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Advanced Colorectal CancerPhase 2NCT06885385

A Phase 2 Study Evaluating the Safety and Efficacy of JS207 With or Without JS015 in Combination With Chemotherapy in Patients With Colorectal Cancer

A Phase 2 study testing JS207, JS015 and Capecitabine in people with Advanced Colorectal Cancer, run by Shanghai Junshi Bioscience 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
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Trial summary

This study is an open label, multicenter Phase II clinical trial aimed at evaluating the safety and efficacy of JS207 with or without JS015 in combination with chemotherapy (XELOX) as a first-line treatment for advanced colorectal cancer with MSS/pMMR. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Advanced Colorectal Cancer
What is being tested?
JS207, JS015 and Capecitabine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
60 participants
Where
2 sitesChina
Study dates
23 Apr 2025to 13 Feb 2027
Phase
Phase 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

  • Subjects aged 18 to 75 (inclusive) at the time of signing the consent form, both male and female
  • Colorectal adenocarcinoma or rectal adenocarcinoma with histological or cytological Qualification, according to the 8th edition of the AJCC colorectal cancer TNM staging stage IV, MSS/pMMR (a qualified report of MSS or pMMR detected by a local laboratory must be provided), and no previous systemic anti-tumor therapy for advanced disease; for patients who have received neoadjuvant or adjuvant systemic therapy, the last treatment to relapse or progression takes more than 12 months
  • ECOG score is 0 or 1
  • Estimated survival ≥ 12 weeks
  • According to the RECIST v1.1 evaluation standard, there is at least one measurable lesion
  • Good organ function
  • Female or male subjects with fertility must agree to have no family planning during the study period and voluntarily use effective contraception with significant others within 6 months after the end of the last medication. Female subjects with fertility (WOCBP) must have a negative serum pregnancy test within 7 days before the first medication and be non-lactating (see section 10.3 for specific contraceptive measures and WOCBP definitions)
  • The patient participated voluntarily, gave full informed consent, signed a written ICF, and had good compliance

