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Advanced Solid TumorsPhase 1NCT03435250

Study of AG-270 in Participants With Advanced Solid Tumors or Lymphoma With MTAP Loss

A Phase 1 study testing AG-270, docetaxel and nab-paclitaxel in people with Advanced Solid Tumors and Lymphoma, run by Institut de Recherches Internationales Servier at 8 sites in 3 countries.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
Search all trials

Trial summary

This study will evaluate the safety, pharmacokinetics, pharmacodynamics, and clinical activity of AG-270 in participants with advanced solid tumors or lymphoma with homozygous MTAP deletion. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Advanced Solid Tumors, Lymphoma
What is being tested?
AG-270, docetaxel and nab-paclitaxel
Could I receive a placebo?
No, everyone receives an active treatment
How many people
123 participants
Where
8 sitesin 3 countries
Study dates
4 Mar 2018to 20 Apr 2023
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • AG-270 Monotherapy
  • Be ≥18 years of age;
  • Have a histologically confirmed diagnosis of an advanced solid tumor or lymphoma that has progressed in spite of at least one prior line of treatment, and for which additional effective standard therapy is not available. For this study, effective standard therapy is defined as treatment that has been shown to be curative and/or to prolong survival. In addition, participants who are considered to not be candidates for standard therapy or who decline standard therapy are eligible for this study; in such cases, documentation of the reason for omitting or declining a standard therapy is required;
  • Have evidence of homozygous loss of cyclin-dependent kinase inhibitor 2A (CDKN2A) and/or MTAP in the participant's tumor tissue;
  • Have disease that can be clinically evaluated for improvement or progression. In the dose-expansion phase of the study arm, participants must have disease that is measurable, as defined by the Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 criteria for solid tumors (Eisenhauer et al, 2009) or the Lugano criteria for lymphoma (Cheson et al, 2014);
  • Have an Eastern Cooperative Oncology Group (ECOG) performance status (PS) of ≤2;
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  • Have a hemoglobin ≥9.0 grams per deciliter (g/dL) without red blood cell transfusion for ≥1 month;
  • Have an absolute neutrophil count (ANC) ≥1.0 × 10^9/liter (L);
  • Have a platelet count ≥75 × 10^9/L;
  • Have a serum total bilirubin ≤1.5 × upper limit of normal (ULN);
  • Have an alanine aminotransferase (ALT) ≤3.0 × ULN. (Note: There are no specific requirements for aspartate aminotransferase (AST) or Alkaline phosphatase [ALP]);
  • Have a serum creatinine ≤1.5 × ULN;
  • Be fully recovered from major surgery and from the acute toxic effects of prior chemotherapy and radiotherapy. Residual chronic toxicities of prior therapy ≤Grade 2 (eg, peripheral neuropathy, residual alopecia) are allowed;
  • Female participants who are pre-menopausal or have experienced menopause for less than 2 years and who have not undergone a hysterectomy, bilateral oophorectomy, or tubal occlusion must have a negative serum pregnancy test during screening and a serum or urine pregnancy test must be re-confirmed as negative no more than 72 hours before starting AG-270. Females of reproductive potential as well as fertile men with partners who are female of reproductive potential must agree to abstain from sexual intercourse or to use 2 effective forms of contraception (including at least 1 barrier form) from the time of giving informed consent, during the study, and for 6 months (for females) and for 3 months (for males) following the last dose of AG-270. Effective forms of contraception are defined as hormonal oral contraceptives, injectables, patches, intrauterine devices, double-barrier methods (eg, synthetic condoms, diaphragm, or cervical cap with spermicidal foam, cream, or gel), or male partner sterilization;
  • Able to understand and has provided written informed consent. A legally authorized representative may consent on behalf of a participant who is otherwise unable to provide informed consent, if acceptable to and approved by the site and/or site's Institutional Review Board (IRB)/Independent Ethics Committee (IEC).
  • AG-270 in Combination with Docetaxel
  • a. Be ≥18 years of age;
  • a. Have histologically confirmed diagnosis of non-small cell lung cancer (NSCLC) that has been treated with no more than 2 prior lines of cytotoxic chemotherapy in the setting of metastatic (Stage 4) disease. Three prior lines of cytotoxic chemotherapy for metastatic disease are allowed if one of the 3 lines was a maintenance treatment. Participants with solid tumors other than NSCLC for which docetaxel is indicated are eligible for the dose-escalation arm, but they also must have received no more than 2 prior lines of cytotoxic chemotherapy in the setting of metastatic disease; For both participants with NSCLC and participants with other malignancies prior treatment with taxanes is permitted, but prior treatment with docetaxel is not allowed. There is no limitation on the number of non-cytotoxic therapies that a participant with NSCLC or with another malignancy may have received;
  • a. Have evidence of homozygous loss of CDKN2A and/or MTAP in the participant's tumor tissue. In the dose expansion phase of the combination, participants must have homozygous MTAP deletion;
