A Study of M802 (HER2 and CD3) in HER2-Positive Advanced Solid Tumors

NCT04501770 | Completed Phase 1 FDA Drug

• 1 other identifier: M80201
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to evaluate the safety and tolerability of different doses of M802 in patients with HER2-positive advanced solid tumors, and to determine the dose limiting toxicity (DLT) and the maximum tolerated dose (MTD) so as to provide basis for the recommended phase 2 dose (RP2D).

Conditions

HER2-Positive Solid Tumors

Outcome Measures

Primary Outcomes (2)

• MTD

  Number of DLTs (dose limiting toxicities) during the first 28 days after the first administrations of study drug in each cohort.

  From the time of first dosing (Day 1) until the forth dosing (Day 28)

• RP2D

  Incidence and severity of AEs, and SAEs, including but not limited to laboratory values, PK and biomarkers. All AEs will be classified as Grades 1 through 5 as defined by NCI CTCAE v5.0.

  From the start of administration to the end of the study or 28 days after the administration is stopped (up to 1 years and 28 days)

Secondary Outcomes (13)

• Area under the curve (AUC) of M802

  From the time of first dosing (Day 1) until disease progression or toxicity intolerance (up to 1 years).

• Maximum observed concentration (Cmax) of M802

  From the time of first dosing (Day 1) until disease progression or toxicity intolerance (up to 1 years).

• Minimum observed concentration (Cmin) of M802

  From the time of first dosing (Day 1) until disease progression or toxicity intolerance (up to 1 years).

• Expression levels of CEA

  From the time of screening period until disease progression or toxicity intolerance (up to 1 years and 28 days).

• Expression levels of CA15-3

  From the time of screening period until disease progression or toxicity intolerance (up to 1 years and 28 days).

Study Arms (1)

M802

EXPERIMENTAL

Subjects who meet the enrollment criteria will enter the core treatment period and receive a cycle of treatment with M802 (once weekly for 4 weeks) via intravenous infusion. And eligible subjects who complete the core treatment period will receive a cycle of extended treatment (once weekly for 4 weeks) until disease progression or toxicity intolerance.

Drug: Chort 1 of M802; Drug: Chort 2 of M802; Drug: Cohort 3 of M802; Drug: Cohort 4 of M802; Drug: Cohort 5 of M802; Drug: Cohort 6 of M802; Drug: Cohort 7 of M802; Drug: Cohort 8 of M802

Interventions

Chort 1 of M802 DRUG

Cohort 1, subjects will be administered M802 via intravenous infusion on Day 1, Day 8, Day 15, and Day 22 of each 28-day treatment cycle at dose levels. The starting dose is 2 μg, and the maintenance dose during core treatment period and extended treatment period is 5 μg.

M802

Chort 2 of M802 DRUG

Cohort 2, subjects will be administered M802 via intravenous infusion on Day 1, Day 8, Day 15, and Day 22 of each 28-day treatment cycle at dose levels. The starting dose is 5 μg, and the maintenance dose during core treatment period and extended treatment period is 10 μg.

M802

Cohort 3 of M802 DRUG

Cohort 3, subjects will be administered M802 via intravenous infusion on Day 1, Day 8, Day 15, and Day 22 of each 28-day treatment cycle at dose levels. The starting dose is 10 μg, and the maintenance dose during core treatment period and extended treatment period is 20 μg.

M802

Cohort 4 of M802 DRUG

Cohort 4, subjects will be administered M802 via intravenous infusion on Day 1, Day 8, Day 15, and Day 22 of each 28-day treatment cycle at dose levels. The starting dose is 20 μg, and the maintenance dose during core treatment period and extended treatment period is 50 μg.

M802

Cohort 5 of M802 DRUG

Cohort 5, subjects will be administered M802 via intravenous infusion on Day 1, Day 8, Day 15, and Day 22 of each 28-day treatment cycle at dose levels. The starting dose is 50 μg, and the maintenance dose during core treatment period and extended treatment period is 100 μg.

M802

Cohort 6 of M802 DRUG

Cohort 6, subjects will be administered M802 via intravenous infusion on Day 1, Day 8, Day 15, and Day 22 of each 28-day treatment cycle at dose levels. The starting dose is 100 μg, and the maintenance dose during core treatment period and extended treatment period is 150 μg.

M802

Cohort 7 of M802 DRUG

Cohort 7, subjects will be administered M802 via intravenous infusion on Day 1, Day 8, Day 15, and Day 22 of each 28-day treatment cycle at dose levels. Dose on D1 is 150 μg, and on D8, D15, D22 is 225 μg.

