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B-cell MalignanciesPhase 1NCT06958679

Evaluation of SYS6005 in Patients With Advanced Malignant Tumor

A Phase 1 study testing SYS6005 in people with B-cell Malignancies and Solid Tumors, run by CSPC Megalith Biopharmaceutical Co.,Ltd. at 1 site 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
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Trial summary

This Phase I, open-label, multicenter study evaluates the safety, tolerability, pharmacokinetics, and preliminary efficacy of SYS6005 in advanced malignancies, comprising dose-escalation and expansion phases. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
B-cell Malignancies, Solid Tumors
What is being tested?
SYS6005
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
132 participants
Where
1 siteChina
Study dates
3 Apr 2025to 30 Jun 2028
Phase
Phase 1
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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Participants who are voluntarily enrolled in this study and sign the informed consent form (ICF);
  • Age ≥ 18 years old, male or female;
  • Patients with advanced malignant tumors confirmed by cytology or histology, who have failed standard therapy or are intolerant to standard therapy and require systemic treatment： Solid tumor: Pathologically confirmed, unresectable advanced solid tumor with disease progression on or after at least 1 line of prior systemic therapy. Preferred tumor types include breast, lung, gynecologic, prostate, skin, adrenal, testicular, colon, bladder, pancreatic, gastric, kidney, cholangiocarcinoma, and esophageal cancers.
  • B-cell malignancies: Pathologically confirmed Hodgkin and non-Hodgkin B-cell lymphoma as defined per 2016 WHO classification, with disease progression on or after at least 2 lines of prior systemic therapy. Preferred tumor types include cHL, DLBCL, MCL, FL, MZL, RTL, CLL/SLL;
  • Patients with at least one evaluable lesion as defined per RECIST v1.1 for solid tumor or 2014 Lugano Classification Criteria for lymphoma, respectively;
  • Eastern Cooperative Oncology Group Performance Status (ECOG PS) score of 0-2;
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  • Expected survival ≥ 3 months;
  • Participants must have adequate organ function and have not received transfusion, erythropoietin, granulocyte colony-stimulating factor, or other medical supportive treatments within 14 days prior to examination
  • For participants enrolled in the dose-expansion phase, tumor tissue must be confirmed as ROR1-positive by the central laboratory during screening in order to be eligible for enrollment.
  • Male and female participants of childbearing potential must agree to use effective contraception from the time of signing the ICF until at least 6 months after the last dose of the investigational product; female participants of childbearing potential must have a negative pregnancy test result within 7 days prior to the first administration of the investigational product;
  • Participants who are willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures

Who cannot join

  • Participants who have participated in other studies involving ROR1-targeted therapies prior to enrollment in this study, or have previously received ADC treatments containing MMAE payloads;
  • Participants with known central nervous system (CNS) lymphoma or CNS metastases from solid tumors that are symptomatic, untreated, or require treatment. Except for participants with metastases to CNS that have been completely resected and/or have stabilized or improved after radiotherapy, provided that imaging examinations prior to screening show stable disease for at least 4 weeks, and there is no evidence of brain oedema and no requirement for corticosteroids or anticonvulsant drugs;
  • Participants deemed suitable for CAR-T therapy or hematopoietic stem cell transplant (HSCT) by the investigator. Participants who have received an allogeneic haematopoietic stem cell transplant within 6 months prior to the first administration of the investigational product, have received an autologous haematopoietic stem cell transplant within 100 days prior to the first administration of the investigational product, or have received CAR-T cell therapy within 3 months prior to the first administration of the investigational product. Participants with active graft versus host disease;
  • Participants have a history of a second malignancy active within the previous 3 years except for locally curable cancers that have been apparently cured, such as basal or squamous cell skin cancer, superficial bladder cancer, or carcinoma in situ of the prostate, cervix, or breast or cancers that have been treated with no expectation of recurrence
  • Participants have a diagnosis of immunodeficiency, or has an active autoimmune disease or other conditions that require systemic steroid therapy For solid tumor: > 10 mg daily prednisone equivalents within 14 days prior to the administration of the first dose of SYS6005; For lymphoma: > 20 mg daily prednisone equivalents within 28 days prior to the administration of the first dose of SYS6005; The use of short-course systemic corticosteroids (≤ 7 days) is permitted, with a wash-out period of 1 week prior to the administration of the first dose of SYS6005
  • Participants with peripheral oedema, pericardial effusion, pleural effusion, or ascites that require medical intervention or limit daily life activities;
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  • Participants with records of cerebrovascular events, angina unstable, myocardial infarction, or a history of NYHA Class III-IV cardiac symptoms within 6 months before the first administration of the investigational product, or a QTcF > 450 ms recorded in three repeated ECG examinations during screening;
  • Participants with any active infection requiring systemic treatment within 2 weeks prior to the first dose of investigational product;
  • Participants who have used strong inhibitors or inducers of CYP3A4 within 7 days prior to the first dose of the investigational product, or are expected to require the use of strong inhibitors or inducers of CYP3A4 during the study treatment;
  • Participants with the severity of any toxicities from prior treatments or surgery (excluding ≤ Grade 2 alopecia, endocrine disorders manageable with hormone replacement therapy, or other toxicities that the investigator considers do not pose a safety risk to the patient) has not returned to baseline or ≤ Grade 1 per NCI-CTCAE Version 5.0;
  • Participants with ≥ grade 2 peripheral neuropathy at baseline;
  • Participants who have received major surgery, radical radiotherapy, antibody-based targeted therapy, or immunotherapy within 28 days prior to the first administration of the investigational product, or who have received palliative radiation, chemotherapy, or small molecule targeted therapy within 14 days prior to the study treatment. Participants who have used anti-tumor Chinese herbal preparations or Chinese patent medicines within 14 days prior to the first administration of the investigational product;
  • Participants with history of immunodeficiency or positive human immunodeficiency virus (HIV) antibody test during screening;
  • Participants with active hepatitis B or hepatitis C, where active hepatitis B is defined as HBsAg positive and HBV DNA > 2000 IU/ml; active hepatitis C is defined as HCV antibody positive and HCV RNA > ULN;
  • Participants who have received a live vaccine within 28 days prior to the first dose of investigational product;
  • Participants with history of hypersensitivity or atopic reactions to excipients of the investigational product or any monoclonal antibodies;
  • Women who are pregnant or breastfeeding;
  • Other situations that may interfere with the participant's participation in the study program or are not in the participant's best interest or affect the study results include: history of mental illness, addiction or drug abuse, any other clinically significant illness or condition, etc.

Trial locations and contacts

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

Clinical Trials Information Group officer contact

86-0311-69085587

ctr-contact@cspc.cn

China1 site, 1 recruiting

  • Institute of Hematology & Blood Diseases Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College

    Tianjin, 300020

    Qiu Lugui, Ph.D, 13821266636, qiulg@ihcams.ac.cn

    Recruiting

Other trials in China

About this study

Official title: A Phase I Dose Escalation and Expansion Study to Evaluate the Safety, Tolerability, Pharmacokinetic Profile, Immunogenicity, and Preliminary Anti-tumor Activity of SYS6005 in Patients With Advanced Malignant Tumor

This Phase I, open-label, multicenter study evaluates the safety, tolerability, pharmacokinetics, and preliminary efficacy of SYS6005 in advanced malignancies, comprising dose-escalation and expansion phases. The escalation phase employs a BOIN design with accelerated titration across seven dose levels, featuring a 21-day DLT observation period in Cycle 1, with dose adjustments guided by a Safety Monitoring Committee. In the expansion phase, one or more dosing regimens and tumor types will be selected, and participants will receive SYS6005 R2PD for further exploration and validation. Treatment continues until disease progression, unacceptable toxicity, or other discontinuation criteria. Safety monitoring includes AEs, labs, and ECOG PS, while efficacy is assessed via imaging. PK and immunogenicity samples are collected, and survival is tracked quarterly until death or study end. The study aims to determine the maximum tolerance dose (MTD)/recommended phase 2 dose (RP2D) and characterize SYS6005's clinical profile.

