Carcinoma, Renal CellPhase 1/2RENACOLNCT05104905

A Phase I/II Open Label Single Centre Trial to Assess the Safety, Tolerability and Efficacy of Single Dose Neoadjuvant Anti-CLEVER-1 Antibody Bexmarilimab in Localised Renal Cell and Colon Carcinoma

A Phase 1/2 study testing bexmarilimab in people with Carcinoma, Renal Cell and Carcinoma Colon, run by Faron Pharmaceuticals Ltd at 1 site in Finland.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record

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Trial summary

Who is it for?: Ages 18 years and older
Conditions the study is for: Carcinoma, Renal Cell, Carcinoma Colon
What is being tested?: bexmarilimab
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 0 participants
Where: 1 siteFinland
Study dates: 7 Oct 2021to 28 Jan 2022
Phase: Phase 1/2
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

Provision of signed and dated informed consent form.
Ability and stated willingness to comply with all study procedures and availability for the duration of the study.
Male or female, aged > 18 years.
Adequate general health (ECOG 0 or 1) to undergo planned radical surgery for renal cell or colon cancer.
Adequate bone marrow, liver and kidney function defined as: Blood white blood cell ≥ lower limit of normal Blood neutrophil count ≥ 1x109/L Blood platelet count ≥ 100x109/L Blood haemoglobin ≥ 9.0 g/dL Creatinine clearance > 40 mL/min calculated by Cockcroft-Gault formula Aspartate Aminotransferase (AST) ≤ 3 X Upper Limit of Normal (ULN) Alanine Aminotransferase (ALT) ≤ 3 X ULN Bilirubin ≤ 1.5 X ULN Albumin ≥ 3.0 g/dL
Histologically confirmed clear cell renal cell cancer planned to be treated with surgery with curative intent (Renal cell cancer cohort). In renal cell observation cohort, histological confirmation not mandatory.

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or Histologically confirmed adenocarcinoma of the colon planned to be treated with surgery with curative intent (Colon cancer cohort).
Additional inclusion criteria for subjects planned to have a single neoadjuvant dose of CLEVER-1 antibody bexmarilimab:
For females of reproductive potential: use of highly effective contraception* for at least 1 month prior to screening and agreement to use such a method during study participation and for an additional 12 weeks after the end of single neoadjuvant dose of bexmarilimab administration.
For males of reproductive potential: use of condoms or other methods to ensure effective contraception with partner during study participation and for an additional 12 weeks after the administration of single neoadjuvant dose of bexmarilimab.
Women of childbearing potential i.e. not post-menopausal or surgically sterilised must use highly effective methods of contraception. For example, combined estrogen and progestogen hormonal contraception to inhibit ovulation; progestogen-only hormonal contraception to inhibit ovulation; intra-uterine device (IUD); intrauterine hormone-releasing system (IUS) or vasectomised partner to prevent pregnancy or abstain. Abstinence must be in line with the preferred and usual lifestyle of the subject. Periodic abstinence such as calendar, ovulation, symptothermal, post-ovulation methods and withdrawal are not acceptable methods of contraception during heterosexual activity for the duration of the trial and for at least 12 weeks following the study drug administration. In addition, barrier contraception (with or without spermicide) may be used but this should not be considered as an adequate form of contraception on its own.
Fertile men whose partners could be of childbearing potential should routinely use a condom for 12 weeks after the study drug administration. The partner, if not pregnant, should also use a reliable form of contraception such as the oral contraceptive pill or an IUD.

Who cannot join

Evidence of metastatic disease making subject not eligible for surgical resection, except for local nodal metastatic disease.
History of previous treatment for renal cell cancer (renal cell cancer cohorts) or colon cancer (colon cancer cohorts).
Less than 3 months since the last dose of any cancer therapy prior to consenting.
Less than 4 weeks since any major surgery.
Treatment with any investigational agent within 4 weeks before consenting.
History of another malignancy without curative treatment or suspicion of disease recurrence.

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Evidence of severe or uncontrolled systemic diseases, congestive cardiac failure New York Heart Association (NYHA) class 2, Myocardial Infarction (MI) within 6 months or laboratory finding that in the view of the investigator makes it undesirable for the subject to participate in the trial.
Any medical condition that the Investigator considers significant to compromise the safety of the subject or that impairs the interpretation of IMP toxicity assessment.
Confirmed human immunodeficiency virus infection.
Confirmed hepatitis B or C virus infection.
Symptomatic cytomegalovirus infection.
Subjects with active autoimmune disorder (except type I diabetes, celiac disease, hypothyroidism requiring only hormone replacement, vitiligo, psoriasis, or alopecia).
The subject requires systemic corticosteroid or other immunosuppressive treatment.
Subjects with organ transplants.
Subjects in dialysis.
Use of Live (attenuated) vaccines for 30 days prior to the start of study treatment, during treatment, and until last visit.
Subject is unwilling or unable to comply with treatment and trial instructions.
Pregnancy or lactation.
Medical history of chronic ulcers, abnormal liver function or previous liver problems/diseases

Trial locations and contacts

1 site in 1 country.

