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Refractory Metastatic Colorectal CancerPhase 1/2NCT05205330

Vorbipiprant (CR6086) / Balstilimab (AGEN2034) Combination in Stage IV Refractory pMMR - MSS CRC, and Other Metastatic GI Cancers

A Phase 1/2 study testing CR6086 and AGEN2034 in people with Refractory Metastatic Colorectal Cancer and Solid Tumor, run by Rottapharm Biotech at 3 sites in Italy.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
Search all trials

Trial summary

This Phase Ib/IIa study comprises a Main Study and a Study Extension. The Main Study has been designed according to a 3+3 Dose Escalation/dose Expansion design in refractory pMMR-MSS mCRC patients. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
CR6086 and AGEN2034
Could I receive a placebo?
No, everyone receives an active treatment
How many people
107 participants
Where
3 sitesItaly
Study dates
23 Nov 2021to Jun 2027
Phase
Phase 1/2
Are there results?
Not yet: the study is under way

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

  • Main Study - patients with MSS mCRC These criteria are applicable for both Dose Escalation and Expansion part of the Main Study; criteria specific for each study part are identified with ESC=Escalation or EXP=Expansion.
  • Signed and dated informed consent obtained before undergoing any study-specific procedure
  • Male or female aged ≥18 years
  • ESC - Histologically confirmed diagnosis of adenocarcinoma originating from the colon or rectum, with known RAS and BRAF mutational status as assessed per standard practice.
  • EXP - Histologically confirmed diagnosis of adenocarcinoma originating from the colon or rectum, with known RAS and BRAF mutational status as assessed per standard practice.
  • For patients included in the Expansion part only: PD-L1 CPS or adequate tissue to perform PD-L1 CPS assessment should be available.
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  • Stage IV (according to the American Joint Committee on Cancer definition)
  • Presence of measurable disease per RECIST v1.1 (based on imaging within 28 days from first study drug administration). Patients must have at least one "target lesion" to be used to assess response, as defined by RECIST v1.1 Note: Subjects with lesions in a previously irradiated field as the sole site of measurable disease will be permitted to enroll provided the lesion(s) have demonstrated clear progression and can be measured accurately
  • ESC - Disease progression after at least two standard treatment lines for mCRC, including fluoropyrimidines, oxaliplatin and irinotecan and, if RAS and BRAF wild-type, cetuximab or panitumumab or, intolerance or refusal of chemotherapy regimens for mCRC Note: Previous oxaliplatin-based adjuvant treatment is considered as a treatment line if disease relapse occurred within 6 months from its completion
  • EXP - Disease progression after at least two standard treatment lines for mCRC, including fluoropyrimidines, oxaliplatin and irinotecan and:
  • if RAS and BRAF wild type, cetuximab or panitumumab
  • if BRAFV600E mutated encorafenib and cetuximab or intolerance or refusal of chemotherapy regimens for mCRC. Note: Previous oxaliplatin-based adjuvant treatment is considered as a treatment line if disease relapse occurred within 6 months from its completion 7. Naïve to any antibody/drug targeting T-cell co-regulatory proteins (immune checkpoints inhibitors) and EP4 receptor antagonists 8. ESC - Availability of adequate and sufficient baseline tumour tissue sample (archival or newly obtained biopsy) Note: an adequate and sufficient sample is defined as formalin fixed paraffin embedded tumour tissue sample, preferably from the most recent biopsy of a tumour lesion, collected either at the time of or after the diagnosis of metastatic disease has been made AND from a site not previously irradiated. If no tumour tissue is available, a fresh tissue from needle or excisional biopsy or from resection is required EXP - Availability of adequate and sufficient newly obtained fresh tumour tissue sample collected after ICF during the screening period and before the treatment starts. In case the biopsy collection is not feasible, according to Investigator judgement or patient decision, archival biopsy or surgical sample can be accepted after discussion with the Sponsor.
