Metastatic Colorectal Cancer (CRC)Phase 1/2NCT06873763
Nelmastobart in Combination With Trifluridine/ Tipiracil and Bevacizumab in Metastatic/ Recurrent Colorectal Cancer
A Phase 1/2 study testing Nelmastobart 800 mg+Trifluridine/Tipiracil+ Bevacizumab in people with Metastatic Colorectal Cancer (CRC) and Recurrent Colorectal Cancer, run by STCube, Inc. at 5 sites in South Korea.
Trial summary
The objective of this multi-center, single-group, open-label Phase Ib/II study is to evaluate the safety, pharmacokinetics, and efficacy of nelmastobart in combination with trifluridine/tipiracil and bevacizumab in metastatic or recurrent colorectal cancer patients with resistance or intolerance to oxaliplatin- and… Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Metastatic Colorectal Cancer (CRC), Recurrent Colorectal Cancer
- What is being tested?
- Nelmastobart 800 mg+Trifluridine/Tipiracil+ Bevacizumab
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 52 participants
- Where
- 5 sitesSouth Korea
- Study dates
- 9 Jun 2025to Mar 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 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects who participate in the study must meet all of the following inclusion criteria.
- Adults ≥19 years old at the time of written informed consent
- Patients with histologically/cytologically confirmed metastatic/recurrent colorectal cancer after failure of, or not eligible for oxaliplatin and irinotecan-based standard anticancer therapy (If a subject had a radical surgery for colorectal cancer followed by adjuvant anticancer therapy, and the disease recurred during the adjuvant anticancer therapy or within 6 months from the end of the adjuvant anticancer therapy, the adjuvant anticancer therapy will be considered primary palliative therapy.)
- Subjects with at least one evaluable lesion, or non-measurable but evaluable lesion according to RECIST v1.1
- Subjects with ECOG performance status 0-1
- Subjects with adequate bone marrow and body organ functions
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- Absolute neutrophil count (ANC) ≥ 1.5 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 (Subjects 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
- Subjects 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
- Subjects 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.
- Subjects 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
- Subjects who consent to sampling tumor tissues or collecting tumor tissue samples obtained within 2 years prior to the screening visit
- Subjects 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
- [Inclusion criteria for the phase 2 study] Subjects who participate in the phase 2 study must meet all of the following criteria.
- Subjects with Tumor Proportion Score (TPS) ≥50 based on immunohistochemistry (IHC) at the screening visit
Who cannot join
- Individuals who meet any of the following exclusion criteria will be excluded from the study.
- Patients who have hypersensitivity to the active ingredient of IP or any of its components (excipients)
- Individuals 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
- Individuals requiring high-dose steroids (>10 mg/day prednisone or equivalent) or other immunosuppressants
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- However, these individuals may be enrolled in the following cases.
- Short-term (<7 days) use of systemic corticosteroids that are considered standard of care will be allowed.
- Subjects 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
- Individuals 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.)
- Individuals 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.
- Individuals 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
- Patients with hypertensive encephalopathy or hypertension that is not adequately controlled with antihypertensives
- Individuals 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
- Individuals who received allogeneic stem cell or solid organ transplants
- Individuals 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.
- Individuals 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)
- Individuals 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
- Patients who had major surgery within 4 weeks prior to the screening visit or who have not recovered from side effects of surgery
- Patients 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
- Patients 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.
- Patients with positive hepatitis B surface antigen (HBsAg) may be enrolled if HBV DNA is negative based on a local test.
- Patients with positive hepatitis B core antibody (IgG anti-HBc) and a history of HBV infection may be enrolled if HBV DNA is negative.
- Patients with positive anti-HCV Ab may be enrolled if HCV RNA is negative.
- Patients with hereditary problems such as galactose intolerance, Lapp lactase deficiency, or glucose-galactose malabsorption
- Individuals 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
5 sites in 1 country. Contact the study team or a site near you to ask about taking part.
