AzTrials
AzTrials

Advanced Solid TumorsPhase 1NCT06134531

First-In-Human Study of Bispecific Antibody MR001 In Subjects With Advanced Solid Tumors

A Phase 1 study testing MR001 in people with Advanced Solid Tumors, run by Nanfang Hospital, Southern Medical University at 1 site in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
Search all trials

Trial summary

Phase 1 open-label study to evaluate the safety, tolerability and preliminary efficacy of bispecific antibody MR001 and to determine the maximal tolerated dose and designate the recommended phase 2 dose in subjects with locally advanced or metastatic solid cancers. 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?
MR001
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
31 participants
Where
1 siteChina
Study dates
Nov 2023to Oct 2026
Phase
Phase 1
Are there results?
None posted in the registry

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

  • Age ≥18 years old and ≤75 years old (including the critical value);
  • Patients with histologically or cytologically confirmed advanced metastatic solid tumors who have failed standard treatments, are intolerant to standard treatments, or refuse standard treatments;
  • According to RECIST 1.1 criteria, there is at least 1 evaluable target lesion;
  • ECOG score physical status is 0-2;
  • Have appropriate organs and hematopoietic function, and no serious organ dysfunction according to the following laboratory tests:
  • Hematology: absolute neutrophil count (ANC) ≥1.5×10e9/L, platelets ≥100×10e9/L, white blood cell count ≥3×10e9/L, hemoglobin ≥90 g/L; Renal function: serum creatinine ≤1.5 times the upper limit of normal (ULN) or creatinine clearance ≥50 mL/min (creatinine clearance using the Cockcroft-Gault formula); Liver function: AST and ALT ≤ 2.5 times ULN, patients with liver metastasis ≤ 5 times ULN; serum bilirubin (TBIL) ≤ 1.5 times ULN; alkaline phosphatase ≤ 1.5 times ULN, patients with liver metastasis or bone metastasis ≤ 5 times ULN ; Coagulation function: international normalized rate (INR) or activated partial thromboplastin time (APTT) ≤ 1.5 times ULN;
Show all 10Show fewer
  • CD4+T lymphocyte count >350 cells/μL;
  • Expected survival ≥3 months;
  • No birth plans within 2 weeks before screening and 3 months after the end of the trial and agree to take effective non-drug contraceptive measures during the trial;
  • Voluntarily participate in the trial and sign the informed consent form.

Who cannot join

  • Those who are allergic to trial drugs or excipients;
  • Subjects with uncontrolled active brain metastasis or meningeal metastasis: those who need to use any radiation, surgery or drug treatment (including steroids, anticonvulsant drugs, etc.) to control metastasis symptoms 1 month before screening are not allowed Enrollment, patients with stable brain metastases can be enrolled;
  • Those who have suffered from autoimmune diseases in the past and need to use glucocorticoids or immunosuppressive drugs;
  • Uncontrolled comorbidities or cancer pain;
  • Hypertension that remains uncontrollable after drug treatment (systolic blood pressure >170 mmHg or diastolic blood pressure >100 mmHg);
  • Those with a history of severe heart disease, such as: a history of acute myocardial infarction or coronary angioplasty or stent implantation within 12 months, unstable angina, myocarditis, chronic heart failure ≥ grade III (New York, USA) Heart Association standards), or those with a history of QT interval prolongation (>470 ms for women; >450 ms for men) or a history of severe arrhythmia as shown by electrocardiogram;
Show all 17Show fewer
  • Those with a history of severe kidney disease, such as chronic nephritis, renal insufficiency, etc.;
  • There is currently an uncontrolled active infection;
  • Active hepatitis B (HBsAg positive, and peripheral blood HBV DNA titer test ≥1×10e3 IU/mL), hepatitis C, syphilis-specific antibodies and human immunodeficiency virus (HIV) antibody screening Patients with positive test results;
  • Other malignant tumors occurred within 5 years before screening, except for cervical cancer in situ, cutaneous squamous cell carcinoma or basal cell carcinoma that has been previously treated for radical treatment;
  • Those who have received the COVID-19 vaccine within 28 days before screening or have received other vaccines within 3 months before screening or plan to receive vaccines during the trial;
  • Subjects who received systemic steroid treatment within 14 days before the first dose and were judged by the investigator to need long-term systemic steroid treatment during treatment (except for inhaled or topical use, physiological replacement dose);
  • Participated in any other interventional clinical trial within 28 days before the first dose;
  • Received blood transfusion and/or colony-stimulating factor-related treatment within 28 days before the first dose;
  • Those who have received major surgical and/or anti-tumor treatments (including but not limited to chemotherapy, radiotherapy, targeted and immunotherapy, etc.) within 28 days before the first dose, and have failed to recover from the toxicity of these interventions (according to NCI-CTCAE version 5.0 toxicity has not returned to ≤ grade 1), except for alopecia;
  • Women preparing for pregnancy, pregnancy, and lactation;
  • Any other circumstances that the researcher believes may increase the risk to the subjects or interfere with the results of the trial, and who are deemed unsuitable to enter this trial.

Trial locations and contacts

1 site in 1 country.

Guoxin Li, MD contact

+86 13802771450

gzliguoxin@163.com

Shun Li, PhD contact

+86 14776580498

lis@majory.com.cn

China1 site

  • Nanfang Hospital, Southern Medical University

    Guangzhou, Guangdong, 510-515

Other trials in China

About this study

Official title: Clinical Study on Evaluating the Safety and Tolerability of Bispecific Antibody MR001 in Patients With Advanced Solid Tumors.