Who cannot join

  • Previously received PD-1 or programmed cell death ligand 1 (PD-L1) inhibitor therapy; or previously received DKK1 inhibitor therapy (only for cohort 2 subjects)
  • Received the following medications or treatments before the first dose Within 28 days before the first dose, major surgery and radiotherapy (palliative radiotherapy for local bone/brain lesions, allowed to be completed within 14 days before the first dose) were performed. Within 7 days before the start of the study, coarse needle aspiration biopsy or other minor surgery was performed, excluding the placement of vascular infusion devices.
  • Within 14 days before the first medication, antiplatelet therapy such as aspirin (≥ 325 mg/day), clopidogrel (≥ 75 mg/day), or anticoagulant therapy for therapeutic purposes have been used.
  • Patients who have received systematic treatment with corticosteroids (> 10 mg prednisone or equivalent dose per day) or other immunosuppressants for more than 1 week before the first dose are allowed to use inhaled or topical steroids or ≤ 10 mg/day systemic prednisone and equivalent doses of similar drugs for treatment.
  • Have received any live vaccine or attenuated live vaccine within 28 days before the first dose, or expect to receive live vaccine or attenuated live vaccine during the study period (limited to patients in combination therapy studies);
  • The toxicity of previous anti-tumor treatment has not been restored to the level specified in CTCAE v5.0 or the level specified in the inclusion/exclusion criteria, except for the following cases: the relevant toxicity that has been judged by the investigator to be well controlled and does not affect the safety and compliance of the patient with the study drug can be screened after qualification with the sponsor
Show all 20Show fewer
  • Digestive tract perforation, fistula, abdominal abscess, and digestive system ulcerative diseases or a history thereof within 6 months prior to the first medication (the investigator may consider inclusion if the ulcer condition is stable)
  • There are pleural effusion, abdominal effusion or pericardial effusion with clinical symptoms that require repeated treatment (puncture or drainage, etc.)
  • History of interstitial lung disease or previous history of non-infectious pneumonia treated with corticosteroids, or evidence of active pneumonia on screening imaging
  • Severe, unhealed or open wounds, active ulcers, or untreated fractures (excluding old fractures evaluated by researchers as not requiring clinical intervention)
  • Evidence of obvious bleeding tendency or severe coagulation dysfunction,Have a history of gastrointestinal bleeding within the 6 months prior to enrollment, or have a clear tendency towards gastrointestinal bleeding (including severe esophageal-gastric varices with bleeding risk, locally active gastrointestinal ulcer lesions, and persistent positive fecal occult blood),Clinically significant hemoptysis or tumor bleeding for any reason within 28 days before the first medication.Screening period imaging shows that the tumor surrounds important blood vessels or has obvious necrosis and cavities, and the researchers believe that it may cause bleeding risks
  • Presence of poorly controlled hypertension (systolic blood pressure ≥ 150 mmHg and/or diastolic blood pressure > 100 mmHg), or a history of hypertensive crisis or hypertensive encephalopathy
  • Severe cardiovascular and cerebrovascular diseases, including but not limited to: myocardial infarction, severe/unstable angina pectoris, congestive heart failure (New York Heart Association [NYHA] heart function classification ≥ 2), clinically significant supraventricular or ventricular arrhythmia requiring drug intervention, aortic aneurysm requiring surgical repair, any arterial thrombosis/embolism events, grade 3 or above (CTCAE v5.0) venous thrombosis/embolism events, transient cerebral ischemic attack, cerebrovascular accident; left ventricular ejection fraction (LVEF) < 50% in cardiac ultrasound examination. The corrected QT interval (QTc) is > 480 ms (calculated using the Fridericia method. If the QTc is abnormal, it can be detected three times continuously every 2 minutes and the average value is taken)
  • There is active Central Nervous System metastasis. If the patient has received radiotherapy or surgery in the past, the imaging examination within 4 weeks before the first medication shows that the brain metastasis is stable and there is no aggravation or new neurological symptoms. Hormonal therapy has been stopped two weeks before the first medication, and screening is allowed; for the presence of meningeal metastasis and brainstem metastasis, screening is not allowed regardless of treatment
  • Severe infection (CTCAE v5.0 > 2) occurred within 28 days before the first study administration, such as severe pneumonia, bacteremia, and comorbidities requiring hospitalization; or active infection requiring systemic anti-infective treatment or fever of unknown cause > 38.5 ℃ occurred within 2 weeks before the first study administration (according to the investigator's judgment, subjects with fever caused by tumors can be enrolled);
  • Active tuberculosis, hepatitis B (hepatitis B surface antigen [HBsAg] positive and HBV DNA higher than 1000 copies/ml or 200 IU/ml), hepatitis C (hepatitis C antibody [HCVAb] positive and HCV RNA higher than the lower limit of the research center)
  • Have a history of immunodeficiency diseases, including a positive test for human immunodeficiency virus (HIV), or a known history of allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation
  • Active autoimmune diseases that require systemic treatment (e.g. corticosteroids or immunosuppressive drugs) within 2 years before the first medication, including but not limited to: systemic systemic lupus erythematosus, multiple sclerosis, rheumatoid arthritis, inflammatory bowel disease, vasculitis, etc. However, thyroid, adrenal or pituitary gland dysfunction that can be controlled only with hormone replacement therapy, type 1 diabetes, psoriasis or vitiligo that do not require systemic treatment, childhood asthma/allergies that have been cured are allowed to be screened
  • Have a history of another primary malignant tumor, except for malignant tumors (such as basal cell carcinoma and squamous cell carcinoma of the skin that have received potential curative treatment) that have received radical treatment before the first dose of the study intervention and have no known active disease (more than 5 years) and low potential recurrence risk
  • Patients who have other serious physical or mental illnesses or laboratory abnormalities that may increase the risk of participating in the study, affect treatment adherence, or interfere with the study results, and are judged by the investigator to be unsuitable for participation in this study

