Non Small Cell Lung CancerPhase 1HyPeRNCT02998567
Combination Study of Guadecitabine/ASTX727 and Pembrolizumab
A Phase 1 study testing Guadecitabine, Pembrolizumab and ASTX727 in people with Non Small Cell Lung Cancer, run by Royal Marsden NHS Foundation Trust at 2 sites in United Kingdom.
Trial summary
HyPeR is a multi-centre Phase 1 Dose Escalation Study of Guadecitabine (SGI-110)/ASTX727 a Second Generation Hypo-Methylating Agent in Combination with Pembrolizumab (MK3475) in Patients with Refractory Solid Tumours. The investigators will be investigating the safety and toxicity of the combination. 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?
- Guadecitabine, Pembrolizumab and ASTX727
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 2 sitesUnited Kingdom
- Study dates
- 26 Jan 2017to Sep 2026
- Phase
- Phase 1
- 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
- Part A and B1/2:
- Histologically or cytologically confirmed advanced solid tumours, refractory to conventional treatment, or for which no conventional therapy exists or is declined by the patient.
- Part B1:
- Histologically or cytologically confirmed advanced solid tumours, refractory to conventional treatment, or for which no conventional therapy exists or is declined by the patient AND:
- Patients with any tumour type that previously responded to a PD-1 or PD-L1 inhibitor and subsequently progressed (defined as secondary resistance to PD-1/PD-L1 inhibitors ie CR or PR by RECIST, or SD by RECIST for 6 months' duration) or/
- Patients with microsatellite-instability-high (MSI-High) tumours, provided they have been defined by validated assays or patients with deficient mismatch repair (dMMR) defined by immunohistochemistry, who have previously received and have progressed on a PD-1 or PD-L1 inhibitor (primary resistance to PD-1/PD-L1 inhibitors) or/
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- Patients with other solid tumour types who could benefit, based on emerging anti-tumour activity data, from combination therapy with a demethylating agent and PD-1 or PD-L1 inhibitors, in consultation with any other relevant preclinical or clinical data, at the Chief Investigator's discretion.
- Part B2:
- Patients with histologically or cytologically confirmed NSCLC previously treated with PD-1 or PD-L1 inhibitor for advanced or metastatic disease.
- Life expectancy of at least 12 weeks.
- Eastern Co-operative Oncology Group (ECOG) performance status of 0-1 with no significant deterioration over the previous 2 weeks (Appendix 1).
- Evaluable or measurable disease as assessed by RECIST 1.1.
- Haematological and biochemical indices within the ranges shown below. These measurements must be performed within one week (Day -7 to Day 1) prior to administration of any investigational medicinal product.
- Haemoglobin (Hb) ≥ 9.0 g/dL
- Absolute neutrophil count ≥ 1.5 x 109/L
- Platelet count ≥ 100 x 109/L
- International normalised ratio (INR) ≤ 1.5x upper limit of normal (ULN)
- Or:
- Prothrombin time ≤ 1.5x upper limit of normal (ULN)
- Serum bilirubin ≤1.5x ULN
- Or:
- Direct bilirubin (for patients with total bilirubin >1.5x ULN) ≤ 1.5x ULN
- Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 2.5x ULN (for patients with liver metastases ≤ 5x ULN is permissible)
- Calculated creatinine clearance (per institutional standard) ≥ 50 mL/min 6.18 years or over. 7. Written (signed and dated) informed consent and be capable of co-operating with treatment and follow-up.
- 8. Agree to the use of archival paraffin embedded tissue (if available) for PD-L1 (programmed death-ligand 1) analysis 9. Agree to provide a fresh tumour biopsy at baseline and on Cycle 2 Day 8 of a tumour lesion not previously irradiated (tumours progressing in a prior site of radiation are allowed for PD-L1 characterization, other exceptions may be considered after consultation with the Chief Investigator).
- 10. Female subjects of childbearing potential should have a negative urine or serum pregnancy test within 14 days prior to receiving the first dose of study medication. If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required.