  • a. Have disease that can be clinically evaluated for improvement or progression. In the dose-expansion phase of this study arm, participants must have disease that is measurable, as defined by the RECIST Version 1.1 criteria for solid tumors (Eisenhauer et al, 2009);
  • a. Have an ECOG PS of ≤1;
  • a. Have a hemoglobin ≥9.0 g/dL without red blood cell transfusion for ≥1 month;
  • a. Have an ANC ≥1.5 × 10^9/L;
  • a. Have a platelet count ≥100 × 10^9/L;
  • a. Have a serum total bilirubin ≤1.5 × ULN;
  • a. Have an ALT ≤3.0 × ULN. If ALP is >2.5 × ULN and the increase in ALP cannot be attributed to bone metastases or other bone disease then the participant must have ALT and AST values that are both <1.0 × ULN; this requirement conforms with the current label for Taxotere®;
  • a. Have a serum creatinine ≤1.5 × ULN;
  • a. Meet any criteria necessary for the safe and proper use of docetaxel;
  • a. Be fully recovered from major surgery and from the acute toxic effects of prior chemotherapy and radiotherapy. Residual chronic toxicities of prior therapy ≤ Grade 2 (eg, peripheral neuropathy, residual alopecia) are allowed;
  • a. Female participants who are pre-menopausal or have experienced menopause for less than 2 years and who have not undergone a hysterectomy, bilateral oophorectomy, or tubal occlusion must have a negative serum pregnancy test during Screening and a serum or urine pregnancy test must be re-confirmed as negative no more than 72 hours before starting AG-270. Females of reproductive potential as well as fertile men with partners who are female of reproductive potential must agree to abstain from sexual intercourse or to use 2 effective forms of contraception (including at least 1 barrier form) from the time of giving informed consent, during the study, and for 6 months (for females) and for 3 months (for males) following the last dose of AG-270. Effective forms of contraception are defined as hormonal oral contraceptives, injectables, patches, intrauterine devices, double-barrier methods (eg, synthetic condoms, diaphragm, or cervical cap with spermicidal foam, cream, or gel), or male partner sterilization;
  • a. Able to understand and has provided written informed consent. A legally authorized representative may consent on behalf of a participant who is otherwise unable to provide informed consent, if acceptable to and approved by the site and/or site's IRB/IEC.
  • AG-270 in Combination with nab-Paclitaxel and Gemcitabine
  • b. Be ≥18 years of age;
  • b. Have locally advanced or metastatic pancreatic ductal adenocarcinoma characterized by CDKN2A deletion and/or MTAP deletion;
  • b. Have evidence of homozygous loss of CDKN2A and/or MTAP in the participant's tumor tissue. In the dose expansion phase of the combination, participants must have homozygous MTAP deletion;
  • b. Have received no more than 1 previous line of cytotoxic chemotherapy for advanced or metastatic disease. Participants may have been treated with cytotoxic chemotherapy in the adjuvant setting if the final dose of such adjuvant treatment was given at least 6 months before administration of the first doses of AG-270, nab-paclitaxel, and gemcitabine; treatment with cytotoxic chemotherapy in the adjuvant setting will not be counted in the lines of previous cytotoxic chemotherapy for advanced or metastatic disease. There is no limitation on the number of non-cytotoxic therapies that a participant may have received;
  • b. Have an ECOG PS of ≤1;
  • b. Have a hemoglobin ≥9.0 g/dL without red blood cell transfusion for ≥1 month;
  • b. Have an ANC ≥1.5 × 10^9/L;
  • b. Have a platelet count ≥100 × 10^9/L;
  • b. Have a serum total bilirubin ≤1.5 × ULN;
  • b. Have an ALT ≤3.0 × ULN. (Note: There are no specific requirements for AST or ALP.);
  • b. Have a serum creatinine ≤1.5 × ULN;
  • b. Meet any criteria necessary for the safe and proper use of nab-paclitaxel and gemcitabine;
  • b. Be fully recovered from major surgery and from the acute toxic effects of prior chemotherapy and radiotherapy. Residual chronic toxicities of prior therapy ≤ Grade 2 (eg, peripheral neuropathy, residual alopecia) are allowed;
  • b. Female participants who are pre-menopausal or have experienced menopause for less than 2 years and who have not undergone a hysterectomy, bilateral oophorectomy, or tubal occlusion must have a negative serum pregnancy test during Screening and a serum or urine pregnancy test must be re-confirmed as negative no more than 72 hours before starting AG-270. Females of reproductive potential as well as fertile men with partners who are female of reproductive potential must agree to abstain from sexual intercourse or to use 2 effective forms of contraception (including at least 1 barrier form) from the time of giving informed consent, during the study, and for 6 months (for females) and for 3 months (for males) following the last dose of AG-270. Effective forms of contraception are defined as hormonal oral contraceptives, injectables, patches, intrauterine devices, double-barrier methods (eg, synthetic condoms, diaphragm, or cervical cap with spermicidal foam, cream, or gel), or male partner sterilization;
  • b. Able to understand and has provided written informed consent. A legally authorized representative may consent on behalf of a participant who is otherwise unable to provide informed consent, if acceptable to and approved by the site and/or site's IRB/IEC.

