---
title: MSB0011359C (M7824) in Participants With Metastatic or Locally Advanced Solid Tumors
nct_id: NCT02699515
overall_status: COMPLETED
phase: PHASE1
sponsor: Merck KGaA, Darmstadt, Germany
study_type: INTERVENTIONAL
primary_condition: Solid Tumors
countries: Japan, South Korea, Taiwan
canonical_url: "https://parkinsonspathways.com/agent/trials/NCT02699515.md"
clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT02699515"
ct_last_update_post_date: 2024-11-18
last_seen_at: "2026-05-12T06:47:14.785Z"
source: ClinicalTrials.gov (mirrored, no enrichment)
---
# MSB0011359C (M7824) in Participants With Metastatic or Locally Advanced Solid Tumors

**Official Title:** A Phase I, Open-label, Multiple-ascending Dose Trial to Investigate the Safety, Tolerability, Pharmacokinetics, Biological and Clinical Activity of MSB0011359C (M7824) in Subjects With Metastatic or Locally Advanced Solid Tumors With Expansion to Selected Indications in Asia

**NCT ID:** [NCT02699515](https://clinicaltrials.gov/study/NCT02699515)

## Key Facts

- **Status:** COMPLETED
- **Phase:** PHASE1
- **Study Type:** INTERVENTIONAL
- **Target Enrollment:** 114
- **Lead Sponsor:** Merck KGaA, Darmstadt, Germany
- **Conditions:** Solid Tumors
- **Start Date:** 2016-03-11
- **Completion Date:** 2022-02-21
- **CT.gov Last Update:** 2024-11-18

## 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.

## Eligibility

- **Minimum age:** 20 Years
- **Sex:** ALL
- **Healthy Volunteers:** No

```
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

Other protocol-defined exclusion criteria could apply.

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)
```

## Arms

- **MSB0011359C (M7824)** (EXPERIMENTAL)

## Interventions

- **MSB0011359C** (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.

## Primary Outcomes

- **Number of Participants With Dose Limiting Toxicity (DLT)** _(time frame: Baseline up to Week 3)_ — A DLT was defined as any grade greater than or equal to (\>=) 3 adverse event suspected to be related to investigational medicinal product (IMP) by the Investigator and / or Sponsor occurring in the DLT evaluation period confirmed by the Safety Monitoring Committee (SMC) to be relevant for the IMP treatment.
- **Number of Participants With Treatment-Emergent Adverse Events (TEAEs) According to National Cancer Institute-Common Terminology Criteria for Adverse Event (NCI-CTCAE) Version 4.03** _(time frame: First study drug administration up to 30 days after the last drug administration assessed up to approximately 5 years)_ — An adverse event (AE) was any untoward medical occurrence in a clinical investigation participant administered a product or medical device; the event needed not necessarily have a causal relationship with the treatment or usage. Serious AE: an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect or was otherwise considered medically important. TEAE: AE with onset after start of treatment or with onset date before the treatment start date but worsening after the treatment start date. TEAEs included both serious and non-serious TEAEs.
- **Number of Participants With Treatment-Related Adverse Events (TRAEs) According to NCI-CTCAE Version 4.03** _(time frame: First study drug administration up to 30 days after the last drug administration assessed up to approximately 5 years)_ — An adverse event (AE) was any untoward medical occurrence in a clinical investigation participant administered a product or medical device; the event needed not necessarily have a causal relationship with the treatment or usage. Serious AE: an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect or was otherwise considered medically important. TEAE: AE with onset after start of treatment or with onset date before the treatment start date but worsening after the treatment start date. TEAEs included both serious and non-serious TEAEs. Treatment-related TEAEs: reasonably related to the study intervention. Number of participants with TEAEs and treatment related TEAEs were reported.

