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Esophageal Squamous Cell CarcinomaEarly Phase 1NCT06690476

Assess the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of IPM514 in Patients with Esophageal Squamous Cell Carcinoma

A Early Phase 1 study testing Dose escalation(IPM514 monotherapy), Dose expansion (IPM514 combined with tislelizumab) and Neoadjuvant therapy cohort(IPM514 combined with tislelizumab, cisplatin and paclitaxel) in people with Esophageal Squamous Cell Carcinoma, run by Peking University at 1 site in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
Search all trials

Trial summary

This is a open-label, multicenter study to assess the safety, tolerability, and preliminary efficacy of IPM514 in patients with esophageal squamous cell carcinoma. This study consists of dose escalation phase (IPM514 monotherapy) ，dose expansion phase (IPM514 combined with anti-PD-1 antibody) and the neoadjuvant… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Esophageal Squamous Cell Carcinoma
What is being tested?
Dose escalation(IPM514 monotherapy), Dose expansion (IPM514 combined with tislelizumab) and Neoadjuvant therapy cohort(IPM514 combined with tislelizumab, cisplatin and paclitaxel)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
74 participants
Where
1 siteChina
Study dates
10 Oct 2024to Oct 2026
Phase
Early 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

  • Able to provide written informed consent and can understand and agree to comply with the requirements of the study and the schedule of assessments.
  • Male or female, aged ≥ 18 years.
  • Histologically confirmed diagnosis of esophageal squamous cell carcinoma.
  • Dose escalation and dose expansion stages: After at least one line of systemic treatment (PD-1 antibody combined with platinum-based chemotherapy) has progressed or is intolerable. The following situations are regarded as the failure of the first-line standard treatment:
  • Tumor recurrence/progression during neoadjuvant/adjuvant immunotherapy combined with platinum-containing chemotherapy.
  • Patients with disease recurrence within 6 months after completing neoadjuvant/adjuvant treatment, and this neoadjuvant/adjuvant treatment is also defined as first-line treatment.
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  • Dose escalation and dose expansion stages :At least one measurable lesion by RECIST v1.1, that is, the long diameter of non-lymph node lesions shown by CT or MRI is ≥10 mm or the short diameter of lymph node lesions is ≥15 mm. If the CT scan slice thickness is >5 mm, the minimum diameter of the lesion is twice the slice thickness (acceptable examination results within 28 days before signing the ICF).
  • Neoadjuvant treatment cohort: Have not received any anti-tumor treatment for esophageal cancer, including radiotherapy, chemotherapy, surgery, etc.; and plan to receive surgical treatment after the completion of neoadjuvant treatment.
  • Eastern Cooperative Oncology Group (ECOG) performance status score: 0 or 1.
  • The expected survival period is ≥12 weeks.
  • The HLA typing is HLA*A: 0201 and/or HLA*A: 1101.
  • The organ function level in the screening period must meet the following requirements (no blood transfusion or blood products, no use of hematopoietic stimulating factors and other drugs to correct the number of blood cells before the examination):
  • Absolute neutrophil count (ANC) ≥ 1.5 × 109/L;
  • Platelet count (PLT) ≥ 100 × 109/L;
  • Hemoglobin (Hb) ≥ 90 g/L;
  • Total bilirubin (TBIL) ≤ 1.5 × ULN;
  • Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 2.5 × ULN, ≤ 5 × ULN for those with liver metastasis;
  • Serum creatinine (Cr) ≤ 1.5 × ULN, or creatinine clearance rate (Cockcroft-Gault formula) ≥ 45 mL/min;
  • International normalized ratio (INR), prothrombin time (PT) ≤ 1.5 × ULN;
  • QTc interval calculated according to the Fridericia standard, ≤ 450 ms for men and ≤ 470 ms for women;
  • Urine routine/24-hour urine protein quantification: Urine protein qualitative ≤ 1+ (if urine protein qualitative ≥ 2+, then 24-hour urine protein < 1 g can be enrolled);
  • Cardiac function: Left ventricular ejection fraction ≥ 50%.
  • Eligible patients (male or female) with fertility must agree to adopt a medically approved physical contraceptive measure (such as an intrauterine device, condom, tubal or vas deferens ligation, etc.) during the trial and within 6 months after the last administration; Serum or urine HCG tests of women of childbearing age must be negative in the screening period.

