Colorectal CancerPhase 2NCT05039944

SI-B001 as a Single Agent or in Combination With Chemotherapy in the Treatment of Digestive System Malignancies

A Phase 2 study testing SI-B001, Irinotecan and FOLFIRI Protocol in people with Colorectal Cancer, run by Sichuan Baili Pharmaceutical Co., Ltd. at 1 site in China.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

Search all trials

Trial summary

Who is it for?: Ages 18 years and older
Conditions the study is for: Colorectal Cancer
What is being tested?: SI-B001, Irinotecan and FOLFIRI Protocol
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 7 participants
Where: 1 siteChina
Study dates: 30 Nov 2021to 6 Jun 2022
Phase: Phase 2
Are there results?: None posted in the registry

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

Male or female, age ≥18;
Expected survival time ≥3 months;
Patients with unresectable or metastatic colorectal cancer or gastric cancer confirmed by histology or pathology:
CohortA: Patients with unresectable or metastatic gastric cancer, HER2-negative, without standard treatment.
CohortB: Patients with MSS KRASwt BRAFwt unresectable or metastatic colorectal cancer, failure of conventional chemotherapy combined with EGFR mab, and withdrawal of EGFR mab for less than 3 months.
CohortC: MSS KRASwt BRAFwt patients with unresectable or metastatic colorectal cancer who have failed multiline conventional chemotherapy (without EGFR monoclonal antibody therapy).

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CohortD: MSI-H KRASwt BRAFwt patients with unresectable or metastatic colorectal cancer and previous first - or second-line treatment failure with anti-PD-1 (L1) mab (excluding EGFR mab).
CohortE: MSI-H KRASwt BRAFwt patients with unresectable or metastatic colorectal cancer who have previously failed first-line anti-PD-1 (L1) mab therapy.
CohortF: MSS KRASwt BRAFwt patients with unresectable or metastatic colorectal cancer who have failed standard therapy with first-line oxaliplatin or irinotecan plus fluorouracil plus or minus bevacizumab.
No previous anti-EGFR antibody therapy (excluding Cohort_B);
Agree to provide 4 specimens (thickness 5μm) of tumor tissue specimens (non-stained sections (anti-removal)) archiving from primary or metastatic tumors;agree to provide 6 unstained sections surgical specimens (anti-removal, thickness 10μm) or fresh tissue samples;
There must be at least one measurable lesion conforming to the RECIST V1.1 definition;
Cohort_A, B, C fitness scores ≤2, Cohort_D, E, F fitness scores ≤1;
Toxicity of previous antitumor therapy has been restored to ≤1 as defined by NCI-CTCAE V5.0 (except for toxicity that the researchers judge to be of no safety risk, such as hair loss, grade 2 peripheral neurotoxicity, and stabilized hypothyroidism after hormone replacement therapy);
Organ function levels must meet the following requirements and meet the following standards:
Bone marrow function: absolute value of neutrophil count (ANC) ≥1.5×109/L, platelet count ≥100×109/L (platelet count ≥75×109/L in Patients with Cohort_A, B and C), hemoglobin ≥90 g/L (hemoglobin ≥85 g/L in patients with Cohort_A, B and C); B) Liver function: Total bilirubin TBIL≤1.5×ULN (total bilirubin TBIL≤ 3×ULN in Gilbert's syndrome, liver cancer or liver metastases); AST and ALT ≤2.5×ULN in patients without liver metastasis; AST and ALT ≤5.0×ULN in patients with liver metastasis; C) Renal function: Creatinine (Cr) ≤1.5×ULN, or creatinine clearance (Ccr) ≥50 mL/min (according to Cockcroft and Gault formula); D) Urine routine / 24-hour protein quantification: qualitative urine protein ≤1+ (if qualitative urine protein ≥2+, 24 hours < 1g can be included); E) Cardiac function: left ventricular ejection fraction ≥50%; F) Coagulation function: International standardized ratio (INR) ≤1.5×ULN, and activated partial thrombin time (APTT) ≤1.5×ULN;
Eligible patients (male and female) who are fertile must agree to use a reliable contraceptive method (hormonal or barrier method or abstinence, etc.) with their partner during the trial and for at least 6 months after the last medication;Women of childbearing age must have a negative blood or urine pregnancy test within 7 days prior to the first use of the study drug.