- 11. Female subjects of childbearing potential should be willing to use 2 methods of birth control or be surgically sterile, or abstain from heterosexual activity for the course of the study through 6 months after the last dose of study medication. Subjects of childbearing potential are those who have not been surgically sterilized or have not been free from menses for >1 year. Decitabine, a metabolite of Guadecitabine/ASTX727, can affect fertility and so oocyte cryopreservation should be discussed with female patients.
- 12. Male subjects should agree to use an adequate method of contraception starting with the first dose of study therapy through 6 months after the last dose of study therapy. Decitabine, a metabolite of Guadecitabine/ASTX727, can affect fertility and so cryopreservation of sperm should be discussed with male patients.
Who cannot join
- Radiotherapy (except brief course for palliative reasons), endocrine therapy, immunotherapy or chemotherapy during the previous four weeks (six weeks for nitrosoureas, Mitomycin-C and 4 weeks for investigational medicinal products) before treatment, except for hormonal therapy with luteinizing hormone-releasing hormone (LHRH) analogues for medical castration in patients with CRPC, which are permitted.
- Patient has a known additional malignancy that is progressing or requires active treatment. Exceptions include basal cell carcinoma of the skin, squamous cell carcinoma of the skin, or in situ bladder or cervical cancer that has undergone potentially curative therapy.
- Spinal cord compression or brain metastases unless asymptomatic, treated and stable and not requiring steroids for at least 4 weeks prior to start of study treatment.
- Ongoing toxic manifestations of previous treatments. Exceptions to this are:
- Grade 1 toxicities, which in the opinion of the investigator should not exclude the patient
- Alopecia of any grade
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- Has a diagnosis of immunodeficiency or is receiving systemic steroid therapy or any other form of immunosuppressive therapy within 14 days prior to the first dose of trial treatment. The use of physiologic doses of corticosteroids may be approved after consultation with the chief Investigator.
- Has an active autoimmune disease that has required systemic treatment in past 3 months (i.e. with use of disease modifying agents, corticosteroids or immunosuppressive drugs). Replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment. Patients with Sjogren's syndrome will not be excluded from the study. In addition patients that experienced a Grade 2 or higher immune-related AE's on treatment with immunotherapy will be excluded from the study.
- Has evidence of interstitial lung disease.
- Has a history of (non-infectious) pneumonitis that required steroid treatment or has active pneumonitis. Pneumonitis includes acute interstitial pneumonitis, pneumonitis and idiopathic pneumonia syndrome.
- Active infection, requiring systemic therapy.
- Has received a live vaccine within 30 days of planned start of study therapy. Note: The killed virus vaccines used for seasonal influenza vaccines for injection are allowed; however intranasal influenza vaccines (e.g. FluMist®) are live attenuated vaccines and are not allowed.
- Major surgery (excluding minor procedures, e.g. placement of vascular access) from which the patient has not yet recovered.
- At high medical risk because of severe or uncontrolled non-malignant systemic disease including active uncontrolled infection, active bleeding diathesis.
- Known to be serologically positive for hepatitis B, hepatitis C or human immunodeficiency virus (HIV). Screening for chronic conditions is not required.
- Any of the following cardiac criteria:
- Mean resting corrected QT interval (QTc) > 470 msec obtained from 3 consecutive electrocardiograms (ECGs) within 5 minutes of each other.
- Any clinically significant abnormalities in rhythm, conduction or morphology of resting ECG, e.g. complete left bundle branch block, third degree heart block.
- Any factors that increase the risk of QTc prolongation or risk of arrhythmic events, such as heart failure, hypokalaemia, congenital long QT syndrome, family history of long QT syndrome or unexplained sudden death under 40 years of age or any concomitant medication known to prolong the QT interval
- Experience of any of the following procedures or conditions in the preceding 6 months: coronary artery bypass graft, angioplasty, vascular stent, myocardial infarction, angina pectoris, congestive heart failure New York Heart Association [NYHA Grade 2 (refer to Appendix 4)]
- Uncontrolled hypertension - Systolic BP >160mmHg and/or diastolic BP >100mmHg
- Left ventricular ejection fraction (LVEF) below institutional lower limit of normal.
