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Gastric CancerPhase 2NCT05411679

EP0057 in Combination With Olaparib in Relapsed Advanced Gastric Cancer and Small Cell Lung Cancer

A Phase 2 study testing EP0057 and Olaparib tablets in people with Gastric Cancer and Small-cell Lung Cancer, run by Ellipses Pharma at 21 sites in 3 countries.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
Search all trials

Trial summary

The aim of EP0057 - 202 is to assess the safety and efficacy of EP0057 in combination with Olaparib (a PARP inhibitor) in two cancers where there is a high unmet need: extensive stage small cell lung cancer (SCLC) and ATM-negative gastric cancer (GC). Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Gastric Cancer, Small-cell Lung Cancer
What is being tested?
EP0057 and Olaparib tablets
Could I receive a placebo?
No, everyone receives an active treatment
How many people
0 participants
Where
21 sitesin 3 countries
Study dates
Apr 2023to Dec 2024
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

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

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

Who may be able to join

  • Applicable to both arms:
  • Patients aged≥ 18 years (or legal age of majority in the jurisdiction) of age at the time of informed consent
  • Ability to understand and provide written informed consent prior to undergoing any study procedures
  • Life expectancy of > 3 months, as estimated by the Investigator
  • Presence of at least 1 measurable lesion using CT/MRI as defined by RECIST v1.1
  • Adequate haematological and organ function
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  • Haemoglobin ≥9.0 g/dL
  • ANC ≥1.5 x 10^9/L
  • Lymphocyte count ≥0.5 x 10^9/L
  • Platelet count ≥100 x 10^9/L
  • Total bilirubin ≤1.5 institutional ULN
  • Serum albumin ≥2.5 g/dL
  • Aspartate transaminase (AST)and alanine transaminase (ALT) ≤2.5 x ULN, unless liver metastases are present in which case, they must be ≤5xULN
  • Creatinine clearance >50 mL/min (calculated using the Cockcroft-Gault formula) for patients with creatinine levels above institutional normal
  • Patients not receiving anti-coagulant medication must have an INR of ≤1.5 and an aPTT ≤1.5xULN
  • In the opinion of the Investigator, all other relevant medical conditions must be well-managed and stable for ≥28days prior to first administration of study drug
  • Willing and able to participate in all required evaluations and procedures in this study protocol
  • Contraception:
  • For female subjects: each female subject of childbearing potential must agree to use two highly effective methods of contraception (ie, a method with less than 1% failure rate per year [eg, sterilization, hormone implants, hormone injections, some intrauterine devices, vasectomized partner, or combined birth control pills]) from screening until 6 months after the last dose of EP0057 or olaparib, whichever was taken last. Females of childbearing potential must have a negative serum pregnancy test at Screening and a negative serum or urine pregnancy test within 24 hours before each dose of EP0057 (and must not be lactating). Each female subject will be considered to be of childbearing potential unless she has been surgically sterilized by hysterectomy or bilateral tubal ligation/salpingectomy or has been postmenopausal for ≥1 year. For male subjects: Sexually active male patients must be willing to use barrier contraception (ie, condoms with spermicide) with all sexual partners for the duration of the study and for 6months after the last EP0057 administration. Where a sexual partner of a male participant is a 'woman of child-bearing potential', she must use a highly effective method contraceptive measures (see above definition) during her partner's participation in the study and for 6 months after her partner has received his last dose of EP0057. Men must not donate sperm for 6 months after the last dose of EP0057.
  • ECOG Performance Status Grade 0-2
  • Arm 1 (ATM-negative relapsed advanced GC) Specific Inclusion Criteria:
  • Patients must meet all of Arm 1-specific Inclusion Criteria and all of the Inclusion Criteria applicable to both arms to be eligible for inclusion in the study:
  • Confirmed histological (cytological diagnosis excluded) of gastric adenocarcinoma or gastro-oesophageal junction adenocarcinoma with archival tumour sample available. In the absence of an archival tumour biopsy sample, a tumour biopsy will need to be collected
  • HER2status known with no HER2 expression.PDL-1 status known (this does not need to be known prior to enrolment)
  • ATM protein expression known by investigational use only immunohistochemical Ventana ATM (Y170) assay, with ATM-negative status confirmed (defined as <25% nuclear staining)
  • Relapse, defined as: clear, documented evidence of locally advanced or metastatic, unresectable disease progression following: -two prior lines of systemic therapy, providing patients have not received irinotecan in the second line setting OR One prior line of therapy if considered to be unwilling or unsuitable for current standard of care treatment options
  • Arm2 (Relapsed, extensive stage SCLC) Specific Inclusion Criteria:
  • Patients must meet all of Arm 2-specific Inclusion Criteria and all of the Inclusion Criteria applicable to both arms to be eligible for inclusion in the study
  • Confirmed histological (cytological diagnosis excluded) SCLC with archival tumour sample available. In the absence of an archival tumour biopsy sample, a tumour biopsy will need to be collected. Note: Patients are eligible irrespective of prior assessment of limited or extensive disease
  • PDL-1 status known (this does not need to be known prior to enrolment)
  • Relapse, defined as: clear, documented evidence of disease progression following at least one (and no more than two) lines of previous therapy. Patients must have received all available standard of care treatment options or be unsuitable or unwilling to receive the current standard of care treatment

