Advanced Solid TumorPhase 1NCT05895825
A Study of EOC237 in Patients With Advanced Solid Tumor
A Phase 1 study testing EOC237 in people with Advanced Solid Tumor, run by Shanghai Yiteng Jingang Bio-pharmaceutical Technology Co., Ltd at 1 site in China.
Trial summary
This research study is studying an investigational drug called EOC237 in Patients With Advanced Solid Tumor. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Advanced Solid Tumor
- What is being tested?
- EOC237
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteChina
- Study dates
- 26 Jul 2023to 30 Sep 2026
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Advanced Solid Tumors for which standard curative or palliative measures do not exist or are no longer effective.
- Expected survival≥ 3 months.
- ECOG performance status 0-1.
- Good organ and marrow function.
Who cannot join
- Patients with a history of severe drug allergic reaction.
- Pregnant or lactating female subjects.
- Uncontrolled, significant intercurrent or recent illness.
- Corrected QT interval calculated by the Fridericia formula (QTcF) > 480 ms per electrocardiogram (ECG)
- Concomitant use of certain medications
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
National Cancer Center/ Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College
Beijing, Beijing Municipality, 100029
Binghe Xu, +861087788495, cancergcp@163.com
About this study
Official title: A Phase I Study Evaluating the Safety, Tolerability and Pharmacokinetics of EOC237 in Patients With Advanced Solid Tumor
This research study is studying an investigational drug called EOC237 in Patients With Advanced Solid Tumor.
Read the detailed description
Part 1 Dose Escalation: an open, single/multiple dose, multi-center phase I study to evaluate the safety, tolerability and pharmacokinetics of EOC237 in Patients With Advanced Solid Tumor.
Part 2 Food influence research: to assess the effect of food on the pharmacokinetics of EOC237, by investigating the bioavailability following single dose administration under fed and fasted conditions.
- Conditions
- Advanced Solid Tumor
- Being tested
- EOC237
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EOC237Drug
EOC237 for orally
| Study group | Role | What they receive |
|---|---|---|
| Part 1: Dose Escalation | Experimental | In Part 1 (dose escalation) participants with selected advanced solid tumors will receive escalating doses of EOC237 as monotherapy. Participants can receive EOC237 until disease progression, adverse event (AE), or other discontinuation criteria, whichever occurs first. Receives: Drug: EOC237 |
| Part 2: Food influence-Group 1 | Experimental | Food influence-Group 1: EOC237 was taken orally under fasted conditions, after a 3-day washout period, EOC237 was taken orally under fed conditions.
Participants can receive EOC237 until disease progression, AE, or other discontinuation criteria, whichever occurs first. Receives: Drug: EOC237 |
| Part 2: Food influence-Group 2 | Experimental | Food influence-Group 2: EOC237 was taken orally under fed conditions, after a 3-day washout period, EOC237 was taken orally under fasted conditions.
Participants can receive EOC237 until disease progression, AE, or other discontinuation criteria, whichever occurs first. Receives: Drug: EOC237 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of subjects with dose-limiting toxicity (DLT)
Number of subjects who experienced DLT events during 28 days after first administration of EOC237, divided by the number of DLT evaluable Subjects
Measured: Up to approximately 3 years
Determination of maximum tolerated dose (MTD)
Measured: Up to approximately 3 years
the recommended phase 2 dose (RP2D)
Measured: Up to approximately 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jun 2023
- Study start26 Jul 2023
- Primary completion30 Apr 2026 (estimated)
- Study completion30 Sep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced Solid TumorStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 48 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Yiteng Jingang Bio-pharmaceutical Technology Co., Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05895825
- Sponsor's protocol ID
- EOC237-X1-101
- Status last verified
- May 2023
- First submitted
- 12 May 2023
- Last updated
- 2 Nov 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Study Evaluating the Safety, Tolerability and Pharmacokinetics of EOC237 in Patients With Advanced Solid Tumor
- ClinicalTrials.gov ID
- NCT05895825
- Acronym / sponsor ID
- EOC237-X1-101
- Conditions
- Advanced Solid Tumor
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 48 participants (estimated)
- Lead sponsor
- Shanghai Yiteng Jingang Bio-pharmaceutical Technology Co., LtdIndustry (pharma, biotech, devices)
- Study start
- 26 Jul 2023 (actual)
- Primary completion
- 30 Apr 2026 (estimated)
- Study completion
- 30 Sep 2026 (estimated)
- First posted
- 9 Jun 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This research study is studying an investigational drug called EOC237 in Patients With Advanced Solid Tumor.