  • Note: an adequate and sufficient sample is defined as formalin fixed paraffin embedded tumour tissue sample, collected from a site not previously irradiated. If the formalin fixed paraffin embedded tumor tissue sample obtained after the last treatment line and 90 days before the ICF signature, the patient is considered eligible, If the fresh tissue from needle or excisional biopsy/resection is not feasible according to the Investigator judgement, the patients may be eligible after discussion with the Sponsor.
  • 9. pMMR/MSS defined as CRC with all 4 MMR proteins intact and/or with instability at ≤1/5 locus (or 30% of loci if larger panel of markers are assayed) 10. Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 1 11. Anticipated life expectancy ≥ 3 months 12. Adequate hematologic and end organ function, defined by the following laboratory results, obtained within 7 days before first dose of study drug treatment:
  • Hemoglobin ≥ 10 g/dL, platelet count ≥100,000/mm3, ANC ≥1500/mm3
  • Creatinine clearance ≥ 50 mL/min
  • Amylase and lipase ≤ 1.5 × ULN
  • Serum bilirubin ≤ 1.5× ULN
  • AST, ALT, and ALP ≤ 2.5 × ULN with the following exceptions:
  • Patients with documented liver metastases: AST and/or ALT ≤ 5 × ULN
  • INR and PTT ≤ 1.5 × ULN.
  • Patients who are on therapeutic doses of anti-coagulants should be on a stable dose for 28 days, with stable INR and PTT values.
  • Serum albumin ≥ 3.0 g/dL
  • 13. Ability e and willingness to participate and comply with the requirements of the entire study
  • Study Extension - other metastatic GI cancers Cohorts A and B - Gastric cancer
  • Signed and dated informed consent obtained before undergoing any study-specific procedure
  • Male or female aged ≥18 years
  • Body weight > 40kg
  • Histologically proven advanced-stage unresectable adenocarcinoma of the stomach or the GEJ
  • Stage IV (according to the American Joint Committee on Cancer definition)
  • Available CPS or available tissue to perform CPS assessment: Cohort A: CPS≥5 - Cohort B CPS<5
  • Failure to at least one prior line of chemotherapy for metastatic disease, given with or without trastuzumab, with or without anti-PD-1. In alternative, early disease recurrence after surgery with neo-adjuvant and/or adjuvant chemotherapy (within 6 months of the last administration of chemotherapy) or progression during neo-adjuvant and/or adjuvant chemotherapy (containing fluoropyrimidine and a platinum derivative).
  • Presence of measurable disease per RECIST v1.1 (based on imaging within 28 days from first study drug administration). Patients must have at least one "target lesion" to be used to assess response, as defined by RECIST v1.1 Note: Subjects with lesions in a previously irradiated field as the sole site of measurable disease will be permitted to enroll provided the lesion(s) have demonstrated clear progression and can be measured accurately
  • Naïve to EP4 receptor antagonists
  • Availability of adequate and sufficient baseline tumour tissue sample (archival or newly obtained biopsy) Note: an adequate and sufficient sample is defined as formalin fixed paraffin embedded tumour tissue sample, preferably from the most recent biopsy of a tumour lesion, collected either at the time of or after the diagnosis of metastatic disease has been made AND from a site not previously irradiated. If no tumour tissue is available, a fresh tissue from needle or excisional biopsy or from resection is required
  • Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 1
  • Anticipated life expectancy ≥ 3 months
  • Adequate hematologic and end organ function, defined by the following laboratory results, obtained within 7 days before first dose of study drug treatment:
  • <!-- -->
  • Hemoglobin ≥ 10 g/dL, platelet count ≥100,000/mm3, ANC ≥1500/mm3
  • Creatinine clearance ≥ 50 mL/min
  • Amylase and lipase ≤ 1.5 × ULN
  • Serum bilirubin ≤ 1.5× ULN
  • AST, ALT, and ALP ≤ 2.5 × ULN with the following exceptions:
  • Patients with documented liver metastases: AST and/or ALT ≤ 5 × ULN
  • INR and PTT ≤ 1.5 × ULN.
  • Patients who are on therapeutic doses of anti-coagulants should be on a stable dose for 28 days, with stable INR and PTT values.
  • Serum albumin ≥ 3.0 g/dL
  • 14. Ability e and willingness to participate and comply with the requirements of the entire study
  • Cohort C - GI cancers other than CRC and GC
  • Signed and dated informed consent obtained before undergoing any study-specific procedure
  • Male or female aged ≥18 years
  • Body weight > 40kg
  • Histologically proven advanced-stage unresectable GI cancer other than CRC and GC
  • Stage IV (according to the American Joint Committee on Cancer definition)
  • Failure to at least one prior line of chemotherapy for metastatic disease, given with or without trastuzumab, with or without anti-PD-1. In alternative, early disease recurrence after surgery with neo-adjuvant and/or adjuvant chemotherapy (within 6 months of the last administration of chemotherapy) or progression during neo-adjuvant and/or adjuvant chemotherapy (containing fluoropyrimidine and a platinum derivative).
  • Presence of measurable disease per RECIST v1.1 (based on imaging within 28 days from first study drug administration). Patients must have at least one "target lesion" to be used to assess response, as defined by RECIST v1.1 Note: Subjects with lesions in a previously irradiated field as the sole site of measurable disease will be permitted to enroll provided the lesion(s) have demonstrated clear progression and can be measured accurately
  • Naïve to EP4 receptor antagonists
  • Availability of adequate and sufficient baseline tumour tissue sample (archival or newly obtained biopsy) Note: an adequate and sufficient sample is defined as formalin fixed paraffin embedded tumour tissue sample, preferably from the most recent biopsy of a tumour lesion, collected either at the time of or after the diagnosis of metastatic disease has been made AND from a site not previously irradiated. If no tumour tissue is available, a fresh tissue from needle or excisional biopsy or from resection is required
  • Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 1
  • Anticipated life expectancy ≥ 3 months
  • Adequate hematologic and end organ function, defined by the following laboratory results, obtained within 7 days before first dose of study drug treatment:
  • <!-- -->
  • Hemoglobin ≥ 10 g/dL, platelet count ≥100,000/mm3, ANC ≥1500/mm3
  • Creatinine clearance ≥ 50 mL/min
  • Amylase and lipase ≤ 1.5 × ULN
  • Serum bilirubin ≤ 1.5× ULN
  • AST, ALT, and ALP ≤ 2.5 × ULN with the following exceptions:
  • Patients with documented liver metastases: AST and/or ALT ≤ 5 × ULN
  • INR and PTT ≤ 1.5 × ULN.
  • Patients who are on therapeutic doses of anti-coagulants should be on a stable dose for 28 days, with stable INR and PTT values.
  • Serum albumin ≥ 3.0 g/dL
  • 13. Ability e and willingness to participate and comply with the requirements of the entire study