Who cannot join

  • Applicable to both arms:
  • Unresolved or unstable serious toxic side-effects of prior chemotherapy or radiotherapy, ie, Grade≥2 per CTCAE (v5.0) except fatigue, alopecia, infertility, or palliative radiotherapy within 6 weeks prior to start of study treatment
  • Known cerebral metastases or CNS involvement including leptomeningeal disease. SCLC patients should not have imaging older than 2 weeks prior to start of screening to exclude brain disease. For GC patients, imaging should not be older than 12 weeks prior to start of screening to exclude brain disease. Note: Any abnormal findings on brain imaging should be discussed with the Medical Monitor as part of the screening process
  • Subjects with previously treated brain metastases are eligible to participate if: a) they are stable (no evidence of progression by imaging; same imaging modality [MRI or computed tomography (CT) scan] must be used for each assessment) for at least 28 days prior to the first dose of study drug; b) any neurologic symptoms returned to baseline; c) they have no evidence of new or enlarging brain metastases; d) they are not using corticosteroids for at least 7 days prior to the first dose of study drug.
  • Malignant disease other than that being treated in this study, with the following exceptions:
  • Malignancies that were treated curatively and have not recurred within 2 years prior to study treatment
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  • Completely resected basal cell and squamous cell skin cancers
  • Any malignancy considered to be indolent and that has never required therapy
  • Completely resected carcinoma in situ of any type
  • Concurrent treatment with other systemic anti-cancer therapy or investigational anti-cancer drugs within 3 weeks (or 5 half-lives, whichever is longer), or 4 weeks for immunotherapy, prior to the start of study treatment
  • Prior treatment with a topoisomerase I inhibitor
  • History of stroke, transient ischemic attack, or myocardial infarction, within 6 months prior to C1D1
  • Uncontrolled pleural effusion, pericardial effusion or ascites requiring recurrent drainage procedures (as defined as once monthly or more frequently). N. B - patients with indwelling catheters (eg, PleurX) are allowed
  • Confirmed QTcF > 470 ms on screening ECG or history of Torsades de pointes or history of congenital long QT syndrome
  • Any evidence of severe or uncontrolled systemic conditions (eg, severe hepatic impairment) or current unstable or uncompensated respiratory or cardiac conditions which makes it undesirable for the patient to participate in the study or which could jeopardize compliance with the protocol
  • Any other concurrent severe and/or uncontrolled medical or surgical condition which, in the view of the Investigator, could compromise the patient's participation in the study
  • Patients with active hepatitis infection (defined as having a positive HBsAg test at screening) or hepatitis C. Patients with past HBV infection or resolved HBV infection (defined as having a negative HBsAg test and a positive antibody to hepatitis B core antigen [anti-HBc], and surface antigen [anti-HBs] antibody test and no HBV DNA detectable without HBV therapy) are eligible. Patients positive for HCV antibody are eligible only if polymerase chain reaction is negative for HCV RNA
  • Active infection with SARS-Cov-2. All patients should be tested for active SARS-Cov-2 infection with an approved diagnostic kit
  • Patients with active HIV infection or known history of HIV infection
  • Active infection requiring IV antibiotics within two weeks prior to treatment
  • Women who are pregnant, likely to become pregnant, breast-feeding or either unable to or refuse to use effective means of contraception during treatment
  • Any major surgical procedure (planned or anticipated) (in the Investigator's judgement) within 2weeks of the first dose of study treatment
  • Known contra-indications, hypersensitivity, or severe intolerance to topoisomerase I inhibitors or Olaparib or the excipients of EP0057 or olaparib
  • Patients with a history, or features suggestive, of bone marrow dysplasia, MDS, or AML
  • The patient is unable to swallow capsules and/or has a surgical or anatomical condition that precludes swallowing and absorbing oral medication on an ongoing basis
  • Concurrent treatment with potent inhibitors or inducers of CYP3A4.
  • Concurrent treatment with Coumadin (Warfarin)
  • Patients considered by the Investigator to be at a higher baseline risk for new onset cystitis (see Section 7.5.4)
  • Palliative radiotherapy (e.g., for pain or bleeding) within 6 weeks prior to enrolment or patients who have not completely recovered (Grade ≥ 2) from the effects of previous radiotherapy
  • Any other condition that would, in the Investigator's judgement, contraindicate the patient's participation in the clinical study due to safety concerns or compliance with clinical study procedures or interpretation of study results
  • Arm 1 (ATM-negative relapsed advanced GC) Specific Exclusion Criteria:
  • Prior irinotecan in the second line setting

Trial locations and contacts

21 sites in 3 countries.