- History of hypersensitivity to active or inactive excipients of guadecitabine or pembrolizumab or drugs with a similar chemical structure or class to either agent.
- Is a participant or plans to participate in another interventional clinical trial, whilst taking part in this Phase I study of guadecitabine and pembrolizumab. Participation in an observational trial would be acceptable.
- Any other condition which in the Investigator's opinion would not make the patient a good candidate for the clinical trial.
Trial locations and contacts
2 sites in 1 country.
United Kingdom2 sites
UCLH
London, W1T 7HA
Royal Marsden Hospital
Sutton, Surrey, SM2 5PT
About this study
Official title: HyPeR: A Phase 1, Dose Escalation Study of Guadecitabine /ASTX727 in Combination With Pembrolizumab (MK3475) in Patients With Refractory Solid Tumours
HyPeR is a multi-centre Phase 1 Dose Escalation Study of Guadecitabine (SGI-110)/ASTX727 a Second Generation Hypo-Methylating Agent in Combination with Pembrolizumab (MK3475) in Patients with Refractory Solid Tumours. The investigators will be investigating the safety and toxicity of the combination.
Read the detailed description
This is a multi-centre, dose escalation, Phase I trial. There are two parts to this study. Part A: dose escalation, and Part B: dose expansion.
Part A (Dose Escalation): Patients with advanced solid tumours will be recruited in cohorts of 3 to 6 patients to investigate the combination of 200 mg of pembrolizumab administered as an intravenous injection (first dose given in Cycle 2 Day 8 and then Day 1 of subsequent Cycles) with escalating doses of guadecitabine administered via a subcutaneous injection once a day for 4 days (Days 1-4) of a 21-day cycle.
Once the MTD is reached (or under the advice from the SRC) patients will be enrolled to the dose expansion phase (Part B).
Part B1 (Dose Expansion): 20 patients will be recruited to Part B1 (expansion phase) to further explore the safety and activity of the combination of guadecitabine and pembrolizumab. This cohort will include, but not be limited to, patients with: secondary resistance to PD-1/PD-L1 inhibitors, patients with primary resistance to PD-1/PD-L1 inhibitors in subgroups predicted to benefit such as those with microsatellite-instability high (MSI-H) tumours and/or those with deficient mismatch repair (dMMR) and, possibly other solid tumours based on emerging anti-tumour activity data from Part A and any other relevant preclinical or clinical published data.
Part B2 (NSCLC Dose Expansion): Up to 25 evaluable patients will be recruited to Part B2 (expansion phase) to further explore the safety and activity of the combination of ASTX727 and pembrolizumab. This cohort will include patients with NSCLC with primary or secondary resistance to PD-1/PD-L1 inhibitors. Utilising a Simon's minimax two-stage design, Part B2 will have 80% power with a one-sided significance level of 5% to discount a response rate of 10% in favour of a response rate of 30%. Fifteen patients will be enrolled to stage one, and if two or more patients experience a response (PR or CR by RECIST v1.1), then a further 10 patients will be enrolled to stage two, totaling 25 patients overall.
- Conditions
- Non Small Cell Lung Cancer
- Being tested
- Guadecitabine, Pembrolizumab, ASTX727
- Keywords
- immunotherapy, non small cell lung cancer
- 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.
GuadecitabineDrug
In arm 1 (escalation) and 2 (expansion).
PembrolizumabDrug
In arm 1 (escalation) and 2 (expansion).
