Non-small Cell Lung CancerPhase 1NCT04440943
A Study of the PD-L1xCD27 Bispecific Antibody CDX-527 in Patients With Advanced Malignancies
A Phase 1 study testing CDX-527 in people with Non-small Cell Lung Cancer and Breast Cancer, run by Celldex Therapeutics at 5 sites in United States.
Trial summary
This is an open-label, non-randomized, multicenter, dose-escalation and expansion study in patients with selected solid tumors. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non-small Cell Lung Cancer, Breast Cancer, Gastric Cancer
- What is being tested?
- CDX-527
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 27 participants
- Where
- 5 sitesUnited States
- Study dates
- 4 Aug 2020to 6 Apr 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
- Recurrent, locally advanced or metastatic solid tumor cancer excluding the following: MSI-low colorectal cancer, glioblastoma multiforme, prostate cancer, pancreatic cancer, mucosal and ocular melanoma.
- Receipt of all standard therapies for the tumor type
- Measurable (target) disease by iRECIST
- If of childbearing potential (male or female), agrees to practice an effective form of contraception during study treatment and for at least 3 months following last treatment
- Willingness to undergo a pre-treatment and on-treatment biopsy, if required
Who cannot join
- History of severe hypersensitivity reactions to other monoclonal antibodies.
- Previous treatment with any anti-CD27 antibody.
- Inadequate washout period from prior therapy as defined in the Protocol.
- Patients who have received more than 0 or 1 prior PD-1/PD-L1 inhibitor depending on their tumor type
- Major surgery within 4 weeks prior to study treatment.
- Use of immunosuppressive medications within 4 weeks or systemic corticosteroids within 2 weeks prior to study treatment.
Show all 14Show fewer
- Other prior malignancy, except for adequately treated basal or squamous cell skin cancer or in situ cancers. For all other cancers, the patient must be disease-free for at least 3 years to be allowed to enroll.
- Thrombotic events within the last 6 months prior to study treatment
- Active, untreated central nervous system metastases.
- Active autoimmune disease or documented history of autoimmune disease.
- History of (non-infectious) pneumonitis or has current pneumonitis.
- Active diverticulitis
- Known infection of HIV, Hepatitis B, or Hepatitis C.
- There are additional criteria your study doctor will review with you to confirm your eligibility for the study.
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites
Northside Hospital
Atlanta, Georgia, 30342
University of Chicago
Chicago, Illinois, 60637
Duke Cancer Center
Durham, North Carolina, 27710
Oncology Hematology West, PC dba Nebraska Cancer Specialists
Omaha, Nebraska, 68130
Providence Portland Medical Center
Portland, Oregon, 97213
About this study
Official title: A Phase 1 Study of the PD-L1xCD27 Bispecific Antibody CDX-527 in Patients With Advanced Malignancies
This is an open-label, non-randomized, multicenter, dose-escalation and expansion study in patients with selected solid tumors.
Read the detailed description
This study will determine the safety, tolerability and activity of CDX-527.
Eligible patients that enroll to the dose-escalation portion of the study will be assigned to one of several dose levels of CDX-527. The dose-escalation part of the study will determine the safety profile of CDX-527 and determine which dose(s) of CDX-527 will be studied in the expansion part of the study.
The expansion part of the study will enroll eligible patients with certain solid tumors to be treated at dose(s) identified during dose-escalation
Up to 40 patients will be enrolled. All patients enrolled in the study will be closely monitored to determine if there is a response to the treatment as well as for any side effects that may occur.
- Conditions
- Non-small Cell Lung Cancer, Breast Cancer, Gastric Cancer, Renal Cell Carcinoma, Ovarian Cancer, Primary Peritoneal Carcinoma
- Being tested
- CDX-527
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung, Breast Neoplasms, Stomach Neoplasms, Carcinoma, Renal Cell, Ovarian Neoplasms, Fallopian Tube Neoplasms, Cholangiocarcinoma, Esophageal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CDX-527Drug
CDX-527 is administered by infusion every 2 weeks
| Study group | Role | What they receive |
|---|---|---|
| CDX-527 | Experimental | Dose-escalation phase: Eligible patients will receive CDX-527 treatment based on cohort assigned until progression or intolerance.
Expansion phase: Patients will receive CDX-527 at the dose level(s) chosen during the escalation phase. Receives: Drug: CDX-527 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety and Tolerability of CDX-527 as assessed by CTCAE v5.0
The rates of drug-related adverse events will be summarized and maximum tolerated dose will be determined.
Measured: From first dose through 28 days after last dose
Secondary outcomes (7)
Objective Response Rate
The percentage of patients who achieve a confirmed immune complete response (iCR) or immune partial response (iPR)
Measured: Every 8 weeks starting with first dose until disease progression, assessed up to approximately 1-2 years.
Clinical Benefit Rate
The percentage of patients who achieve best response of confirmed iCR or iPR, or immune stable disease (iSD) for at least four months
Measured: Every 8 weeks, starting with first dose until disease progression, assessed up to approximately 1-2 years.