21 sites in 3 countries

China8 sites

  • Affiliated Hospital of Hebei University

    Baoding, Yuhua East Road 212, Lianchi District

  • Hunan Cancer Hospital & The Affiliated Cancer Hospital of Xiangya School of Medicine, Central South

    Changsha, Tongzipo Road, Yuelu District, 410013

  • The First Affiliated Hospital of Xiamen University

    Fujian, Siming District, Xiamen, 361026

  • Henan Cancer Hospital

    Henan, Jinshui District, Zhengzhou, 450003

  • Linyi Cancer Hospital

    Linyi, Linyi, Lanshan District, Shandong, 276001

  • Shanghai Chest Hospital

    Shanghai, Changning District, 交通大学 邮政编码, 200052

  • Fudan University Shanghai Cancer Center

    Shanghai, Dongan Rd, 270, Xuhui District, 200032

  • Shanxi Cancer Hospital

    Shanxi, Xinghualing District, Taiyuan, 030013

Other trials in China

South Korea8 sites

  • Dong-A University Hospital

    Busan, Daesingongwon-ro 26, Seo-gu

  • Chungbuk National University Hospital

    Cheongju-si, Sunhuanro 776 (1), Heungduk-gu, Cheongju-city

  • Cha University Bundang Medical Center

    Gyeonggi-do, Yatap-ro 59, Bundang-gu, Seongnam

  • Seoul St. Mary Hospital

    Seoul, Banpo-daero 222, Banpo-dong, Seocho-gu

  • Seoul National University Bundang Hospital

    Seoul, Gumi-ro 82 173(baekchilsipsam)beo, Bundang-gu, Seongnam-si

  • Samsung Medical Center

    Seoul, Irwon-ro 81, Gangnam-gu

  • South Korea University Hospital

    Seoul, Jongno-gu, Daehak-ro, 101, 03080

  • Asan Medical Center

    Seoul, Olympic-ro 88 43-gil, Songpa-gu

Other trials in South Korea

Taiwan5 sites

  • Changhua Christian Hospital

    Changhua, No. 176, Zhonghua Rd, 500

  • Kaohsiung Medical University Chung-Ho Memorial Hospital

    Kaohsiung City, No. 100號, Ziyou 1st Rd, Sanmin District, 80756

  • Tapei Medical University - Shuang-Ho Hospital Ministry of Health and Welfare

    New Taipei City, No. 291, Zhongzheng Rd, Zhonghe District, 235

  • Chi Mei Hospital Liouying

    Tainan, Yongkang District, Zhonghua Rd, 710

  • Chang Gung Medical Foundation Linkou

    Taoyuan, No.5, Fuxing St., Guishan Dist

Other trials in Taiwan

About this study

Official title: A Phase 2 Multi-arm, Open Label Study to Assess the Safety and Efficacy of EP0057 in Combination With Olaparib in Defined Populations of Patients With Relapsed Advanced Gastric Cancer and Small Cell Lung Cancer

The aim of EP0057 - 202 is to assess the safety and efficacy of EP0057 in combination with Olaparib (a PARP inhibitor) in two cancers where there is a high unmet need: extensive stage small cell lung cancer (SCLC) and ATM-negative gastric cancer (GC).

EP0057-202 is a non-comparative, multi-arm, multi-centre, open label, Phase 2 study to determine the efficacy, safety, and tolerability of EP0057 in combination with olaparib (an approved PARP inhibitor) in defined patient populations with relapsed* GC and SCLC.

Read more

*(see Eligibility Criteria for definition of "relapse" for each tumour type/population) The treatment cohorts will open sequentially at the Sponsor's discretion and patients may be enrolled into each cohort concurrently.

EP0057 is an investigational nanoparticle-drug conjugate administered intravenously. The rationale for developing EP0057 is to enable selective entry of EP0057 into tumour tissue and as a result create preferential accumulation of EP0057, and therefore of the payload Camptothecin, to translate into maximum tumour cell killing.

Read the detailed description

EP0057 - 202 is a Phase 2 multi arm, open label study in defined populations of patients with SCLC and GC.

