Advanced Squamous Non-Small Cell Lung CarcinomaPhase 1/2NCT05127590
RBN-2397 in Combination With Pembrolizumab in Patients With SCCL
A Phase 1/2 study testing RBN-2397 in people with Advanced Squamous Non-Small Cell Lung Carcinoma, run by Ribon Therapeutics, Inc. at 19 sites in 4 countries.
Trial summary
RBN-2397 inhibits PARP7, an enzyme that is switched on by cancer stresses, such as the toxins in cigarette smoke. Cancer cells use PARP7 to hide from the immune system by stopping the cell from sending a signal (Type 1 interferon) that tells the immune system that something is wrong and to kill the cell. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Advanced Squamous Non-Small Cell Lung Carcinoma
- What is being tested?
- RBN-2397
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 19 sitesin 4 countries
- Study dates
- 15 Mar 2022to Dec 2023
- 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 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Confirmed diagnosis of advanced/metastatic NSCLC of squamous cell histology as determined by local testing practices.
- Patients should have received prior therapy including a platinum containing chemotherapy regimen and an ICI, including anti-PD-1/anti-PD-L1, anti-cytotoxic T-lymphocyte-associated antigen 4 (CTLA-4) inhibitors, either sequentially or as combination of chemo + checkpoint inhibitor.
- The last regimen prior to enrolling in the study must be a checkpoint inhibitor-containing regimen where the best response for at least one tumor response assessment was stable disease (SD), partial response (PR), or complete response (CR).
- Patients experienced PD as determined by the investigator during or following their most recent treatment regimen
- Must agree to undergo tumor biopsy if medically safe and feasible. Archival biopsy samples may be submitted if fresh biopsy can't be obtained.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1
Show all 9Show fewer
- CT or MRI imaging done within 28 days prior to study treatment and have at least one measurable target lesion
- Normal organ and bone marrow function
- Patient and his/her partner agree to use adequate contraception during and for 3 months after the last study drug dose
Who cannot join
- Has non-squamous histology NSCLC. Patients whose tumors have a mixed histology are ineligible.
- Patient should not have received more than two prior lines of therapy with ICI including anti-PD-1/anti-PD-L1, anti-CTLA-4 inhibitors and one prior line of a chemotherapy treatment.
- Patient is unable to swallow oral medications, has impairment of gastrointestinal (GI) function or GI disease that may significantly alter drug absorption (e.g., active inflammatory bowel disease, uncontrolled nausea, vomiting, diarrhea, or malabsorption syndrome).
- Prior radiation within 2 weeks of Cycle 1 Day 1 (C1D1), except for palliative radiotherapy to a limited field. 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.
- A patient with CNS metastases is excluded if:
- Has active CNS metastases (new lesions or progression from prior imaging study) requiring treatment within 28 days prior to study treatment and/or ongoing corticosteroid therapy.
Show all 25Show fewer
- Has symptomatic or untreated leptomeningeal disease.
- Patients who discontinue prior treatment with an ICI due to irAEs.
- Has a known history of prior malignancy within the last 5 years. Except: malignancies that were treated curatively and have not recurred within 2 years prior to study treatment; completely resected basal cell and squamous cell skin cancers; any malignancy considered to be indolent and that has never required therapy; and completely resected carcinoma in situ of any type.
- Has received a live-virus vaccination within 30 days of planned treatment start. Vaccines that do not contain live virus are permitted.
- Any of the following in the previous 6 months: myocardial infarction or current history of New York heart Association (NYHA) Class III or IV heart failure, uncontrolled angina, severe uncontrolled ventricular anemias, or electrocardiographic evidence of acute ischemia.
- Patient has a history of prolonged QT syndrome or Torsades de pointes, and/or has a familial history of prolonged QT syndrome.
- Patient is taking a concomitant medication that is a strong inhibitor or inducer of cytochrome P450 [CYP]-mediated metabolism or that is metabolized by CYP 2B6, 3A4 or 2C19, 2C9, or other members of the IIC subfamily of the CYP genes and that, if underdosed, would constitute a significant risk to the patient. Individual cases may be discussed with the Medical Monitor.
- Ingestion of herbal medicines and grapefruit, grapefruit juice, pomegranate juice, star fruit, or orange marmalade (made with Seville oranges) from the start of the screening period. (Note that there are well- reported cases of CYP3A drug-drug interactions with these foodstuffs.)