Duration of Response
The interval from which measurement criteria are first met for iCR or iPR until the first date that progressive disease is objectively documented
Measured: First occurrence of a documented objective response to disease progression or death (up to approximately 1-2 years)
Progression-free Survival
The time from start of study drug to time of progression or death, whichever occurs first
Measured: From the first dose to the first occurrence of disease progression or death due to any cause (up to approximately 1-2 years)
Overall Survival
The time from start of study drug to death
Measured: The time from start of study drug to death from any cause (up to approximately 1-2 years)
Immunogenicity Evaluation
Serum samples will be obtained for assessment of human anti-CDX-527 antibodies
Measured: Prior to the first dose of study treatment, then intermittently before dosing, and up to 60 days after the last dose
Pharmacokinetic Evaluation
CDX-527 serum concentrations will be measured at specified visits.
Measured: Before and after dosing, with additional timepoints after the first two doses, then intermittently before dosing and up to 60 days after the last dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2020
- Study start4 Aug 2020
- Primary completion6 Apr 2023
- Study completion6 Apr 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-small Cell Lung CancerStudies 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
- Single group
- Masking
- None (open label)
- Enrolment
- 27 participants (actual)
Sponsor and investigators
- Lead sponsor
- Celldex Therapeutics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04440943
- Sponsor's protocol ID
- CDX527-01
- Status last verified
- Jun 2023
- First submitted
- 11 Jun 2020
- Last updated
- 18 Jun 2023
- Results posted
- No
- 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 18 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1 Study of the PD-L1xCD27 Bispecific Antibody CDX-527 in Patients With Advanced Malignancies
- ClinicalTrials.gov ID
- NCT04440943
- Acronym / sponsor ID
- CDX527-01
- Conditions
- Non-small Cell Lung Cancer, Breast Cancer, Gastric Cancer, Renal Cell Carcinoma, Ovarian Cancer, Primary Peritoneal Carcinoma
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 27 participants (actual)
- Lead sponsor
- Celldex TherapeuticsIndustry (pharma, biotech, devices)
- Study start
- 4 Aug 2020 (actual)
- Primary completion
- 6 Apr 2023 (actual)
- Study completion
- 6 Apr 2023 (actual)
- First posted
- 22 Jun 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 an open-label, non-randomized, multicenter, dose-escalation and expansion study in patients with selected solid tumors.
Detailed description
This study will determine the safety, tolerability and activity of CDX-527.
Eligible patients that enroll to the dose-escalation portion of the study will be assigned to one of several dose levels of CDX-527. The dose-escalation part of the study will determine the safety profile of CDX-527 and determine which dose(s) of CDX-527 will be studied in the expansion part of the study.
The expansion part of the study will enroll eligible patients with certain solid tumors to be treated at dose(s) identified during dose-escalation
Up to 40 patients will be enrolled. All patients enrolled in the study will be closely monitored to determine if there is a response to the treatment as well as for any side effects that may occur.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| CDX-527 | Experimental | Drug: CDX-527Dose-escalation phase: Eligible patients will receive CDX-527 treatment based on cohort assigned until progression or intolerance. Expansion phase: Patients will receive CDX-527 at the dose level(s) chosen during the escalation phase. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Recurrent, locally advanced or metastatic solid tumor cancer excluding the following: MSI-low colorectal cancer, glioblastoma multiforme, prostate cancer, pancreatic cancer, mucosal and ocular melanoma.
- Receipt of all standard therapies for the tumor type
- Measurable (target) disease by iRECIST
- If of childbearing potential (male or female), agrees to practice an effective form of contraception during study treatment and for at least 3 months following last treatment
- Willingness to undergo a pre-treatment and on-treatment biopsy, if required
Key exclusion criteria (14 listed)
- History of severe hypersensitivity reactions to other monoclonal antibodies.
- Previous treatment with any anti-CD27 antibody.
- Inadequate washout period from prior therapy as defined in the Protocol.
- Patients who have received more than 0 or 1 prior PD-1/PD-L1 inhibitor depending on their tumor type
- Major surgery within 4 weeks prior to study treatment.
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 |
|---|---|---|
| CDX-527CDX-527 is administered by infusion every 2 weeks | Drug | CDX-527 |
Primary outcome
Safety and Tolerability of CDX-527 as assessed by CTCAE v5.0
Time frame: From first dose through 28 days after last dose
The rates of drug-related adverse events will be summarized and maximum tolerated dose will be determined.
7 secondary outcomes
Objective Response Rate
Time frame: Every 8 weeks starting with first dose until disease progression, assessed up to approximately 1-2 years.
Clinical Benefit Rate
Time frame: Every 8 weeks, starting with first dose until disease progression, assessed up to approximately 1-2 years.
Duration of Response
Time frame: First occurrence of a documented objective response to disease progression or death (up to approximately 1-2 years)
Progression-free Survival
Time frame: From the first dose to the first occurrence of disease progression or death due to any cause (up to approximately 1-2 years)
Overall Survival
Time frame: The time from start of study drug to death from any cause (up to approximately 1-2 years)
Immunogenicity Evaluation
Time frame: Prior to the first dose of study treatment, then intermittently before dosing, and up to 60 days after the last dose
Pharmacokinetic Evaluation
Time frame: Before and after dosing, with additional timepoints after the first two doses, then intermittently before dosing and up to 60 days after the last dose
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 18 Jun 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.
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 CDX-527 in people with Non-small Cell Lung Cancer and Breast Cancer, run by Celldex Therapeutics 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 5 inclusion and 14 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 18 Jun 2023. 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 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?
Safety and Tolerability of CDX-527 as assessed by CTCAE v5.0 (time frame: From first dose through 28 days after last dose). 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 18 Jun 2023.