Who cannot join

  • Have a primary central nervous system (CNS) malignancy (eg, glioblastoma multiforme [GBM]);
  • Have metastasis to the CNS that is symptomatic and/or requires therapy with corticosteroids or anti-convulsant medication. However, participants who have completed treatment (radiation therapy) for CNS metastases and do not require continued treatment with corticosteroids or anti-convulsants may be enrolled in this study;
  • Have a history of Gilbert's syndrome;
  • Have a degenerative retinal disease. Retinal diseases that require a participant's exclusion include: glaucoma (with the exception of narrow angle glaucoma), hereditary retinal diseases such as retinitis pigmentosa; retinal arterial occlusive disease; and retinal disease with advanced scarring, to include age-related macular degeneration and myopic degeneration with geographic atrophy;
  • Have impairment of gastrointestinal (GI) function or GI disease that may significantly alter the absorption of AG-270, including any unresolved nausea, vomiting, or diarrhea that is National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) grade >1;
  • Have had significant active cardiac disease within 6 months prior to the start of study treatment, including any of the following:
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  • New York Heart Association (NYHA) class III or IV congestive heart failure;
  • Acute myocardial infarction or angina pectoris;
  • Stroke;
  • Uncontrolled cardiac arrhythmia (participants with rate-controlled atrial fibrillation are not excluded).
  • Have a heart-rate corrected QT interval using Fridericia's method (QTcF) >470 milliseconds (msec);
  • Have any other concurrent severe and/or uncontrolled concomitant medical condition that could compromise participation in the study (eg, clinically significant pulmonary disease, clinically significant neurological disorder, active or uncontrolled infection);
  • Have received systemic anti-cancer treatment or radiotherapy less than 2 weeks before the first dose of AG-270. Participants with castration-resistant prostate cancer may continue therapy with a luteinizing hormone releasing hormone (LHRH) agonist while participating in this study. Continuation of supportive therapy with bisphosphonates or denosumab is also allowed, regardless of the underlying malignancy;
  • Have received radioimmunotherapy (eg, 131I-tositumomab, 90Y-ibritumomab tiuxetan) less than 6 weeks before the first dose of AG-270;
  • Have received treatment with a therapeutic antibody less than 4 weeks before the first dose of AG-270. A minimum 2-week period between the last treatment with a therapeutic antibody and the first dose of AG-270 may be permitted in participants with rapidly progressive or aggressive subtypes of lymphoma following discussion with the medical monitor;
  • Have received treatment with an investigational small molecule less than 2 weeks before the first dose of AG-270. In addition, the first dose of AG-270 should not occur before a period greater than or equal to 5 half-lives of the investigational small molecule has elapsed;
  • Require continued treatment with a medication that is known to be a strong inhibitor of cytochrome P450 (CYP)3A enzymes. (Treatment with moderate or weak CYP enzyme inhibitors is allowed.);
  • Require continued treatment with a medication that is known to be a strong inducer of CYP3A;
  • Require continued treatment with a medication that is known to be a strong inhibitor of CYP2C8;
  • Require continued treatment with a medication that is a sensitive CYP2C9 substrate with a narrow therapeutic index;
  • Require continued treatment with medications that are known to carry a risk of torsades de pointes;
  • Are pregnant or breastfeeding;
  • Have any other medical or psychological condition deemed by the Investigator to likely interfere with the participant's ability to give informed consent or participate in the study;
  • Are unable to take no food or liquids other than water for 2 hours before and 2 hours after each dose of AG-270.