Being tested
SYS6005

What participants receive

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

  • SYS6005Drug

    SYS6005 administered via IV infusion on , Day 1 of each 21-day cycle

Study groups in NCT06958679
Study groupRoleWhat they receive
Dose escalation and Dose expansionExperimentalParticipants will receive escalating doses of SYS6005 intravenously (IV) on Day 1 of each 21-day cycle in dose escalation phase and will receive selected doses of SYS6005 intravenously (IV) on Day 1 of each 21-day cycle in dose expansion phase
Receives: Drug: SYS6005

What is being measured

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

  1. Incidence of Dose limiting toxicities (for dose escalation part)

    A DLT is defined as a protocol pre-specified treatment-emergent adverse event (TEAE) that occurs in Cycle 1 of SYS6005 therapy and is considered drug-related.

    Measured: each cycle is 21 days

  2. Recommended Phase 2 Dose(RP2D) of SYS6005 (for dose escalation part)

    The selection of RP2D will be based on consideration of overall safety information together with available pharmacokinetic, pharmacodynamic, and efficacy data. The RP2D may be the MTD or may be a lower dose within the tolerable dose range.

    Measured: About up to 6 months

  3. Incidence and severity of adverse events (for both dose escalation and expansion part)

    Measured: About up to 12 months

  4. Overall response (for dose expansion part)

    Measured: About up to 12 months

  5. Complete remission (for dose expansion part)

    Measured: About up to 12 months

Secondary outcomes (11)

  1. Pharmacokinetic (P K) profiles of SYS6005 including AUClast, AUCinf, Cmax, Tmax, t1/2, and CL, etc.

    Measured: About up to 12 months

  2. Immunogenicity of SYS6005： incidence and titer of ADAs, and incidence of neutralizing antibodies (Nabs) (if applicable)

    Measured: About up to 12 months

  3. Area Under the Concentration-Time Curve from Time Zero to the Last Quantifiable Concentration (AUClast) of SYS6005

    AUClast reflects total drug exposure from administration to the last measurable concentration, calculated using the linear trapezoidal method.

    Measured: Cycle 1: Pre-dose, end of infusion (0,4,12,24,48,96,168,240,336 hours post); Cycle 2: Pre-dose, 0 hour post; Cycle 3: Pre-dose, end of infusion (0,4,12,24,48,96,168,240,336 hours post); Cycle 4: Pre-dose, 0 hour post

  4. Area Under the Concentration-Time Curve from Time Zero Extrapolated to Infinity (AUCinf) of SYS6005

    AUCinf estimates total exposure by extrapolating AUClast using the terminal elimination rate (λz)

    Measured: Cycle 1: Pre-dose, end of infusion (0,4,12,24,48,96,168,240,336 hours post); Cycle 2: Pre-dose, 0 hour post; Cycle 3: Pre-dose, end of infusion (0,4,12,24,48,96,168,240,336 hours post); Cycle 4: Pre-dose, 0 hour post

  5. Maximum Observed Plasma Concentration (Cmax) of SYS6005

    Peak plasma concentration, directly indicating the rate and extent of absorption

    Measured: Cycle 1: Pre-dose, end of infusion (0,4,12,24,48,96,168,240,336 hours post); Cycle 2: Pre-dose, 0 hour post; Cycle 3: Pre-dose, end of infusion (0,4,12,24,48,96,168,240,336 hours post); Cycle 4: Pre-dose, 0 hour post

  6. Time to Reach Maximum Plasma Concentration (Tmax) of SYS6005

    Time point at which Cmax occurs, reflecting absorption kinetics.

