MSB0011359C (M7824) in Participants With Metastatic or Locally Advanced Solid Tumors

NCT ID: NCT02699515

Last Updated: 2024-11-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 114 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-03-11
• Study Completion Date: 2022-02-21

Brief Summary

The main purpose of this study was to assess the safety and tolerability of MSB0011359C. Study consists of dose-escalation part and an expansion part in participants with metastatic or locally advanced solid tumors, for which no standard effective therapy exists or a standard therapy had failed.

Conditions

Solid Tumors

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

MSB0011359C (M7824)

Group Type: EXPERIMENTAL

MSB0011359C

Intervention Type: DRUG

Subjects with metastatic or locally advanced solid tumors received intravenous infusion of MSB0011359C over 1 hour once every two weeks for up to 12 months until confirmed progressive disease (PD), unacceptable toxicity, or any criterion for withdrawal from the trial or investigational medicinal product (IMP) occurs.

Interventions

MSB0011359C

Subjects with metastatic or locally advanced solid tumors received intravenous infusion of MSB0011359C over 1 hour once every two weeks for up to 12 months until confirmed progressive disease (PD), unacceptable toxicity, or any criterion for withdrawal from the trial or investigational medicinal product (IMP) occurs.

Intervention Type: DRUG

Other Intervention Names

M7824

Eligibility Criteria

Inclusion Criteria

• Able and willing to give written informed consent and had signed the appropriate written informed consent form (ICF), prior to performance of any trial activities
• Eligible male and female participants aged greater than or equal to (>=)20 years
• Histologically or cytologically proven metastatic or locally advanced solid tumors, for which no effective standard therapy exists or standard therapy had failed
• Eastern Cooperative Oncology Group performance status (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*10^9/Liter with absolute neutrophil count (ANC) >=1.5*10^9/Liter, lymphocyte count >=0.5* 10^9/Liter, platelet count >=75*10^9/Liter, and Hemoglobin (Hgb) >= 9 grams per deciliter (g/dL) (in absence of blood transfusion)
• Adequate hepatic function defined by a total bilirubin level <=1.5 × Upper limit of normal (ULN), an AST level <= 2.5 × ULN, and an ALT level <= 2.5 × ULN
• Adequate renal function defined by an estimated creatinine clearance >50 milliliter per minute (mL/min) according to the Cockcroft-Gault formula or by measure of creatinine clearance from 24 hour urine collection

Exclusion Criteria

• Concurrent treatment with non-permitted drugs and other interventions
• Anticancer treatment within 28 days before the start of trial treatment, for example cyto reductive 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
• Previous malignant disease other than the target malignancy to be investigated in this trial with the exception of cervical carcinoma in situ and superficial or non invasive bladder cancer (treated with curative intent) within the last 5 years or basal cell or squamous cell carcinoma in situ within the last 3 years
• Rapidly progressive disease which, in the opinion of the Investigator, may predispose to inability to tolerate treatment or trial procedures
• Active or history of central nervous system metastases, except as in the melanoma-specific Central nervous system (CNS) criteria listed above
• Receipt of any organ transplantation, including allogeneic stem-cell transplantation, but with the exception of transplants that do not require immunosuppression (eg, corneal transplant, hair transplant)

• Minimum Eligible Age: 20 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Merck KGaA, Darmstadt, Germany

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Medical Responsible

Role: STUDY_DIRECTOR

Merck KGaA, Darmstadt, Germany

Locations

NHO Kyushu Cancer Center

Fukuoka, , Japan

National Cancer Center East, Department of Experimental Therapeutics

Kashiwa, , Japan

National Cancer Center East, Department of hepatobiliary and pancreatic oncology

Kashiwa, , Japan

Saitama Cancer Center

Kitaadachi-gun, , Japan

NHO Shikoku Cancer Center

Matsuyama, , Japan

Aichi Cancer Center Hospital

Nagoya, , Japan

Kinki University Hospital

Sayama, , Japan

National Cancer Center, Department of Experimental Therapeutics

Tokyo, , Japan

National Cancer Center, Department of hepatobiliary and pancreatic oncology

Tokyo, , Japan

Kanagawa Cancer Center, Department of Gastroenterology

Yokohama, , Japan

Kanagawa Cancer Center, Department of Gastrointestinal Surgery

Yokohama, , Japan

Asan Medical Center

Seoul, , South Korea

Seoul National University Hospital

Seoul, , South Korea

Severance Hospital

Seoul, , South Korea

National Cheng Kung University Hospital

Tainan City, , Taiwan

Mackay Memorial Hospital

Taipei, , Taiwan

National Taiwan University Hospital

Taipei, , Taiwan

Chang Gung Memorial Hospital; Linkou

Taoyuan District, , Taiwan

Countries

Japan; South Korea; Taiwan

References

Lin CC, Doi T, Muro K, Hou MM, Esaki T, Hara H, Chung HC, Helwig C, Dussault I, Osada M, Kondo S. Bintrafusp Alfa, a Bifunctional Fusion Protein Targeting TGFbeta and PD-L1, in Patients with Esophageal Squamous Cell Carcinoma: Results from a Phase 1 Cohort in Asia. Target Oncol. 2021 Jul;16(4):447-459. doi: 10.1007/s11523-021-00810-9. Epub 2021 Apr 11.

Reference Type: RESULT

PMID: 33840050 (View on PubMed)

Yoo C, Oh DY, Choi HJ, Kudo M, Ueno M, Kondo S, Chen LT, Osada M, Helwig C, Dussault I, Ikeda M. Phase I study of bintrafusp alfa, a bifunctional fusion protein targeting TGF-beta and PD-L1, in patients with pretreated biliary tract cancer. J Immunother Cancer. 2020 May;8(1):e000564. doi: 10.1136/jitc-2020-000564.

Reference Type: RESULT

PMID: 32461347 (View on PubMed)

Vugmeyster Y, Grisic AM, Wilkins JJ, Loos AH, Hallwachs R, Osada M, Venkatakrishnan K, Khandelwal A. Model-informed approach for risk management of bleeding toxicities for bintrafusp alfa, a bifunctional fusion protein targeting TGF-beta and PD-L1. Cancer Chemother Pharmacol. 2022 Oct;90(4):369-379. doi: 10.1007/s00280-022-04468-6. Epub 2022 Sep 6.

Reference Type: DERIVED

PMID: 36066618 (View on PubMed)

Wilkins JJ, Vugmeyster Y, Dussault I, Girard P, Khandelwal A. Population Pharmacokinetic Analysis of Bintrafusp Alfa in Different Cancer Types. Adv Ther. 2019 Sep;36(9):2414-2433. doi: 10.1007/s12325-019-01018-0. Epub 2019 Jul 5.

Reference Type: DERIVED

PMID: 31278692 (View on PubMed)

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Related Links

http://www.intrapidclinicaltrials.com

INTR@PID Clinical Trial Program

https://clinicaltrials.emdgroup.com/en/trial-details/?id=200647-0008

Trial Awareness and Transparency website

https://www.merckgroup.com/en/company/contact-us/medinfo-contact-map.html

Medical Information Location Map - Med Info Contacts

Other Identifiers

200647-0008

Identifier Type: -

Identifier Source: org_study_id