Trial locations and contacts

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

Chengbo Jia, Master contact

18542765054

chengbo_jia@junshipharma.com

China2 sites, 2 recruiting

  • Beijing Cancer Hospital

    Beijing, Beijing Municipality, 100142

    Lin Shen, Master, 13911219511, doctorshenlin@sina.cn

    Lin Shen, Master

    Recruiting

  • Shanghai Oriental Hospital

    Shanghai, Shanghai Municipality, 200120

    Yong Gao, Doctor of Medicine, 13310167477, drgaoyong@163.com

    Yong Gao, Doctor of Medicine

    Recruiting

Other trials in China

About this study

Official title: An Open-label, Multicenter, Phase 2 Clinical Study Evaluating the Safety and Efficacy of JS207 With or Without JS015 in Combination With Chemotherapy (XELOX) as First-line (1L) Treatment in Patients With MSS/pMMR Advanced Colorectal Cance

This study is an open label, multicenter Phase II clinical trial aimed at evaluating the safety and efficacy of JS207 with or without JS015 in combination with chemotherapy (XELOX) as a first-line treatment for advanced colorectal cancer with MSS/pMMR. The study was divided into two cohorts: Cohort 1 was JS207 combined with XELOX, and Cohort 2 was JS207 combined with JS015 and XELOX.

Being tested
JS207, JS015, Capecitabine, Oxaliplatin

What participants receive

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

  • JS207Biological

    JS207 will be administered every 3 weeks for a treatment cycle of 21 days

  • JS015Biological

    JS015 will be administered every 3 weeks for a treatment cycle of 21 days

  • CapecitabineDrug

    Capecitabine of 1000mg/m2 will be administered orally twice daily from day 1 to 14 every 21 day cycle

  • OxaliplatinDrug

    Oxaliplatin of 130mg/m2 will be administered intravenously (IV) on day 1 every 21 day cycle

Study groups in NCT06885385
Study groupRoleWhat they receive
JS207ExperimentalNot described
Receives: Biological: JS207; Biological: JS015; Drug: Capecitabine; Drug: Oxaliplatin

What is being measured

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

  1. Dose-limiting toxicity （DLT)

    Incidence and severity of DLT

    Measured: 2 Years

  2. Adverse event（AE）

    Adverse events (AE), Abnormal changes in laboratory and other tests with clinical significance

    Measured: 2 Years

  3. RP3D

    Recommended dose for phase II trial

    Measured: 2 Years

  4. Objective response rate (ORR) based on Response Evaluation Criteria In Solid Tumors 1.1 (RECIST1.1)

    Defined as the proportion of subjects who achieved partial response (PR) or complete response (CR)

    Measured: 2 years

Secondary outcomes (3)

  1. Progression free survival(PFS)

    The time from first dose to Disease progression or death

    Measured: 2 years

  2. Overall survival (OS)

    The time from first dose to death from any cause

    Measured: 2 years

  3. Immunogenicity

    Incidence of Anti-Drug Antibody (ADA)

    Measured: 2 years

Timeline

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

  1. First posted20 Mar 2025
  2. Study start23 Apr 2025
  3. Primary completion27 Nov 2026 (estimated)
  4. Study completion13 Feb 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 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
60 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06885385
Sponsor's protocol ID
JS207-007-II-CRC
Status last verified
Jun 2025
First submitted
9 Mar 2025
Last updated
24 Jun 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing JS207, JS015 and Capecitabine in people with Advanced Colorectal Cancer, run by Shanghai Junshi Bioscience 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 8 inclusion and 20 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 24 Jun 2025. 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 phase mean?

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 Chengbo Jia, Master (18542765054, chengbo_jia@junshipharma.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Dose-limiting toxicity （DLT) (time frame: 2 Years). 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?

On the ClinicalTrials.gov record for NCT06885385.

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 24 Jun 2025.

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