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Status unknownNCT04930354Updated Feb 16, 2023

ECP-1014 Treatment for Patients With Solid Tumor Cancers

A Phase 1 interventional study of ECP-1014 in Solid Tumor, sponsored by Euclises Pharmaceuticals, Inc.. Status unknown at 1 site in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-02-16.

Sponsored by Euclises Pharmaceuticals, Inc. · Phase 1, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Feb 2023), so the status shown — last known as Recruiting — may be out of date.
Phase
Phase 1
Study type
Interventional
Enrollment
29
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study summary

The primary objective of this study is to evaluate the safety, tolerability, pharmacokinetics, and optimal recommended Phase 2 dose (RP2D) during a 28-day dosing period of ECP-1014 in patients with solid tumors and by evaluation of dose limiting toxicities.

Read the detailed description

This is a single arm, single-center, open-label, ascending dose study in which dose escalation will be determined based on safety and tolerability. Up to a total of 6 cohorts of patients will be enrolled unless additional intermediate doses are studied, not to exceed the maximal dose per protocol.

There are 2 Parts to this study.

  • Part 1 involves enrolling sequential cohorts of patients into a dose-escalation design, in which doses are assessed for safety/tolerability.
  • Part 2 involves randomizing a cohort of patients to the highest and second-highest tolerated doses as identified in Part 1.
02

Conditions studied

  • Solid Tumor
03

In context

Lead sponsor

This is the only study on the registry with Euclises Pharmaceuticals, Inc. as lead sponsor.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. The patient is male or female 18 years of age or older
  2. The patient or legal representative has voluntarily signed and dated an Institutional Review Board (IRB)/Independent Ethics Committee (IEC) approved written informed consent.
  3. Female patients must be of non-childbearing potential (surgically sterile or post-menopausal for at least 1 year) or be practicing a highly effective contraception method from consent to at least 30 days after the last dose of study medication. Highly effective contraception methods include: vasectomized partner (at least 6 months prior to dosing); double barrier (diaphragm with spermicide; condoms with spermicide); intrauterine device; implanted or intrauterine hormonal contraceptives in use for at least 6 consecutive months prior to study dosing and throughout the study duration; oral, patch, or injected contraceptives in use for at least 3 consecutive months prior to study dosing.
  4. Male patients will be required to practice highly effective contraception methods such as: having had a vasectomy, double barrier (condoms with spermicide) or abstinence.
  5. Female patients of childbearing potential have a negative pregnancy test (serum β human chorionic gonadotropin [HCG]) during screening and ≤ 24 hours prior to dosing and are not lactating.
  6. Histologically confirmed solid malignant tumors, which are suspected to over express COX-2 by elevations in urinary PGE-M, such as, but not limited to colorectal, non-small cell lung cancer, head and neck, etc.
  7. Patients who (1) have failed all standard of care therapy (relapsed/refractory) or (2) have relapsed and are not a candidate for an available standard of care therapy as assessed by the investigator.
  8. Elevated urinary PGE-M levels at least 1.5 times the upper normal limits (Males 10.4+1.5, Females 6.0+0.7 ng/mg creatinine).
  9. Eastern Cooperative Oncology Group (ECOG) performance status 0, 1, or 2 and able to comply with protocol.
  10. Patients with treated brain metastases are eligible if there is no evidence of progression for at least 2 weeks after CNS-directed treatment, as ascertained by clinical examination and brain imaging during the screening period.
  11. Life Expectancy ≥ 12 weeks.

  12. Normal organ function as defined below:

    1. platelets ≥100,000/mcL
    2. total bilirubin ≤1.5X the institutional upper limit of normal (ULN)
    3. AST(SGOT)/ALT(SGPT) \<2.5X institutional ULN or \<5X institutional ULN in the presence of liver metastases
    4. creatinine clearance ≥45 mL/min/1.73 m2 for subjects with creatinine levels above institutional normal (use Cockcroft-Gault formula)
    5. absolute neutrophil count ≥1,500/mcL.
  13. No prior history of myocardial infarction, angina pectoris, coronary artery bypass graft (CABG) within 6 months prior to starting study treatment
  14. No congestive heart failure, clinically significant cardiac arrhythmias, complete left bundle branch block, high-grade AV block, left ventricular ejection fraction \<50% evaluated by ECHO or MUGA requiring treatment.
  15. No increased QTCF (>450 for men and >470 for women).
  16. No NSAIDS, full dose oral anticoagulation such as warfarin within 2 weeks of screening.
  17. No gastric acid-reducing agents.
  18. Avoid strong inhibitors or inducers of CYP450
  19. The patient is willing and able to understand the study procedures and to comply with the study protocol.

