Colorectal CancerPhase 1/2XS-03-II201NCT06936527
XS-03 in Combination With FOLFOX or FOLFIRI and Bevacizumab for Treatment of Metastatic Colorectal Cancer Patients With RAS Mutation
A Phase 1/2 study testing Drug: XS-03, Biological: Bevacizumab, Drug: FOLFOX, Drug: FOLFIRI, Drug: XS-03 and Biological: Bevacizumab, Drug: FOLFOX, Drug: FOLFIRI in people with Colorectal Cancer and Metastatic Colorectal Cancer With RAS Mutation, run by Shanghai Fosun Pharmaceutical Industrial Development Co. Ltd. at 1 site in China.
Trial summary
XS-03 in combination with FOLFOX or FOLFIRI and Bevacizumab for treatment of metastatic colorectal cancer patients with RAS mutation Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Colorectal Cancer, Metastatic Colorectal Cancer With RAS Mutation
- What is being tested?
- Drug: XS-03, Biological: Bevacizumab, Drug: FOLFOX, Drug: FOLFIRI, Drug: XS-03 and Biological: Bevacizumab, Drug: FOLFOX, Drug: FOLFIRI
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 102 participants
- Where
- 1 siteChina
- Study dates
- 23 May 2025to 30 Jul 2028
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Voluntarily participate in the clinical trial and sign the informed consent form.
- Age ≥18 and ≤ 75 years. No gender restrictions.
- Patients with histologically and/or cytologically confirmed metastatic colorectal cancer who are not suitable for surgical treatment.
- Advanced or metastatic colorectal cancer: Stage Ib patients must have received at least one prior systemic therapy; Stage II patients have no prior systemic therapy. For patients with previously neoadjuvant/adjuvant therapy, disease progression must occur no less than 6 months after the end of therapy to be eligible for inclusion.
- Documentation of RAS mutation. The previously gene test report issued by qualified testing institution is acceptable. BRAF status is not restricted.
- Consent to provide tumor tissue samples and peripheral blood for biomarker analysis.
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- Has measurable extracranial lesion according to RECIST v1.1 criteria, defined as at least one lesion that has not received radiotherapy. For previously radiotherapy lesion, there must be imaging evidence of progression after radiotherapy.
- Eastern Cooperative Oncology Group (ECOG) performance status score 0-1.
- Expected life expectancy ≥ 6 months.
- The patient has adequate hepatic, renal and bone marrow function.
- For a woman of child-bearing potential must have a negative serum pregnancy test within 7 days prior to enrollment. Woman of child-bearing potential and fertile men must agree to use adequate contraception for the duration of study participation and for 6 months after the last dose.
Who cannot join
- Patients with known high microsatellite instability (MSI-H) or mismatch repair deficiency (dMMR) primary or metastatic colorectal cancer and suitable for immune checkpoint inhibitor treatment assessed by investigators.
- Previously received bevacizumab and its biosimilar therapy. (Only for phase II)
- Central nervous system metastases which are symptomatic or require therapy.
- Imaging shows major blood vessel invasion (such as the aorta, pulmonary artery, pulmonary vein, vena cava, etc.).
- Adverse events and/or complications that caused by previous antitumor therapy have not recovered to baseline level or ≤ CTCAE grade 1.
- Baseline level or ≤ Grade 1. However, any grade of alopecia, pigmentation, or ≤ Grade 2 peripheral sensory neuropathy, or other conditions assessed by the investigator as having become chronic and not affecting the safety of the study medication are allowed for inclusion.
Show all 21Show fewer
- With a history of other malignancies within 5 years or with other malignancies currently prior to screening, except colorectal cancer. Exception: curatively treated early-stage malignancies (in situ carcinoma or stage I tumors), such as adequately treated basal cell or squamous cell skin cancer or in situ cancer of the cervix.
- Patients have a significant risk of bleeding.
- Patients have a significant risk of thrombus.
- Patients have severe cardiovascular disease, including but not limited to: Ischemic heart disease within the past 6 months prior to screening; coronary artery disease post-surgery or stent implantation within 6 months; New York Heart Association (NYHA) functional classification ≥ Class II within 6 months prior to screening; or known left ventricular insufficiency (LVEF <50%)；transient ischemic attack or cerebrovascular accident within 6 months prior to screening; uncontrolled hypertension (systolic blood pressure >150 mmHg or diastolic blood pressure >100 mmHg) despite standard treatment, or history of hypertensive crisis or hypertensive encephalopathy;severe arrhythmia requiring clinical intervention; any other cardiovascular disease that researchers regard the patient unsuitable for participation in the study.
