A Study of MRG003 in the Treatment of Patients With EGFR-positive Advanced or Metastatic Solid Tumors

NCT05688605 | Unknown Phase 1

• 1 other identifier: HX008/MRG003-C001
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 2

Brief Summary

The objective of this study is to assess the safety, efficacy, pharmacokinetics, and immunogenicity of MRG003 in combination with HX008 in patients with EGFR-positive advanced or metastatic solid tumors.

Conditions

Advanced Solid Tumors

Keywords

MRG003; HX008; Antibody Drug Conjugate (ADC); EGFR; Solid tumors

Outcome Measures

Primary Outcomes (3)

• Maximum Tolerated Dose (MTD)

  MTD is the highest dose with the proportion of DLT less than 1/3

  Within 21 days after the first dose of the last patient of the MTD group

• Recommended Phase II Dose (RP2D)

  The dose level of MRG003 recommended for further clinical studies based on assessment of the safety, efficacy and PK data from this study.

  Baseline to study completion (up to 12 months)

• Objective Response Rate (ORR)

  ORR is defined as the proportions of patients with a complete response (CR) and partial response (PR). ORR will be assessed by investigator according to RECIST v1.1.

  Baseline to study completion (up to 12 months)

Secondary Outcomes (8)

• Duration of Response (DOR)

  Baseline to study completion (up to 12 months)

• Disease Control Rate (DCR)

  Baseline to study completion (up to 12 months)

• Progression Free Survival (PFS)

  Baseline to study completion (up to 12 months)

• Overall Survival (OS)

  Baseline to study completion (up to 12 months)

• Immunogenicity (ADA)

  Baseline to 90 days after the last dose.

Study Arms (1)

MRG003+HX008

EXPERIMENTAL

MRG003 will be administrated via intravenous infusion at 1.5, 2.0 mg/kg (MTD=2.5 mg/kg) once on Day 1 of every 3 weeks (21-day cycle). HX008 will be administrated via intravenous infusion at 3 mg/kg once on Day 1 of every 3 weeks (21-day cycle).

Drug: MRG003+HX008

Interventions

MRG003+HX008 DRUG

Administered intravenously

MRG003+HX008

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Willing to sign the informed consent form and follow the requirements specified in the protocol.
• Aged 18 to 75 (including 18 and 75), both genders.
• BMI ≥17
• Life expectancy ≥ 12 weeks.
• Patients with EGFR-positive advanced or metastatic solid tumors, including non-small cell lung cancer (NSCLC), squamous cell carcinoma of head and neck (SCCHN), and nasopharyngeal carcinoma (NPC).
• EGFR-positive determined by immunohistochemistry (except NSCLC, SCCHN and NPC).
• Patients must have measurable lesions according to the Response Evaluation Criteria in Solid Tumors (RECIST v1.1).
• The score of ECOG for performance status is 0 or 1.
• No severe cardiac dysfunction.
• Acceptable liver, renal, and hematologic function.
• Patients with childbearing potential must use effective contraception during the treatment and for 6 months after the last dose of treatment.

You may not qualify if:

• History of hypersensitivity to any component of the investigational product.
• Prior treatment with chemotherapy, biological therapy, immunotherapy, radiotherapy, investigational drugs, attenuated live vaccines, immunomodulators, CYP3A4 inhibitors/inducers, antibody-drug conjugates, Received major surgery without complete recovery, etc.
• Treatment with MMAE/MMAF ADC drugs
• Central nervous system metastasis.
• Toxic reaction or abnormal value of laboratory test caused by previous anti-tumor treatment ≥ 2 (CTCAE v5.0)
• Presence of peripheral neuropathy ≥ Grade 2.
• Liver function Child Pugh Grade B or Grade C。
• Pleural and peritoneal effusion or pericardial effusion with clinical symptoms requiring drainage.
• Poorly controlled systemic diseases (hypertension and hyperglycemia, etc.)
• Evidence of active infection of hepatitis B, hepatitis C or HIV.
• Patients with poorly controlled heart diseases
• History of ophthalmic abnormalities.
• History of severe skin disease requiring oral or intravenous therapy.
• History of interstitial pneumonia, radiation pneumonia, severe chronic obstructive pulmonary disease, severe pulmonary insufficiency, symptomatic bronchospasm, etc.
• Active, known or suspected autoimmune disease or drug related immune disease or the disease history within the past 2 years.

Sponsors & Collaborators

• Shanghai Miracogen Inc.: lead

Study Sites (2)

Sun Yat-sen University Cancer Center

Guangzhou, Guangdong, 510060, China

RECRUITING

Hunan Cancer Hospital

Changsha, Hunan, 410029, China

NOT YET RECRUITING

Study Officials

• Ruihua Xu, M.D.

  Sun Yat-sen University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Program Director

CONTACT

86-21-61637960; clinicaltrials@miracogen.com.cn

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: January 6, 2023
• First Posted: January 18, 2023
• Study Start: June 30, 2022
• Primary Completion: May 1, 2025
• Study Completion: July 1, 2025
• Last Updated: January 18, 2023

Record last verified: 2023-01

Data Sharing

• IPD Sharing: Will not share

Locations

CN (2)