ASTX727Drug
In arm B2 (lung expansion) replacing guadecitabine
| Study group | Role | What they receive |
|---|---|---|
| Escalation | Experimental | Fixed dose of Pembrolizumab with escalating dose of Guadecitabine to establish the phase 2 recommended dose. Receives: Drug: Guadecitabine; Drug: Pembrolizumab |
| Expansion | Experimental | Continuation of the Guadecitabine and Pembrolizumab dose established in arm 1: expansion in the recommended patient population. Receives: Drug: Guadecitabine; Drug: Pembrolizumab |
| B2: Lung Expansion | Experimental | To further explore the safety and activity of the combination of ASTX727 (replacement of guadecitabine to an oral dose tablet) with pembrolizumab in patients with NSCLC with primary or secondary resistance to PD-1/PD-L1 inhibitors. Receives: Drug: Pembrolizumab; Drug: ASTX727 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Establish maximum tolerated dose (MTD)
To establish a maximum tolerated dose (MTD) and recommended phase II dose (RP2D) of the combination of guadecitabine and pembrolizumab in patients with advanced solid tumours.
To determine the maximum dose at which no more than 1 of 6 patients at the same dose level experience a drug related toxicity (DLT), as defined in section 3.1.4 of the protocol.
Measured: 12 months
Measure Adverse Events according to CTCAE v4.0
To assess the safety and toxicity profile of the combination of guadecitabine and pembrolizumab.
To determine causality and grading severity of each adverse event by National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
Measured: 24 months
Secondary outcomes (7)
Pharmacodynamic profile of guadecitabine in combination with pembrolizumab.
Transcriptome analysis in whole bloods using the PAXgene assay.
Measured: 24 months
Pharmacodynamic profile of guadecitabine in combination with pembrolizumab.
Targeted sequencing in plasma circulating free DNA.
Measured: 24 months
Pharmacodynamic profile of guadecitabine in combination with pembrolizumab.
White blood cell analysis by flow cytometry.
Measured: 24 months
Pharmacodynamic profile of guadecitabine in combination with pembrolizumab.
DNA methylation analysis in blood peripheral blood mononuclear cells (PBMC).
Measured: 24 months
Pharmacodynamic studies in guadecitabine in combination with pembrolizumab.
Immunohistochemistry of immune cell in serial biopsies.
Measured: 24 months
Pharmacodynamic studies in guadecitabine in combination with pembrolizumab.
DNA methylation analysis in serial biopsies.
Measured: 24 months
Pharmacodynamic studies in guadecitabine in combination with pembrolizumab.
Transcriptome analysis in serial biopsies.
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Dec 2016 (estimated)
- Study start26 Jan 2017
- Primary completionSep 2026 (estimated)
- Study completionSep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Non Small Cell Lung CancerStudies of the same condition, open and under way.
- More trials run by Royal Marsden NHS Foundation TrustThe 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
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Royal Marsden NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Collaborators
- Astex Pharmaceuticals, Inc., Merck Sharp & Dohme LLC, Institute of Cancer Research, United Kingdom
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02998567
- Sponsor's protocol ID
- CCR4420
- Acronym
- HyPeR
- Status last verified
- Aug 2025
- First submitted
- 2 Nov 2016
- Last updated
- 12 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Papadatos-Pastos D, Yuan W, Pal A, Crespo M, Ferreira A, Gurel B, Prout T, Ameratunga M, Chenard-Poirier M, Curcean A, Bertan C, Baker C, Miranda S, Masrour N, Chen W, Pereira R, Figueiredo I, Morilla R, Jenkins B, Zachariou A, Riisnaes R, Parmar M, Turner A, Carreira S, Yap C, Brown R, Tunariu N, Banerji U, Lopez J, de Bono J, Minchom A. Phase 1, dose-escalation study of guadecitabine (SGI-110) in combination with pembrolizumab in patients with solid tumors. J Immunother Cancer. 2022 Jun;10(6):e004495. doi: 10.1136/jitc-2022-004495.
PubMed 35717027
Study at a glance
From the registry record, last updated by the sponsor on 12 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- HyPeR: A Phase 1, Dose Escalation Study of Guadecitabine /ASTX727 in Combination With Pembrolizumab (MK3475) in Patients With Refractory Solid Tumours
- ClinicalTrials.gov ID
- NCT02998567
- Acronym / sponsor ID
- HyPeR / CCR4420
- Conditions
- Non Small Cell Lung Cancer
- Keywords
- immunotherapy, non small cell lung cancer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Royal Marsden NHS Foundation TrustUniversity, hospital or other
- Collaborators
- Astex Pharmaceuticals, Inc., Merck Sharp & Dohme LLC, Institute of Cancer Research, United Kingdom
- Study start
- 26 Jan 2017 (actual)
- Primary completion
- Sep 2026 (estimated)
- Study completion
- Sep 2026 (estimated)
- First posted
- 20 Dec 2016 (estimated)
- 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.