Trial locations and contacts

8 sites in 3 countries.

8 sites in 3 countries

United States6 sites

  • Massachusetts General Hospital

    Boston, Massachusetts, 02114

  • Beth Israel

    Boston, Massachusetts, 02215

  • Dana Farber Cancer Institute

    Boston, Massachusetts, 02215

  • Sarah Cannon Cancer Center

    Nashville, Tennessee, 37203

  • Yale University

    New Haven, Connecticut, 06519

  • Memorial Sloan Kettering Cance Center

    New York, New York, 10065

Other trials in United States

France1 site

  • Institut Gustave Roussy

    Villejuif, 94805

Other trials in France

Spain1 site

  • Hospital Universitario Vall d'Hebron

    Barcelona, 08035

Other trials in Spain

About this study

Official title: A Phase 1 Study of AG-270 in the Treatment of Subjects With Advanced Solid Tumors or Lymphoma With Homozygous Deletion of MTAP

This study will evaluate the safety, pharmacokinetics, pharmacodynamics, and clinical activity of AG-270 in participants with advanced solid tumors or lymphoma with homozygous MTAP deletion.

Read the detailed description

The purpose of this Phase 1, multicenter, open-label study is to determine the maximum tolerated dose (MTD) of AG-270, administered as a single agent or in combination with taxane-based chemotherapy, and to characterize its dose-limiting toxicities (DLTs) when given daily by mouth to participants with advanced solid tumors or lymphoma with homozygous deletion of methylthioadenosine phosphorylase (MTAP).

In each arm of the study, successive cohorts of participants will receive increasing oral doses of AG-270 to determine the MTD, the dose with maximum pharmacologic activity or the maximum feasible dose, as a single agent and in combination with taxane-based chemotherapy. In the subsequent dose-expansion parts of the study, additional participants in each treatment arm will be treated at the MTD (or one of the described alternative doses) to further characterize that dose's safety, tolerability, pharmacokinetics (PK) and pharmacodynamics (PD), and to detect preliminary evidence of anti-tumor activity.

Being tested
AG-270, docetaxel, nab-paclitaxel, gemcitabine
Keywords
MTAP, MTAP deletion, CDKN2A deletion, MAT2A inhibitor, Advanced solid tumors, Lymphoma
Medical subject headings
Lymphoma

What participants receive

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

  • AG-270Drug

    Also called MAT2A inhibitor

    AG-270, orally, once or twice daily, on Days 1 through 28 of each 28-day cycle, until disease progression or unacceptable toxicity.

  • AG-270Drug

    Also called MAT2A inhibitor

    AG-270, orally, once or twice daily, for 1 week prior to the first dose of docetaxel. Thereafter, AG-270 continues to be given daily, on Days 1 through 21 of each 21-day cycle, until disease progression or unacceptable toxicity.

