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

COMPLETEDPHASE1/PHASE2

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

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

NCT04835896•Yonsei University

View on ClinicalTrials.gov

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. 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.

Eligibility

Age

19 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Able and willing to give written informed consent and has signed the informed consent form (ICF), prior to performance of any trial activities.
•2. Eligible male and female subjects aged ≥19 years.
•3. Histologically or cytologically proven metastatic or locally advanced HER2 negative gastric cancer after 1st line failure.
•4. ECOG performance status of 0 to 1 at trial entry.
•5. Life expectancy ≥12 weeks as judged by the Investigator.
•6. 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).
•7. 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.
•8. 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.
•9. Adequate coagulation function: normal international normalized ratio (INR), PT ≤1.5×ULN and activated partial thromboplastin time (aPTT) ≤1.5×ULN.
•10. 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.
+2 more criteria

Exclusion Criteria

•1. Concurrent treatment with non-permitted drugs.
•2. 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.
•3. Prior therapy with any antibody/drug targeting TGFβ or TGF receptor.
•4. 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.
•5. Major surgery within 28 days before the start of trial treatment (excluding prior diagnostic biopsy).
•6. 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.
•7. Has persistent ≥Grade 2 toxicity that was not resolved from previous anticancer treatment, such as neuropathy (exceptions are alopecia and anemia).
•8. A WOCBP who has a positive urine pregnancy test within 72 hours prior to allocation.
•9. Has received a live vaccine within 30 days prior to the first dose of study drug.
•10. 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.
+15 more criteria

Locations (1)

Yonsei University Health System, Severance Hospital

Seoul, South Korea

Key Dates

Start Date

June 2, 2021

Primary Completion Date

October 27, 2023

Completion Date

October 27, 2023

Last Updated

May 6, 2024

Enrollment

ACTUAL participants

Conditions

Recurrent/Metastatic Gastric Cancer

Interventions

M7824+paclitaxel

DRUG