Metastatic Colorectal NeoplasmsPhase 1/2IGNITE-CRCNCT07591597
A Multicenter, Phase Ib/II Clinical Trial to Evaluate the Efficacy and Safety of Concurrent Combination Therapy of S-531011 Plus Fruquintinib or S-531011 Plus Fruquintinib Plus Pembrolizumab in Patients With MSS/pMMR Colorectal Cancer
A Phase 1/2 study testing S-531011, Fruquintinib and Pembrolizumab in people with Metastatic Colorectal Neoplasms and Microsatellite Stable / Proficient Mismatch Repair Colorectal Cancer, run by National Cancer Center Hospital East.
Trial summary
This study aims to evaluate the efficacy and safety of the concurrent combination therapy of S 531011 + fruquintinib or S 531011 + fruquintinib + pembrolizumab in patients with MSS/pMMR colorectal cancer. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Metastatic Colorectal Neoplasms, Microsatellite Stable / Proficient Mismatch Repair Colorectal Cancer
- What is being tested?
- S-531011, Fruquintinib and Pembrolizumab
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 68 participants
- Where
- No sites listed yet
- Study dates
- May 2026to May 2029
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with histologically confirmed unresectable adenocarcinoma of the colon or rectum.
- Confirmed microsatellite stable (MSS) or proficient mismatch repair (pMMR) status.
- Prior treatment with standard systemic chemotherapy and refractory or intolerant* to such therapies. Standard chemotherapy must include all of the following:
- Fluoropyrimidine, irinotecan, and oxaliplatin (with or without anti-VEGF antibody therapy)
- For patients with RAS and BRAF wild-type tumors: prior treatment with anti-EGFR monoclonal antibody (cetuximab or panitumumab)
- For patients with BRAF V600E mutation: prior treatment with a BRAF inhibitor (encorafenib)
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- For patients who relapse during adjuvant chemotherapy or within 6 months after the last dose of postoperative adjuvant chemotherapy, that adjuvant therapy counts as prior systemic therapy.
- Presence of measurable disease according to RECIST version 1.1.
- Age ≥ 18 years at the time of informed consent.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
- Laboratory values within 14 days prior to enrollment meeting all of the following (tests performed on the same weekday 2 weeks before the enrollment date are acceptable):
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- Absolute neutrophil count ≥ 1,500/mm³
- Hemoglobin ≥ 9.0 g/dL
- Platelet count ≥ 75,000/mm³
- Total bilirubin ≤ 1.5 × institutional upper limit of normal (ULN)
- AST (GOT) ≤ 2.5 × ULN; ≤ 5 × ULN if liver metastases are present
- ALT (GPT) ≤ 2.5 × ULN; ≤ 5 × ULN if liver metastases are present
- Creatinine ≤ 1.5 mg/dL
- Proteinuria ≤ 1+ or < 1.0 g/24 h (urine protein-to-creatinine ratio < 1 may be used; if 24-hour urine is collected, the measured value takes precedence) 8. No blood transfusion within 7 days prior to enrollment (a transfusion given on the same weekday 1 week earlier is considered ineligible).
- 9. Women of childbearing potential must have a negative pregnancy test within 14 days prior to enrollment. Both male and female participants must agree to use appropriate contraception during the study and for 4 months after the last dose of study treatment. Female participants must also agree not to breastfeed during the study and for 4 months after the last dose. (Tests performed on the same weekday 2 weeks before the enrollment date are acceptable.) 10. Able to take oral medication. 11. Written informed consent obtained from the participant.
Who cannot join
- Prior treatment with fruquintinib for metastatic colorectal cancer.
- Prior treatment with any anti-CCR8 antibody, regardless of indication.
- Receipt of chemotherapy, radiotherapy, immunotherapy, or any antitumor therapy, or investigational agents within 14 days prior to enrollment, or persistence of CTCAE Grade ≥ 2 toxicities from prior therapies (excluding alopecia, hyperpigmentation, and peripheral sensory neuropathy).
- History of acute coronary syndrome (including myocardial infarction or unstable angina), coronary angioplasty, or stent placement within 6 months prior to enrollment.