  • AG-270Drug

    Also called MAT2A inhibitor

    AG-270, orally, once or twice daily for 1 week prior to the first doses of nab-paclitaxel and gemcitabine. Thereafter, AG-270 continues to be given daily on Days 1 through 28 of each 28-day cycle, until disease progression or unacceptable toxicity.

  • docetaxelDrug

    Also called Taxotere®

    Docetaxel, IV, once during each 21-day cycle, until disease progression or unacceptable toxicity.

  • nab-paclitaxelDrug

    Also called Abraxane®

    Nab-paclitaxel, IV, on Days 1, 8, and 15 of each 28-day cycle, until disease progression or unacceptable toxicity.

  • gemcitabineDrug

    Also called Gemzar®

    Gemcitabine, IV, on Days 1, 8, and 15 of each 28-day cycle, until disease progression or unacceptable toxicity.

Study groups in NCT03435250
Study groupRoleWhat they receive
AG-270ExperimentalAG-270 will be administered on Days 1 to 28 of each 28-day cycle. Treatment will continue until disease progression or unacceptable toxicity.
Receives: Drug: AG-270
AG-270/docetaxelExperimentalAG-270 will be administered daily, starting 1 week prior to docetaxel infusion. Starting on Cycle 1 Day 1, docetaxel (by intravenous infusion [IV]) will be administered once during each 21-day cycle. Treatment with AG-270 and docetaxel will continue until disease progression or unacceptable toxicity.
Receives: Drug: AG-270; Drug: docetaxel
AG-270/nab-paclitaxel/gemcitabineExperimentalAG-270 will be administered daily, starting 1 week prior to nab-paclitaxel and gemcitabine infusion. Starting on Cycle 1 Day 1, nab-paclitaxel and gemcitabine IV will be administered on Days 1,8, and 15 during each 28-day cycle. Treatment with AG-270, nab-paclitaxel, and gemcitabine will continue until disease progression or unacceptable toxicity.
Receives: Drug: AG-270; Drug: nab-paclitaxel; Drug: gemcitabine

What is being measured

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

  1. Percentage of Participants with DLTs Associated with AG-270 Administration During the First Cycle (First 28 Days) of Treatment

    Measured: Up to 28 days, on average

  2. Percentage of Participants with DLTs Associated with the Combination of AG-270 and Docetaxel Administration During the First Cycle (First 28 Days) of Treatment

    Measured: Up to 28 days, on average

  3. Percentage of Participants with DLTs Associated with the Combination of AG-270, nab-paclitaxel, and Gemcitabine Administration During the First Cycle (First 28 Days) of Treatment

    Measured: Up to 28 days, on average

Secondary outcomes (17)

  1. Percentage of Participants with Treatment-related Adverse Events and Serious Adverse Events

    Measured: Up to 30 weeks, on average

  2. Changes in Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) Score

    Measured: Up to 30 weeks, on average

  3. Area under the Concentration-versus-time Curve (AUC) from 0 to Time of Last Measurable Concentration (AUC0-t) of AG-270