M802

Cohort 8 of M802 DRUG

Cohort 8, subjects will be administered M802 via intravenous infusion on Day 1, Day 8, Day 15, and Day 22 of each 28-day treatment cycle at dose levels. The starting dose is 225 μg, and the maintenance dose during core treatment period and extended treatment period is 300 μg.

M802

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Males or females, aged ≥18 years old.
• Patients must have a diagnosis of histologically or cytologically confirmed metastatic advanced solid tumor with failure to standard treatment and who have no available therapy that may confer clinical benefit. Patients with HER2-positive metastatic breast cancer should have received standard anti-HER2 therapies.
• HER2 expression status report should be provided during the screening period with fluorescence in-situ hybridization (FISH) or Chromogenic in situ hybridization (CISH) test positive, or immunohistochemistry IHC 3+, or immunohistochemistry IHC 2+ and confirmed by amplification of FISH or CISH.
• Patients must have stopped anti-tumor treatment for at least 4 weeks prior to the first dose of M802. The anti-tumor treatment includes chemotherapy, immunotherapy, targeted therapy, endocrine therapy, and radiotherapy (except for local radiation therapy for alleviating pain, at least 14 days after end of treatment).
• Patients must have measurable lesions at baseline according to the RECIST Version 1.1.
• Patients must have an ECOG performance status (PS) Score of 0-1.
• Patients must have an expected survival \> 12 weeks.
• Patients must have a baseline left ventricular ejection fraction (LVEF) ≥ 50%.
• Patients must have adequate haematological and organ functions as indicated by the following laboratory values:
• Haematological: Absolute Neutrophil Count (ANC) ≥ 1.5 ×10\^9/L; Blood Platelet Count (BPC) ≥ 80 ×10\^9/L; Hemoglobin ≥ 9.0 g/dL (No blood transfusions within 14 days).
• Hepatic: Bilirubin ≤ 1.5 × upper limit of normal (ULN); AST and ALT ≤ 2.5 × ULN (AST, ALT ≤ 5 × ULN is allowed when there is liver metastasis).
• Renal: Serum creatinine ≤ 1.5 × ULN.
• Patients must understand and voluntarily agree to participate by signing written informed consent.

You may not qualify if:

• Patients who had prior treatment with trastuzumab or similar monoclonal drugs within 4 weeks before first dosing of M802.
• Patients with brain metastasis.
• Patients who have uncontrollable active infections (Grade ≥ 2 according to CTCAE Version 5.0).
• Patients with severe respiratory disease who are not suitable for the study at the judgment of investigator.
• Patients with severe immunosuppression (long-term use of immunosuppressant or glucocorticoid with daily dosage of dexamethasone ≥10 mg).
• Patients who have other malignant tumors in the past 5 years, except the complete cured cervical carcinoma in situ or basal cell or squamous cell carcinoma.
• Patients with a history of serious cardiovascular disease, including receiving coronary artery bypass grafts or coronary stenting, occurrence of myocardial infarction, congestive heart failure within 6 months, or a history of unstable angina, uncontrolled severe hypertension or arrhythmia requiring medication.
• Patients with a history of autoimmune diseases (e.g. inflammatory bowel disease, idiopathic thrombocytopenic purpura, lupus erythematosus, hemolytic anemia, scleroderma, severe psoriasis, rheumatoid arthritis).
• Patients with severe hyperthyroidism or hypothyroidism.
• Patients with metabolic diseases such as uncontrolled diabetes, severe gastrointestinal bleeding, severe diarrhea (Grade ≥ 2 according to CTCAE Version 5.0), or severe gastrointestinal obstruction requiring intervention.
• Patients with a history of immunodeficiency, including HIV positive.
• Patients with Hepatitis b surface antigen test positive or hepatitis c antibody test positive.
• Patients who have received inoculation of (attenuated) live virus vaccine within 4 weeks before first dosing of M802.
• Pregnant, lactating women, or females or males who have fertility plan within 12 months.
• Patients with a previous history of definite neurological or psychiatric disorders, including epilepsy or dementia.

Sponsors & Collaborators

• Wuhan YZY Biopharma Co., Ltd.: lead

Study Sites (1)

wuhan YZY Biopharma Co.,Ltd.

Wuhan, Hubei, 430000, China

Location

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 31, 2020
• First Posted: August 6, 2020
• Study Start: September 27, 2018
• Primary Completion: May 6, 2022
• Study Completion: September 14, 2022
• Last Updated: July 20, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)