Who cannot join

Colorectal cancer patients with HER2 positive (immunohistochemical +++, or immunohistochemical ++ with FISH amplification);
Have received chemotherapy, radiotherapy, biotherapy, endocrine therapy, immunotherapy and other anti-tumor therapy within 4 weeks prior to the first use of the study drug, except the following:
Oral fluorouracil and small molecule targeted drugs are 2 weeks before the first administration of the study drug or within the 5 half-lives of the drug (whichever is longer); The traditional Chinese medicines with anti-tumor indications were within 2 weeks before the first use of the study drug;
Received an unmarketed clinical investigational drug or treatment within 4 weeks prior to the first use of the investigational drug;
Has undergone major organ surgery (excluding needle biopsy, tracheotomy, gastrostomy, etc.) or has significant trauma within 4 weeks before the first use of study drugs, or needs to undergo elective surgery during the trial;
Previous recipients of allogeneic hematopoietic stem cell transplantation or organ transplantation;

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A history of serious cardiovascular and cerebrovascular diseases, including but not limited to:
Severe cardiac rhythm or conduction abnormalities, such as ventricular arrhythmias requiring clinical intervention, grade iii atrioventricular block, etc.
In the resting state, QT interval was prolonged (QTc > 450 msec in men or QTc > 470 msec in women); Acute coronary syndrome, congestive heart failure, aortic dissection, stroke or other grade 3 or higher cardio-cerebrovascular events within 6 months prior to the first administration; New York Heart Association (NYHA) heart function grade ≥II heart failure;
Active autoimmune and inflammatory diseases, such as systemic lupus erythematosus, inflammatory bowel disease, etc., except type I diabetes, hypothyroidism that can be controlled only with replacement therapy, and skin diseases that do not require systemic treatment (e.g., vitiligo, psoriasis);
A history of other malignant tumors within 3 years prior to the first administration, with no signs of recurrence and metastasis;
Poorly controlled hypertension (systolic blood pressure \& GT;150 mmHg or diastolic pressure \>100 mmHg);
Pulmonary disease defined as grade 3 or higher according to CTCAE V5.0;Patients with past or present interstitial lung disease (ILD);
Cerebral parenchymal or meningeal metastases with clinical symptoms are not suitable for inclusion by the investigator;
Had ≥ grade 3 infusion-related reactions during prior anti-EGFR antibody therapy (Cohort_B only);
There are known allergic contraindications to any excipients of SI-B001 and chemotherapeutic agents selected in this study;
Human immunodeficiency virus antibody (HIVAb) positive, active tuberculosis, active hepatitis B virus infection (HBV-DNA copy number > 104) or hepatitis C virus infection (HCV-RNA > center detection lower limit);
Active infections requiring systemic treatment, such as severe pneumonia, bacteremia, sepsis, etc.;
Pregnant or lactating women;
Persons with mental disorders or poor compliance;
The investigator considers that the subject has a history of other serious systemic diseases or other reasons and is not suitable to participate in this clinical study.

Trial locations and contacts

1 site in 1 country.

China1 site

Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, 200032

Other trials in China

About this study

Official title: A Phase II Clinical Study to Evaluate the Efficacy and Safety of SI-B001 as a Single Agent or in Combination With Chemotherapy in the Treatment of Unresectable or Metastatic Digestive System Malignancies (Colorectal and Gastric Cancer)

This multi-center, open label Phase II clinical study is performed in patients with unresectable or metastatic malignant tumors of the digestive system (colorectal cancer, gastric cancer). This study is investigating the safety and efficacy of SI-B001 at monotherapy or optimal combination dose with chemotherapy in patients.

