Advanced Endometrial CancerPhase 2NCT05106127
Safety Lead-In Study of a Repurposed Drug Added to the Combination of Len Plus Pem
A Phase 2 study testing EG-007, Pembrolizumab 100 mg/4 mL (25 mg/ml) Injection and Lenvatinib Capsules in people with Advanced Endometrial Cancer, run by Evergreen Therapeutics, Inc..
Trial summary
This is a Phase 2 trial Safety Lead-in trial conducted in 3 cohorts of patients. A safety lead-in study of the impact of adding the Repurposed Drugs a third agent will be conducted prior to opening enrollment into the compassionate use study. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Advanced Endometrial Cancer
- What is being tested?
- EG-007, Pembrolizumab 100 mg/4 mL (25 mg/ml) Injection and Lenvatinib Capsules
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- No sites listed yet
- Study dates
- Aug 2026to Mar 2027
- Phase
- Phase 2
- 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
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Female, 18 years and older at the time of informed consent, who has a histologically confirmed diagnosis of endometrial carcinoma, endometroid histology, that is not MSI-H or dMMR ).
- Documented evidence of advanced (Stage III or IV), or recurrent EC.
- Must have a recurrence or progressed on a platinum containing chemotherapy regimen and are not candidates for curative surgery or radiation
- Has historical or fresh tumor biopsy specimen for confirmation of mismatch repair (MMR) status as not MSI-H or dMMR.
- Has measurable or evaluable disease according to Response Evaluation Criteria In Solid Tumors (RECIST v1.1).
- Is a candidate for initiation of treatment with the combined regimen of Keytruda plus Lenvima (Len+Pem) OR IS CURRENTLY RECEIVING a tolerated regimen of Len+Pem at the doses specified as the Len+Pem Regimen (per Labeling July 2021)
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- Life expectancy of 12 weeks or more.
- Has an Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1 within 7 days of starting study treatment.
- Adequately controlled blood pressure (BP) with or without antihypertensive medications, defined as BP less than or equal to 150/90 mmHg at screening and no change in antihypertensive medications within 1 week prior to the Cycle 1 Day 1.
- Adequate renal function defined as creatinine less than or equal to 1.5 × ULN (upper limit of normal) or calculated creatinine clearance greater than or equal to 40 mL/min per the Cockcroft and Gault formula with creatinine levels greater than 1.5 × ULN.
- Additional detail upon request.
Who cannot join
- Brain metastasis: Previously treated CNS disease needs to be asymptomatic and does not require steroids. Brain metastases must be asymptomatic, fully treated and stable and not requiring steroids within 4 weeks prior to study treatment initiation.
- Has carcinosarcoma (malignant mixed mullerian tumor), serous carcinoma, endometrial leiomyosarcoma and endometrial stromal sarcomas.
- Has failed treatment of lenvatinib + pembrolizumab in prior lines of therapy.
- Except for the allowance of ongoing use of Len+Pem, the protocol excludes patients having received any other prior anticancer treatment within 28 days (or 5 times the half-life time, whichever is shorter) or any investigational agent within 30 days prior to the first dose of study drugs. All acute toxicities related to prior treatments must be resolved to Grade less than or equal to 1.
- Participants must have recovered adequately from any toxicity and/or complications from major surgery prior to starting therapy.
- Participants having greater than 1+ proteinuria on urinalysis will undergo 24-h urine collection for quantitative assessment of proteinuria. Participants with urine protein greater than or equal to 1 g/24-hour will be ineligible.
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- Gastrointestinal malabsorption, gastrointestinal anastomosis, or any other condition that might affect the absorption of the study drugs
- Has a pre-existing greater than or equal (>=) Grade 3 gastrointestinal or non-gastrointestinal fistula.
- Has radiographic evidence of major blood vessel invasion/infiltration.
- Has clinically significant tumor bleeding within 2 weeks prior to the first dose of study treatment.
- Additional detail upon request.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: A Phase 2, Open-Label, Safety Lead-In With Long Term Safety Study of EG-007, Added to the Combination of Lenvatinib Plus Pembrolizumab
This is a Phase 2 trial Safety Lead-in trial conducted in 3 cohorts of patients.
A safety lead-in study of the impact of adding the Repurposed Drugs a third agent will be conducted prior to opening enrollment into the compassionate use study. All patients enrolled in the safety lead-in study may continue long-term treatment under this protocol without interruption of dosing.
- Conditions
- Advanced Endometrial Cancer
- Being tested
- EG-007, Pembrolizumab 100 mg/4 mL (25 mg/ml) Injection, Lenvatinib Capsules
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EG-007Drug
A Repurposed Drug
Pembrolizumab 100 mg/4 mL (25 mg/ml) InjectionDrug
Pembrolizumab will be provided as a sterile, preservative-free, clear to slightly opalescent, colorless to slightly yellow solution that requires dilution for intravenous infusion. Each vial contains 100 mg of pembrolizumab in 4 mL of solution.