Exclusion criteria

Exclusion Criteria:

  1. Receiving other investigational drugs or participated in a clinical investigation trial of an agent within 30-days prior to or washout of at least 5 half-lives of the investigational drug prior to Day 1 (dosing of ECP-1014), whichever is longest.
  2. Patients with known hypersensitivity to COX-2, aspirin, or other NSAIDs, history of asthma, urticaria, or allergic-type reactions after taking aspirin or other NSAIDs. And those with history of allergic-type reactions to sulfonamides.
  3. Significant gastrointestinal abnormalities that may affect absorption (e.g., gastric bypass, short gut syndrome).
  4. History of gastric ulcer or gastrointestinal bleed.
  5. Known human immunodeficiency virus (HIV), acute or chronic hepatitis B virus surface antigen or (HBsAg) hepatitis C virus (HCV).
  6. Ongoing ≥ CTCAE grade 2 toxicity (except alopecia) due to prior cancer therapy.
  7. Patient has a condition that precludes ability to consume study medication.
  8. Concomitant disease or condition that, in the clinical judgment of the treating physician, is likely to prevent the subject from complying with any aspect of the protocol or that may put the subject at unacceptable risk.
05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
29 participants (estimated)

Study arms

  • Experimental
    Single arm

    Single arm dose escalation study; ECP1014 oral capsule of10mg, 20mg, 40mg, 80mg and 160mg given once daily for 28 days

    Drug: ECP-1014

Interventions

  • DrugECP-1014

    Patients will be selected who (1) have failed all standard of care therapy (relapsed/refractory) or (2) have relapsed and are not a candidate for an available standard of care therapy as assessed by the investigator (such as, but not limited to, colorectal cancer (CRC), Non-Small Cell Lung Cancer (NSCLC), head and neck, etc.) with COX-2 overexpression, ultimately resulting in elevated production of prostaglandin E2 (PGE2).

    Also known as: GIBH-1014

06

What researchers measure

Primary outcomes

  1. This is a safety and tolerability-based study in which the MTD may be determined

    All AEs will be classified with respect to the MedDRA System Organ Class (SOC) and preferred term. The number and percent of patients who report treatment-emergent adverse events (TEAEs) will be summarized for each treatment group. Additional summaries by severity, relationship, and subgroup will be presented. Serious AEs (SAEs) will be summarized similarly. Clinical chemistry, hematology, and urinalysis will be preformed and changes will be compared to baseline.

    Time frame: 28 days

Secondary outcomes

  1. Plasma for Peak Plasma Concentration (Cmax)

    A 24-hour intensive blood plasma sampling for pharmacokinetic concentration determination will be performed on Day 1 at Hours 0 (immediately pre-morning dose), and Hours 0.5, 1.0, 2, 3, 4, 6, 8, 10, 12, 18 and 24. Patients will be required to remain in-clinic overnight for this sampling. The patient will return to the clinic on the morning of Day 5 after fasting from the evening before. Following the Hour 0 (trough) PK sample, the subject will be given their morning dose of study medication. Additional PK samples will be collected at Hours 0.5, 1.0, 2, 3, 4, 6, 8, 10, 12, 18 and 24.

    Time frame: Day 1 at Hours 0 (immediately pre-morning dose), and Hours 0.5, 1.0, 2, 3, 4, 6, 8, 10, 12, 18 and 24. The patient will return to the clinic on the morning of Day 5 after fasting

  2. Urine for PGE-M levels

    Exploratory biomarkers such as urinary PGE-M will be measured to assess the pharmacodynamic effects of the investigational drug. Starting the morning of Day 4 through the morning of Day 5, a 24-hour urine collection will be performed to allow for assessment of ECP-1014 and metabolite excretion.

