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Completed

NCT Number: NCT04868344

A Study of MRG003 in Patients With Advanced Solid Tumors

The objective of this study is to assess the safety, efficacy, and pharmacokinetics of MRG003, as well as immunogenicity as defined by the incidence of anti-drug antibody (ADA) of MRG003 in patients with advanced solid tumors, including colorectal cancer, squamous cell carcinoma of head and neck, and nasopharyngeal carcinoma.

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Key information

Conditions

Advanced Solid Tumors

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Sun Yat-sen University Cancer Center

Guangzhou, Guangdong, 510060, China

About this study

This study consists of two parts: Phase Ia dose escalation and Phase Ib dose expansion. The objective of Phase Ia is to determine MTD or RP2D, and Phase Ib is conducted to evaluate efficacy of MRG003 in patients with advanced colorectal cancer, squamous cell carcinoma of head and neck (SCCHN), and nasopharyngeal carcinoma.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Willing to sign the ICF and follow the requirements specified in the protocol.
  • Age: ≥18 years and ≤75 years, both genders
  • Expected survival time≥12 weeks
  • Phase Ia: Patients with histologically and cytologically confirmed advanced or metastatic solid tumor
  • Phase Ib: Patients with histologically and cytologically confirmed EGFR-positive advanced or metastatic colorectal cancer, squamous cell carcinoma of head and neck, and nasopharyngeal carcinoma
  • Subjects must have measurable lesions according to the response Evaluation Criteria In Solid Tumors（RECIST v1.1）
  • ECOG performance score 0 or 1
  • 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

Exclusion criteria

  • History of hypersensitivity to any component of the investigational product
  • Presence of central nervous system metastasis
  • Prior history of other primary malignancies
  • Known history of clinically significant hepatic diseases
  • Evidence of active infection of human immunodeficiency virus (HIV)
  • History of ophthalmic abnormalities
  • Any severe or uncontrolled systemic disease judged by the investigator
  • Patients with poorly controlled heart diseases
  • Received radiotherapy, chemotherapy, biotherapy, immunotherapy or other anti-tumor drugs within 4 weeks prior to the first dose of study treatment
  • Major surgery or surgical therapy for any cause within 4 weeks prior to the first dose of investigational drug
  • Planned surgery or surgery is the best interest of patients as determined by investigator
  • History of severe skin disease requiring interruption of previous EGFR targeted therapy; or chronic skin disease requiring oral or intravenous therapy
  • Active concomitant diseases that might increase risks of toxicity
  • Pregnancy, or breast feeding

Treatment and study plan

MRG003

Drug

Administered intravenously

Primary outcomes

  1. Dose Limiting Toxicity (DLT) - Phase Ia

    Time frame: First cycle (21 days)

    DLT is assessed on Day 21 (Day 1 to 21) of the first dose administration.

  2. Objective Response Rate (ORR) - Phase Ib

    Time frame: Baseline to study completion (up to 24 weeks)

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

Secondary outcomes

  1. PK parameter for MRG003: Maximum Drug Concentration (Cmax)

    Time frame: Baseline to study completion (up to 24 weeks)

    Cmax will be derived from the PK blood samples collected and will be summarized with descriptive statistics.

  2. PK parameter for MRG003: Area Under the Curve Up to the Last Validated Measurable Plasma Concentration (AUClast)

    Time frame: Baseline to study completion (up to 24 weeks)

    AUClast will be derived from the PK blood samples collected and will be summarized with descriptive statics.

  3. PK parameter for total antibody (TAb): Cmax

    Time frame: Baseline to study completion (up to 24 weeks)

    Cmax will be derived from the PK blood samples collected and will be summarized with descriptive statistics.

  4. PK parameter for TAb: AUClast

    Time frame: Baseline to study completion (up to 24 weeks)

    AUClast will be derived from the PK blood samples collected and will be summarized with descriptive statics.

  5. PK parameter for Monomethyl Auristatin E (MMAE): Cmax

    Time frame: Baseline to study completion (up to 24 weeks)

    Cmax will be derived from the PK blood samples collected and will be summarized with descriptive statistics.

  6. PK parameter for MMAE: AUClast

    Time frame: Baseline to study completion (up to 24 weeks)

    AUClast will be derived from the PK blood samples collected and will be summarized with descriptive statics.

  7. Immunogenicity

    Time frame: Baseline to study completion (up to 24 weeks)

    Blood samples for anti-drug antibody (ADA) analysis will be collected each time according to the pre-defined timepoints.

  8. Progression Free Survival (PFS) - Phase Ib only

    Time frame: Baseline to study completion (up to 24 weeks)

    PFS was defined as the duration from the start of treatment to the onset of tumor progression or death of any cause.

  9. Duration of Response (DoR) - Phase Ib only

    Time frame: Baseline to study completion (up to 24 weeks)

    DOR was defined as the duration from the initial recording of objective disease response to the first onset of tumor progression, or death of any cause.

  10. Overall Survival (OS) - Phase Ib only

    Time frame: Baseline to study completion (up to 24 weeks)

    OS was defined as the duration from the start of treatment to death of any cause.

  11. Incidence of Adverse Events (AEs)

    Time frame: Baseline to 30 days after the last dose of study treatment

    Incidence of AEs and serious adverse events (SAEs) will be assessed based on NCI-CTCAE v5.0

Sponsors and collaborators

Lead sponsor

Shanghai Miracogen Inc.

Industry

Registry information

Official study title

An Open-Label, Dose-Finding, Phase I Study in Solid Tumors.

Important dates

Study start
2018
Primary completion
2021
Study completion
2021
First posted
Apr 30, 2021
Registry last updated
Apr 30, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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