Who cannot join

  • Exclusion criteria 1-37 are applicable to all patients to be enrolled in the study, in both Main Study (both Dose Escalation and Expansion) and Study Extension.
  • Criteria 38-40 are applicable to patients to be enrolled in Study Extension only.
  • Medical Condition/History:
  • Cancer and anti-cancer therapy:
  • Additional malignancy that progressed or required active treatment within the last 2 years. Exceptions include basal cell carcinoma of the skin, superficial bladder cancer, squamous cell carcinoma of the skin that has undergone potentially curative therapy with no evidence of recurrence for 5 years since initiation of that curative therapy, or carcinoma in situ (breast carcinoma, cervical cancer)
  • Active brain tumour, metastasis or leptomeningeal metastases. Patients with brain metastases are eligible if these have been treated and there is no magnetic resonance imaging (MRI except where contraindicated in which CT scan is acceptable) evidence of progression for at least 8 weeks after treatment is complete and within 28 days prior to first dose of study drug administration. Cases should be discussed with the Sponsor. There must also be no requirement for immunosuppressive doses of systemic corticosteroids (>10mg/day prednisone equivalents) for at least 2 weeks prior to study drug administration
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  • Major surgery within 28 days before Cycle 1 Day 1 or anticipation of needing such procedure during the trial
  • Treatment with any systemic or localized anti-cancer therapy, including chemotherapy, biological therapy, radiotherapy, or hormonal therapy within 28 days before initiation of Cycle 1 Day 1 or expected to require such a treatment during the trial
  • Persistent toxicity related to prior therapy, Grade >1 according to NCI CTCAE Version 5.0 Note 1: Patients must have recovered from all AEs due to previous therapies, to CTCAE ≤Grade 1 or to baseline condition. Participants with CTCAE ≤Grade 2 neuropathy or alopecia may be eligible Note 2: If patients received major surgery, they must have recovered adequately from the toxicity and/or complications from the intervention prior to starting study treatment Note 3: Patients must have recovered from all radiation-related toxicities, not require corticosteroids, and not have had radiation pneumonitis. A 1-week washout is permitted for palliative radiation (≤2 weeks of radiotherapy) to non-CNS disease
  • Uncontrolled tumour-related pain. Patients requiring narcotic pain medication must be on a stable regimen at study entry
  • Uncontrolled pleural effusion, pericardial effusion or ascites requiring repeated drainage more than once every 28 days. Indwelling drainage catheters are allowed
  • Cardiovascular:
  • Unstable angina
  • Myocardial infarction within 6 months before enrolment
  • History of stroke, reversible ischemic neurological defect, or transient ischemic attack within 6 months before enrolment
  • Uncontrolled ventricular arrhythmia
  • Congestive heart failure (New York Hearth Association class ≥II)
  • Poorly controlled hypertension
  • Infections:
  • Confirmed infection with SARS-CoV-2 as documented by molecular testing at nasopharyngeal swab (only if required by the epidemiological situation)
  • HIV infection
  • Active tuberculosis
  • Acute or chronic viral hepatitis B or C infection
  • Any severe infection within 14 days before Cycle 1 Day 1
  • General Medical History:
  • Active autoimmune disease in the past 2 years
  • History of allogenic tissue/solid organ transplant (including allogeneic bone marrow transplantation)
  • History of immunodeficiency
  • History or presence of interstitial lung disease or history of pneumonitis that has required oral or iv corticosteroids.
  • History of gastric/duodenal ulcers, colitis and/or gastrointestinal bleeding
  • History of severe gastrointestinal adverse reactions
  • History of hypersensitivity reactions to fully human monoclonal antibodies, Grade ≥ 3 according to NCI CTCAE Version 5.0
  • History of anaphylaxis, or uncontrolled asthma
  • Allergy/hypersensitivity/intolerance to any component of CR6086 or AGEN2034
  • Any other clinically relevant disease and condition, including psychiatric or substance abuse disorders, that, in the opinion of the Investigator, may jeopardize efficacy or safety assessments, confound the result of the trial or may compromise the patient's safety during trial participation
  • Concomitant Treatments
  • Administration of a live, attenuated vaccine within 28 days before Cycle 1 D1
  • Systemic steroid therapy or any other form of immunosuppressive therapy within 7 days before screening Note: Corticosteroid use for management of immune-related adverse events, and/or as a premedication for iv contrast allergies/reactions is allowed.
  • Daily corticosteroid replacement therapy is allowed: permitted therapy are daily prednisone at doses of 5 to 7.5 mg or equivalent hydrocortisone dose, and steroid therapy administered by topical, intraocular, intranasal, and/or inhalation routes
  • Regular use of any illicit drugs or recent history (within the last year) of substance abuse (including alcohol)
  • Others:
  • Participation in a study with an investigational drug or medical device within 28 days before Cycle 1 Day 1 Note: Participants who have entered the follow-up phase of another investigational study may participate as long as at least 4 weeks have elapsed since the last dose of the investigational agent
  • Inability to swallow medications
  • Malabsorption conditions
  • For women of childbearing potential:
  • Pregnancy (i.e. positive pregnancy test at Screening) or breastfeeding
  • Failure to agree to practice a highly effective method of contraception , from enrolment up to at least 120 days after the last IMP intake
  • expecting to conceive within the projected duration of the trial, starting with the screening visit through 120 days after the last dose of study treatment
  • For sexually active men with a female partner of childbearing potential: failure to agree to use condom and refrain from donating sperm from enrolment up to at least 120 days after the last IMP intake.
  • Patients who are legally incapacitated or has limited legal capacity
  • Criteria for Study Extension only
  • Presence of portal hypertension
  • Presence of oesophageal varices
  • Presence of gastric infiltration, severe gastritis, duodenal or gastric ulcer, or any other condition that may lead to bleeding or perforation, as assessed by an EGDS performed during screening period.
  • Criteria referring to Cycle 1 D1, should be reassessed on study D1, before starting the study treatment.