Who cannot join

  • After stent implantation in esophagus; Patients who are at high risk of bleeding or perforation due to significant tumor invasion of adjacent organs (aorta or trachea).
  • Uncontrollable pleural effusion, pericardial effusion, or ascites requiring frequent drainage.
  • Known allergy to the components of the study drug.
  • Prior treatment with an mRNA vaccine.
  • Subjects received major surgery within 4 weeks before the first administration or are expected to receive major surgery during the study (as judged by the investigator).
  • Dose escalation and dose expansion stages: Subjects received any anti-tumor therapy, such as chemotherapy, radiotherapy, targeted therapy, immunotherapy, and biological therapy, or any investigational therapy within 28 days or 5 half-lives (whichever is shorter but at least 14 days) of the first study drug administration:
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  • Expected to use immunosuppressant drugs during the 4-week period before the first administration and during the study, except for corticosteroid nasal sprays, inhalants or systemic prednisone ≤ 10 mg/day and equivalent drugs of the same kind.
  • With a history of organ transplantation, bone marrow transplantation or hematopoietic stem cell transplantation.
  • Received live attenuated vaccines within 28 days before the first administration.
  • Dose escalation and dose expansion stages: Subjects with symptomatic, untreated or requiring continuous treatment (including corticosteroids and antiepileptic drugs) of central nervous system (CNS) metastasis (for those who have received treatment in the past, those who have been clinically stable for at least 4 weeks before enrollment, have excluded evidence of new or expanded metastasis and have discontinued steroid treatment can be enrolled; those with asymptomatic brain metastasis and do not require treatment can be enrolled.
  • 10 Dose escalation and dose expansion stages: The toxicity after previous anti-tumor treatment has not returned to the baseline or grade 0-1 as stipulated in NCI-CTCAE v5.0 (except for hair loss and pigmentation). Those with irreversible toxicities that are not expected to be aggravated by the investigational drug and can be enrolled after confirmation with the investigator.
  • With a history of autoimmune diseases, such as systemic lupus erythematosus, psoriasis requiring systemic treatment, rheumatoid arthritis, inflammatory bowel diseases, etc. Type 1 diabetes mellitus, hypothyroidism that can only be controlled by replacement therapy, and skin diseases (such as vitiligo, psoriasis) that do not require systemic treatment can be enrolled.
  • With a history of immediate allergic reaction, eczema that cannot be controlled by topical corticosteroids or asthma.
  • With concomitant diseases that cannot be controlled, including but not limited to: unexplained fever > 38.5°C (subjects with tumor fever are judged by the investigator whether to include in the study), symptomatic congestive heart failure with New York Heart Association (NYHA) cardiac function classification ≥ grade 2, left ventricular ejection fraction (LVEF) < 50%, poorly controlled hypertension (systolic blood pressure > 160 mmHg and/or diastolic blood pressure > 100 mmHg after treatment, and the investigator assesses that it is of clinical significance), unstable angina pectoris or acute myocardial infarction occurred within 3 months before the first administration, poorly controlled arrhythmia; patients with chronic obstructive pulmonary disease, asthma, interstitial lung disease and those with decreased pulmonary function.
  • With active infection and currently require systemic anti-infective treatment; those with active tuberculosis.
  • Known history of HIV, active Treponema pallidum infection; HBsAg positive and HBV-DNA > 500 IU/L; HCV-RNA positive.
  • Other situations judged by the investigator not suitable for participating in this study, including but not limited to having any diseases or histories that may confuse the study results or interfere with the patient's compliance.

Trial locations and contacts

1 site in 1 country.

Zhi hao Lu contact

13810549767

13810549767@126.com

China1 site, 1 recruiting

  • Peking University Cancer Hospital

    Beijing

    zhihao Lu, 13810549767, 13810549767@126.com

    Recruiting

Other trials in China

About this study

Official title: A Open-Label, Multicenter Study to Assess the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of IPM514 in Patients with Esophageal Squamous Cell Carcinoma

This is a open-label, multicenter study to assess the safety, tolerability, and preliminary efficacy of IPM514 in patients with esophageal squamous cell carcinoma. This study consists of dose escalation phase (IPM514 monotherapy) ，dose expansion phase (IPM514 combined with anti-PD-1 antibody) and the neoadjuvant therapy cohort(IPM514 combined with anti-PD-1 antibody, cisplatin and paclitaxel).The dose escalation and dose expansion stages will include patients with unresectable advanced, recurrent or metastatic ESCC who have failed first-line treatment. After confirming the preliminary safety and effectiveness in the dose escalation and dose expansion stages, a neoadjuvant therapy cohort study will be developed, and resectable ESCC subjects will be included.

