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Colonrectal Cancer (CRC)Phase 1NCT07656038

Nelmastobart in Combination With Tas-102 and Bevacizumab in Recurrent/Metastatic Colorectal Cancer

A Phase 1 study testing Nelmastobart in combination with TAS-102 and Bevacizumab in people with Colonrectal Cancer (CRC), run by STCube, Inc..

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
Search all trials

Trial summary

Nelmastobart（hSTC810） is a novel humanized monoclonal antibody that fuses on IgG4 and targets a novel immune checkpoint protein, BTN1A1+.This is an phase Ib bridging trial conducted in China to assess the safety, tolerability, and pharmacokinetic characteristics of Nelmastobart in combined with TAS-102 and Bevacizumab… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Colonrectal Cancer (CRC)
What is being tested?
Nelmastobart in combination with TAS-102 and Bevacizumab
Could I receive a placebo?
No, everyone receives an active treatment
How many people
45 participants
Where
No sites listed yet
Study dates
30 Jun 2026to 31 Jul 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 participate in the study must meet all of the following inclusion criteria.
  • Adults ≥18 years old and of any gender when signing the informed consent form.
  • Participants with metastatic/recurrent colorectal cancer confirmed by histopathology/cytology who have not responded to or are unable to receive standard anti-cancer therapy based on oxaliplatin and irinotecan. Participants who undergo curative surgery for colorectal cancer and receive adjuvant anti-cancer therapy will be considered to have received their first palliative anti-cancer therapy if their disease recurs during or within 6 months after completion of the adjuvant anti-cancer treatment.
  • According to the Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1, there must be at least one measurable or assessable lesion present.
  • Participants with ECOG performance status 0-1
  • Participants with adequate bone marrow and body organ functions
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  • Absolute neutrophil count (ANC) ≥ 2.0 x 109/L
  • Hemoglobin count (Hgb) ≥ 9.0 g/dL
  • Platelet count ≥ 100 x 109/L
  • Serum creatinine ≤ ULN x 1.5 or serum creatinine clearance > 30mL/min
  • Total bilirubin ≤ 1.5 x ULN (Participants with biliary obstruction may be enrolled if they meet the criterion after adequate biliary drainage.)
  • AST and ALT ≤ 3 x ULN in the absence of liver metastasis;
  • or AST and ALT ≤ 5 x ULN in the presence of liver metastasis
  • Confirm that participants with adequate cardiac function at the screening visit QTc calculated using the Fredericia formula ≤ 480 msec (Those with QTc >480 msec may be enrolled if the mean of 3 consecutive QTc measurements is <480 msec.).
  • A negative serum β-HCG test within 14 days prior to IP dosing for women of childbearing potential
  • Participants who agree, and are able to use during the study medically reliable methods of contraception as follows:
  • To be eligible for enrollment, women of childbearing potential (all women who can have physiological pregnancy during IP treatment and for 6 months after the end of IP treatment unless they use appropriate methods of contraception) must use the following methods of contraception.
  • Participants must refrain from any type of sexual intercourse, and persistent abstinence in daily life is recommended. Periodic abstinence (e.g., rhythm method, cervical mucus method, basal body temperature method, etc.) and withdrawal method are not acceptable methods of contraception.
  • Female sterilization procedures: Bilateral ovariectomy with or without hysterectomy; tubal ligation within 6 weeks prior to enrollment in this study. If the subject is confirmed to have childbearing potential based on the assessment of hormone level, only bilateral ovariectomy will be permitted.
  • Vasectomized partner (at least 6 months prior to screening). For women who participate in the study, the vasectomized partner must be the only partner during her participation in this study.
  • Men must use condoms during sexual intercourse during and after IP treatment (for 6 months after the last IP dose).
  • Life expectancy ≥3 months
  • Participants who consent to sampling tumor tissues or collecting tumor tissue samples obtained within 2 years prior to the screening visit.
  • Participants who, after being fully informed of the study, voluntarily decide to participate in the study, provide written informed consent, and agree to comply with study procedures during the study.