## Secondary Outcomes

- **Dose-Escalation Phase: Maximum Serum Concentration (Cmax) of M7824** _(time frame: Pre-dose, 0, 4 hour post dose on Day 1, 2,8,15,29,43)_
- **Dose-Escalation Phase: Terminal Half Life (t1/2) of M7824** _(time frame: Pre-dose, 0, 4 hour post dose on Day 1, 2,8,15,29,43)_
- **Dose-Escalation Phase: Area Under the Serum Concentration Time Curve From Zero to Last Sampling Time (AUC0-t) of M7824** _(time frame: Pre-dose, 0, 4 hour post dose on Day 1, 2, 8, 15, 29, 43)_
- **Dose-Escalation Phase: Area Under The Concentration Time Curve From Time Zero to Infinity (AUC0-inf) of M7824** _(time frame: Pre-dose, 0, 4 hour post dose on Day 1, 2, 8, 15, 29, 43)_
- **Dose-Escalation Phase: Number of Participants With Positive Serum Titers of Anti-Drug Antibodies of M7824** _(time frame: Predose, Day 15, 43, 85 and every 6-weekly until progression or end of the treatment whichever occur first, assessed up to 3 years)_
- **Dose-Escalation Part: Number of Participants With Best Overall Response (BOR) As Assessed By Investigator** _(time frame: Date of randomization up to 2 years)_
- **Expansion Part: Best Overall Response (BOR) As Assessed By Investigator** _(time frame: Date of randomization up to 2 years)_
- **Expansion Part: BOR According to RECIST 1.1 As Adjudicated By The Independent Review Committee (IRC)** _(time frame: Up to 2 years)_
- **Expansion Part: Duration of Response (DOR)** _(time frame: Up to 2 years)_
- **Expansion Part: Disease Control Rate** _(time frame: Up to 2 years)_
- **Expansion Part: Progression Free Survival (PFS) Time** _(time frame: Date of randomization until death or progressive disease assessed up to 2 years)_
- **Expansion Part: Overall Survival (OS) Time** _(time frame: Date of randomization until death assessed up to 2 years)_

## Locations (18)

- 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, Taiwan
- Mackay Memorial Hospital, Taipei, Taiwan
- National Taiwan University Hospital, Taipei, Taiwan
- Chang Gung Memorial Hospital; Linkou, Taoyuan, Taiwan

## Recent Field Changes (last 30 days)

- `status.overallStatus` — added _(2026-05-12)_
- `status.primaryCompletionDate` — added _(2026-05-12)_
- `status.completionDate` — added _(2026-05-12)_
- `status.lastUpdatePostDate` — added _(2026-05-12)_
- `design.phases` — added _(2026-05-12)_
- `design.enrollmentCount` — added _(2026-05-12)_
- `eligibility.criteria` — added _(2026-05-12)_
- `eligibility.minAge` — added _(2026-05-12)_
- `eligibility.sex` — added _(2026-05-12)_
- `outcomes.primary` — added _(2026-05-12)_
- `outcomes.secondary` — added _(2026-05-12)_
- `armsInterventions.arms` — added _(2026-05-12)_
- `armsInterventions.interventions` — added _(2026-05-12)_
- `sponsor.lead` — added _(2026-05-12)_
- `results.hasResults` — added _(2026-05-12)_
- `locations.nho kyushu cancer center|fukuoka||japan` — added _(2026-05-12)_
- `locations.national cancer center east, department of experimental therapeutics|kashiwa||japan` — added _(2026-05-12)_
- `locations.national cancer center east, department of hepatobiliary and pancreatic oncology|kashiwa||japan` — added _(2026-05-12)_
- `locations.saitama cancer center|kitaadachi-gun||japan` — added _(2026-05-12)_
- `locations.nho shikoku cancer center|matsuyama||japan` — added _(2026-05-12)_
- `locations.aichi cancer center hospital|nagoya||japan` — added _(2026-05-12)_
- `locations.kinki university hospital|sayama||japan` — added _(2026-05-12)_
- `locations.national cancer center, department of experimental therapeutics|tokyo||japan` — added _(2026-05-12)_
- `locations.national cancer center, department of hepatobiliary and pancreatic oncology|tokyo||japan` — added _(2026-05-12)_
- `locations.kanagawa cancer center, department of gastroenterology|yokohama||japan` — added _(2026-05-12)_
- `locations.kanagawa cancer center, department of gastrointestinal surgery|yokohama||japan` — added _(2026-05-12)_
- `locations.asan medical center|seoul||south korea` — added _(2026-05-12)_
- `locations.seoul national university hospital|seoul||south korea` — added _(2026-05-12)_
- `locations.severance hospital|seoul||south korea` — added _(2026-05-12)_
- `locations.national cheng kung university hospital|tainan||taiwan` — added _(2026-05-12)_
- `locations.mackay memorial hospital|taipei||taiwan` — added _(2026-05-12)_
- `locations.national taiwan university hospital|taipei||taiwan` — added _(2026-05-12)_
- `locations.chang gung memorial hospital; linkou|taoyuan||taiwan` — added _(2026-05-12)_

---

*Canonical: https://parkinsonspathways.com/agent/trials/NCT02699515.md*  
*Source data (authoritative): https://clinicaltrials.gov/study/NCT02699515*  
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