- History or current findings of congestive heart failure of NYHA Class III or higher.
- Uncontrolled hypertension.
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- Known central nervous system metastases. (If CNS metastasis is clinically suspected, brain CT or MRI must be performed during screening.)
- Active double primary malignancy (simultaneous or metachronous with disease-free interval < 2 years), except for carcinoma in situ or intramucosal carcinoma lesions considered curable by local therapy.
- Serious comorbidities requiring inpatient treatment (e.g., paralytic ileus, bowel obstruction, pulmonary fibrosis, uncontrolled diabetes, heart failure, myocardial infarction, angina, renal failure, hepatic failure, psychiatric disorders, cerebrovascular disorders, or transfusion-requiring ulcers).
- Active infections, including:
- HBs antigen positive
- Patients may be eligible if receiving nucleoside analog antiviral therapy and HBV-DNA < 20 IU/mL (1.3 log IU/mL).
- HBs antibody positive or HBc antibody positive AND HBV-DNA positive
- If HBV-DNA < 20 IU/mL, the patient may be eligible. - HCV antibody positive
- Patients may be eligible if HCV-RNA is below the detection limit. - HIV positive
- Patients may be eligible if HIV infection is ruled out by confirmatory testing.
- Other active infections requiring treatment.
- History of autoimmune disease or chronic/recurrent autoimmune disease (patients with type 1 diabetes, hypothyroidism manageable with hormone replacement, or localized skin diseases such as vitiligo, psoriasis, or alopecia not requiring systemic therapy are eligible).
- Requirement for systemic corticosteroids or immunosuppressive agents, or receipt of such therapy within 2 weeks prior to enrollment (treatment given on the same weekday 2 weeks earlier renders the patient ineligible), except for temporary administration for testing, allergic reactions, or edema associated with radiotherapy.
- Lack of willingness or inability to comply with study procedures.
- Considered unsuitable for the study by the principal investigator or sub-investigator.
- Pregnancy and Contraception:
- A woman of childbearing potential includes any female who has experienced menarche, has not undergone permanent sterilization (e.g., hysterectomy, bilateral tubal ligation, or bilateral oophorectomy), and is not postmenopausal. Postmenopause is defined as at least 12 consecutive months of amenorrhea without another medical cause. Women using oral contraceptives, intrauterine devices, or mechanical barrier methods are considered capable of becoming pregnant. If a female participant is determined to be not capable of becoming pregnant, this must be documented in source records.
- Women must use effective contraception for at least 1 month prior to first study treatment, from the time of consent, and for at least 4 months after the last dose. Men must use effective contraception during study treatment and for at least 4 months after the last dose.
- Acceptable contraception includes vasectomy or condom use for male participants or male partners, and tubal ligation, contraceptive pessary, intrauterine devices, or oral contraceptives for female participants or female partners.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
This study aims to evaluate the efficacy and safety of the concurrent combination therapy of S 531011 + fruquintinib or S 531011 + fruquintinib + pembrolizumab in patients with MSS/pMMR colorectal cancer.
Read the detailed description
This study aims to evaluate the efficacy and safety of the concurrent combination therapy of S-531011 plus fruquintinib, or S-531011 plus fruquintinib plus pembrolizumab, in patients with MSS/pMMR colorectal cancer. Eligible participants include patients with metastatic colon or rectal cancer who are 18 years of age or older, have an ECOG Performance Status of 0-1, and have MSS or pMMR tumor status. After written explanation and the provision of written informed consent, participants will be enrolled.
The study consists of a Phase Ib part and a Phase II part. In the Phase Ib part (N = 6-12/Arm), participants will be assigned to Arm A or Arm B. Enrollment into Arm B will begin only after enrollment into Arm A has been completed in both phases.
Arm A consists of S-531011 (intravenous, once every 3 weeks) plus fruquintinib (5 mg orally once daily on Days 1-21 of a 28-day cycle).
Arm B consists of S-531011 (intravenous, once every 3 weeks), fruquintinib (5 mg orally once daily on Days 1-21 of a 28-day cycle), and pembrolizumab (200 mg, intravenous, once every 3 weeks).