Conditions: Colorectal Cancer
Being tested: SI-B001, Irinotecan, FOLFIRI Protocol, FOLFOX Protocol
Keywords: CRC
Medical subject headings: Colorectal Neoplasms

What participants receive

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

SI-B001Drug
In Arm_A, B and C, the intravenous infusion dose of SI-B001 was single drug RP2D selected in phase I (Q2W); In Cohort_D, E, and F, SI-B001 was divided into two doses, the high dose was the single drug RP2D selected in phase I clinical trial, and the low dose was the second low dose of single drug RP2D, both of which were administered by intravenous infusion.
IrinotecanDrug
Administration by intravenous infusion, 180 mg/m2 Q2W.
FOLFIRI ProtocolDrug
FOLFIRI is administered intravenously at the standard dose recommended by the guidelines(Q2W).
FOLFOX ProtocolDrug
FOLFOX is administered intravenously at the standard dose recommended by the guidelines(Q2W).

Study groups in NCT05039944
Study group	Role	What they receive
SI-B001_A	Experimental	Patients with unresectable or metastatic gastric cancer, HER2-negative and without standard treatment were treated with SI-B001 monotherapy.SI-B001 is administered by intravenous drip twice weekly (Q2W). Receives: Drug: SI-B001
SI-B001_B	Experimental	Patients with MSS KRASwt BRAFwt unresectable or metastatic colorectal cancer who had failed conventional chemotherapy combined with EGFR mab were treated with SI-B001 monotherapy.SI-B001 is administered by intravenous drip twice weekly (Q2W). Receives: Drug: SI-B001
SI-B001_C	Experimental	Patients with MSS KRASwt BRAFwt unresectable or metastatic colorectal cancer who had failed multiple lines of conventional chemotherapy (excluding EGFR monoclonal antibody) were treated with SI-B001 monotherapy.SI-B001 is administered by intravenous drip twice weekly (Q2W). Receives: Drug: SI-B001
SI-B001 combined with irinetecan_D	Experimental	Patients with MSI-H KRASwt BRAFwt unresectable or metastatic colorectal cancer who had previously failed to receive anti-PD-1 (L1) mab (excluding EGFR mab) in the first or second line were treated with SI-B001 in combination with irinetecan in the third line.SI-B001 is administered by intravenous drip twice weekly (Q2W). Receives: Drug: SI-B001; Drug: Irinotecan
SI-B001 combined with FOLFIRI or FOLFOX_E	Experimental	Patients with MSI-H KRASwt BRAFwt unresectable or metastatic colorectal cancer who had previously failed first-line anti-PD-1 (L1) mab were treated with SI-B001 in combination with FOLFIRI or FOLFOX for second-line treatment.SI-B001 is administered by intravenous drip twice weekly (Q2W). Receives: Drug: SI-B001; Drug: FOLFIRI Protocol; Drug: FOLFOX Protocol
SI-B001 combined with irinetecan_F	Experimental	Patients with MSS KRASwt BRAFwt unresectable or metastatic colorectal cancer who had failed standard first-line treatment containing oxaliplatin or irinotecan plus fluorouracil plus or minus bevacizumab were treated with SI-B001 plus irinotecan in the second-line.SI-B001 is administered by intravenous drip twice weekly (Q2W). Receives: Drug: SI-B001; Drug: Irinotecan

What is being measured

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

ORR
Objective Response Rate
Measured: Up to approximately 24 months
Optimal combination dose (only IIa)
Optimal combination dose of SI-B001 with chemothreapy (only IIa)
Measured: Up to approximately 24 months

Secondary outcomes (9)

PFS
Progression-free Survival
Measured: Up to approximately 24 months
DCR
Disease Control Rate
Measured: Up to approximately 24 months
DOR
Duration of Response
Measured: Up to approximately 24 months
OS
Overall Survival
Measured: Up to approximately 24 months
TEAE
Treatment Emergent Adverse Events
Measured: Up to approximately 24 months
Cmax
Maximum serum concentration
Measured: Up to approximately 24 months
Tmax
Time to maximum serum concentration
Measured: Up to approximately 24 months
Ctrough
Minimum serum concentration
Measured: Up to approximately 24 months
ADA
anti-SI-B001 antibody
Measured: Up to approximately 24 months