Being tested
Dose escalation(IPM514 monotherapy), Dose expansion (IPM514 combined with tislelizumab), Neoadjuvant therapy cohort(IPM514 combined with tislelizumab, cisplatin and paclitaxel)
Medical subject headings
Esophageal Squamous Cell Carcinoma

What participants receive

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

  • Dose escalation(IPM514 monotherapy)Drug

    Drug：IPM514 Intramuscular Injection A total of 7 administrations, including 2 cycles of vaccination with each cycle at QW × 3 doses; there is a 2-weeks interval between the two cycles, then followed by a boost dose 3 weeks after the 2'nd cycle.

  • Dose expansion (IPM514 combined with tislelizumab)Drug

    Drug：IPM514 Intramuscular Injection Drug：tislelizumab intravenous administration The usage and dosage of the tislelizumab will be based on the drug instructions. IPM514 administration is planned to be concomitant with PD-1 antibody and to be stopped after 9 doses of treatment, while the PD-1 antibody will be continuously administered for a maximum of 1 year.

  • Neoadjuvant therapy cohort(IPM514 combined with tislelizumab, cisplatin and paclitaxel)Drug

    Drug：IPM514 Intramuscular Injection Drug：tislelizumab intravenous administration Drug：cisplatin intravenous administration Drug：paclitaxel intravenous administration In this stage, subjects will receive the treatment of IPM514 combined with Tislelizumab, cisplatin and paclitaxel. All four drugs will be administered once every 3 weeks (± 1 day). IPM514 will be administered for the first time on D0, and Tislelizumab, cisplatin and paclitaxel will be administered for the first time on D3 (the administration order: Tislelizumab - paclitaxel - cisplatin). IPM514 will be administered a total of 3 times, and PD-1 antibody, cisplatin and paclitaxel will all be administered a total of 2 times (that is, IPM514 is administered on D0/D21/D42, and Tislelizumab, paclitaxel and cisplatin are administered on D3/D24).

Study groups in NCT06690476
Study groupRoleWhat they receive
Dose escalation(IPM514 monotherapy)ExperimentalDrug：IPM514 Intramuscular Injection A total of 7 administrations, including 2 cycles of vaccination with each cycle at QW × 3 doses; there is a 2-weeks interval between the two cycles, then followed by a boost dose 3 weeks after the 2'nd cycle.
Receives: Drug: Dose escalation(IPM514 monotherapy)
Dose expansion (IPM514 combined with tislelizumab)ExperimentalDrug：IPM514 Intramuscular Injection Drug：tislelizumab intravenous administration The usage and dosage of the tislelizumab will be based on the drug instructions. IPM514 administration is planned to be concomitant with PD-1 antibody and to be stopped after 9 doses of treatment, while the PD-1 antibody will be continuously administered for a maximum of 1 year.
Receives: Drug: Dose expansion (IPM514 combined with tislelizumab)
Neoadjuvant therapy cohort(IPM514 combined with tislelizumab, cisplatin and paclitaxel)ExperimentalDrug：IPM514 Intramuscular Injection Drug：tislelizumab intravenous administration Drug：cisplatin intravenous administration Drug：paclitaxel intravenous administration In this stage, subjects will receive the treatment of IPM514 combined with Tislelizumab, cisplatin and paclitaxel. All four drugs will be administered once every 3 weeks (± 1 day). IPM514 will be administered for the first time on D0, and Tislelizumab, cisplatin and paclitaxel will be administered for the first time on D3 (the administration order: Tislelizumab - paclitaxel - cisplatin). IPM514 will be administered a total of 3 times, and PD-1 antibody, cisplatin and paclitaxel will all be administered a total of 2 times (that is, IPM514 is administered on D0/D21/D42, and Tislelizumab, paclitaxel and cisplatin are administered on D3/D24).
Receives: Drug: Neoadjuvant therapy cohort(IPM514 combined with tislelizumab, cisplatin and paclitaxel)