HyPeR is a multi-centre Phase 1 Dose Escalation Study of Guadecitabine (SGI-110)/ASTX727 a Second Generation Hypo-Methylating Agent in Combination with Pembrolizumab (MK3475) in Patients with Refractory Solid Tumours. The investigators will be investigating the safety and toxicity of the combination.
Detailed description
This is a multi-centre, dose escalation, Phase I trial. There are two parts to this study. Part A: dose escalation, and Part B: dose expansion.
Part A (Dose Escalation): Patients with advanced solid tumours will be recruited in cohorts of 3 to 6 patients to investigate the combination of 200 mg of pembrolizumab administered as an intravenous injection (first dose given in Cycle 2 Day 8 and then Day 1 of subsequent Cycles) with escalating doses of guadecitabine administered via a subcutaneous injection once a day for 4 days (Days 1-4) of a 21-day cycle.
Once the MTD is reached (or under the advice from the SRC) patients will be enrolled to the dose expansion phase (Part B).
Part B1 (Dose Expansion): 20 patients will be recruited to Part B1 (expansion phase) to further explore the safety and activity of the combination of guadecitabine and pembrolizumab. This cohort will include, but not be limited to, patients with: secondary resistance to PD-1/PD-L1 inhibitors, patients with primary resistance to PD-1/PD-L1 inhibitors in subgroups predicted to benefit such as those with microsatellite-instability high (MSI-H) tumours and/or those with deficient mismatch repair (dMMR) and, possibly other solid tumours based on emerging anti-tumour activity data from Part A and any other relevant preclinical or clinical published data.
Part B2 (NSCLC Dose Expansion): Up to 25 evaluable patients will be recruited to Part B2 (expansion phase) to further explore the safety and activity of the combination of ASTX727 and pembrolizumab. This cohort will include patients with NSCLC with primary or secondary resistance to PD-1/PD-L1 inhibitors. Utilising a Simon's minimax two-stage design, Part B2 will have 80% power with a one-sided significance level of 5% to discount a response rate of 10% in favour of a response rate of 30%. Fifteen patients will be enrolled to stage one, and if two or more patients experience a response (PR or CR by RECIST v1.1), then a further 10 patients will be enrolled to stage two, totaling 25 patients overall.
Study design
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Escalation | Experimental | Drug: Guadecitabine, Drug: PembrolizumabFixed dose of Pembrolizumab with escalating dose of Guadecitabine to establish the phase 2 recommended dose. |
| Expansion | Experimental | Drug: Guadecitabine, Drug: PembrolizumabContinuation of the Guadecitabine and Pembrolizumab dose established in arm 1: expansion in the recommended patient population. |
| B2: Lung Expansion | Experimental | Drug: Pembrolizumab, Drug: ASTX727To further explore the safety and activity of the combination of ASTX727 (replacement of guadecitabine to an oral dose tablet) with pembrolizumab in patients with NSCLC with primary or secondary resistance to PD-1/PD-L1 inhibitors. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (28 listed)
- Part A and B1/2:
- Histologically or cytologically confirmed advanced solid tumours, refractory to conventional treatment, or for which no conventional therapy exists or is declined by the patient.
- Histologically or cytologically confirmed advanced solid tumours, refractory to conventional treatment, or for which no conventional therapy exists or is declined by the patient AND:
- Patients with histologically or cytologically confirmed NSCLC previously treated with PD-1 or PD-L1 inhibitor for advanced or metastatic disease.
- Life expectancy of at least 12 weeks.