- Has active autoimmune disease that has required systemic treatment in the past 12 months (i.e., with use of disease modifying agents, corticosteroids or immunosuppressive drugs). Replacement therapy (e.g., ≤ 10 mg daily prednisolone or steroid equivalent, thyroxine, insulin, or corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment. Patients with vitiligo, resolved childhood asthma/atopy, type I diabetes mellitus, and residual hypothyroidism due to an autoimmune condition and only requiring hormone replacement, are not excluded.
- Is on chronic systemic steroids (e.g., > 10 mg daily prednisolone or steroid equivalent for > 6 months). Subjects with asthma that require intermittent use of bronchodilators, inhaled steroids, or local steroid injections would not be excluded from the study.
- Has an active systemic infection requiring therapy (e.g.: bacterial, fungal, viral).
- Has known active Hepatitis B or C. Active Hepatitis B is defined as a known positive HBsAg result. Active Hepatitis C is defined by a known positive Hepatitis C Antibody result and known quantitative hepatitis C virus ribonucleic acid (RNA) results greater than the lower limits of detection of the assay.
- Has known psychiatric or substance abuse disorder that would interfere with cooperation with the requirements of the trial.
- Has interstitial lung disease or a history of pneumonitis that required oral or intravenous steroids to assist with management. Lymphangitic spread of the NSCLC is not exclusionary.
- Is pregnant or breastfeeding or expecting to conceive or father children while on study medication and for the required duration of contraception after the last dose of study medication.
- Has ongoing acute clinical AEs of National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Grade ≥2 resulting from prior cancer therapies (except alopecia, peripheral neuropathy and ototoxicity, which are excluded if ≥ Grade 3).
- Has had, within the past 6 months, the occurrence of one or more of the following events: cerebrovascular accident, deep vein thrombosis, pulmonary embolism, hemorrhage (CTCAE Grade 3 or 4), chronic liver disease (meeting criteria for Child Pugh Class B or C), organ transplantation.
- Has, within 2 weeks prior to Day 1, received systemic therapeutic doses of corticosteroids (e.g., > 10 mg daily prednisolone or steroid equivalent). Topical, inhaled, nasal and ophthalmic steroids are allowed for short term treatment of acute conditions (e.g.: asthma, poison ivy contact dermatitis); for other immunosuppressive agents, the exclusionary dose and duration will be determined in consultation with the Medical Monitor.
- Has any other medical or personal condition that, in the opinion of the Investigator, may potentially compromise the safety or compliance of the patient, or may preclude the patient's successful completion of the clinical study.
Trial locations and contacts
19 sites in 4 countries.
19 sites in 4 countries
Spain8 sites
Hospital Clinico Universitario De Santiago De Compostela
A Coruña
NEXT Oncology Barcelona
Barcelona
Vall D'Hebron Insitute of Oncology
Barcelona
Hospital Universitario Ramon Y Cajal
Madrid
Hospital Regional Universitario de Malaga
Málaga
Hospital Quiron Madrid
Pozuelo de Alarcón
Hospital Universitario Virgen Macarena
Seville
INCLIVA Biomedical Research Institute
Valencia
United States4 sites
Hematology and Oncology Clinic
Baton Rouge, Louisiana, 70809
Sarah Cannon Research Institute
Nashville, Tennessee, 37203
Helen F. Graham Cancer Center (Christiana Care)
Newark, Delaware, 19713
Cancer Treatment Centers of America
Newnan, Georgia, 30265
United Kingdom4 sites
Beatson West of Scotland Cancer Centre
Glasgow, Scotland
Imperial College London
London
Sarah Cannon Research Institute UK (University College London Hospitals)
London
The Christie NHS Foundation Trust
Manchester
Israel3 sites
Rambam Care Campus
Haifa
Hadassah Medical Center
Jerusalem
Shaare Zedek Medical Center
Jerusalem
About this study
Official title: A Phase 1b/2, Multicenter, Single Arm Study of RBN-2397 in Combination With Pembrolizumab in Patients With Squamous Cell Carcinoma of the Lung (SCCL)
RBN-2397 inhibits PARP7, an enzyme that is switched on by cancer stresses, such as the toxins in cigarette smoke. Cancer cells use PARP7 to hide from the immune system by stopping the cell from sending a signal (Type 1 interferon) that tells the immune system that something is wrong and to kill the cell. RBN-2397 has been shown in animal and human studies to inhibit tumor growth and also shuts down the "don't kill me" signal the tumor is sending to evade the immune system.