Lenvatinib CapsulesDrug
Lenvatinib will be provided as 4-mg and 10-mg capsules. Lenvatinib is formulated with calcium carbonate, mannitol, microcrystalline cellulose, hydroxypropyl cellulose, low-substituted hydroxypropylcellulose, and talc.
| Study group | Role | What they receive |
|---|---|---|
| EG-007 1000mg + Len + Pem | Experimental | 3 to 6 patients will receive EG-007 1000 mg once weekly starting on the day of injection of Pembrolizimab starting the next 21-day cycle of treatment. Receives: Drug: EG-007; Drug: Pembrolizumab 100 mg/4 mL (25 mg/ml) Injection; Drug: Lenvatinib Capsules |
| EG-007 1000mg Loading + Len + Pem | Experimental | 6 to 10 patients will receive EG-007 loading dose of 5000 mg given as 1000 mg daily over 5 consecutive days starting 4 days before the first dose of Pembrolizumab under this protocol. Receives: Drug: EG-007; Drug: Pembrolizumab 100 mg/4 mL (25 mg/ml) Injection; Drug: Lenvatinib Capsules |
| EG-007 1000mg D-4 Loading + Len + Pem | Experimental | 6 to 12 patients initiating new regimens of Len+Pem will receive EG-007 loading dose of 5000 mg given as 1000 mg daily over 5 consecutive days starting 4 days before the first dose of Pembrolizumab. Receives: Drug: EG-007; Drug: Pembrolizumab 100 mg/4 mL (25 mg/ml) Injection; Drug: Lenvatinib Capsules |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse Events Assessment using CTCAE v5.0
Number of Participants With Treatment-Related Adverse Events as Assessed by NCI CTCAE v5.0, toxicities will be characterized in terms including seriousness, causality, toxicity grading, and action taken with regard to trial treatment. Data Monitoring committee review for safety to proceed through dose escalation.
Measured: 1 Cycle of 21 days
Tolerability Score measurement using NCI-PRO CTCAE
Using NCI-PRO CTCAE to record the tolerability score for patients to evaluate symptomatic toxicities.
Measured: 1 Cycle of 21 days
Secondary outcomes (1)
Long-term Safety Monitoring for EG-007 plus Len+Pem
To conduct long-term monitoring of the safety and clinical outcomes for EG-007 plus Len+Pem. The proportion of Participants With Treatment-Related Adverse Events during long-term monitoring.
Measured: At the end of every Cycle (21 days per Cycle), up to 12 Cycles; and upon study exit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Nov 2021
- Study startAug 2026 (estimated)
- Primary completionMar 2027 (estimated)
- Study completionMar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced Endometrial CancerStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 28 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Evergreen Therapeutics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05106127
- Sponsor's protocol ID
- HPC-EG-007-2.1
- Status last verified
- Dec 2025
- First submitted
- 22 Sep 2021
- Last updated
- 8 Dec 2025
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2, Open-Label, Safety Lead-In With Long Term Safety Study of EG-007, Added to the Combination of Lenvatinib Plus Pembrolizumab
- ClinicalTrials.gov ID
- NCT05106127
- Acronym / sponsor ID
- HPC-EG-007-2.1
- Conditions
- Advanced Endometrial Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 28 participants (estimated)
- Lead sponsor
- Evergreen Therapeutics, Inc.Industry (pharma, biotech, devices)
- Study start
- Aug 2026 (estimated)
- Primary completion
- Mar 2027 (estimated)
- Study completion
- Mar 2027 (estimated)
- First posted
- 3 Nov 2021 (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 is a Phase 2 trial Safety Lead-in trial conducted in 3 cohorts of patients.