- Patients with a significantly increased risk of QTc prolongation.
- Patients unable to swallow drugs or have severe diseases that significantly affect drug absorption.
- Patients have one of the following viral active infections: active hepatitis B or C; human immunodeficiency virus (HIV) infection; active syphilis
- During screening, the presence of interstitial lung disease, interstitial pneumonia, pulmonary interstitial fibrosis requiring therapy, or a history of pneumonia caused by tyrosine kinase inhibitors.
- Patients received radiotherapy within the past 4 weeks prior to the first first dose of study drug.
- Patients received therapeutic surgeries (excluding diagnosis, biopsy, or drainage procedures) within the past 4 weeks prior to the first dose of study drug, including local treatments such as radiofrequency ablation for liver metastases, or are expected to have major surgeries during the study period.
- Severity infection need intravenous infusion of antibiotics, antiviral drugs, or hospitalisation within the past 2 weeks prior to the first dose of study drug.
- Patients must use strong CYP3A4 inducers or inhibitors within the past 2 weeks prior to the first administration, or during the anticipated study period,
- History of severe allergy, or known allergy to any active or inactive components of the study drug product.
- Pregnancy or lactation.
- Patients with severe diseases of any organs or systems, any clinical or laboratory test abnormalities, or other reasons that investigator assess them unsuitable to participate in this clinical study.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: An Open-label, Multicenter Phase Ib/II Clinical Study: Aim to Valuate the Efficacy and Safety of XS-03 Comination With FOLFOX or FOLFIRI and Bevacizumab in Metastatic Colorectal Cancer Patients With RAS Mutation
XS-03 in combination with FOLFOX or FOLFIRI and Bevacizumab for treatment of metastatic colorectal cancer patients with RAS mutation
- Being tested
- Drug: XS-03, Biological: Bevacizumab, Drug: FOLFOX, Drug: FOLFIRI, Drug: XS-03, Biological: Bevacizumab, Drug: FOLFOX, Drug: FOLFIRI
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Drug: XS-03, Biological: Bevacizumab, Drug: FOLFOX, Drug: FOLFIRIBiological
XS-03 orally Bevacizumab intravenously FOLFOX intravenously FOLFIRI intravenously
Drug: XS-03Biological
XS-03 orally
Biological: Bevacizumab, Drug: FOLFOX, Drug: FOLFIRIBiological
Bevacizumab intravenously FOLFOX intravenously FOLFIRI intravenously
| Study group | Role | What they receive |
|---|---|---|
| Experimental arm 1: XS-03 + FOLFOX/FOLFIRI + Bevacizumab | Experimental | Phase 1b: XS-03 escalating orally Day 1 through Day 5 and Day 15 through Day 19 of each 28-day cycle in combination with FOLFOX or FOLFIRI and bevacizumab.
FOLFOX (85 mg/m^2 oxaliplatin, 400 mg/m^2 leucovorin, 400 mg/m^2 bolus 5-fluorouracil (5-FU), and 2400 mg/m^2 continuous intravenous infusion 5-FU) , 5 mg/kg bevacizumab FOLFIRI (180 mg/m^2 irinotecan, 400 mg/m^2 leucovorin, 400 mg/m^2 bolus 5-fluorouracil (5-FU), and 2400 mg/m^2 continuous intravenous infusion 5-FU), 5 mg/kg bevacizumab Receives: Biological: Drug: XS-03, Biological: Bevacizumab, Drug: FOLFOX, Drug: FOLFIRI |
| Experimental arm 2: XS-03 + FOLFOX/FOLFIRI + Bevacizumab | Experimental | Phase 2: XS-03 Recommended Phase 2 Dose (RP2D) and selected one more dosage orally Day 1 through Day 5 and Day 15 through Day 19 of each 28-day cycle in combinationwith FOLFOX or FOLFIRI and bevacizumab.
FOLFOX (85 mg/m^2 oxaliplatin, 400 mg/m^2 leucovorin, 400 mg/m^2 bolus 5-fluorouracil (5-FU), and 2400 mg/m^2 continuous intravenous infusion 5-FU) , 5 mg/kg bevacizumab FOLFIRI (180 mg/m^2 irinotecan, 400 mg/m^2 leucovorin, 400 mg/m^2 bolus 5-fluorouracil (5-FU), and 2400 mg/m^2 continuous intravenous infusion 5-FU), 5 mg/kg bevacizumab Receives: Biological: Drug: XS-03 |
| Comparator: FOLFOX/FOLFIRI + Bevacizumab | Active comparator | Phase 2: Comparator arm treat with FOLFOX or FOLFIRI + bevacizumab intravenously.