    Measured: At multiple time points up to 30 weeks, on average

  4. AUC from 0 to Infinity (AUC0-∞) of AG-270

    Measured: At multiple time points up to 30 weeks, on average

  5. AUC over One Dosing Interval at Steady State (AUCtau,ss) of AG-270

    Measured: At multiple time points up to 30 weeks, on average

  6. Time to Maximum Concentration (Tmax) of AG-270

    Measured: At multiple time points up to 30 weeks, on average

  7. Maximum Concentration (Cmax) of AG-270

    Measured: At multiple time points up to 30 weeks, on average

  8. Trough Concentration (Ctrough) of AG-270

    Measured: At multiple time points up to 30 weeks, on average

  9. Half-life (t1/2) of AG-270

    Measured: At multiple time points up to 30 weeks, on average

  10. Apparent Volume of Distribution (Vd/F) of AG-270

    Measured: At multiple time points up to 30 weeks, on average

  11. Apparent Clearance (CL/F) of AG-270

    Measured: At multiple time points up to 30 weeks, on average

  12. Change from Baseline in Circulating Concentration of S-adenosylmethionine (SAM)

    Measured: Up to 30 weeks, on average

  13. Change from Baseline in Circulating Concentration of Methionine

    Measured: Up to 30 weeks, on average

  14. Clinical Activity of AG-270 in Solid Tumors as Assessed by RECIST V1.1

    Measured: Up to 30 weeks, on average

  15. Clinical Activity of AG-270 in Lymphoma as Assessed by Lugano Criteria

    Measured: Up to 30 weeks, on average

  16. Duration of Response (DOR)

    Measured: Up to 30 weeks, on average

  17. Progression-free Survival (PFS)

    Measured: Up to 30 weeks, on average

Timeline

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

  1. First posted19 Feb 2018
  2. Study start4 Mar 2018
  3. Primary completion20 Apr 2023
  4. Study completion20 Apr 2023

Why it stopped: Strategic reasons

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
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
123 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03435250
Sponsor's protocol ID
AG270-C-001
Status last verified
Jul 2024
First submitted
1 Feb 2018
Last updated
25 Jul 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: Qualified scientific and medical researchers can request access to anonymized patient-level and study-level clinical trial data. Access can be requested for all interventional clinical studies: * used for Marketing Authorization (MA) of medicines and new indications approved after 1 January 2014 in the European Economic Area (EEA) or the United States (US). * where Servier is the Marketing Authorization Holder (MAH). The date of the first MA of the new medicine (or the new indication) in one of the EEA Member States will be considered for this scope. In addition, access can be requested for all interventional clinical studies in patients: * sponsored by Servier * with a first patient enrolled as of 1 January 2004 onwards * for New Chemical Entity or New Biological Entity (new pharmaceutical form excluded) for which development has been terminated before any Marketing authorization (MA) approval.

Publications

  • Heist RS, Gounder MM, Postel-Vinay S, Wilson F, Garralda E, Do K, Shapiro GI, Martin-Romano P, Wulf G, Cooper M, Almon C, Nabhan S, Iyer V, Zhang Y, Marks K, Aguado-Fraile E, Basile F, Flaherty K, Burris HA. A phase 1 trial of AG-270 in patients with advanced solid tumors or lymphoma with homozygous MTAP deletion [abstract]. Mol Cancer Ther 2019;18(12 Suppl):Abstract nr PR03. doi:10.1158/1535-7163.TARG-19-PR03

  • Gounder M, Johnson M, Heist RS, Shapiro GI, Postel-Vinay S, Wilson FH, Garralda E, Wulf G, Almon C, Nabhan S, Aguado-Fraile E, He P, Romagnoli M, Hossain M, Narayanaswamy R, Sadou-Dubourgnoux A, Cooper M, Askoxylakis V, Burris HA, Tabernero J. MAT2A inhibitor AG-270/S095033 in patients with advanced malignancies: a phase I trial. Nat Commun. 2025 Jan 6;16(1):423. doi: 10.1038/s41467-024-55316-5.

    PubMed 39762248

  • Konteatis Z, Travins J, Gross S, Marjon K, Barnett A, Mandley E, Nicolay B, Nagaraja R, Chen Y, Sun Y, Liu Z, Yu J, Ye Z, Jiang F, Wei W, Fang C, Gao Y, Kalev P, Hyer ML, DeLaBarre B, Jin L, Padyana AK, Dang L, Murtie J, Biller SA, Sui Z, Marks KM. Discovery of AG-270, a First-in-Class Oral MAT2A Inhibitor for the Treatment of Tumors with Homozygous MTAP Deletion. J Med Chem. 2021 Apr 22;64(8):4430-4449. doi: 10.1021/acs.jmedchem.0c01895. Epub 2021 Apr 8.

    PubMed 33829783

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing AG-270, docetaxel and nab-paclitaxel in people with Advanced Solid Tumors and Lymphoma, run by Institut de Recherches Internationales Servier at 8 sites in 3 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 47 inclusion and 24 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: stopped early, as of the sponsor's last update on 25 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 8 sites in United States, France, Spain. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was stopped early (reason given: Strategic reasons). 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?

Percentage of Participants with DLTs Associated with AG-270 Administration During the First Cycle (First 28 Days) of Treatment (time frame: Up to 28 days, on average). 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 NCT03435250, which also lists 3 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 25 Jul 2024.

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