In the Phase II part (N = 22/Arm), the recommended dose determined in the Phase Ib part will be used.
- Conditions
- Metastatic Colorectal Neoplasms, Microsatellite Stable / Proficient Mismatch Repair Colorectal Cancer
- Being tested
- S-531011, Fruquintinib, Pembrolizumab
- Keywords
- Colorectal Neoplasms, Metastatic Colorectal Cancer, Microsatellite Stability, DNA Mismatch Repair, Receptors, CCR8, CCR8 Antagonists, Fruquintinib, Pembrolizumab, Antibodies, Monoclonal, Immune Checkpoint Inhibitors, VEGFR Inhibitors, Combination Drug Therapy, Phase Ib Clinical Trial, Phase II Clinical Trial
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
S-531011Biological
S-531011 will be administered intravenously once every 3 weeks (q3w). In the Phase Ib part, A reduced dose of S-531011 may be used in Dose Level -1 according to the predefined dose-finding scheme by evaluating DLT profile. In the Phase II part, S-531011 will be administered at the recommended dose determined in the Phase Ib part.
FruquintinibDrug
Also called FRUZAQLA
Fruquintinib will be administered orally once daily on Days 1-21 of each 28-day cycle.
In the Phase Ib part, fruquintinib will be started at 5 mg (Dose Level 0). A reduced dose of 4 mg may be used in Dose Level -1 according to the predefined dose-finding scheme by evaluating DLT profile. In the Phase II part, fruquintinib will be administered at the recommended dose determined in the Phase Ib part.
PembrolizumabBiological
Also called KEYTRUDA
Pembrolizumab will be administered intravenously at a dose of 200 mg once every 3 weeks (q3w).
| Study group | Role | What they receive |
|---|---|---|
| Arm A S-531011 + Fruquintinib | Experimental | Participants receive S-531011 and fruquintinib. In the Phase Ib part, dose levels may vary according to the dose finding scheme. In Phase II, the recommended dose determined in Phase Ib will be used. Receives: Biological: S-531011; Drug: Fruquintinib |
| Arm B S-531011 + Fruquintinib + Pembrolizumab | Experimental | Participants receive S-531011, fruquintinib, and pembrolizumab. In the Phase Ib part, dose levels of S-531011 and fruquintinib may vary according to the dose finding scheme. In Phase II, the recommended dose determined in Phase Ib will be used.
Pembrolizumab is administered at a fixed dose throughout both the Phase Ib and Phase II parts. Receives: Biological: S-531011; Drug: Fruquintinib; Biological: Pembrolizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dose-Limiting Toxicity (DLT) Rate [Phase Ib Part]
Percentage of participants experiencing dose-limiting toxicities (DLTs).
Measured: Up to 29 days after first dose
Objective Response Rate (ORR) [Phase II Part]
Objective response rate assessed by the principal investigator or sub-investigator.Participants treated at the recommended dose in Phase Ib are included.
Measured: From baseline to objective disease progression or death, assessed up to 24 months.
Secondary outcomes (13)
Maximum Observed Serum Concentration of S-531011 (Cmax)
Maximum observed concentration of S-531011 in serum.
Measured: From the first through the ninth administration of S-531011 (each cycle is 21 days) and at 30 days after the final administration
Time to Maximum Observed Serum Concentration of S-531011 (Tmax)
Time to reach the maximum observed serum concentration of S-531011.
Measured: From the first through the ninth administration of S-531011 (each cycle is 21 days) and at 30 days after the final administration
Area Under the Serum Concentration-Time Curve of S-531011 (AUC)
Area under the serum concentration-time curve of S-531011.
Measured: From the first through the ninth administration of S-531011 (each cycle is 21 days) and at 30 days after the final administration
Terminal Elimination Half-Life of S-531011 (t1/2)
Terminal elimination half-life of S-531011 estimated from serum concentration-time data.
Measured: From the first through the ninth administration of S-531011 (each cycle is 21 days) and at 30 days after the final administration
Anti-S-531011 Antibody (ADA) Titer
Titer of anti-S-531011 antibodies measured to assess immunogenicity.
