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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05688605
Recruitment Status : Recruiting
First Posted : January 18, 2023
Last Update Posted : January 18, 2023
Sponsor:
Information provided by (Responsible Party):
Shanghai Miracogen Inc.

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.

Condition or disease Intervention/treatment Phase
Advanced Solid Tumors Drug: MRG003+HX008 Phase 1 Phase 2

Detailed Description:
This study consists of two parts: Phase I and Phase II. The objective of this study is to assess the safety and tolerability of MRG003 in combination with HX008 in patients with EGFR-positive advanced or metastatic solid tumors; and to explore the maximum tolerated dose (MTD) and to determine the recommended phase II dose (RP2D) of combination therapy; and to evaluate the preliminary efficacy, pharmacokinetics, and immunogenicity of combination therapy in the targeted study population.

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Study Type : Interventional
Estimated Enrollment : 18 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Open-label, Multi-center, Phase I/II Dose Escalation and Expansion Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Efficacy of MRG003 in Combination With HX008 in Patients With EGFR-positive Advanced Solid Tumors
Actual Study Start Date : June 30, 2022
Estimated Primary Completion Date : May 2025
Estimated Study Completion Date : July 2025

Arm Intervention/treatment
Experimental: MRG003+HX008

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
Administered intravenously




Primary Outcome Measures :
  1. Maximum Tolerated Dose (MTD) [ Time Frame: Within 21 days after the first dose of the last patient of the MTD group ]
    MTD is the highest dose with the proportion of DLT less than 1/3

  2. Recommended Phase II Dose (RP2D) [ Time Frame: Baseline to study completion (up to 12 months) ]
    The dose level of MRG003 recommended for further clinical studies based on assessment of the safety, efficacy and PK data from this study.

  3. Objective Response Rate (ORR) [ Time Frame: Baseline to study completion (up to 12 months) ]
    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.


Secondary Outcome Measures :
  1. Duration of Response (DOR) [ Time Frame: Baseline to study completion (up to 12 months) ]
    DOR is defined as the duration from the initial recording of objective disease response to the first onset of tumor progression, or death of any cause.

  2. Disease Control Rate (DCR) [ Time Frame: Baseline to study completion (up to 12 months) ]
    DCR is defined as the proportion of subjects achieving CR, PR, and SD after treatment.

  3. Progression Free Survival (PFS) [ Time Frame: Baseline to study completion (up to 12 months) ]
    PFS is defined as the duration from the start of treatment to the onset of tumor progression or death of any cause.

  4. Overall Survival (OS) [ Time Frame: Baseline to study completion (up to 12 months) ]
    OS is defined as the duration from the start of treatment to death of any cause.

  5. Immunogenicity (ADA) [ Time Frame: Baseline to 90 days after the last dose. ]
    The proportion of patients with positive ADA results.

  6. Adverse Events (AEs) [ Time Frame: Baseline to 30 days after the last dose of study treatment ]
    Any reaction, side effect, or untoward event that occurs during the course of the clinical trial whether or not the event is considered related to the study drug.

  7. Serious Adverse Events (SAEs) [ Time Frame: Baseline to 90 days after the last dose of study treatment ]
    Adverse events that are difficult to deal with in clinical drug research

  8. PK parameters: concentration-time curve [ Time Frame: Baseline to 90 days after the last dose. ]
    Plot of drug concentration changing with time after drug administration



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Willing to sign the informed consent form and follow the requirements specified in the protocol.
  2. Aged 18 to 75 (including 18 and 75), both genders.
  3. BMI ≥17
  4. Life expectancy ≥ 12 weeks.
  5. 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).
  6. EGFR-positive determined by immunohistochemistry (except NSCLC, SCCHN and NPC).
  7. Patients must have measurable lesions according to the Response Evaluation Criteria in Solid Tumors (RECIST v1.1).
  8. The score of ECOG for performance status is 0 or 1.
  9. No severe cardiac dysfunction.
  10. Acceptable liver, renal, and hematologic function.
  11. Patients with childbearing potential must use effective contraception during the treatment and for 6 months after the last dose of treatment.

Exclusion Criteria:

  1. History of hypersensitivity to any component of the investigational product.
  2. 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.
  3. Treatment with MMAE/MMAF ADC drugs
  4. Central nervous system metastasis.
  5. Toxic reaction or abnormal value of laboratory test caused by previous anti-tumor treatment ≥ 2 (CTCAE v5.0)
  6. Presence of peripheral neuropathy ≥ Grade 2.
  7. Liver function Child Pugh Grade B or Grade C。
  8. Pleural and peritoneal effusion or pericardial effusion with clinical symptoms requiring drainage.
  9. Poorly controlled systemic diseases (hypertension and hyperglycemia, etc.)
  10. Evidence of active infection of hepatitis B, hepatitis C or HIV.
  11. Patients with poorly controlled heart diseases
  12. History of ophthalmic abnormalities.
  13. History of severe skin disease requiring oral or intravenous therapy.
  14. History of interstitial pneumonia, radiation pneumonia, severe chronic obstructive pulmonary disease, severe pulmonary insufficiency, symptomatic bronchospasm, etc.
  15. Active, known or suspected autoimmune disease or drug related immune disease or the disease history within the past 2 years.
  16. The patient is using immunosuppressant or systemic hormone therapy.
  17. Patients with any past arteriovenous bleeding within 3 months or current history of coagulation disorder.
  18. Any clinically significant VTE occurred within 6 months.
  19. Received allogeneic tissue/solid organ transplantation.
  20. Inoculate live vaccine within 30 days before the first dose.
  21. Patients with a positive serum pregnancy test or who are breast-feeding or who do not agree to take adequate contraceptive measures during the treatment and for 180 days after the last dose of study treatment.
  22. History of other primary malignant tumor diseases.
  23. Investigator considers which not suitable to participate in the clinical trial

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05688605


Contacts
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Contact: Program Director 86-21-61637960 clinicaltrials@miracogen.com.cn

Locations
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China, Guangdong
Sun Yat-sen University Cancer Center Recruiting
Guangzhou, Guangdong, China, 510060
Contact: Ruihua Xu, M.D.    86-18127912775    xurh@sysucc.org.cn   
China, Hunan
Hunan Cancer Hospital Not yet recruiting
Changsha, Hunan, China, 410029
Contact: Yingrui Shi, M.D.    13607441956    shiyingrui@hnca.org.cn   
Sponsors and Collaborators
Shanghai Miracogen Inc.
Investigators
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Principal Investigator: Ruihua Xu, M.D. Sun Yat-sen University
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Responsible Party: Shanghai Miracogen Inc.
ClinicalTrials.gov Identifier: NCT05688605    
Other Study ID Numbers: HX008/MRG003-C001
First Posted: January 18, 2023    Key Record Dates
Last Update Posted: January 18, 2023
Last Verified: January 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Shanghai Miracogen Inc.:
MRG003
HX008
Antibody Drug Conjugate (ADC)
EGFR
Solid tumors
Additional relevant MeSH terms:
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Neoplasms