The purpose of this study is to determine if RBN-2397 in combination with pembrolizumab (a PD-1 inhibitor) has the ability to restore the response to treatment in patients with SCCL that have been previously treated with a PD-1/PD-1 ligand (PD-L1) inhibitor and have had a response followed by disease progression.
Read more
The Phase 1b portion of the study will assess the safety of RBN-2397 in combination with pembrolizumab (a PD-1 inhibitor) and define the dose of RBN-2397 to be used in combination with pembrolizumab for the Phase 2.
The Phase 2 portion of the study will assess the anti-tumor activity of RBN-2397 in combination with pembrolizumab.
Read the detailed description
This is an open label, multicenter Phase 1b/2 single arm study that will evaluate the safety and antitumor activity of RBN-2397 in combination with pembrolizumab in patients with confirmed diagnosis of advanced squamous cell carcinoma of the lung who have received prior therapy. The study consists of a Phase 1b Safety Run in and Phase 2.
During the Phase 1b Safety Run-in, approximately 10 patients will be enrolled in a 3+3 fashion and treated with continuous oral dosing with RBN-2397 twice daily (BID) in combination with the fixed approved dose of intravenous (IV) pembrolizumab every 3 weeks [Q3W]) to establish RP2D of RBN-2397 in combination with pembrolizumab.
During Phase 2, approximately 40 patients will be treated with continuous oral dosing with the RP2D of RBN-2397 BID in combination with the fixed approved dose of IV pembrolizumab.
In both the Phase 1b Safety Run in and Phase 2, a treatment cycle is defined as 21 days. On Day 1 of each treatment cycle, RBN-2397 will be administered orally and followed by IV infusion of pembrolizumab at the fixed approved dose according to the approved local product label. During the remaining days of the 21-day treatment cycle, only RBN-2397 BID will be administered. Treatment cycles will continue until disease progression, unacceptable treatment-related toxicity, or withdrawal of consent
- Being tested
- RBN-2397
- Keywords
- NSCLC, Squamous Cell Lung Cancer, Squamous - NSCLC
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RBN-2397Drug
Also called Pembrolizumab, Keytruda
Continuous oral dosing with the RP2D of RBN-2397 (outpatient basis). Pembrolizumab IV infusion over 30 minutes in clinic on Day 1 of each cycle.
| Study group | Role | What they receive |
|---|---|---|
| RBN-2397 in combination with pembrolizumab | Experimental | RBN-2397 orally in combination with the fixed approved dose of IV pembrolizumab Receives: Drug: RBN-2397 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Determine recommended Phase 2 dose (RP2D) (Phase 1b)
Incidence rate of Dose limiting Toxicities (DLTs) of RBN 2397 in combination with pembrolizumab
Measured: through study completion (an average of 6 months)
Overall Response Rate (Phase 2)
Proportion of patients with confirmed response of CR or PR (RECIST v1.1)
Measured: From start of treatment (C1D1) up to 78 weeks
Secondary outcomes (5)
Safety determined by Treatment-Emergent Adverse Events
Incidence and severity of adverse events/serious adverse events as assessed by NCI CTCAE, version 5.0
Measured: From start of treatment through 90 days after the last dose of study drug
Cmax of RBN-2397
Assessment of Maximum plasma concentration (Cmax)
Measured: Through Study Day 22
Tmax of RBN-2397
Time to maximum plasma concentration (Tmax)
Measured: Through Study Day 22
AUC of RBN-2397
Assessment of area under the curve (AUC) of RBN-2397
Measured: Through Study Day 22
T1/2 of RBN-2397
Assessment of terminal half-life (T1/2) of RBN-2397
Measured: Through Study Day 22
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Nov 2021
- Study start15 Mar 2022
- Primary completionNov 2023 (estimated)
- Study completionDec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Advanced Squamous Non-Small Cell Lung CarcinomaStudies 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
- Not applicable
- Intervention model
- Single group
- Model description
- RBN-2397 in combination with pembrolizumab
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ribon Therapeutics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Melissa Johnson, MD, Principal investigator, Tennessee Oncology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05127590
- Sponsor's protocol ID
- RBN-2397-21-002
- Status last verified
- Jun 2023
- First submitted
- 4 Nov 2021
- Last updated
- 3 Jul 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Cohen MS, Chang P. Insights into the biogenesis, function, and regulation of ADP-ribosylation. Nat Chem Biol. 2018 Feb 14;14(3):236-243. doi: 10.1038/nchembio.2568.