    Measured: Cycle 1: Pre-dose, end of infusion (0,4,12,24,48,96,168,240,336 hours post); Cycle 2: Pre-dose, 0 hour post; Cycle 3: Pre-dose, end of infusion (0,4,12,24,48,96,168,240,336 hours post); Cycle 4: Pre-dose, 0 hour post

  7. Terminal Elimination Half-Life (t1/2) of SYS6005

    Time for plasma concentration to reduce by 50% in the elimination phase, calculated as ln(2)/λz

    Measured: Cycle 1: Pre-dose, end of infusion (0,4,12,24,48,96,168,240,336 hours post); Cycle 2: Pre-dose, 0 hour post; Cycle 3: Pre-dose, end of infusion (0,4,12,24,48,96,168,240,336 hours post); Cycle 4: Pre-dose, 0 hour post

  8. Systemic Clearance (CL) of SYS6005

    Volume of plasma cleared of drug per unit time (CL = Dose/AUCinf for IV administration).

    Measured: Cycle 1: Pre-dose, end of infusion (0,4,12,24,48,96,168,240,336 hours post); Cycle 2: Pre-dose, 0 hour post; Cycle 3: Pre-dose, end of infusion (0,4,12,24,48,96,168,240,336 hours post); Cycle 4: Pre-dose, 0 hour post

  9. Incidence of Anti-Drug Antibodies (ADAs) Against SYS6005

    Proportion of subjects who develop detectable ADAs at any time during the study, expressed as a percentage.

    Measured: Pre-dose on Day 1 of Cycles 1, 2, 3, 4; Pre-dose on Cycle 6; Pre-dose every 4 cycles thereafter (e.g., Cycle 10, 14, 18…); 30 days after last dose (follow-up).

  10. Titer of Anti-Drug Antibodies (ADAs) Against SYS6005

    Magnitude of ADA response (e.g., reported as geometric mean titer or median titer in ADA-positive subjects).

    Measured: Pre-dose on Day 1 of Cycles 1, 2, 3, 4; Pre-dose on Cycle 6; Pre-dose every 4 cycles thereafter (e.g., Cycle 10, 14, 18…); 30 days after last dose (follow-up).

  11. Incidence of Neutralizing Antibodies (NAbs) Against SYS6005 (if applicable)

    Proportion of subjects with NAbs capable of inhibiting SYS6005's pharmacological activity in a cell-based or competitive ligand-binding assay.

    Measured: Pre-dose on Day 1 of Cycles 1, 2, 3, 4; Pre-dose on Cycle 6; Pre-dose every 4 cycles thereafter (e.g., Cycle 10, 14, 18…); 30 days after last dose (follow-up).

Timeline

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

  1. First posted6 May 2025
  2. Study start3 Apr 2025
  3. Primary completion30 Jan 2027 (estimated)
  4. Study completion30 Jun 2028 (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
Sequential
Model description
Open-label, single-arm, dose-escalation study using Bayesian Optimal Interval (BOIN) design. Seven dose levels will be tested. Dose-limiting toxicities (DLTs) will be assessed in Cycle 1 (21 days). The Safety Monitoring Committee (SMC) will review data to guide escalation. Pharmacokinetic analysis will use non-compartmental modeling.
Masking
None (open label)
Enrolment
132 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06958679
Sponsor's protocol ID
SYS6005-001
Status last verified
Apr 2025
First submitted
21 Apr 2025
Last updated
14 May 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing SYS6005 in people with B-cell Malignancies and Solid Tumors, run by CSPC Megalith Biopharmaceutical Co.,Ltd. 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 11 inclusion and 18 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 14 May 2025. 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?

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 Clinical Trials Information Group officer (86-0311-69085587, ctr-contact@cspc.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Incidence of Dose limiting toxicities (for dose escalation part) (time frame: each cycle is 21 days). The study lists 5 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 NCT06958679.

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 14 May 2025.

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