5 sites in 1 country
South Korea5 sites, 5 recruiting
- Not yet recruiting
Seoul National University Bundang Hospital
Seongnam-si, Gyeonggi-do, 13620
Keun-Wook Lee
- Not yet recruiting
Seoul National University Hospital
Seoul, KR, 03080
Sae-Won Han
- Not yet recruiting
Severance Hospital
Seoul, KR, 03722
Seunghoon Beom
- Not yet recruiting
Asan Medical Center
Seoul, KR, 05505
Seon-young Kim, 025513370, ID@stcube.com
- Recruiting
Korea University Anam Hospital
Seoul, 02841
Soohyeon Lee
About this study
Official title: A Single-arm, Phase Ib/2 Study of Nelmastobart in Combination With Trifluridine/Tipiracil and Bevacizumab in Metastatic/Recurrent Colorectal Cancer Patients With Resistance or Intolerance to Oxaliplatin and Irinotecan-based Chemotherapy
The objective of this multi-center, single-group, open-label Phase Ib/II study is to evaluate the safety, pharmacokinetics, and efficacy of nelmastobart in combination with trifluridine/tipiracil and bevacizumab in metastatic or recurrent colorectal cancer patients with resistance or intolerance to oxaliplatin- and irinotecan-based chemotherapy, and to determine the maximum tolerated dose (MTD), recommended Phase 2 dose (RP2D), and the efficacy and safety of the combination therapy in BTN1A1-positive patients.
- Being tested
- Nelmastobart 800 mg+Trifluridine/Tipiracil+ Bevacizumab
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nelmastobart 800 mg+Trifluridine/Tipiracil+ BevacizumabDrug
Trifluridine/tipiracil is dose-deescalated from 35 mg/m² to 30 mg/m² and 25 mg/m² to determine the RP2D, in combination with fixed doses of Nelmastobart and Bevacizumab, in patients with metastatic colorectal cancer who are refractory or intolerant to prior oxaliplatin- and irinotecan-based chemotherapy.
| Study group | Role | What they receive |
|---|---|---|
| Nelmastobart 800 mg+Trifluridine/Tipiracil+Bevacizumab | Experimental | 3 reducing doses of Trifluridine/Tipiracil will be administered to participants Receives: Drug: Nelmastobart 800 mg+Trifluridine/Tipiracil+ Bevacizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of DLT
Status of DLT will be presented with frequency, percentage and its 95% confidence interval (CI).
Measured: up to 6 months
RP2D(Recommended Phase 2 Dose)
The recommended phase 2 dose (RP2D) of nelmastobart in combination with trifluridine/tipiracil and bevacizumab
Measured: up to 2 years
MTD(Maximum Tolerated Dose)
To find the maximum tolerated dose (MTD)
Measured: up to 2 years
Progression Free Survival (PFS) rate
Time from the start of treatment to objective tumor progression or all-cause death will be presented with survival curve, median survival time and its 95% CI using the Kaplan-Meier estimation.
Measured: up to 2 years
Secondary outcomes (8)
Phase 2 study; Overall Survival (OS)
Time from the start of treatment to all cause death
Measured: up to 2 years
Phase 2 study; Objective Response Rate (ORR)
Investigator assessed ORR defined by RECIST 1.1 or iRECIST
Measured: up to 2 years
Maximum plasma concentration (Cmax)
Maximum plasma concentration of Nelmastobart to evaluate PK parameters
Measured: up to 6 months
Phase 2 study; Disease Control Rate (DCR)
Investigator assessed DCR at 16 weeks defined by RECIST 1.1 or iRECIST
Measured: up to 2 years
PFS(Progression free survival)
Time from first dose until the date of objective disease progression or death
Measured: up to 2 years
Phase 2 study; Duration of Response (DOR)
Time from the date of first confirmed objective response (CR or PR) after investigational drug administration to the first documented disease progression (PD) or death from any cause, with documentation of disease progression status and cause of death
Measured: up to 2 years
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 2 years
Tmax(Time to Maximum Plasma Concentration)
Time to reach Tmax of Nelmastobart to evaluate the PK parameters.