What is being measured

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

  1. Safety and tolerability

    Dose escalation \& Dose expansion：(1) Incidence and severity of adverse events (AEs), immune-related adverse events (irAEs), serious adverse events (SAEs) assessed by NCI-CTCAE v5.0. (2) The incidence and titer of anti-drug antibodies (ADA)

    Measured: up to 12 months

  2. The MTD, if any, and RP2D

    Dose escalation \& Dose expansion：IPM514 will be determined based on safety, tolerability, PK, preliminary efficacy, and other available data

    Measured: up to 12 months

  3. PK parameter

    Dose escalation \& Dose expansion：mRNA quantitation in blood by qPCR

    Measured: up to 12 months

  4. the pCR rate

    Neoadjuvant Treatment Cohort：The rate of pathological complete response

    Measured: up to 12 months

Secondary outcomes (11)

  1. Objective response rate (ORR)

    Dose escalation \& Dose expansion：Objective response rate (ORR) per RECIST 1.1 criteria according to investigators assessment

    Measured: up to 12 months

  2. disease control rate (DCR)

    Dose escalation \& Dose expansion：disease control rate (DCR) per RECIST 1.1 criteria according to investigators assessment

    Measured: up to 12 months

  3. progression-free survival (PFS)

    Dose escalation \& Dose expansion：Progression free survival (PFS) rates

    Measured: up to 12 months

  4. overall survival (OS)

    Dose escalation \& Dose expansion：Overall survival (OS) rates

    Measured: up to 12 months

  5. duration of response (DOR)

    Dose escalation \& Dose expansion：Duration of response (DOR) per RECIST 1.1 criteria according to investigators assessment

    Measured: up to 12 months

  6. the MPR rate

    Neoadjuvant Treatment Cohort：The rate of major pathological response

    Measured: up to 12 months

  7. the rate of R0 resection

    Neoadjuvant Treatment Cohort：the rate of R0 resection

    Measured: up to 12 months

  8. AE

    Neoadjuvant Treatment Cohort：The incidence and severity of adverse events (AEs), immune-related adverse events (irAEs), and serious adverse events (SAEs) as evaluated according to NCI-CTCAE v5.0;

    Measured: up to 12 months

  9. Surgical safety

    Neoadjuvant Treatment Cohort：surgical complications within 30 days after surgery or during the postoperative hospital stay, length of hospital stay, reoperation rate, and 30-day postoperative mortality rate;

    Measured: up to 12 months

  10. Biological responses

    Neoadjuvant Treatment Cohort：(1) Lymphocyte subset analysis, including T/B/NK cell count and phenotyping of memory T cell; (2) TAA-specific T cell identification through tetramer and intracellular cytokine production via flow cytometry; (3) Immune responses of CTLs via IFN-γ ELISPOT; (4) Single-cell phenotypic analysis.

    Measured: up to 12 months

  11. Predictive biomarkers

    Neoadjuvant Treatment Cohort：including but not limited to tumor tissue antigen expression, minimal residual disease (MRD) and blood-based tumor mutational burden (bTMB)

    Measured: up to 12 months

Timeline

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

  1. First posted15 Nov 2024
  2. Study start10 Oct 2024
  3. Primary completionJul 2026 (estimated)
  4. Study completionOct 2026 (estimated)

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
Early Phase 1
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
74 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06690476
Sponsor's protocol ID
IPM514-001
Status last verified
Jul 2024
First submitted
13 Nov 2024
Last updated
15 Nov 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Early Phase 1 study testing Dose escalation(IPM514 monotherapy), Dose expansion (IPM514 combined with tislelizumab) and Neoadjuvant therapy cohort(IPM514 combined with tislelizumab, cisplatin and paclitaxel) in people with Esophageal Squamous Cell Carcinoma, run by Peking University 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 23 inclusion and 17 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 15 Nov 2024. 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?

Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.

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 Zhi hao Lu (13810549767, 13810549767@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Safety and tolerability (time frame: up to 12 months). The study lists 4 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 NCT06690476.

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 15 Nov 2024.

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