Phase 1 open-label study to evaluate the safety, tolerability and preliminary efficacy of bispecific antibody MR001 and to determine the maximal tolerated dose and designate the recommended phase 2 dose in subjects with locally advanced or metastatic solid cancers.

Read the detailed description

Phase 1 open-label study to evaluate the safety, tolerability and preliminary efficacy of bispecific antibody MR001 and to determine the maximal tolerated dose and designate the recommended phase 2 dose in subjects with locally advanced or metastatic solid cancers. The study will be conducted in 2 parts: part 1 will involve dose escalation and part 2 will involve expansion of the recommended phase 2 dose.

Being tested
MR001

What participants receive

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

  • MR001Drug

    Also called anti-CD4/anti-TGFβ1 bispecific antibody

    Dose Level 1: 0.5 mg/kg Intravenously (IV) Frequency: administered on Day 1 of each cycle (every 3 weeks), 1 cycle

    Dose Level 2: 2 mg/kg Intravenously (IV) Frequency: administered on Day 1 of each cycle (every 3 weeks), 4 cycle

    Dose Level 3: 6 mg/kg Intravenously (IV) Frequency: administered on Day 1 of each cycle (every 3 weeks), 4 cycle

    Dose Level 4: 10 mg/kg Intravenously (IV) Frequency: administered on Day 1 of each cycle (every 3 weeks), 4 cycle

    Dose Level 5: 15 mg/kg Intravenously (IV) Frequency: administered on Day 1 of each cycle (every 3 weeks), 4 cycle

    Dose Level 6: 20 mg/kg Intravenously (IV) Frequency: administered on Day 1 of each cycle (every 3 weeks), 4 cycle

Study groups in NCT06134531
Study groupRoleWhat they receive
MR001ExperimentalThe investigational product is MR001 which will be supplied in glass vials containing 50 mg of Freeze-dried powder. MR001 could be diluted in saline for intravenous (IV) administration.
Receives: Drug: MR001

What is being measured

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

  1. Incidence of treatment-emergent adverse events, and serious adverse events

    Safety profile of MR001

    Measured: 12 months

  2. Dose Limited Toxicity (DLT) and Maximum Tolerated Dose (MTD)

    Determine the DLT and MTD and designate a recommended phase 2 dose (RP2D)

    Measured: 12 months

Secondary outcomes (12)

  1. Peak Time (Tmax) of MR001

    Determine the Tmax of MR001

    Measured: 12 months

  2. Maximum Plasma Concentration (Cmax) of MR001

    Determine the Cmax of MR001

    Measured: 12 months

  3. Area under the Concentration versus Time Curve (AUC) of MR001

    Determine the AUC(0-t) and AUC(0-∞) of MR001

    Measured: 12 months

  4. Elimination of Half-life (t1/2) of MR001

    Determine the t1/2 of MR001

    Measured: 12 months

  5. Clearance (CL) of MR001

    Determine the CL of MR001

    Measured: 12 months

  6. Volume of Distribution (Vd) of MR001

    Determine the Vd of MR001

    Measured: 12 months

  7. Objective Response Rate (ORR)

    ORR in accordance with Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 and modified RECIST guidelines for immunotherapy trials (iRECIST).

    Measured: 12 months

  8. Progression Free Survival (PFS)

    Progression-free Survival (PFS) by RECIST Version 1.1 and iRECIST.

    Measured: 12 months

  9. Overall Survival (OS)

    Overall Survival (OS) by RECIST Version 1.1 and iRECIST.

    Measured: 12 months

  10. Duration of Response (DOR)

    Duration of Response (DOR) by RECIST Version 1.1 and iRECIST.

    Measured: 12 months

  11. Disease Control Rate (DCR)

    Disease Control Rate (DCR) by RECIST Version 1.1 and iRECIST.

    Measured: 12 months

  12. Anti-drug Antibody (ADA)

    Determine the Anti-MR001 antibody in the plasma

    Measured: 12 months

Timeline

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

  1. First posted18 Nov 2023
  2. Study startNov 2023 (estimated)
  3. Primary completionJul 2026 (estimated)
  4. Study completionOct 2026 (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
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
31 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06134531
Sponsor's protocol ID
NFEC-2023-382
Status last verified
Nov 2023
First submitted
16 Oct 2023
Last updated
18 Nov 2023
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Li S, Liu M, Do MH, Chou C, Stamatiades EG, Nixon BG, Shi W, Zhang X, Li P, Gao S, Capistrano KJ, Xu H, Cheung NV, Li MO. Cancer immunotherapy via targeted TGF-beta signalling blockade in TH cells. Nature. 2020 Nov;587(7832):121-125. doi: 10.1038/s41586-020-2850-3. Epub 2020 Oct 21.

    PubMed 33087933

  • Liu M, Kuo F, Capistrano KJ, Kang D, Nixon BG, Shi W, Chou C, Do MH, Stamatiades EG, Gao S, Li S, Chen Y, Hsieh JJ, Hakimi AA, Taniuchi I, Chan TA, Li MO. TGF-beta suppresses type 2 immunity to cancer. Nature. 2020 Nov;587(7832):115-120. doi: 10.1038/s41586-020-2836-1. Epub 2020 Oct 21.

    PubMed 33087928

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing MR001 in people with Advanced Solid Tumors, run by Nanfang Hospital, Southern Medical University at 1 site 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 10 inclusion and 17 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: status not confirmed, as of the sponsor's last update on 18 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site 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 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.

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

Are results available for this study?

Results are not available in the source record.

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

Contact Guoxin Li, MD (+86 13802771450, gzliguoxin@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Incidence of treatment-emergent adverse events, and serious adverse events (time frame: 12 months). The study lists 2 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 NCT06134531, which also lists 2 linked publications.

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 18 Nov 2023.

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