Non-small Cell Lung CancerPhase 1NCT05171062
Dose Escalation Trial of Bexmarilimab (FP-1305) Plus Pembrolizumab in Non-Small Cell Lung Cancer
A Phase 1 study testing bexmarilimab (FP-1305) and Pembrolizumab in people with Non-small Cell Lung Cancer, run by The University of Texas Health Science Center at San Antonio at 1 site in United States.
Trial summary
This study enrolls patients with Non-small cell lung cancer and treats them with the investigational drug Bexmarilimab (FP-1305) plus standard of care Pembrolizumab to block Common lymphatic endothelial and vascular endothelial receptor-1 (CLEVER-1). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non-small Cell Lung Cancer
- What is being tested?
- bexmarilimab (FP-1305) and Pembrolizumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2023to Dec 2026
- 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
- Able to provide written Informed Consent
- Aged ≥ 18 years
- Tumor sample obtained less than six months from the date of consent
- Histologically confirmed NSCLC eligible for pembrolizumab as standard of care
- Known tumor PD-L1 TPS score
- Measurable disease based on RECIST 1.1 as determined by the site
- Women of child-bearing potential must have a negative pregnancy test prior to trial entry and cycle 1 day 1 and should not be breast feeding.
- Women of child-bearing potential and men who have partners of child-bearing potential must be willing to practice highly effective contraception for the duration of the trial and for three months after the completion of treatment
Who cannot join
- Less than 21 days since the last dose of intravenous anticancer chemotherapy or less than five half-lives from a small molecule targeted therapy or oral anticancer chemotherapy before the first bexmarilimab administration
- Any immunotherapy within preceding 3 weeks from the first bexmarilimab administration
- Has untreated central nervous system (CNS) metastases and/or carcinomatous meningitis identified either on the baseline brain imaging obtained during the screening period. Subjects whose brain metastases have been treated may participate provided they show radiographic stability (defined as 2 brain images, both of which are obtained after treatment to the brain metastases. These imaging scans should both be obtained at least four weeks apart and show no evidence of intracranial progression). In addition, any neurologic symptoms that developed either as a result of the brain metastases or their treatment must have returned to baseline or resolved. Any steroids administered as part of this therapy must be completed at least three days prior to study medication.
- Investigational therapy or major surgery within 4 weeks from the date of consent
- Active clinically serious infection >grade 2 NCI-CTCAE version 5.0 (Appendix 6) within preceding 2 weeks from the date of consent
- Subject has not recovered from the previous therapies to Grade 1 severity as classified by the NCI-CTCAE version 5.0 (except Grade 2 alopecia, neuropathy or thyroid disorders)
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- Pregnant or lactating women
- The subject requires systemic corticosteroid or other immunosuppressive treatment
- Use of live (attenuated) vaccines for 30 days prior to the start of study treatment, d during treatment, and until last visit
- Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial.
- Subject is unwilling or unable to comply with treatment and trial instructions
- Any condition that study investigators consider an impediment to safe trial participation
- Prior therapy for advanced stage or metastatic disease
Trial locations and contacts
1 site in 1 country.
United States1 site
Mays Cancer Center, UT Health San Antonio
San Antonio, Texas, 78229
About this study
Official title: Safety and Tolerability of Bexmarilimab Plus Pembrolizumab for Patients With Advanced (Inoperable or Metastatic) Non-small Cell Lung Cancer (NSCLC)
This study enrolls patients with Non-small cell lung cancer and treats them with the investigational drug Bexmarilimab (FP-1305) plus standard of care Pembrolizumab to block Common lymphatic endothelial and vascular endothelial receptor-1 (CLEVER-1). Treating with an antiCLEVER-1 antibody, such as bexmarilimab, could lead to immune system activation, which, in turn, may lead to cancer elimination.