Who cannot join

  • Participants who meet any of the following exclusion criteria will be excluded from the study.
  • Participants who have hypersensitivity to the active ingredient of IP or any of its components (excipients)
  • Participants who had cytotoxic chemotherapy within 14 days prior to randomization; treatment with IP in another clinical trial with the elapse of ≤2 weeks from the last dose of that IP or ≤5 folds the half-life of that IP; or treatment with monoclonal antibody therapy within the past 4 weeks
  • Uncontrolled serious infection
  • Confirmed PD during treatment with trifluridine/tipiracil for palliative care or confirmed recurrence within 6 months after the end of such treatment
  • Participants requiring high-dose steroids (>10 mg/day prednisone or equivalent) or other immunosuppressants However, these participants may be enrolled in the following cases.
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  • Short-term (<7 days) use of systemic corticosteroids that are considered standard of care will be allowed.
  • Participants requiring intermittent use of bronchodilators, inhalant steroids, or local steroid injections will be allowed.
  • Replacement therapy (e.g., thyroxine, insulin, physiological corticosteroid replacement therapy for adrenal or pituitary insufficiency) is not considered as a type of systemic treatment and will be allowed.
  • Pregnant or lactating women
  • Participants with a history of autoimmune disease requiring systemic treatment (i.e., use of disease modifying therapy, corticosteroids, or immunosuppressants) within 2 years prior to the screening visit (However, enrollment will be possible for subjects with vitiligo, psoriasis not requiring systemic treatment, type 1 diabetes mellitus, hypothyroidism stably managed with hormone replacement therapy, Sjogren's syndrome, or resolved pediatric asthma/atopy.)
  • Participants with active central nervous system lesions (radiologically unstable or symptomatic brain lesions). With the exception of patients with meningeal metastasis, individuals who had radiotherapy or surgical treatment may be enrolled if there is evidence that the patient's condition is maintained without steroid therapy and that the disease of the brain lesion has not progressed for ≥4 weeks.
  • Participants with a documented history of cerebrovascular events (stroke or transient ischemic attack), unstable angina pectoris, myocardial infarction, or cardiac symptoms consistent with New York Heart Association (NYHA) Class IV within 6 months prior to the screening visit
  • Participants with hypertensive encephalopathy or hypertension that is not adequately controlled with antihypertensives
  • Participants with a history of idiopathic pulmonary fibrosis, organizing pneumonia, drug-induced pneumonitis, or idiopathic pneumonia; or with active pneumonia based on screening chest X-rays
  • Participants who received allogeneic stem cell or solid organ transplants
  • Participants who received live attenuated vaccines within 30 days prior to the screening visit. Examples of live vaccines include, but are not limited to measles, mumps, rubella, varicella/(varicella) zoster, yellow fever, rabies, bacillus Calmette-Guerin, and typhoid vaccines. Injectable seasonal influenza vaccines are generally killed virus vaccines and will be allowed. However, intranasal influenza vaccines are live attenuated vaccines and will not be allowed.
  • Participants with a history of other primary cancers However, enrollment will be possible for the following cancers.
  • Adequately treated skin cancer (basal cell or squamous carcinoma) that is not melanoma, superficial cervical cancer or stage 1 bladder cancer, completely resected thyroid cancer which did not metastasize and for which all treatment is completed (Scars must have been adequately treated prior to study enrollment).
  • Treated solid tumor with no evidence of recurrent disease at least 36 months prior to screening
  • Side effects of prior anticancer therapy that did not recover to Grade ≤1 (with the exception of alopecia)
  • Participants who had radiotherapy in an extensive lesion involving ≥30 % of the bone marrow within 4 weeks prior to the screening visit or limited range radiotherapy for palliative care within 2 weeks
  • Participants who had major surgery within 4 weeks prior to the screening visit or who have not recovered from side effects of surgery
  • Participants who are unable to take drugs orally or who have a past history, or pathological findings of major gastrointestinal surgery that may affect the absorption of IP
  • Participants who have evidence of active infection including hepatitis B, hepatitis C, and human immunodeficiency virus (HIV) However, enrollment will be possible for the following cases.
  • Participants with positive hepatitis B surface antigen (HBsAg) may be enrolled if HBV DNA is negative based on a local test.
  • Participants with positive hepatitis B core antibody (IgG anti-HBc) and a history of HBV infection may be enrolled if HBV DNA is negative.
  • Participants with positive anti-HCV Ab may be enrolled if HCV RNA is negative.
  • Participants with hereditary problems such as galactose intolerance, Lapp lactase deficiency, or glucose-galactose malabsorption
  • Participants with medical, psychiatric, or cognitive disorders or impaired ability to understand information, provide prior consent, comply with protocol procedures, or complete the study
  • Those whom the investigator deems inappropriate for participation in this clinical trial

Trial locations and contacts

No sites are listed yet. Contact the study team or a site near you to ask about taking part.

