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Recurrent/Metastatic Gastric CancerPhase 1/2NCT04835896

Study of M7824 and Paclitaxel Combination as a Second-line Treatment in Patients With Recurrent/Metastatic Gastric Cancer

A Phase 1/2 study testing M7824+paclitaxel in people with Recurrent/Metastatic Gastric Cancer, run by Yonsei University at 1 site in South Korea.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This is a Phase 1b/2 study to identify the recommended dose of M7824 for further study with weekly paclitaxel, and to assess the safety and clinical efficacy of this combined treatment in advanced gastric cancer after first line treatment. Read more about this study

Who is it for?
Ages 19 years and older
Conditions the study is for
Recurrent/Metastatic Gastric Cancer
What is being tested?
M7824+paclitaxel
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
49 participants
Where
1 siteSouth Korea
Study dates
2 Jun 2021to 27 Oct 2023
Phase
Phase 1/2
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 19 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Able and willing to give written informed consent and has signed the informed consent form (ICF), prior to performance of any trial activities.
  • Eligible male and female subjects aged ≥19 years.
  • Histologically or cytologically proven metastatic or locally advanced HER2 negative gastric cancer after 1st line failure.
  • ECOG performance status of 0 to 1 at trial entry.
  • Life expectancy ≥12 weeks as judged by the Investigator.
  • Adequate hematological function defined by white blood cell (WBC) count ≥3×109/L with absolute neutrophil count (ANC) ≥1.5×109/L, lymphocyte count ≥0.5×109/L, platelet count ≥100×109/L, and Hb ≥9 g/dL (in absence of blood transfusion).
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  • Adequate hepatic function defined by a total bilirubin level ≤1.5×ULN, an AST level ≤1.5×ULN, and an ALT level ≤1.5×ULN. For subjects with liver involvement in their tumor, AST ≤5.0×ULN, ALT ≤5.0×ULN, and bilirubin ≤3.0 is acceptable.
  • Adequate renal function defined by an estimated creatinine clearance >50 mL/min according to the Cockcroft-Gault formula or by measure of creatinine clearance from 24-hour urine collection.
  • Adequate coagulation function: normal international normalized ratio (INR), PT ≤1.5×ULN and activated partial thromboplastin time (aPTT) ≤1.5×ULN.
  • HIV patient must be stable on ART for at least 4 weeks, having documented evidence of multi-drug resistance, viral load of <400 copies/ml and CD4+ T-cells ≤350 cells/µL.
  • HBV/HCV positive participant must be on a stable dose of antiviral therapy, having HBV viral load below the limit of quantification (HBV titer <2000 IU/ml) and HCV RNA is not detected.
  • Has measurable or evaluable disease as determined by RECIST 1.1.

Who cannot join

  • Concurrent treatment with non-permitted drugs.
  • Prior therapy with any antibody/drug targeting T cell coregulatory proteins (immune checkpoints) such as anti-PD-1, anti-cytotoxic T lymphocyte antigen-4 (CTLA-4) antibody, or anti-4-1BB antibody, is not allowed.
  • Prior therapy with any antibody/drug targeting TGFβ or TGF receptor.
  • Anticancer treatment within 21 days before the start of trial treatment, e.g., cytoreductive therapy, radiotherapy (with the exception of palliative bone-directed radiotherapy), immune therapy, or cytokine therapy.
  • Major surgery within 28 days before the start of trial treatment (excluding prior diagnostic biopsy).
  • Systemic therapy with immunosuppressive agents within 7 days before the start of trial treatment; or use of any investigational drug within 28 days before the start of trial treatment.
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  • Has persistent ≥Grade 2 toxicity that was not resolved from previous anticancer treatment, such as neuropathy (exceptions are alopecia and anemia).
  • A WOCBP who has a positive urine pregnancy test within 72 hours prior to allocation.
  • Has received a live vaccine within 30 days prior to the first dose of study drug.
  • Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior to the first dose of study drug.
  • Has a known additional malignancy that is progressing or has required active treatment within the past 5 years.
  • Has known active CNS metastases and/or carcinomatous meningitis.
  • Has active autoimmune disease that has required systemic treatment in the past 2 years (i.e. with use of disease modifying agents, corticosteroids, or immunosuppressive drugs).
  • Has a history of (non-infectious) pneumonitis that required steroids or has current pneumonitis.
  • Has an active infection requiring systemic therapy.
  • Has uncontrolled or severe cardiovascular disease, as per following criteria: Myocardial infarction within 180 days before the start of trial treatment; Uncontrolled angina pectoris within 180 days before the start of trial treatment; New York Heart Association (NYHA) Class III or IV congestive heart failure; Uncontrolled hypertension despite appropriate treatment (systolic blood pressure ≥150 mmHg or diastolic blood pressure ≥90 mmHg lasting 24 hours or more); Arrhythmia requiring treatment
  • History of bleeding diathesis or recent major bleeding event.
  • Has a known history of Human Immunodeficiency Virus (HIV) without treatment.
  • Has an active of Hepatitis B (defined as Hepatitis B surface antigen [HBsAg] reactive and HBV titer >2000 IU/ml) or known active Hepatitis C virus (defined as HCV RNA is detected) infection.
  • Has an active TB (Bacillus Tuberculosis) with treatment.
  • Has known history of hypersensitivity to one or more of the study treatments or their substances, or known severe hypersensitivity to monoclonal antibodies (≥Grade 3), history of anaphylaxis, or uncontrolled asthma within 5 months before start of trial treatment.
  • Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the study, interfere with the subject's participation for the full duration of the study, or is not in the best interest of the subject to participate, in the opinion of the treating investigator.
  • Have received more than 2nd line of chemotherapy.
  • Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial.
  • Otherwise inappropriate for this study in the investigator's or sub-investigator's opinion.