Timeline

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

30 Nov 20216 Jun 2022

First posted10 Sep 2021
Study start30 Nov 2021
Primary completion6 Jun 2022
Study completion6 Jun 2022

Why it stopped: Company research strategy adjustment

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Colorectal CancerStudies of the same condition, open and under way.
More trials run by Sichuan Baili Pharmaceutical Co., Ltd.The sponsor's other registered studies.
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 2
Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 7 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05039944
Sponsor's protocol ID: SI-B001_211
Status last verified: Jul 2024
First submitted: 22 Aug 2021
Last updated: 18 Jul 2024
Results posted: No
FDA-regulated drug: No
FDA-regulated device: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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RecruitingPhase 1
Individual Response to Hyperthermic Intraperitoneal Chemotherapy (HIPEC) Treatment of Peritoneal Carcinomatosis From Peritoneal Mesothelioma or Atypical Mesothelial Proliferation or From Ovarian, Colorectal, or Appendiceal Histologies
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All Colorectal Cancer trials

Study at a glance

From the registry record, last updated by the sponsor on 18 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase II Clinical Study to Evaluate the Efficacy and Safety of SI-B001 as a Single Agent or in Combination With Chemotherapy in the Treatment of Unresectable or Metastatic Digestive System Malignancies (Colorectal and Gastric Cancer)
ClinicalTrials.gov ID: NCT05039944
Acronym / sponsor ID: SI-B001_211
Conditions: Colorectal Cancer
Keywords: CRC
Phase: Phase 2
Study type: Interventional
Recruitment status: TerminatedReason stopped: Company research strategy adjustment
Enrolment: 7 participants (actual)
Lead sponsor: Sichuan Baili Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
Study start: 30 Nov 2021 (actual)
Primary completion: 6 Jun 2022 (actual)
Study completion: 6 Jun 2022 (actual)
First posted: 10 Sep 2021 (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.

Study design

Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 6

Arm	Type	Receives
SI-B001_A	Experimental	Drug: SI-B001Patients with unresectable or metastatic gastric cancer, HER2-negative and without standard treatment were treated with SI-B001 monotherapy.SI-B001 is administered by intravenous drip twice weekly (Q2W).
SI-B001_B	Experimental	Drug: SI-B001Patients with MSS KRASwt BRAFwt unresectable or metastatic colorectal cancer who had failed conventional chemotherapy combined with EGFR mab were treated with SI-B001 monotherapy.SI-B001 is administered by intravenous drip twice weekly (Q2W).
SI-B001_C	Experimental	Drug: SI-B001Patients with MSS KRASwt BRAFwt unresectable or metastatic colorectal cancer who had failed multiple lines of conventional chemotherapy (excluding EGFR monoclonal antibody) were treated with SI-B001 monotherapy.SI-B001 is administered by intravenous drip twice weekly (Q2W).
SI-B001 combined with irinetecan_D	Experimental	Drug: SI-B001, Drug: IrinotecanPatients with MSI-H KRASwt BRAFwt unresectable or metastatic colorectal cancer who had previously failed to receive anti-PD-1 (L1) mab (excluding EGFR mab) in the first or second line were treated with SI-B001 in combination with irinetecan in the third line.SI-B001 is administered by intravenous drip twice weekly (Q2W).
SI-B001 combined with FOLFIRI or FOLFOX_E	Experimental	Drug: SI-B001, Drug: FOLFIRI Protocol, Drug: FOLFOX ProtocolPatients with MSI-H KRASwt BRAFwt unresectable or metastatic colorectal cancer who had previously failed first-line anti-PD-1 (L1) mab were treated with SI-B001 in combination with FOLFIRI or FOLFOX for second-line treatment.SI-B001 is administered by intravenous drip twice weekly (Q2W).
SI-B001 combined with irinetecan_F	Experimental	Drug: SI-B001, Drug: IrinotecanPatients with MSS KRASwt BRAFwt unresectable or metastatic colorectal cancer who had failed standard first-line treatment containing oxaliplatin or irinotecan plus fluorouracil plus or minus bevacizumab were treated with SI-B001 plus irinotecan in the second-line.SI-B001 is administered by intravenous drip twice weekly (Q2W).