Measured: From the first through the ninth administration of S-531011 (each cycle is 21 days) and at 30 days after the final administration
Incidence of Anti-S-531011 Antibody (ADA) Positivity
Proportion of participants with detectable anti-S-531011 antibodies.
Measured: From the first through the ninth administration of S-531011 (each cycle is 21 days) and at 30 days after the final administration
Neutralizing Anti-S-531011 Antibody (NAb) Titer
Titer of neutralizing anti-S-531011 antibodies in participants who test positive for anti-S-531011 antibodies.
Measured: From the first through the ninth administration of S-531011 (each cycle is 21 days) and at 30 days after the final administration
Incidence of Neutralizing Anti-S-531011 Antibody (NAb) Positivity
Proportion of participants with detectable neutralizing anti-S-531011 antibodies.
Measured: From the first through the ninth administration of S-531011 (each cycle is 21 days) and at 30 days after the final administration
Duration of Response (DoR) [Phase Ib/II Part]
Duration of confirmed objective response.
Measured: From first documented response until disease progression or death from any cause, whichever occurs first, assessed up to 12 months after the last subject is enrolled
Disease Control Rate (DCR) [Phase Ib/II Part]
Percentage of participants achieving CR, PR, or SD.
Measured: Up to 12 months after the last subject is enrolled
Progression-Free Survival (PFS) [Phase Ib/II Part]
Time from enrollment to radiological progression or death.
Measured: From enrollment until disease progression or death from any cause, whichever occurs first, assessed up to 12 months after the last subject is enrolled
Overall Survival (OS) [Phase Ib/II Part]
Time from enrollment to death.
Measured: From enrollment until death from any cause, assessed up to 12 months after the last subject is enrolled
Incidence of Adverse Events [Phase Ib/II Part]
Percentage of participants experiencing adverse events.
Measured: From first dose until 30 days after last dose for all adverse events, and thereafter for related adverse events up to 12 months after the last subject is enrolled
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 May 2026
- Study startMay 2026 (estimated)
- Primary completionJul 2027 (estimated)
- Study completionMay 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metastatic Colorectal NeoplasmsStudies 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
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- This study uses a parallel assignment model with two experimental arms (Arm A and Arm B). Enrollment into Arm B will begin only after enrollment into Arm A has been completed. Participants will receive the assigned intervention throughout the study without crossover between arms.
- Masking
- None (open label)
- Enrolment
- 68 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Cancer Center Hospital East
- Sponsor type
- University, hospital or other
- Collaborators
- Shionogi
- Responsible party
- Principal investigator, Akihito Kawazoe, National Cancer Center Hospital East
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07591597
- Sponsor's protocol ID
- EPOC2501
- Other IDs
- jRCT2031260047
- Acronym
- IGNITE-CRC
- Status last verified
- Apr 2026
- First submitted
- 13 Apr 2026
- Last updated
- 18 May 2026
- 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 18 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Phase Ib/II Clinical Trial to Evaluate the Efficacy and Safety of Concurrent Combination Therapy of S-531011 Plus Fruquintinib or S-531011 Plus Fruquintinib Plus Pembrolizumab in Patients With MSS/pMMR Colorectal Cancer
- ClinicalTrials.gov ID
- NCT07591597
- Acronym / sponsor ID
- IGNITE-CRC / EPOC2501
- Conditions
- Metastatic Colorectal Neoplasms, Microsatellite Stable / Proficient Mismatch Repair Colorectal Cancer
- Keywords
- Colorectal Neoplasms, Metastatic Colorectal Cancer, Microsatellite Stability, DNA Mismatch Repair, Receptors, CCR8, CCR8 Antagonists, Fruquintinib, Pembrolizumab
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 68 participants (estimated)
- Lead sponsor
- National Cancer Center Hospital EastUniversity, hospital or other
- Collaborators
- Shionogi
- Study start
- May 2026 (estimated)
- Primary completion
- Jul 2027 (estimated)
- Study completion
- May 2029 (estimated)
- First posted
- 18 May 2026 (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.
This study aims to evaluate the efficacy and safety of the concurrent combination therapy of S 531011 + fruquintinib or S 531011 + fruquintinib + pembrolizumab in patients with MSS/pMMR colorectal cancer.