Read the detailed description
This study is an open label, Phase Ib, standard 3+3 dose escalation trial of bexmarilimab (FP-1305) plus pembrolizumab in 4 planned dose escalation cohorts in Non-Small Cell Lung Cancer (NSCLC) to determine the safety and tolerability of repeated doses of bexmarilimab plus pembrolizumab administered in three-week intervals (Q3W) (Figures 1 and 2) defined as treatment cycles. Bexmarilimab is a monoclonal antibody to common lymphatic endothelial and vascular endothelial receptor-1 (CLEVER-1), administered by IV infusion every 3 weeks. Pembrolizumab is a monoclonal antibody to programmed death-1 (PD-1), administered by 30-minute IV infusion every 3 weeks. When pembrolizumab and bexmarilimab are given on the same day, bexmarilimab is given before pembrolizumab. No pre-medication(s) is/are needed before infusion of either drug.
Dose levels will be escalated to determine the maximum tolerated dose (MTD) in trial subjects with NSCLC eligible for pembrolizumab as standard of care (SOC) treatment. The MTD level will be determined based on the occurrence of dose limiting toxicities (DLTs) by standard 3+3 escalation. For the purposes of DLT, only DLT attributable to or likely due to bexmarilimab are counted. DLTs clearly related to pembrolizumab do not count as DLTs for the purposes of dose escalation. The pre-determined dose levels in the dose escalation part are 0.1, 1.0, 3.0, 10.0, and 30 mg/kg, In Cohort 0, if the first dose at 0.1 mg/kg is tolerated, that patient will advance to Cohort 1 to finish the trial at the Cohort 1 bexmarilimab dose. Dose escalation within individual patients beyond Cohort 0 is not permitted.
Beyond the Level 0 dose level, each subject will be observed for three weeks for DLT (subject at Level 0 will advance to the next level after a 3-week observation period). In the absence of DLT, once three subjects have received the second dose at dose level (for example at Level 1), each of them with a minimum of three-week follow-up, the dose is escalated to the third dose level (in this example to Level 2). If a subject is withdrawn/discontinued for any reason or dies before the completion of Cycle 3, week 1, the withdrawn/discontinued subject must be replaced with a new subject enrolled at the same dose level until three subjects have reached the three-week follow-up and the dose escalation to the next level may occur.
The dose cannot be escalated to the next level before a three-week DLT period is reached for all the subjects at the current level. Beyond Level 0, if subjects fail to reach the three-week DLT window in a given cohort for any reason, they must be replaced, and the replacement subject will be observed accordingly before escalation can proceed. If a subject misses a dose in the DLT period that subject must be replaced so that each subject receives 2 doses of bexmarilimab in the DLT window.
Once a DLT is observed in any of the treated patients, an additional 3 subjects will be enrolled at this dose. If no further DLTs are observed, escalation proceeds as planned. If a second DLT occurs, the MTD is defined as the prior cohort. A maximum of 36 evaluable subjects will be accrued for the MTD determination.
- Conditions
- Non-small Cell Lung Cancer
- Being tested
- bexmarilimab (FP-1305), Pembrolizumab
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
bexmarilimab (FP-1305)Drug
Also called FP-1305
standard 3+3 dose escalation trial of bexmarilimab (FP-1305)
PembrolizumabDrug
Also called Keytruda
Pembrolizumab 200mg IV is administered in 4 planned bexmarilimab dose escalation cohorts
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1 | Experimental | Study patients will receive 0.1-1 mg/kg bexmarilimab (FP-1350) given in combination with Pembrolizumab 200mg IV once every three weeks. The first subject will be started on 0.1mg to establish toleration, for one dose, and then the dose will be escalated to 1mg. This subject will be included in Cohort 1 data. Receives: Drug: bexmarilimab (FP-1305); Drug: Pembrolizumab |
| Cohort 2 | Experimental | Study participants will receive 3mg/kg Bexmarilimab given in combination with Pembrolizumab 200mg IV once every three weeks. 3 participants will need to complete this level before the next cohort dosing begins. Receives: Drug: bexmarilimab (FP-1305); Drug: Pembrolizumab |