Key exclusion criteria (25 listed)
- Radiotherapy (except brief course for palliative reasons), endocrine therapy, immunotherapy or chemotherapy during the previous four weeks (six weeks for nitrosoureas, Mitomycin-C and 4 weeks for investigational medicinal products) before treatment, except for hormonal therapy with luteinizing hormone-releasing hormone (LHRH) analogues for medical castration in patients with CRPC, which are permitted.
- Patient has a known additional malignancy that is progressing or requires active treatment. Exceptions include basal cell carcinoma of the skin, squamous cell carcinoma of the skin, or in situ bladder or cervical cancer that has undergone potentially curative therapy.
- Spinal cord compression or brain metastases unless asymptomatic, treated and stable and not requiring steroids for at least 4 weeks prior to start of study treatment.
- Ongoing toxic manifestations of previous treatments. Exceptions to this are:
- Has a diagnosis of immunodeficiency or is receiving systemic steroid therapy or any other form of immunosuppressive therapy within 14 days prior to the first dose of trial treatment. The use of physiologic doses of corticosteroids may be approved after consultation with the chief Investigator.
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 |
|---|---|---|
| GuadecitabineIn arm 1 (escalation) and 2 (expansion). | Drug | Escalation, Expansion |
| PembrolizumabIn arm 1 (escalation) and 2 (expansion). | Drug | B2: Lung Expansion, Escalation, Expansion |
| ASTX727In arm B2 (lung expansion) replacing guadecitabine | Drug | B2: Lung Expansion |
Primary outcome
Establish maximum tolerated dose (MTD)
Time frame: 12 months
To establish a maximum tolerated dose (MTD) and recommended phase II dose (RP2D) of the combination of guadecitabine and pembrolizumab in patients with advanced solid tumours. To determine the maximum dose at which no more than 1 of 6 patients at the same dose level experience a drug related toxicity (DLT), as defined in section 3.1.4 of the protocol.
Measure Adverse Events according to CTCAE v4.0
Time frame: 24 months
To assess the safety and toxicity profile of the combination of guadecitabine and pembrolizumab. To determine causality and grading severity of each adverse event by National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
7 secondary outcomes
Pharmacodynamic profile of guadecitabine in combination with pembrolizumab.
Time frame: 24 months
Pharmacodynamic profile of guadecitabine in combination with pembrolizumab.
Time frame: 24 months
Pharmacodynamic profile of guadecitabine in combination with pembrolizumab.
Time frame: 24 months
Pharmacodynamic profile of guadecitabine in combination with pembrolizumab.
Time frame: 24 months
Pharmacodynamic studies in guadecitabine in combination with pembrolizumab.
Time frame: 24 months
Pharmacodynamic studies in guadecitabine in combination with pembrolizumab.
Time frame: 24 months
Pharmacodynamic studies in guadecitabine in combination with pembrolizumab.
Time frame: 24 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 May 2026.
- Results publication: PubMed 35717027Papadatos-Pastos D, Yuan W, Pal A, Crespo M, Ferreira A, Gurel B, Prout T, Ameratunga M, Chenard-Poirier M, Curcean A, Bertan C, Baker C, Miranda S, Masrour N, Chen W, Pereira R, Figueiredo I, Morilla R, Jenkins B, Zachariou A, Riisnaes R, Parmar M, Turner A, Carreira S, Yap C, Brown R, Tunariu N, Banerji U, Lopez J, de Bono J, Minchom A. Phase 1, dose-escalation study of guadecitabine (SGI-110) in combination with pembrolizumab in patients with solid tumors. J Immunother Cancer. 2022 Jun;10(6):e004495. doi: 10.1136/jitc-2022-004495.
- Related InfoLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Guadecitabine, Pembrolizumab and ASTX727 in people with Non Small Cell Lung Cancer, run by Royal Marsden NHS Foundation Trust at 2 sites in United Kingdom.
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 28 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: under way, not looking for participants, as of the sponsor's last update on 12 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United Kingdom. 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?
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?
Establish maximum tolerated dose (MTD) (time frame: 12 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 NCT02998567, which also lists 1 linked publication.
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 12 May 2026.