Measured: up to 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2025
- Study start9 Jun 2025
- Primary completionDec 2025 (estimated)
- Study completionMar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metastatic Colorectal Cancer (CRC)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Sequential
- Masking
- None (open label)
- Enrolment
- 52 participants (estimated)
Sponsor and investigators
- Lead sponsor
- STCube, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06873763
- Sponsor's protocol ID
- STCUBE-003
- Status last verified
- Jul 2025
- First submitted
- 17 Feb 2025
- Last updated
- 11 Jul 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-arm, Phase Ib/2 Study of Nelmastobart in Combination With Trifluridine/Tipiracil and Bevacizumab in Metastatic/Recurrent Colorectal Cancer Patients With Resistance or Intolerance to Oxaliplatin and Irinotecan-based Chemotherapy
- ClinicalTrials.gov ID
- NCT06873763
- Acronym / sponsor ID
- STCUBE-003
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 52 participants (estimated)
- Lead sponsor
- STCube, Inc.Industry (pharma, biotech, devices)
- Study start
- 9 Jun 2025 (actual)
- Primary completion
- Dec 2025 (estimated)
- Study completion
- Mar 2027 (estimated)
- First posted
- 13 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The objective of this multi-center, single-group, open-label Phase Ib/II study is to evaluate the safety, pharmacokinetics, and efficacy of nelmastobart in combination with trifluridine/tipiracil and bevacizumab in metastatic or recurrent colorectal cancer patients with resistance or intolerance to oxaliplatin- and irinotecan-based chemotherapy, and to determine the maximum tolerated dose (MTD), recommended Phase 2 dose (RP2D), and the efficacy and safety of the combination therapy in BTN1A1-positive patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Nelmastobart 800 mg+Trifluridine/Tipiracil+Bevacizumab | Experimental | Drug: Nelmastobart 800 mg+Trifluridine/Tipiracil+ Bevacizumab3 reducing doses of Trifluridine/Tipiracil will be administered to participants |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (26 listed)
- Subjects who participate in the study must meet all of the following inclusion criteria.
- Adults ≥19 years old at the time of written informed consent
- Patients with histologically/cytologically confirmed metastatic/recurrent colorectal cancer after failure of, or not eligible for oxaliplatin and irinotecan-based standard anticancer therapy (If a subject had a radical surgery for colorectal cancer followed by adjuvant anticancer therapy, and the disease recurred during the adjuvant anticancer therapy or within 6 months from the end of the adjuvant anticancer therapy, the adjuvant anticancer therapy will be considered primary palliative therapy.)
- Subjects with at least one evaluable lesion, or non-measurable but evaluable lesion according to RECIST v1.1
- Subjects with ECOG performance status 0-1
Key exclusion criteria (34 listed)
- Individuals who meet any of the following exclusion criteria will be excluded from the study.
- Patients who have hypersensitivity to the active ingredient of IP or any of its components (excipients)
- Individuals 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Nelmastobart 800 mg+Trifluridine/Tipiracil+ BevacizumabTrifluridine/tipiracil is dose-deescalated from 35 mg/m² to 30 mg/m² and 25 mg/m² to determine the RP2D, in combination with fixed doses of Nelmastobart and Bevacizumab, in patients with metastatic colorectal cancer who are refractory or intolerant to prior oxaliplatin- and irinotecan-based chemotherapy. | Drug | Nelmastobart 800 mg+Trifluridine/Tipiracil+Bevacizumab |
Primary outcome
Incidence of DLT
Time frame: up to 6 months
Status of DLT will be presented with frequency, percentage and its 95% confidence interval (CI).
RP2D(Recommended Phase 2 Dose)
Time frame: up to 2 years
The recommended phase 2 dose (RP2D) of nelmastobart in combination with trifluridine/tipiracil and bevacizumab
MTD(Maximum Tolerated Dose)
Time frame: up to 2 years
To find the maximum tolerated dose (MTD)
Progression Free Survival (PFS) rate
Time frame: up to 2 years
Time from the start of treatment to objective tumor progression or all-cause death will be presented with survival curve, median survival time and its 95% CI using the Kaplan-Meier estimation.
8 secondary outcomes
Phase 2 study; Overall Survival (OS)
Time frame: up to 2 years
Phase 2 study; Objective Response Rate (ORR)
Time frame: up to 2 years
Maximum plasma concentration (Cmax)
Time frame: up to 6 months
Phase 2 study; Disease Control Rate (DCR)
Time frame: up to 2 years
PFS(Progression free survival)
Time frame: up to 2 years
Phase 2 study; Duration of Response (DOR)
Time frame: up to 2 years
AEs(Adverse Events)
Time frame: up to 2 years
Tmax(Time to Maximum Plasma Concentration)
Time frame: up to 2 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jul 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Nelmastobart 800 mg+Trifluridine/Tipiracil+ Bevacizumab in people with Metastatic Colorectal Cancer (CRC) and Recurrent Colorectal Cancer, run by STCube, Inc. at 5 sites in South Korea.
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 26 inclusion and 34 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 11 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in South Korea. 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 Hyunju Yoo (+8225513370, ID@stcube.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 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 11 Jul 2025.