| Cohort 3 | Experimental | Study participants will receive 10 mg/kg Bexmarilimab plus pembrolizumab 200mg IV once every 3 weeks. 3 participants will need to complete this level before the next cohort dosing begins. Receives: Drug: bexmarilimab (FP-1305); Drug: Pembrolizumab |
| Cohort 4 | Experimental | Study participants will receive 30 mg/kg Bexmarilimab plus pembrolizumab 200mg IV once every 3 weeks. Receives: Drug: bexmarilimab (FP-1305); Drug: Pembrolizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety and tolerability
Measured by the number of adverse events according to the National Cancer Institute Common Terminology Criteria for Adverse events (NCI-CTCAE v. 5) ≥Grade 3 occuring during the 21 days 3 weeks) following the first dose of bexmarilimab plus pembrolizumab in Cycle 2 and related to bexmarilimab are considered dose limiting toxicity (DLT) with the following exceptions:
- Grade 3 infusion reactions that resolve within 8 hours from the onset of the reaction and are not defined as a DLT
- For nausea/vomiting/diarrhea, only adequately pre-treated grade 3 or 4 toxicity will qualify as DLT
- For thrombocytopenia, hemorrhage is required to qualify grade 3 toxicity as DLT; grade 4 thrombocytopenia is DLT regardless of hemorrhaged
- For neutropenia, fever is required to qualify grade 3 toxicity as DLT. A duration > 5 days is required to qualify grade 4 toxicity as DLT
Measured: Cycle 2 plus 3 weeks (21 days following the first dose of both study drugs)
Programmed Death Cell Ligand 1 (PD-L1) level
Measured using analysis of soluble CLEVER-1 (sClever) levels
Measured: Cycle 1 (21 days), pre-dose levels at start of Cycle 3 (42 days)
Secondary outcomes (1)
Immunophenotyping
Assessed by measurement of the circulating immune cell populations in serum over time
Measured: Baseline to study end (approximately 12 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Dec 2021
- Study startJun 2023 (estimated)
- Primary completionDec 2025 (estimated)
- Study completionDec 2026 (estimated)
Why it stopped: No participants were enrolled, the study was inactivated with the IRB on May 15, 2023. The sponsor notified the PI that a Phase II trial had been allowed to proceed by the FDA.
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.
- More trials run by The University of Texas Health Science Center at San AntonioThe 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
- Single group
- Model description
- Dose levels will be escalated to determine maximum tolerated dose (MTD) in participants with non-small cell lung cancer (NSCLC) eligible for standard of care pembrolizumab treatment. MTD will be determined based on occurence of dose limiting toxicities (DLTs) by standard 3+3 escalation.
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Faron Pharmaceuticals Ltd
- Responsible party
- Sponsor
- Investigators
- Supreet Kaur, MD, Principal investigator, The University of Texas Health Science Center at San Antonio
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05171062
- Sponsor's protocol ID
- CTMS# 21-0153
- Other IDs
- 20210791HU
- Status last verified
- Jul 2023
- First submitted
- 10 Dec 2021
- Last updated
- 20 Jul 2023
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 20 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Tolerability of Bexmarilimab Plus Pembrolizumab for Patients With Advanced (Inoperable or Metastatic) Non-small Cell Lung Cancer (NSCLC)
- ClinicalTrials.gov ID
- NCT05171062
- Acronym / sponsor ID
- CTMS# 21-0153
- Conditions
- Non-small Cell Lung Cancer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: No participants were enrolled, the study was inactivated with the IRB on May 15, 2023. The sponsor notified the PI that a Phase II trial had been allowed to proceed by the FDA.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- The University of Texas Health Science Center at San AntonioUniversity, hospital or other
- Collaborators
- Faron Pharmaceuticals Ltd
- Study start
- Jun 2023 (estimated)
- Primary completion
- Dec 2025 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 28 Dec 2021 (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 study enrolls patients with Non-small cell lung cancer and treats them with the investigational drug Bexmarilimab (FP-1305) plus standard of care Pembrolizumab to block Common lymphatic endothelial and vascular endothelial receptor-1 (CLEVER-1). Treating with an antiCLEVER-1 antibody, such as bexmarilimab, could lead to immune system activation, which, in turn, may lead to cancer elimination.