A safety lead-in study of the impact of adding the Repurposed Drugs a third agent will be conducted prior to opening enrollment into the compassionate use study. All patients enrolled in the safety lead-in study may continue long-term treatment under this protocol without interruption of dosing.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| EG-007 1000mg + Len + Pem | Experimental | Drug: EG-007, Drug: Pembrolizumab 100 mg/4 mL (25 mg/ml) Injection, Drug: Lenvatinib Capsules3 to 6 patients will receive EG-007 1000 mg once weekly starting on the day of injection of Pembrolizimab starting the next 21-day cycle of treatment. |
| EG-007 1000mg Loading + Len + Pem | Experimental | Drug: EG-007, Drug: Pembrolizumab 100 mg/4 mL (25 mg/ml) Injection, Drug: Lenvatinib Capsules6 to 10 patients will receive EG-007 loading dose of 5000 mg given as 1000 mg daily over 5 consecutive days starting 4 days before the first dose of Pembrolizumab under this protocol. |
| EG-007 1000mg D-4 Loading + Len + Pem | Experimental | Drug: EG-007, Drug: Pembrolizumab 100 mg/4 mL (25 mg/ml) Injection, Drug: Lenvatinib Capsules6 to 12 patients initiating new regimens of Len+Pem will receive EG-007 loading dose of 5000 mg given as 1000 mg daily over 5 consecutive days starting 4 days before the first dose of Pembrolizumab. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Female, 18 years and older at the time of informed consent, who has a histologically confirmed diagnosis of endometrial carcinoma, endometroid histology, that is not MSI-H or dMMR ).
- Documented evidence of advanced (Stage III or IV), or recurrent EC.
- Must have a recurrence or progressed on a platinum containing chemotherapy regimen and are not candidates for curative surgery or radiation
- Has historical or fresh tumor biopsy specimen for confirmation of mismatch repair (MMR) status as not MSI-H or dMMR.
- Has measurable or evaluable disease according to Response Evaluation Criteria In Solid Tumors (RECIST v1.1).
Key exclusion criteria (11 listed)
- Brain metastasis: Previously treated CNS disease needs to be asymptomatic and does not require steroids. Brain metastases must be asymptomatic, fully treated and stable and not requiring steroids within 4 weeks prior to study treatment initiation.
- Has carcinosarcoma (malignant mixed mullerian tumor), serous carcinoma, endometrial leiomyosarcoma and endometrial stromal sarcomas.
- Has failed treatment of lenvatinib + pembrolizumab in prior lines of therapy.
- Except for the allowance of ongoing use of Len+Pem, the protocol excludes patients having received any other prior anticancer treatment within 28 days (or 5 times the half-life time, whichever is shorter) or any investigational agent within 30 days prior to the first dose of study drugs. All acute toxicities related to prior treatments must be resolved to Grade less than or equal to 1.
- Participants must have recovered adequately from any toxicity and/or complications from major surgery prior to starting therapy.
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 |
|---|---|---|
| EG-007A Repurposed Drug | Drug | EG-007 1000mg + Len + Pem, EG-007 1000mg D-4 Loading + Len + Pem, EG-007 1000mg Loading + Len + Pem |
| Pembrolizumab 100 mg/4 mL (25 mg/ml) InjectionPembrolizumab will be provided as a sterile, preservative-free, clear to slightly opalescent, colorless to slightly yellow solution that requires dilution for intravenous infusion. Each vial contains 100 mg of pembrolizumab in 4 mL of solution. | Drug | EG-007 1000mg + Len + Pem, EG-007 1000mg D-4 Loading + Len + Pem, EG-007 1000mg Loading + Len + Pem |
| Lenvatinib CapsulesLenvatinib will be provided as 4-mg and 10-mg capsules. Lenvatinib is formulated with calcium carbonate, mannitol, microcrystalline cellulose, hydroxypropyl cellulose, low-substituted hydroxypropylcellulose, and talc. | Drug | EG-007 1000mg + Len + Pem, EG-007 1000mg D-4 Loading + Len + Pem, EG-007 1000mg Loading + Len + Pem |
Primary outcome
Adverse Events Assessment using CTCAE v5.0
Time frame: 1 Cycle of 21 days
Number of Participants With Treatment-Related Adverse Events as Assessed by NCI CTCAE v5.0, toxicities will be characterized in terms including seriousness, causality, toxicity grading, and action taken with regard to trial treatment. Data Monitoring committee review for safety to proceed through dose escalation.
Tolerability Score measurement using NCI-PRO CTCAE
Time frame: 1 Cycle of 21 days
Using NCI-PRO CTCAE to record the tolerability score for patients to evaluate symptomatic toxicities.
1 secondary outcome
Long-term Safety Monitoring for EG-007 plus Len+Pem
Time frame: At the end of every Cycle (21 days per Cycle), up to 12 Cycles; and upon study exit
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 8 Dec 2025.
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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.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing EG-007, Pembrolizumab 100 mg/4 mL (25 mg/ml) Injection and Lenvatinib Capsules in people with Advanced Endometrial Cancer, run by Evergreen Therapeutics, Inc..
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 11 inclusion and 11 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: opening soon, as of the sponsor's last update on 8 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
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?
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?
Contact Xin Du, Ph.D. (2404064016, david.du@egpharm.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adverse Events Assessment using CTCAE v5.0 (time frame: 1 Cycle of 21 days). 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?
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 8 Dec 2025.