PubMed 29443986Gozgit JM, Vasbinder MM, Abo RP, Kunii K, Kuplast-Barr KG, Gui B, Lu AZ, Molina JR, Minissale E, Swinger KK, Wigle TJ, Blackwell DJ, Majer CR, Ren Y, Niepel M, Varsamis ZA, Nayak SP, Bamberg E, Mo JR, Church WD, Mady ASA, Song J, Utley L, Rao PE, Mitchison TJ, Kuntz KW, Richon VM, Keilhack H. PARP7 negatively regulates the type I interferon response in cancer cells and its inhibition triggers antitumor immunity. Cancer Cell. 2021 Sep 13;39(9):1214-1226.e10. doi: 10.1016/j.ccell.2021.06.018. Epub 2021 Jul 22.
PubMed 34375612
Study at a glance
From the registry record, last updated by the sponsor on 3 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1b/2, Multicenter, Single Arm Study of RBN-2397 in Combination With Pembrolizumab in Patients With Squamous Cell Carcinoma of the Lung (SCCL)
- ClinicalTrials.gov ID
- NCT05127590
- Acronym / sponsor ID
- RBN-2397-21-002
- Keywords
- NSCLC, Squamous Cell Lung Cancer, Squamous - NSCLC
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Ribon Therapeutics, Inc.Industry (pharma, biotech, devices)
- Study start
- 15 Mar 2022 (actual)
- Primary completion
- Nov 2023 (estimated)
- Study completion
- Dec 2023 (estimated)
- First posted
- 19 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.
RBN-2397 inhibits PARP7, an enzyme that is switched on by cancer stresses, such as the toxins in cigarette smoke. Cancer cells use PARP7 to hide from the immune system by stopping the cell from sending a signal (Type 1 interferon) that tells the immune system that something is wrong and to kill the cell. RBN-2397 has been shown in animal and human studies to inhibit tumor growth and also shuts down the "don't kill me" signal the tumor is sending to evade the immune system.
The purpose of this study is to determine if RBN-2397 in combination with pembrolizumab (a PD-1 inhibitor) has the ability to restore the response to treatment in patients with SCCL that have been previously treated with a PD-1/PD-1 ligand (PD-L1) inhibitor and have had a response followed by disease progression.
The Phase 1b portion of the study will assess the safety of RBN-2397 in combination with pembrolizumab (a PD-1 inhibitor) and define the dose of RBN-2397 to be used in combination with pembrolizumab for the Phase 2.
The Phase 2 portion of the study will assess the anti-tumor activity of RBN-2397 in combination with pembrolizumab.
Detailed description
This is an open label, multicenter Phase 1b/2 single arm study that will evaluate the safety and antitumor activity of RBN-2397 in combination with pembrolizumab in patients with confirmed diagnosis of advanced squamous cell carcinoma of the lung who have received prior therapy. The study consists of a Phase 1b Safety Run in and Phase 2.
During the Phase 1b Safety Run-in, approximately 10 patients will be enrolled in a 3+3 fashion and treated with continuous oral dosing with RBN-2397 twice daily (BID) in combination with the fixed approved dose of intravenous (IV) pembrolizumab every 3 weeks [Q3W]) to establish RP2D of RBN-2397 in combination with pembrolizumab.
During Phase 2, approximately 40 patients will be treated with continuous oral dosing with the RP2D of RBN-2397 BID in combination with the fixed approved dose of IV pembrolizumab.
In both the Phase 1b Safety Run in and Phase 2, a treatment cycle is defined as 21 days. On Day 1 of each treatment cycle, RBN-2397 will be administered orally and followed by IV infusion of pembrolizumab at the fixed approved dose according to the approved local product label. During the remaining days of the 21-day treatment cycle, only RBN-2397 BID will be administered. Treatment cycles will continue until disease progression, unacceptable treatment-related toxicity, or withdrawal of consent
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- RBN-2397 in combination with pembrolizumab
| Arm | Type | Receives |
|---|---|---|
| RBN-2397 in combination with pembrolizumab | Experimental | Drug: RBN-2397RBN-2397 orally in combination with the fixed approved dose of IV pembrolizumab |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Confirmed diagnosis of advanced/metastatic NSCLC of squamous cell histology as determined by local testing practices.