Detailed description
This study is an open label, Phase Ib, standard 3+3 dose escalation trial of bexmarilimab (FP-1305) plus pembrolizumab in 4 planned dose escalation cohorts in Non-Small Cell Lung Cancer (NSCLC) to determine the safety and tolerability of repeated doses of bexmarilimab plus pembrolizumab administered in three-week intervals (Q3W) (Figures 1 and 2) defined as treatment cycles. Bexmarilimab is a monoclonal antibody to common lymphatic endothelial and vascular endothelial receptor-1 (CLEVER-1), administered by IV infusion every 3 weeks. Pembrolizumab is a monoclonal antibody to programmed death-1 (PD-1), administered by 30-minute IV infusion every 3 weeks. When pembrolizumab and bexmarilimab are given on the same day, bexmarilimab is given before pembrolizumab. No pre-medication(s) is/are needed before infusion of either drug.
Dose levels will be escalated to determine the maximum tolerated dose (MTD) in trial subjects with NSCLC eligible for pembrolizumab as standard of care (SOC) treatment. The MTD level will be determined based on the occurrence of dose limiting toxicities (DLTs) by standard 3+3 escalation. For the purposes of DLT, only DLT attributable to or likely due to bexmarilimab are counted. DLTs clearly related to pembrolizumab do not count as DLTs for the purposes of dose escalation. The pre-determined dose levels in the dose escalation part are 0.1, 1.0, 3.0, 10.0, and 30 mg/kg, In Cohort 0, if the first dose at 0.1 mg/kg is tolerated, that patient will advance to Cohort 1 to finish the trial at the Cohort 1 bexmarilimab dose. Dose escalation within individual patients beyond Cohort 0 is not permitted.
Beyond the Level 0 dose level, each subject will be observed for three weeks for DLT (subject at Level 0 will advance to the next level after a 3-week observation period). In the absence of DLT, once three subjects have received the second dose at dose level (for example at Level 1), each of them with a minimum of three-week follow-up, the dose is escalated to the third dose level (in this example to Level 2). If a subject is withdrawn/discontinued for any reason or dies before the completion of Cycle 3, week 1, the withdrawn/discontinued subject must be replaced with a new subject enrolled at the same dose level until three subjects have reached the three-week follow-up and the dose escalation to the next level may occur.
The dose cannot be escalated to the next level before a three-week DLT period is reached for all the subjects at the current level. Beyond Level 0, if subjects fail to reach the three-week DLT window in a given cohort for any reason, they must be replaced, and the replacement subject will be observed accordingly before escalation can proceed. If a subject misses a dose in the DLT period that subject must be replaced so that each subject receives 2 doses of bexmarilimab in the DLT window.
Once a DLT is observed in any of the treated patients, an additional 3 subjects will be enrolled at this dose. If no further DLTs are observed, escalation proceeds as planned. If a second DLT occurs, the MTD is defined as the prior cohort. A maximum of 36 evaluable subjects will be accrued for the MTD determination.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 4
- Model description
- Dose levels will be escalated to determine maximum tolerated dose (MTD) in participants with non-small cell lung cancer (NSCLC) eligible for standard of care pembrolizumab treatment. MTD will be determined based on occurence of dose limiting toxicities (DLTs) by standard 3+3 escalation.