Zhang Jian, M.D contact

0086-13911127863

zhjian940105@163.com

About this study

Official title: A Single-arm, Open-label, Phase Ib Clinical Trial Evaluating the Safety, Pharmacokinetics, Immunogenicity, and Preliminary Efficacy of Nelmastobart in Combination With TAS-102 and Bevacizumab in Recurrent/Metastatic Colorectal Cancer

Nelmastobart（hSTC810） is a novel humanized monoclonal antibody that fuses on IgG4 and targets a novel immune checkpoint protein, BTN1A1+.This is an phase Ib bridging trial conducted in China to assess the safety, tolerability, and pharmacokinetic characteristics of Nelmastobart in combined with TAS-102 and Bevacizumab in Chinese participants with mCRC, and to verify that the safety results align with those from the Korean STCUBE-003 phase Ib trial. The phase Ib trial will also provide supportive data for conducting a randomized, double-blind, controlled Phase II study in China.

Being tested
Nelmastobart in combination with TAS-102 and Bevacizumab

What participants receive

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

  • Nelmastobart in combination with TAS-102 and BevacizumabDrug

    1. Drug name: Nelmastobart. Specifications: 400 mg/8 ml. Formulation: Sterile concentrated solution for injection. Batch number: XXX. Manufactured and supplied by Samsung Biologics Co., Ltd. (SBL), on behalf of STCube, Inc.
    2. Drug name: Qufluorodeoxyuridine/tipiracil. Specifications: 15mg, 20mg. Formulation: film-coated tablet. Batch number: XXX. Produced and supplied by Taiho Pharmaceutical Co., Ltd.
    3. Drug name: Bevacizumab. Specifications: 100 mg, 400 mg. Formulation: concentrated solution for injection. Batch number: XXX. Produced and supplied by XXX Company.

    Experimental: Cohort (Phase 1b) Nelmastobart 800 mg + Tas102 35 mg/m² + Bevacizumab 5 mg/kg (Starting Dose)

Study groups in NCT07656038
Study groupRoleWhat they receive
Nelmastobart in combination with TAS-102 and Bevacizumab for recurrent/metastatic CRCExperimentalNot described
Receives: Drug: Nelmastobart in combination with TAS-102 and Bevacizumab

What is being measured

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

  1. Incidence of DLT

    Definition of DLT: The severity of AEs observed during the trial was determined and recorded according to the NCI CTCAE v6.0 grading criteria. The DLT observation period spanned the first treatment cycle (i.e., from C1D1, the first administration, to C1D28).According to the definition of DLT, "drug-related" is defined as follows: an AE is considered to be related to the investigational product if, in the opinion of the investigator, the relationship is "definitely related," "likely related," or "possibly related."

    Measured: up to 6 months

  2. Permanent discontinuation of IP due to adverse drug reactions (ADRs)

    The incidence and rate of permanent discontinuation of IP due to adverse drug reactions (ADRs)

    Measured: up to 6 months

  3. AEs(Adverse Events)

    Status of AEs will be presented with frequency, percentage and its 95% CI. AEs will be classified by SOC and PT of MedDRA (latest version) and presented with frequency, percentage and its 95% CI.

    Measured: up to 6 months

Secondary outcomes (5)

  1. Maximum plasma concentration (Cmax)

    Maximum plasma concentration of Nelmastobart to evaluate PK parameters for the first and the subsequent cycles.

    Measured: up to 6 months

  2. Objective response rate (ORR)

    To evaluated by the Independent Review Committee (IRC) in accordance with the RECIST1.1 criteria.

    Measured: up to 6 months

  3. Immunogenicity indicators:

    Incidence of antibody formation against drugs (ADA)

    Measured: up to 6 months

  4. Tmax(Time to Maximum Plasma Concentration)

    Time to reach Tmax of Nelmastobart to evaluate the PK parameters for the first and the subsequent cycles.

    Measured: up to 6 months

  5. ORR assessed by researchers

    ORR assessed primarily by researchers based on the RECIST1.1 criteria.

    Measured: up to 6 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 Jun 2026
  2. Study start30 Jun 2026 (estimated)
  3. Primary completion31 Jul 2028 (estimated)
  4. Study completion31 Jul 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
Single group
Masking
None (open label)
Enrolment
45 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07656038
Sponsor's protocol ID
STCUBE-003CN-01
Status last verified
May 2026
First submitted
27 May 2026
Last updated
18 Jun 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Nelmastobart in combination with TAS-102 and Bevacizumab in people with Colonrectal Cancer (CRC), run by STCube, Inc..

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 24 inclusion and 31 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: opening soon, as of the sponsor's last update on 18 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.

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 Zhang Jian, M.D (0086-13911127863, zhjian940105@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Incidence of DLT (time frame: up to 6 months). 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 NCT07656038.

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 Jun 2026.

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