Trial locations and contacts

1 site in 1 country.

South Korea1 site

  • Yonsei University Health System, Severance Hospital

    Seoul

Other trials in South Korea

About this study

Official title: An Open Label, Single-arm, Multi-center Phase 1b/2 Combination Study of M7824 (Bintrafusp Alfa) and Paclitaxel in Recurrent/Metastatic Gastric Cancer as a Second-line Treatment

This is a Phase 1b/2 study to identify the recommended dose of M7824 for further study with weekly paclitaxel, and to assess the safety and clinical efficacy of this combined treatment in advanced gastric cancer after first line treatment. The study will be conducted in two parts: Part 1 (Phase 1b) dose escalation study to determine the MTD and RP2D of weekly paclitaxel in combination with fixed dose M7824, Part 2 (Phase 2) to further evaluate the safety and tolerability of the combination of M7824 and paclitaxel at the RP2D and determine anti-tumor activity.

Being tested
M7824+paclitaxel
Medical subject headings
Stomach Neoplasms

What participants receive

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

  • M7824+paclitaxelDrug

    M7824 will be administered intravenously at a dose of 1200 mg every 3 weeks in combination with paclitaxel 80 (or 70) mg/m2 once a week for 3 weeks (each cycle is 4 weeks)

Study groups in NCT04835896
Study groupRoleWhat they receive
Study treatmentExperimentalNot described
Receives: Drug: M7824+paclitaxel

What is being measured

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

  1. Phase 1b: Dose-limiting toxicity in subjects with M7824 and paclitaxel combination treatment

    Measured: Within first 4 weeks

  2. Phase 2: Progression-free survival in subjects with M7824 and paclitaxel combination treatment

    Measured: At 24 weeks

Secondary outcomes (6)

  1. Overall survival

    Measured: 3 months after the last dose study treatment of the last subject

  2. Objective response rate according to RECIST 1.1

    Measured: 3 months after the last dose study treatment of the last subject

  3. Disease control rate according to RECIST 1.1

    Measured: 3 months after the last dose study treatment of the last subject

  4. Duration of response according to RECIST 1.1

    Measured: 3 months after the last dose study treatment of the last subject

  5. Progression-free survival according to RECIST 1.1

    Measured: 3 months after the last dose study treatment of the last subject

  6. Safety and Tolerability, in terms of the number, severity, and duration of treatment-emergent adverse events as assessed by CTCAE v5.0

    Measured: Throughout the overall trial period as well as up to 3 months after the last dose study treatment for each subject

Timeline

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

  1. First posted8 Apr 2021
  2. Study start2 Jun 2021
  3. Primary completion27 Oct 2023
  4. Study completion27 Oct 2023

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 1/2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Sequential
Masking
None (open label)
Enrolment
49 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04835896
Sponsor's protocol ID
4-2020-1334
Status last verified
May 2024
First submitted
1 Apr 2021
Last updated
6 May 2024
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing M7824+paclitaxel in people with Recurrent/Metastatic Gastric Cancer, run by Yonsei University at 1 site in South Korea.

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 12 inclusion and 25 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: finished, as of the sponsor's last update on 6 May 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 South Korea. 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 combined 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.

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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Phase 1b: Dose-limiting toxicity in subjects with M7824 and paclitaxel combination treatment (time frame: Within first 4 weeks). 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?

On the ClinicalTrials.gov record for NCT04835896.

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 6 May 2024.

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