The Primary objectives of Arm 1 will be to investigate the efficacy, as defined by best Objective Response Rate (ORR) of EP0057 in combination with Olaparib in patients with ataxia-telangiectasia mutated protein (ATM)-negative relapsed, advanced GC.

The Primary objectives of Arm 2 will be to investigate the efficacy, as defined by the best ORR of EP0057 in combination with Olaparib in patients with relapsed extensive stage SCLC.

The secondary objectives of both arms will be to further investigate the efficacy of EP0057 in combination with olaparib in the target patient population of each arm by assessment of the following:

  • Progression-free survival (PFS)
  • Overall survival (OS)
  • Duration of overall response (DoR)
  • Disease control rate (DCR)

Secondary objectives of arms 1 and 2 also include exploring the safety and tolerability of EP0057 when combined with olaparib in patients with GC and SCLC.

Exploratory objectives may or may not be performed during the course of the study, but if so, where available at the time of publication, results from these analyses will be reported in the clinical study report (CSR). Exploratory objectives are to:

  • Examine the PK characteristics of EP0057 in combination with olaparib
  • Investigate the impact of HRD (homologous recombination deficiency) status on primary and secondary endpoints, as analysed by sub-groups of HRD status.

It is estimated that approximately 115 patients will be enrolled into the study. The study will aim to recruit 34 patients across both arms of the study in stage 1. The study will then aim to recruit an additional 81 patients across both arms in the second stage.

Being tested
EP0057, Olaparib tablets
Keywords
ATM-negative gastric cancer
Medical subject headings
Stomach Neoplasms, Small Cell Lung Carcinoma

What participants receive

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

  • EP0057Drug

    EP0057 is an investigational nanoparticle-drug conjugate with a Camptothecin payload, that is administered intravenously

  • Olaparib tabletsDrug

    Olaparib is a PARP inhibitor (poly [adenosine diphosphate-ribose] polymerase inhibitor) Other names: Lynparza

Study groups in NCT05411679
Study groupRoleWhat they receive
Arm 1Experimentalpatients with ataxia-telangiectasia mutated protein (ATM)-negative relapsed, advanced GC.
Receives: Drug: EP0057; Drug: Olaparib tablets
Arm 2Experimentalpatients with relapsed extensive stage SCLC.
Receives: Drug: EP0057; Drug: Olaparib tablets

What is being measured

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

  1. Overall Response Rate (ORR) as measured using RECIST v1.1

    Measured: Approximately 18 months

Secondary outcomes (10)

  1. Progression Free Survival (PFS) as measured using RECIST v1.1

    Measured: Approximately 18 months

  2. Duration of Overall Response (DoR) as measured using RECIST v1.1

    Measured: Approximately 18 months

  3. Disease Control Rate (DCR) as measured using RECIST v1.1

    Measured: Approximately 18 months

  4. Overall Survival (OS) defined as time from start of study treatment until date of death due to any cause

    Measured: Approximately 18 months

  5. Incidence of treatment emergent adverse events (AE's) as assessed by NCI CTCAE version 5

    Measured: Approximately 18 months

  6. Incidence of treatment emergent serious adverse events (SAE's)

    Measured: Approximately 18 months

  7. Incidence of treatment-emergent Grade ≥ 3 AEs

    Measured: Approximately 18 months

  8. Incidence of treatment-emergent AEs leading to discontinuation of trial therapy

    Measured: Approximately 18 months

  9. Incidence of treatment-emergent AEs leading to interruption of trial therapy

    Measured: Approximately 18 months

  10. Incidence of treatment-emergent AEs leading to dose reduction of trial treatment

    Measured: Approximately 18 months

Timeline

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

  1. First posted9 Jun 2022
  2. Study startApr 2023 (estimated)
  3. Primary completionAug 2024 (estimated)
  4. Study completionDec 2024 (estimated)

Why it stopped: Futility analysis decision to terminate EP0057 compound and all Ellipses sponsored studies involving EP0057.

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 2
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05411679
Sponsor's protocol ID
EP0057-202
Status last verified
Jun 2023
First submitted
25 May 2022
Last updated
12 Jun 2023
Results posted
No
FDA-regulated drug
Yes
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing EP0057 and Olaparib tablets in people with Gastric Cancer and Small-cell Lung Cancer, run by Ellipses Pharma at 21 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 31 inclusion and 32 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: withdrawn, as of the sponsor's last update on 12 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 21 sites in China, South Korea, Taiwan. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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

Are results available for this study?

The study was withdrawn before enrolling participants, so there are no results.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Overall Response Rate (ORR) as measured using RECIST v1.1 (time frame: Approximately 18 months). 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 NCT05411679.

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 Jun 2023.

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