Finland1 site

Turku University Hospital
Turku, 20521

Other trials in Finland

About this study

Official title: A Phase I/II Open Label Single Centre Trial to Assess the Safety, Tolerability and Efficacy of Single Dose Neoadjuvant Anti-CLEVER-1 Antibody Bexmarilimab in Localised Renal Cell and Colon Carcinoma (Macrophage Antibody To Inhibit Immune Suppression in RENAl Cell and COLon Carcinomas)

Bexmarilimab treatment has demonstrated tolerable safety profile and anticancer efficacy in some subjects with advanced malignancies. This is the first study to investigate the effect of single neoadjuvant dose of anti-CLEVER-1 antibody bexmarilimab prior to radical surgery of renal cell and colon cancers. We expect that the single dose will demonstrate measurable effects on the tumour immunological microenvironment as well as systemic effects on subject´s immunological status and that this evidence may be used to guide future neoadjuvant studies. There will be a dose escalation to investigate the effect of different doses of bexmarilimab. In addition to subjects receiving single neoadjuvant dose of bexmarilimab, there will be an observational cohort without Investigational Medicinal Product (IMP) for either cancer. All patients participating in the study (whether in investigational or observational cohort) will attend each visit and are assessed for the same endpoints.

Conditions: Carcinoma, Renal Cell, Carcinoma Colon
Being tested: bexmarilimab
Medical subject headings: Carcinoma, Renal Cell, Colonic Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

bexmarilimabDrug
A single neoadjuvant dose will be administered prior to surgery.

Study groups in NCT05104905
Study group	Role	What they receive
Renal cell intervention 1.0 mg/kg	Experimental	Not described Receives: Drug: bexmarilimab
Renal cell intervention 3.0 mg/kg	Experimental	Not described Receives: Drug: bexmarilimab
Renal cell intervention 10 mg/kg	Experimental	Not described Receives: Drug: bexmarilimab
Renal cell Observation	No intervention	Not described
Colon cancer intervention 1.0 mg/kg	Experimental	Not described Receives: Drug: bexmarilimab
Colon cancer intervention 3.0 mg/kg	Experimental	Not described Receives: Drug: bexmarilimab
Colon cancer intervention 10 mg/kg	Experimental	Not described Receives: Drug: bexmarilimab
Colon cancer Observation	No intervention	Not described

What is being measured

The primary outcome is the main question the study is designed to answer.

Adverse Events ≥Grade 3 during the 28 days (4 weeks) following the single dose of bexmarilimab and surgical adverse events ≥Grade 3 during the 14days (2 weeks) following the surgery
Adverse Events ≥Grade 3 according to the National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 5.0 during the 28 days (4 weeks) following the single dose of bexmarilimab and surgical adverse events ≥Grade 3 according to the Clavien-Dindo classification occurring during the 14 days (2 weeks) following the surgery
Measured: 28 days and 14 days

Secondary outcomes (4)

Adverse events until the follow-up visit on Day 84
Measured: Day 84
Radiological response rate according to the response evaluation criteria in solid tumours (RECIST 1.1) (Day 13)
Measured: Day 13
Pathological response rate evaluated with Ryan tumour regression grade (Day 14), percentage of tumour cell necrosis
Measured: Day 14
Long-term clinical benefit measured by disease-free survival assessed at 1, 3 and 5 years
Measured: 1, 3, and 5 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

7 Oct 202128 Jan 2022

First posted3 Nov 2021
Study start7 Oct 2021
Primary completion28 Jan 2022
Study completion28 Jan 2022

Why it stopped: Since no patients have been enrolled in RENACOL, and safety and tolerability data is rapidly accumulating in another ongoing study, sponsor considered that RENACOL study is no longer needed to assess the safety profile of bexmarilimab

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Carcinoma, Renal CellStudies 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: Non-randomised
Intervention model: Sequential
Masking: None (open label)
Enrolment: 0 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05104905
Sponsor's protocol ID: FP2CLI003
Other IDs: 2021-001030-19
Acronym: RENACOL
Status last verified: May 2022
First submitted: 22 Oct 2021
Last updated: 11 May 2022
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 11 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase I/II Open Label Single Centre Trial to Assess the Safety, Tolerability and Efficacy of Single Dose Neoadjuvant Anti-CLEVER-1 Antibody Bexmarilimab in Localised Renal Cell and Colon Carcinoma (Macrophage Antibody To Inhibit Immune Suppression in RENAl Cell and COLon Carcinomas)
ClinicalTrials.gov ID: NCT05104905
Acronym / sponsor ID: RENACOL / FP2CLI003
Conditions: Carcinoma, Renal Cell, Carcinoma Colon
Phase: Phase 1/2
Study type: Interventional
Recruitment status: WithdrawnReason stopped: Since no patients have been enrolled in RENACOL, and safety and tolerability data is rapidly accumulating in another ongoing study, sponsor considered that RENACOL study is no longer needed to assess the safety profile of bexmarilimab
Enrolment: 0 participants (actual)
Lead sponsor: Faron Pharmaceuticals LtdIndustry (pharma, biotech, devices)
Study start: 7 Oct 2021 (actual)
Primary completion: 28 Jan 2022 (actual)
Study completion: 28 Jan 2022 (actual)
First posted: 3 Nov 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.