Trial locations and contacts

3 sites in 1 country.

Italy3 sites

  • Istituto Nazionale dei Tumori

    Milan, Milano, 20133

  • Istituto Oncologico Veneto IRCCS

    Padova, Padova, 35128

  • Azienda Ospedaliero Universitaria Pisana

    Pisa, Pisa, 56126

Other trials in Italy

About this study

Official title: An Open-label, Single-arm, Phase Ib/IIa Trial to Evaluate the Safety and Efficacy of the EP4 Receptor Antagonist Vorbipiprant (CR6086) in Combination With the PD-1 Inhibitor Balstilimab (AGEN2034), in Patients With Pretreated Mismatch-repair-proficient and Microsatellite Stable Metastatic Colorectal Cancer, and Other Metastatic GI Cancers.

This Phase Ib/IIa study comprises a Main Study and a Study Extension.

The Main Study has been designed according to a 3+3 Dose Escalation/dose Expansion design in refractory pMMR-MSS mCRC patients. The fixed-dose Expansion phase will be conducted at the recommended dose for expansion (RDE), with the purpose of generating additional and more robust safety and efficacy data. 27 patients are predicted in the Dose Escalation phase and 52 in the Expansion phase, respectively.

Read more

The Study Extension explores in other metastatic GI cancers the Vorbipiprant (CR6086) RDE obtained in the Main Study. 27 patients are predicted.

No control arm was included, as the target patient population of this study consists of patients in whom the overall survival is less than 6 months and treatment options are very limited and often poorly tolerated, making unlikely that the study results can be significantly biased.

Read the detailed description

In this study, the combination of the PGE2 inhibition (through the EP4 receptor antagonist CR6086) with the immune checkpoint blockade (through the anti-PD-1 AGEN2034) is being evaluated in refractory pMMR-MSS mCRC and other metastatic GI cancers. CR6086 (Vorbipiprant) is a potent and selective, orally bioavailable, targeted immunomodulator small molecule acting as an EP4 receptor antagonist. AGEN2034 (balstilimab) is a novel, fully human monoclonal immunoglobulin G4 antibody, designed to block programmed cell death 1 (PD-1) from interacting with its ligands (PD-L) PD-L1 and PD-L2, currently being developed for the treatment of advanced malignancies. EP4 receptor antagonists turn the status of the tumor microenvironment into a favourable one, i.e. immune-responsive, representing thus a rational therapeutic approach in combination with ICIs in primarily refractory cancers.

Being tested
CR6086, AGEN2034
Keywords
prostaglandin E2 (PGE2), EP4 antagonist, CR6086, Balstilimab, anti PD-1, immune checkpoint inhibitors, Immuno-Oncology, vorbipiprant
Medical subject headings
Colorectal Neoplasms, Stomach Neoplasms

What participants receive

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

  • CR6086Drug

    Also called vorbipiprant

    oral CR6086, twice a day for 14 days

  • AGEN2034Biological

    Also called balstilimab

    AGEN2034 3 mg/Kg iv on D1 of each 14- day cycle

Study groups in NCT05205330
Study groupRoleWhat they receive
30 mg (Dose Level 1)Experimental14-day cycles of combined AGEN2034 3 mg/Kg iv on D1 of each cycle, and oral CR6086 30 mg twice a day for 14 days
Receives: Drug: CR6086; Biological: AGEN2034
90 mg (Dose Level 2)Experimental14-day cycles of combined AGEN2034 3 mg/Kg iv on D1 of each cycle, and oral CR6086 90 mg twice a day for 14 days
Receives: Drug: CR6086; Biological: AGEN2034
180 mg (Dose Level 3)Experimental14-day cycles of combined AGEN2034 3 mg/Kg iv on D1 of each cycle, and oral CR6086 180 mg twice a day for 14 days
Receives: Drug: CR6086; Biological: AGEN2034
other mGI cancersExperimental14-day cycles of combined AGEN2034 3 mg/Kg iv on D1 of each cycle, and oral CR6086 90 mg twice a day for 14 days
Receives: Drug: CR6086; Biological: AGEN2034
Expansion in MSS/pMMR mCRC patientsExperimental14-day cycles of combined AGEN2034 3 mg/Kg iv on D1 of each cycle, and oral CR6086 90 mg twice a day for 14 days
Receives: Drug: CR6086; Biological: AGEN2034