Detailed description
This study aims to evaluate the efficacy and safety of the concurrent combination therapy of S-531011 plus fruquintinib, or S-531011 plus fruquintinib plus pembrolizumab, in patients with MSS/pMMR colorectal cancer. Eligible participants include patients with metastatic colon or rectal cancer who are 18 years of age or older, have an ECOG Performance Status of 0-1, and have MSS or pMMR tumor status. After written explanation and the provision of written informed consent, participants will be enrolled.
The study consists of a Phase Ib part and a Phase II part. In the Phase Ib part (N = 6-12/Arm), participants will be assigned to Arm A or Arm B. Enrollment into Arm B will begin only after enrollment into Arm A has been completed in both phases.
Arm A consists of S-531011 (intravenous, once every 3 weeks) plus fruquintinib (5 mg orally once daily on Days 1-21 of a 28-day cycle).
Arm B consists of S-531011 (intravenous, once every 3 weeks), fruquintinib (5 mg orally once daily on Days 1-21 of a 28-day cycle), and pembrolizumab (200 mg, intravenous, once every 3 weeks).
In the Phase II part (N = 22/Arm), the recommended dose determined in the Phase Ib part will be used.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- This study uses a parallel assignment model with two experimental arms (Arm A and Arm B). Enrollment into Arm B will begin only after enrollment into Arm A has been completed. Participants will receive the assigned intervention throughout the study without crossover between arms.
| Arm | Type | Receives |
|---|---|---|
| Arm A S-531011 + Fruquintinib | Experimental | Biological: S-531011, Drug: FruquintinibParticipants receive S-531011 and fruquintinib. In the Phase Ib part, dose levels may vary according to the dose finding scheme. In Phase II, the recommended dose determined in Phase Ib will be used. |
| Arm B S-531011 + Fruquintinib + Pembrolizumab | Experimental | Biological: S-531011, Drug: Fruquintinib, Biological: PembrolizumabParticipants receive S-531011, fruquintinib, and pembrolizumab. In the Phase Ib part, dose levels of S-531011 and fruquintinib may vary according to the dose finding scheme. In Phase II, the recommended dose determined in Phase Ib will be used. Pembrolizumab is administered at a fixed dose throughout both the Phase Ib and Phase II parts. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (21 listed)
- Patients with histologically confirmed unresectable adenocarcinoma of the colon or rectum.
- Confirmed microsatellite stable (MSS) or proficient mismatch repair (pMMR) status.
- Prior treatment with standard systemic chemotherapy and refractory or intolerant* to such therapies. Standard chemotherapy must include all of the following:
- For patients who relapse during adjuvant chemotherapy or within 6 months after the last dose of postoperative adjuvant chemotherapy, that adjuvant therapy counts as prior systemic therapy.
- Presence of measurable disease according to RECIST version 1.1.
Key exclusion criteria (25 listed)
- Prior treatment with fruquintinib for metastatic colorectal cancer.
- Prior treatment with any anti-CCR8 antibody, regardless of indication.
- Receipt of chemotherapy, radiotherapy, immunotherapy, or any antitumor therapy, or investigational agents within 14 days prior to enrollment, or persistence of CTCAE Grade ≥ 2 toxicities from prior therapies (excluding alopecia, hyperpigmentation, and peripheral sensory neuropathy).
- History of acute coronary syndrome (including myocardial infarction or unstable angina), coronary angioplasty, or stent placement within 6 months prior to enrollment.
- History or current findings of congestive heart failure of NYHA Class III or higher.