- Patients should have received prior therapy including a platinum containing chemotherapy regimen and an ICI, including anti-PD-1/anti-PD-L1, anti-cytotoxic T-lymphocyte-associated antigen 4 (CTLA-4) inhibitors, either sequentially or as combination of chemo + checkpoint inhibitor.
- The last regimen prior to enrolling in the study must be a checkpoint inhibitor-containing regimen where the best response for at least one tumor response assessment was stable disease (SD), partial response (PR), or complete response (CR).
- Patients experienced PD as determined by the investigator during or following their most recent treatment regimen
- Must agree to undergo tumor biopsy if medically safe and feasible. Archival biopsy samples may be submitted if fresh biopsy can't be obtained.
Key exclusion criteria (25 listed)
- Has non-squamous histology NSCLC. Patients whose tumors have a mixed histology are ineligible.
- Patient should not have received more than two prior lines of therapy with ICI including anti-PD-1/anti-PD-L1, anti-CTLA-4 inhibitors and one prior line of a chemotherapy treatment.
- Patient is unable to swallow oral medications, has impairment of gastrointestinal (GI) function or GI disease that may significantly alter drug absorption (e.g., active inflammatory bowel disease, uncontrolled nausea, vomiting, diarrhea, or malabsorption syndrome).
- Prior radiation within 2 weeks of Cycle 1 Day 1 (C1D1), except for palliative radiotherapy to a limited field. 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.
- A patient with CNS metastases is excluded if:
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 |
|---|---|---|
| RBN-2397Also: Pembrolizumab, KeytrudaContinuous oral dosing with the RP2D of RBN-2397 (outpatient basis). Pembrolizumab IV infusion over 30 minutes in clinic on Day 1 of each cycle. | Drug | RBN-2397 in combination with pembrolizumab |
Primary outcome
Determine recommended Phase 2 dose (RP2D) (Phase 1b)
Time frame: through study completion (an average of 6 months)
Incidence rate of Dose limiting Toxicities (DLTs) of RBN 2397 in combination with pembrolizumab
Overall Response Rate (Phase 2)
Time frame: From start of treatment (C1D1) up to 78 weeks
Proportion of patients with confirmed response of CR or PR (RECIST v1.1)
5 secondary outcomes
Safety determined by Treatment-Emergent Adverse Events
Time frame: From start of treatment through 90 days after the last dose of study drug
Cmax of RBN-2397
Time frame: Through Study Day 22
Tmax of RBN-2397
Time frame: Through Study Day 22
AUC of RBN-2397
Time frame: Through Study Day 22
T1/2 of RBN-2397
Time frame: Through Study Day 22
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jul 2023.
- Background: PubMed 29443986Cohen MS, Chang P. Insights into the biogenesis, function, and regulation of ADP-ribosylation. Nat Chem Biol. 2018 Feb 14;14(3):236-243. doi: 10.1038/nchembio.2568.
- Background: PubMed 34375612Gozgit JM, Vasbinder MM, Abo RP, Kunii K, Kuplast-Barr KG, Gui B, Lu AZ, Molina JR, Minissale E, Swinger KK, Wigle TJ, Blackwell DJ, Majer CR, Ren Y, Niepel M, Varsamis ZA, Nayak SP, Bamberg E, Mo JR, Church WD, Mady ASA, Song J, Utley L, Rao PE, Mitchison TJ, Kuntz KW, Richon VM, Keilhack H. PARP7 negatively regulates the type I interferon response in cancer cells and its inhibition triggers antitumor immunity. Cancer Cell. 2021 Sep 13;39(9):1214-1226.e10. doi: 10.1016/j.ccell.2021.06.018. Epub 2021 Jul 22.
- Individual participant dataSharing planned: No
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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.
Melissa Johnson, MD principal investigator
Tennessee Oncology
19 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing RBN-2397 in people with Advanced Squamous Non-Small Cell Lung Carcinoma, run by Ribon Therapeutics, Inc. at 19 sites in 4 countries.
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 9 inclusion and 25 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: status not confirmed, as of the sponsor's last update on 3 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 19 sites in Spain, United States, United Kingdom, Israel. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Determine recommended Phase 2 dose (RP2D) (Phase 1b) (time frame: through study completion (an average of 6 months)). 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?
On the ClinicalTrials.gov record for NCT05127590, which also lists 2 linked publications.
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 3 Jul 2023.