Study design

Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Sequential
Masking: None (open label)
Number of arms: 8

Arm	Type	Receives
Renal cell intervention 1.0 mg/kg	Experimental	Drug: bexmarilimab
Renal cell intervention 3.0 mg/kg	Experimental	Drug: bexmarilimab
Renal cell intervention 10 mg/kg	Experimental	Drug: bexmarilimab
Renal cell Observation	No intervention	–
Colon cancer intervention 1.0 mg/kg	Experimental	Drug: bexmarilimab
Colon cancer intervention 3.0 mg/kg	Experimental	Drug: bexmarilimab
Colon cancer intervention 10 mg/kg	Experimental	Drug: bexmarilimab
Colon cancer Observation	No intervention	–

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (12 listed)

Provision of signed and dated informed consent form.
Ability and stated willingness to comply with all study procedures and availability for the duration of the study.
Male or female, aged > 18 years.
Adequate general health (ECOG 0 or 1) to undergo planned radical surgery for renal cell or colon cancer.
Adequate bone marrow, liver and kidney function defined as: Blood white blood cell ≥ lower limit of normal Blood neutrophil count ≥ 1x109/L Blood platelet count ≥ 100x109/L Blood haemoglobin ≥ 9.0 g/dL Creatinine clearance > 40 mL/min calculated by Cockcroft-Gault formula Aspartate Aminotransferase (AST) ≤ 3 X Upper Limit of Normal (ULN) Alanine Aminotransferase (ALT) ≤ 3 X ULN Bilirubin ≤ 1.5 X ULN Albumin ≥ 3.0 g/dL

Key exclusion criteria (19 listed)

Evidence of metastatic disease making subject not eligible for surgical resection, except for local nodal metastatic disease.
History of previous treatment for renal cell cancer (renal cell cancer cohorts) or colon cancer (colon cancer cohorts).
Less than 3 months since the last dose of any cancer therapy prior to consenting.
Less than 4 weeks since any major surgery.
Treatment with any investigational agent within 4 weeks before consenting.

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
bexmarilimabA single neoadjuvant dose will be administered prior to surgery.	Drug	Colon cancer intervention 1.0 mg/kg, Colon cancer intervention 10 mg/kg, Colon cancer intervention 3.0 mg/kg, Renal cell intervention 1.0 mg/kg, Renal cell intervention 10 mg/kg, Renal cell intervention 3.0 mg/kg

Primary outcome

Adverse Events ≥Grade 3 during the 28 days (4 weeks) following the single dose of bexmarilimab and surgical adverse events ≥Grade 3 during the 14days (2 weeks) following the surgery
Time frame: 28 days and 14 days
Adverse Events ≥Grade 3 according to the National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 5.0 during the 28 days (4 weeks) following the single dose of bexmarilimab and surgical adverse events ≥Grade 3 according to the Clavien-Dindo classification occurring during the 14 days (2 weeks) following the surgery

4 secondary outcomes

Adverse events until the follow-up visit on Day 84
Time frame: Day 84
Radiological response rate according to the response evaluation criteria in solid tumours (RECIST 1.1) (Day 13)
Time frame: Day 13
Pathological response rate evaluated with Ryan tumour regression grade (Day 14), percentage of tumour cell necrosis
Time frame: Day 14
Long-term clinical benefit measured by disease-free survival assessed at 1, 3 and 5 years
Time frame: 1, 3, and 5 years

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 11 May 2022.

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Not yet recruitingObservational study
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RecruitingPhase 2
Testing the Effectiveness of Two Immunotherapy Drugs (Nivolumab and Ipilimumab) With One Anti-cancer Targeted Drug (Cabozantinib) for Rare Genitourinary Tumors
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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.

Peter Boström principal investigator

Turku University Hospital

1 site 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 bexmarilimab in people with Carcinoma, Renal Cell and Carcinoma Colon, run by Faron Pharmaceuticals Ltd at 1 site in Finland.

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 12 inclusion and 19 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 11 May 2022. 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 Finland. 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?

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?

Adverse Events ≥Grade 3 during the 28 days (4 weeks) following the single dose of bexmarilimab and surgical adverse events ≥Grade 3 during the 14days (2 weeks) following the surgery (time frame: 28 days and 14 days). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05104905.

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 11 May 2022.