| Arm | Type | Receives |
|---|---|---|
| Cohort 1 | Experimental | Drug: bexmarilimab (FP-1305), Drug: PembrolizumabStudy patients will receive 0.1-1 mg/kg bexmarilimab (FP-1350) given in combination with Pembrolizumab 200mg IV once every three weeks. The first subject will be started on 0.1mg to establish toleration, for one dose, and then the dose will be escalated to 1mg. This subject will be included in Cohort 1 data. |
| Cohort 2 | Experimental | Drug: bexmarilimab (FP-1305), Drug: PembrolizumabStudy participants will receive 3mg/kg Bexmarilimab given in combination with Pembrolizumab 200mg IV once every three weeks. 3 participants will need to complete this level before the next cohort dosing begins. |
| Cohort 3 | Experimental | Drug: bexmarilimab (FP-1305), Drug: PembrolizumabStudy participants will receive 10 mg/kg Bexmarilimab plus pembrolizumab 200mg IV once every 3 weeks. 3 participants will need to complete this level before the next cohort dosing begins. |
| Cohort 4 | Experimental | Drug: bexmarilimab (FP-1305), Drug: PembrolizumabStudy participants will receive 30 mg/kg Bexmarilimab plus pembrolizumab 200mg IV once every 3 weeks. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Able to provide written Informed Consent
- Aged ≥ 18 years
- Tumor sample obtained less than six months from the date of consent
- Histologically confirmed NSCLC eligible for pembrolizumab as standard of care
- Known tumor PD-L1 TPS score
Key exclusion criteria (13 listed)
- Less than 21 days since the last dose of intravenous anticancer chemotherapy or less than five half-lives from a small molecule targeted therapy or oral anticancer chemotherapy before the first bexmarilimab administration
- Any immunotherapy within preceding 3 weeks from the first bexmarilimab administration
- Has untreated central nervous system (CNS) metastases and/or carcinomatous meningitis identified either on the baseline brain imaging obtained during the screening period. Subjects whose brain metastases have been treated may participate provided they show radiographic stability (defined as 2 brain images, both of which are obtained after treatment to the brain metastases. These imaging scans should both be obtained at least four weeks apart and show no evidence of intracranial progression). In addition, any neurologic symptoms that developed either as a result of the brain metastases or their treatment must have returned to baseline or resolved. Any steroids administered as part of this therapy must be completed at least three days prior to study medication.
- Investigational therapy or major surgery within 4 weeks from the date of consent
- Active clinically serious infection >grade 2 NCI-CTCAE version 5.0 (Appendix 6) within preceding 2 weeks from the date of consent
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 |
|---|---|---|
| bexmarilimab (FP-1305)Also: FP-1305standard 3+3 dose escalation trial of bexmarilimab (FP-1305) | Drug | Cohort 1, Cohort 2, Cohort 3, Cohort 4 |
| PembrolizumabAlso: KeytrudaPembrolizumab 200mg IV is administered in 4 planned bexmarilimab dose escalation cohorts | Drug | Cohort 1, Cohort 2, Cohort 3, Cohort 4 |
Primary outcome
Safety and tolerability
Time frame: Cycle 2 plus 3 weeks (21 days following the first dose of both study drugs)
Measured by the number of adverse events according to the National Cancer Institute Common Terminology Criteria for Adverse events (NCI-CTCAE v. 5) ≥Grade 3 occuring during the 21 days 3 weeks) following the first dose of bexmarilimab plus pembrolizumab in Cycle 2 and related to bexmarilimab are considered dose limiting toxicity (DLT) with the following exceptions: * Grade 3 infusion reactions that resolve within 8 hours from the onset of the reaction and are not defined as a DLT * For nausea/vomiting/diarrhea, only adequately pre-treated grade 3 or 4 toxicity will qualify as DLT * For thrombocytopenia, hemorrhage is required to qualify grade 3 toxicity as DLT; grade 4 thrombocytopenia is DLT regardless of hemorrhaged * For neutropenia, fever is required to qualify grade 3 toxicity as DLT. A duration > 5 days is required to qualify grade 4 toxicity as DLT
Programmed Death Cell Ligand 1 (PD-L1) level
Time frame: Cycle 1 (21 days), pre-dose levels at start of Cycle 3 (42 days)
Measured using analysis of soluble CLEVER-1 (sClever) levels
1 secondary outcome
Immunophenotyping
Time frame: Baseline to study end (approximately 12 months)
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jul 2023.
- Individual participant dataSharing planned: Undecided
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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.
Supreet Kaur, MD principal investigator
The University of Texas Health Science Center at San Antonio
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing bexmarilimab (FP-1305) and Pembrolizumab in people with Non-small Cell Lung Cancer, run by The University of Texas Health Science Center at San Antonio at 1 site 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 8 inclusion and 13 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 20 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 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 and tolerability (time frame: Cycle 2 plus 3 weeks (21 days following the first dose of both study drugs)). 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 20 Jul 2023.