What is being measured

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

  1. Safety and Tolerability of CR6086 combined with AGEN2034

    Incidence of TEAEs using NCI CTCAE v5.0

    Measured: From the time of the first dose up to 24 weeks of treatment

  2. Disease Control rate (DCR)

    Proportion of patients who have achieved CR, PR, or stable disease (SD) per RECIST 1.1 / iRECIST during the Dose Escalation part

    Measured: up to 24 weeks of treatment

  3. Objective Response Rate (ORR)

    Proportion of patients who have achieved CR or PR per RECIST 1.1 / iRECIST during the Expansion part (Phase IIa)

    Measured: up to 24 weeks of treatment

Secondary outcomes (7)

  1. Disease Control Rate (DCR)

    Proportion of patients who have achieved CR, PR, or stable disease (SD) per RECIST 1.1 / iRECIST during the Dose Escalation part

    Measured: throughout the study

  2. Objective Response Rate (ORR)

    Proportion of patients who have achieved CR or PR per RECIST 1.1 / iRECIST during the Expansion part (Phase IIa)

    Measured: throughout the study

  3. Duration Of Response (DOR)

    Time from first documentation of response (CR or PR) until the time of first documentation of disease progression per RECIST 1.1 / iRECIST

    Measured: throughout the study, up to 2 years

  4. Progression-Free Survival (PFR)

    Time from the first dose of study drugs to the earlier date of assessment of progression per RECIST 1.1 / iRECIST, or death by any cause in the absence of progression

    Measured: throughout the study, up to 2 years

  5. Progression-Free Survival Rate (PFSR)

    Proportion of patients alive and free of disease progression per RECIST 1.1 / iRECIST at specific timepoints, or death by any cause in the absence of progression

    Measured: throughout the study, up to 2 years

  6. Overall Survival (OS)

    Time from the first dose of study drugs to the date of death by any cause

    Measured: throughout the study, up to 2 years

  7. Safety and Tolerability of CR6086 combined with AGEN2034

    Incidence of TEAEs

    Measured: throughout the study, up to 2 years

Timeline

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

  1. First posted25 Jan 2022
  2. Study start23 Nov 2021
  3. Primary completionDec 2026 (estimated)
  4. Study completionJun 2027 (estimated)

Resources

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
Single group
Model description
Prospective, open label, non-randomized, single-arm (non-controlled), multiple ascending dose (Dose Escalation) in refractory pMMR-MSS mCRC patients, followed by a fixed-dose Expansion (at RDE) in refractory pMMR-MSS mCRC patients, and a fixed-dose (at RDE) Study Extension in other metastatic GI cancers
Masking
None (open label)
Enrolment
107 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05205330
Sponsor's protocol ID
CR6086-1-04
Other IDs
2024-515446-16-00, 2020-002435-29
Status last verified
Oct 2025
First submitted
20 Jan 2022
Last updated
29 Oct 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing CR6086 and AGEN2034 in people with Refractory Metastatic Colorectal Cancer and Solid Tumor, run by Rottapharm Biotech at 3 sites in Italy.

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 73 inclusion and 55 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: under way, not looking for participants, as of the sponsor's last update on 29 Oct 2025. 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 Italy. 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?

This study is still under way. Results are not available in the source record yet.

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 CR6086 combined with AGEN2034 (time frame: From the time of the first dose up to 24 weeks of treatment). 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?

On the ClinicalTrials.gov record for NCT05205330.

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 29 Oct 2025.

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