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 |
|---|---|---|
| S-531011S-531011 will be administered intravenously once every 3 weeks (q3w). In the Phase Ib part, A reduced dose of S-531011 may be used in Dose Level -1 according to the predefined dose-finding scheme by evaluating DLT profile. In the Phase II part, S-531011 will be administered at the recommended dose determined in the Phase Ib part. | Biological | Arm A S-531011 + Fruquintinib, Arm B S-531011 + Fruquintinib + Pembrolizumab |
| FruquintinibAlso: FRUZAQLAFruquintinib will be administered orally once daily on Days 1-21 of each 28-day cycle. In the Phase Ib part, fruquintinib will be started at 5 mg (Dose Level 0). A reduced dose of 4 mg may be used in Dose Level -1 according to the predefined dose-finding scheme by evaluating DLT profile. In the Phase II part, fruquintinib will be administered at the recommended dose determined in the Phase Ib part. | Drug | Arm A S-531011 + Fruquintinib, Arm B S-531011 + Fruquintinib + Pembrolizumab |
| PembrolizumabAlso: KEYTRUDAPembrolizumab will be administered intravenously at a dose of 200 mg once every 3 weeks (q3w). | Biological | Arm B S-531011 + Fruquintinib + Pembrolizumab |
Primary outcome
Dose-Limiting Toxicity (DLT) Rate [Phase Ib Part]
Time frame: Up to 29 days after first dose
Percentage of participants experiencing dose-limiting toxicities (DLTs).
Objective Response Rate (ORR) [Phase II Part]
Time frame: From baseline to objective disease progression or death, assessed up to 24 months.
Objective response rate assessed by the principal investigator or sub-investigator.Participants treated at the recommended dose in Phase Ib are included.
13 secondary outcomes
Maximum Observed Serum Concentration of S-531011 (Cmax)
Time frame: From the first through the ninth administration of S-531011 (each cycle is 21 days) and at 30 days after the final administration
Time to Maximum Observed Serum Concentration of S-531011 (Tmax)
Time frame: From the first through the ninth administration of S-531011 (each cycle is 21 days) and at 30 days after the final administration
Area Under the Serum Concentration-Time Curve of S-531011 (AUC)
Time frame: From the first through the ninth administration of S-531011 (each cycle is 21 days) and at 30 days after the final administration
Terminal Elimination Half-Life of S-531011 (t1/2)
Time frame: From the first through the ninth administration of S-531011 (each cycle is 21 days) and at 30 days after the final administration
Anti-S-531011 Antibody (ADA) Titer
Time frame: From the first through the ninth administration of S-531011 (each cycle is 21 days) and at 30 days after the final administration
Incidence of Anti-S-531011 Antibody (ADA) Positivity
Time frame: From the first through the ninth administration of S-531011 (each cycle is 21 days) and at 30 days after the final administration
Neutralizing Anti-S-531011 Antibody (NAb) Titer
Time frame: From the first through the ninth administration of S-531011 (each cycle is 21 days) and at 30 days after the final administration
Incidence of Neutralizing Anti-S-531011 Antibody (NAb) Positivity
Time frame: From the first through the ninth administration of S-531011 (each cycle is 21 days) and at 30 days after the final administration
Duration of Response (DoR) [Phase Ib/II Part]
Time frame: From first documented response until disease progression or death from any cause, whichever occurs first, assessed up to 12 months after the last subject is enrolled
Disease Control Rate (DCR) [Phase Ib/II Part]
Time frame: Up to 12 months after the last subject is enrolled
Progression-Free Survival (PFS) [Phase Ib/II Part]
Time frame: From enrollment until disease progression or death from any cause, whichever occurs first, assessed up to 12 months after the last subject is enrolled
Overall Survival (OS) [Phase Ib/II Part]
Time frame: From enrollment until death from any cause, assessed up to 12 months after the last subject is enrolled
Incidence of Adverse Events [Phase Ib/II Part]
Time frame: From first dose until 30 days after last dose for all adverse events, and thereafter for related adverse events up to 12 months after the last subject is enrolled
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 18 May 2026.
- 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.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing S-531011, Fruquintinib and Pembrolizumab in people with Metastatic Colorectal Neoplasms and Microsatellite Stable / Proficient Mismatch Repair Colorectal Cancer, run by National Cancer Center Hospital East.
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 21 inclusion and 25 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 May 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 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 Akihito Kawazoe, MD (+81-4-7133-1111, ignite-crc_core@east.ncc.go.jp), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dose-Limiting Toxicity (DLT) Rate [Phase Ib Part] (time frame: Up to 29 days after first dose). 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?
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 May 2026; AzTrials last refreshed its copy on 1 Nov 2026.