Detailed description
Part 1 Dose Escalation: an open, single/multiple dose, multi-center phase I study to evaluate the safety, tolerability and pharmacokinetics of EOC237 in Patients With Advanced Solid Tumor.
Part 2 Food influence research: to assess the effect of food on the pharmacokinetics of EOC237, by investigating the bioavailability following single dose administration under fed and fasted conditions.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Part 1: Dose Escalation | Experimental | Drug: EOC237In Part 1 (dose escalation) participants with selected advanced solid tumors will receive escalating doses of EOC237 as monotherapy. Participants can receive EOC237 until disease progression, adverse event (AE), or other discontinuation criteria, whichever occurs first. |
| Part 2: Food influence-Group 1 | Experimental | Drug: EOC237Food influence-Group 1: EOC237 was taken orally under fasted conditions, after a 3-day washout period, EOC237 was taken orally under fed conditions. Participants can receive EOC237 until disease progression, AE, or other discontinuation criteria, whichever occurs first. |
| Part 2: Food influence-Group 2 | Experimental | Drug: EOC237Food influence-Group 2: EOC237 was taken orally under fed conditions, after a 3-day washout period, EOC237 was taken orally under fasted conditions. Participants can receive EOC237 until disease progression, AE, or other discontinuation criteria, whichever occurs first. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Advanced Solid Tumors for which standard curative or palliative measures do not exist or are no longer effective.
- Expected survival≥ 3 months.
- ECOG performance status 0-1.
- Good organ and marrow function.
Key exclusion criteria (5 listed)
- Patients with a history of severe drug allergic reaction.
- Pregnant or lactating female subjects.
- Uncontrolled, significant intercurrent or recent illness.
- Corrected QT interval calculated by the Fridericia formula (QTcF) > 480 ms per electrocardiogram (ECG)
- Concomitant use of certain medications
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 |
|---|---|---|
| EOC237EOC237 for orally | Drug | Part 1: Dose Escalation, Part 2: Food influence-Group 1, Part 2: Food influence-Group 2 |
Primary outcome
Proportion of subjects with dose-limiting toxicity (DLT)
Time frame: Up to approximately 3 years
Number of subjects who experienced DLT events during 28 days after first administration of EOC237, divided by the number of DLT evaluable Subjects
Determination of maximum tolerated dose (MTD)
Time frame: Up to approximately 3 years
the recommended phase 2 dose (RP2D)
Time frame: Up to approximately 3 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Nov 2023.
Related trials for Advanced Solid Tumor
Not yet recruitingPhase 1
First-in-Human, Multicenter, Phase I Study to Evaluate Safety, Tolerability, Pharmacokinetics, and Preliminary Antitumor Activity of YL-18319 Monotherapy in Patients With Locally Advanced/Metastatic Solid Tumors
Solid Tumors, Ovarian
RecruitingPhase 2
BiCaZO: A Study Combining Two Immunotherapies (Cabozantinib and Nivolumab) to Treat Patients With Advanced Melanoma or Squamous Cell Head and Neck Cancer, an immunoMATCH Pilot Study
Clinical Stage III Cutaneous Melanoma AJCC v8, Clinical Stage III HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC v8
RecruitingPhase 1
A Study to Find a Suitable Dose of ASP5834 in Adults With Solid Tumors
Solid Tumor, Non-Small-Cell Lung Cancer
RecruitingPhase 1/2
Study of GVV858 as a Single Agent or in Combination With Endocrine Therapy in Patients With HR+/HER2- Breast Cancer and Other Advanced Solid Tumors
Advanced HR+/HER2- Breast Cancer, Advanced CCNE1-amplified Solid Tumors
RecruitingPhase 1/2
A Study of BL-M08D in Patients With Locally Advanced or Metastatic Melanoma and Other Solid Tumors
Melanoma, Solid Tumors
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing EOC237 in people with Advanced Solid Tumor, run by Shanghai Yiteng Jingang Bio-pharmaceutical Technology Co., Ltd at 1 site in China.
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 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 2 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Binghe Xu, MD (8610-87788495, cancergcp@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of subjects with dose-limiting toxicity (DLT) (time frame: Up to approximately 3 years). 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?
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 2 Nov 2023.