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (17 listed)

Male or female, age ≥18;
Expected survival time ≥3 months;
Patients with unresectable or metastatic colorectal cancer or gastric cancer confirmed by histology or pathology:
CohortA: Patients with unresectable or metastatic gastric cancer, HER2-negative, without standard treatment.
CohortB: Patients with MSS KRASwt BRAFwt unresectable or metastatic colorectal cancer, failure of conventional chemotherapy combined with EGFR mab, and withdrawal of EGFR mab for less than 3 months.

Key exclusion criteria (21 listed)

Colorectal cancer patients with HER2 positive (immunohistochemical +++, or immunohistochemical ++ with FISH amplification);
Have received chemotherapy, radiotherapy, biotherapy, endocrine therapy, immunotherapy and other anti-tumor therapy within 4 weeks prior to the first use of the study drug, except the following:
Oral fluorouracil and small molecule targeted drugs are 2 weeks before the first administration of the study drug or within the 5 half-lives of the drug (whichever is longer); The traditional Chinese medicines with anti-tumor indications were within 2 weeks before the first use of the study drug;
Received an unmarketed clinical investigational drug or treatment within 4 weeks prior to the first use of the investigational drug;
Has undergone major organ surgery (excluding needle biopsy, tracheotomy, gastrostomy, etc.) or has significant trauma within 4 weeks before the first use of study drugs, or needs to undergo elective surgery during the trial;

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
SI-B001In Arm_A, B and C, the intravenous infusion dose of SI-B001 was single drug RP2D selected in phase I (Q2W); In Cohort_D, E, and F, SI-B001 was divided into two doses, the high dose was the single drug RP2D selected in phase I clinical trial, and the low dose was the second low dose of single drug RP2D, both of which were administered by intravenous infusion.	Drug	SI-B001 combined with FOLFIRI or FOLFOX_E, SI-B001 combined with irinetecan_D, SI-B001 combined with irinetecan_F, SI-B001_A, SI-B001_B, SI-B001_C
IrinotecanAdministration by intravenous infusion, 180 mg/m2 Q2W.	Drug	SI-B001 combined with irinetecan_D, SI-B001 combined with irinetecan_F
FOLFIRI ProtocolFOLFIRI is administered intravenously at the standard dose recommended by the guidelines(Q2W).	Drug	SI-B001 combined with FOLFIRI or FOLFOX_E
FOLFOX ProtocolFOLFOX is administered intravenously at the standard dose recommended by the guidelines(Q2W).	Drug	SI-B001 combined with FOLFIRI or FOLFOX_E

Primary outcome

ORR
Time frame: Up to approximately 24 months
Objective Response Rate
Optimal combination dose (only IIa)
Time frame: Up to approximately 24 months
Optimal combination dose of SI-B001 with chemothreapy (only IIa)

9 secondary outcomes

PFS
Time frame: Up to approximately 24 months
DCR
Time frame: Up to approximately 24 months
DOR
Time frame: Up to approximately 24 months
OS
Time frame: Up to approximately 24 months
TEAE
Time frame: Up to approximately 24 months
Cmax
Time frame: Up to approximately 24 months
Tmax
Time frame: Up to approximately 24 months
Ctrough
Time frame: Up to approximately 24 months
ADA
Time frame: Up to approximately 24 months

Results and safety

The study was stopped early (reason given: Company research strategy adjustment). Results are not available in the source record.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 18 Jul 2024.

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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. This study is not recruiting at the moment.

Weijian Guo principal investigator

Fudan University

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing SI-B001, Irinotecan and FOLFIRI Protocol in people with Colorectal Cancer, run by Sichuan Baili Pharmaceutical 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 17 inclusion and 21 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: stopped early, as of the sponsor's last update on 18 Jul 2024. 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 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?

The study was stopped early (reason given: Company research strategy adjustment). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

ORR (time frame: Up to approximately 24 months). 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?

On the ClinicalTrials.gov record for NCT05039944.

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 Jul 2024.