    Time frame: Pretreatment, Days 5 & 28

  3. Plasma for Area Under the Curve (AUC)

    A 24-hour intensive blood plasma sampling for pharmacokinetic concentration determination will be performed on Day 1 at Hours 0 (immediately pre-morning dose), and Hours 0.5, 1.0, 2, 3, 4, 6, 8, 10, 12, 18 and 24. Patients will be required to remain in-clinic overnight for this sampling. The patient will return to the clinic on the morning of Day 5 after fasting from the evening before. Following the Hour 0 (trough) PK sample, the subject will be given their morning dose of study medication. Additional PK samples will be collected at Hours 0.5, 1.0, 2, 3, 4, 6, 8, 10, 12, 18 and 24.

    Time frame: Day 1 at Hours 0 (immediately pre-morning dose), and Hours 0.5, 1.0, 2, 3, 4, 6, 8, 10, 12, 18 and 24. The patient will return to the clinic on the morning of Day 5 after fasting

  4. Plasma for Half-life (t1/2)

    A 24-hour intensive blood plasma sampling for pharmacokinetic concentration determination will be performed on Day 1 at Hours 0 (immediately pre-morning dose), and Hours 0.5, 1.0, 2, 3, 4, 6, 8, 10, 12, 18 and 24. Patients will be required to remain in-clinic overnight for this sampling. The patient will return to the clinic on the morning of Day 5 after fasting from the evening before. Following the Hour 0 (trough) PK sample, the subject will be given their morning dose of study medication. Additional PK samples will be collected at Hours 0.5, 1.0, 2, 3, 4, 6, 8, 10, 12, 18 and 24.

    Time frame: Day 1 at Hours 0 (immediately pre-morning dose), and Hours 0.5, 1.0, 2, 3, 4, 6, 8, 10, 12, 18 and 24. The patient will return to the clinic on the morning of Day 5 after fasting

  5. Plasma for Time to Maximum Plasma Concentration (Tmax)

    A 24-hour intensive blood plasma sampling for pharmacokinetic concentration determination will be performed on Day 1 at Hours 0 (immediately pre-morning dose), and Hours 0.5, 1.0, 2, 3, 4, 6, 8, 10, 12, 18 and 24. Patients will be required to remain in-clinic overnight for this sampling. The patient will return to the clinic on the morning of Day 5 after fasting from the evening before. Following the Hour 0 (trough) PK sample, the subject will be given their morning dose of study medication. Additional PK samples will be collected at Hours 0.5, 1.0, 2, 3, 4, 6, 8, 10, 12, 18 and 24.

    Time frame: Day 1 at Hours 0 (immediately pre-morning dose), and Hours 0.5, 1.0, 2, 3, 4, 6, 8, 10, 12, 18 and 24. The patient will return to the clinic on the morning of Day 5 after fasting

07

Study locations

1 of 1 sites recruiting
  • The Sixth Affiliated Hospital Sun Yat-sen University
    Guangzhou, Guangdong 510655, China
    • Yanhoug Deng, MD · Contact
    Recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Start is estimated for May 2023; primary completion for Sep 2023, 4 months later.

How these figures are worked out, and which studies are left out of them.

Registered
May 26, 2021
First posted
Jun 18, 2021
StartEst.
May 2023
Primary completionEst.
Sep 2023
CompletionEst.
Dec 2023
Last update
Feb 16, 2023
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Feb 16, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04930354
Lead sponsor
Euclises Pharmaceuticals, Inc.
Responsible party
Sponsor
First posted
Jun 18, 2021
Start date
May 2023 (estimated)
Primary completion
Sep 2023 (estimated)
Completion
Dec 2023 (estimated)
Last update
Feb 16, 2023

Study contacts

Bobby W Sandage, PhD
Contact
bobby.sandage@gmail.com
5086622531
Yanhong Deng, MD
Contact
Yanhong Deng, MD
principal investigator · The Sixth Affiliated Hospital Sun Yat-sen University, Guangzhou, China

Oversight

Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is status unknown, as verified in Feb 2023. You cannot join it, but the record below documents what was studied.

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