AzTrials
AzTrials

Advanced Solid TumorsPhase 1/2NCT05688605

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

A Phase 1/2 study testing MRG003+HX008 in people with Advanced Solid Tumors, run by Lepu Biopharma Co., Ltd. at 2 sites in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Advanced Solid Tumors
What is being tested?
MRG003+HX008
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
18 participants
Where
2 sitesChina
Study dates
30 Jun 2022to Aug 2027
Phase
Phase 1/2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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).
Show all 11Show fewer
  • 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.

Who cannot join

  • 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.
Show all 23Show fewer
  • 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.
  • The patient is using immunosuppressant or systemic hormone therapy.
  • Patients with any past arteriovenous bleeding within 3 months or current history of coagulation disorder.
  • Any clinically significant VTE occurred within 6 months.
  • Received allogeneic tissue/solid organ transplantation.
  • Inoculate live vaccine within 30 days before the first dose.
  • 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.
  • History of other primary malignant tumor diseases.
  • Investigator considers which not suitable to participate in the clinical trial

Trial locations and contacts

2 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Program Director contact

86-21-61637960

clinicaltrials@miracogen.com.cn

China2 sites, 2 recruiting

  • Hunan Cancer Hospital

    Changsha, Hunan, 410029

    Yingrui Shi, M.D., 13607441956, shiyingrui@hnca.org.cn

    Not yet recruiting

  • Sun Yat-sen University Cancer Center

    Guangzhou, Guangdong, 510060

    Ruihua Xu, M.D., 86-18127912775, xurh@sysucc.org.cn

    Recruiting

Other trials in China

About this study

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

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.

Read the 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.

Being tested
MRG003+HX008
Keywords
MRG003, HX008, Antibody Drug Conjugate (ADC), EGFR, Solid tumors

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • MRG003+HX008Drug

    Administered intravenously

Study groups in NCT05688605
Study groupRoleWhat they receive
MRG003+HX008ExperimentalMRG003 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).
Receives: Drug: MRG003+HX008

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Maximum Tolerated Dose (MTD)

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

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

  2. 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.

    Measured: Baseline to study completion (up to 12 months)

  3. 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.

    Measured: Baseline to study completion (up to 12 months)

Secondary outcomes (8)

  1. Duration of Response (DOR)

    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.

    Measured: Baseline to study completion (up to 12 months)

  2. Disease Control Rate (DCR)

    DCR is defined as the proportion of subjects achieving CR, PR, and SD after treatment.

    Measured: Baseline to study completion (up to 12 months)

  3. Progression Free Survival (PFS)

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

    Measured: Baseline to study completion (up to 12 months)

  4. Overall Survival (OS)

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

    Measured: Baseline to study completion (up to 12 months)

  5. Immunogenicity (ADA)

    The proportion of patients with positive ADA results.

    Measured: Baseline to 90 days after the last dose.

  6. Adverse Events (AEs)

    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.

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

  7. Serious Adverse Events (SAEs)

    Adverse events that are difficult to deal with in clinical drug research

    Measured: Baseline to 90 days after the last dose of study treatment

  8. PK parameters: concentration-time curve

    Plot of drug concentration changing with time after drug administration

    Measured: Baseline to 90 days after the last dose.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Jan 2023
  2. Study start30 Jun 2022
  3. Primary completionAug 2027 (estimated)
  4. Study completionAug 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
18 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05688605
Sponsor's protocol ID
HX008/MRG003-C001
Status last verified
Sep 2026
First submitted
6 Jan 2023
Last updated
4 Sep 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Ruan DY, Wang FH, Zhou Y, Xiang Y, Lin J, Liu L, Liu P, Tang L, Ma Y, Hou T, Chen Q, Li ZM, Han F, Qu S, Qiu S, Han C, Ma H, Su F, Gao J, Guo Y, Wu Z, Wu HJ, Zhao Y, Fang M, Hu M, Wu Y, Cui S, Li M, Zhao Q, Xu RH. Becotatug Vedotin Combined With Pucotenlimab in Platinum- and Immunotherapy-Resistant Recurrent or Metastatic Nasopharyngeal Carcinoma. J Clin Oncol. 2026 Aug 25:JCO2600640. doi: 10.1200/JCO-26-00640. Online ahead of print.

    PubMed 42641116

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing MRG003+HX008 in people with Advanced Solid Tumors, run by Lepu Biopharma Co., Ltd. at 2 sites in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 11 inclusion and 23 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 4 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Program Director (86-21-61637960, clinicaltrials@miracogen.com.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Maximum Tolerated Dose (MTD) (time frame: Within 21 days after the first dose of the last patient of the MTD group). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05688605, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Sep 2026.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in