 5 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 10 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 16 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 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 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 stopped early. Results are not available in the source record.
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?
Occurrence of Dose Limiting Toxicities (DLTs) (time frame: Up to 28 days). 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 16 Sep 2025.