FOLFOX (85 mg/m^2 oxaliplatin, 400 mg/m^2 leucovorin, 400 mg/m^2 bolus 5-fluorouracil (5-FU), and 2400 mg/m^2 continuous intravenous infusion 5-FU) , 5 mg/kg bevacizumab FOLFIRI (180 mg/m^2 irinotecan, 400 mg/m^2 leucovorin, 400 mg/m^2 bolus 5-fluorouracil (5-FU), and 2400 mg/m^2 continuous intravenous infusion 5-FU), 5 mg/kg bevacizumab Receives: Biological: Biological: Bevacizumab, Drug: FOLFOX, Drug: FOLFIRI |
What is being measured
The primary outcome is the main question the study is designed to answer.
Phase 1b: Number of participants with Dose-limiting Toxicities (DLTs) in experimental arm of XS-03 in combination with FOLFOX or FOLFIRI and Bevacizumab
Dose-limiting toxicities were defined as events related to XS-03 that were considered an adverse reaction or suspected adverse reaction during the first cycle of treatment
Measured: up to day 28
Phase 1b: Determine the Maximum Tolerated Dose (MTD) in experimental arm of XS-03 in combination with FOLFOX or FOLFIRI and Bevacizumab
MTD is defined as at most 1 patient out of 6 experiencing DLT
Measured: up to day 28
Phase 2: Objective Response Rate (ORR) of two experimental arms and comparator arm
Defined as the percentage of participants that achieve a best overall response of complete response (CR) or partial response (PR) (per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 criteria)
Measured: up to 18 months after first dose of last patient
Secondary outcomes (15)
Phase 1b: Objective Response Rate (ORR) of all treated participants
Measured: up to 18 months after first dose of last patient
Duration of response (DOR) of all treated participants
Duration of response defined as time from when response was first documented until first documented disease progression or death, whichever occurs first.
Measured: up to 18 months after first dose of last patient
Progression-free survival (PFS) of treated participants
as determined based on RECIST version 1.1 criteria
Measured: up to 18 months after first dose of last patient
Overall survival (OS) of treated participants
Time in months from date of first dose for phase 1b and randomization for phase 2 to death due to any cause
Measured: up to 18 months after first dose of last patient
Number of Participants With Adverse Events (AEs) of treated participants
The severity of each AE will be graded using the Common Terminology Criteria for Adverse Events (CTCAE).
Measured: up to 28 days after last dose of study drug
Number of Participants With Clinically Significant Change From Baseline in safety monitoring
Measured: up to 28 days after last dose of study drug
Number of Participants With dose adjustment
AE associated with dose reduction, interruption and discontinuation
Measured: up to 28 days after last dose of study drug
Time to Reach Maximum Peak Plasma Concentration (Tmax)
Pharmacokinetic parameter
Measured: From pre-dose on day 1 of cycle 1 to day 5 of cycle 3 (28-day cycle length)
Maximum Plasma Concentration(Cmax)
Pharmacokinetic parameter
Measured: From pre-dose on day 1 of cycle 1 to day 5 of cycle 3 (28-day cycle length)
Area under the plasma concentration versus time curve from time zero to the last measurable concentration(AUC0-t)
Pharmacokinetic parameter
Measured: From pre-dose on day 1 of cycle 1 to day 5 of cycle 3 (28-day cycle length)
Elimination Half-life (T1/2)
Pharmacokinetic parameter
Measured: From pre-dose on day 1 of cycle 1 to day 5 of cycle 3 (28-day cycle length)
Systemic Clearance From Plasma Following Extravascular Administration (CL/F)
Pharmacokinetic parameter
Measured: From pre-dose on day 1 of cycle 1 to day 5 of cycle 3 (28-day cycle length)
The volume of distribution(Vd/F)
Pharmacokinetic parameter
Measured: From pre-dose on day 1 of cycle 1 to day 5 of cycle 3 (28-day cycle length)
Average concentration at steady state(Cavg,ss)
Pharmacokinetic parameter
Measured: From pre-dose on day 1 of cycle 1 to day 5 of cycle 3 (28-day cycle length)
Minimum observed concentration at steady state(Cmin,ss)
Pharmacokinetic parameter
Measured: From pre-dose on day 1 of cycle 1 to day 5 of cycle 3 (28-day cycle length)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Apr 2025
- Study start23 May 2025
- Primary completion30 Apr 2028 (estimated)
- Study completion30 Jul 2028 (estimated)
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 Shanghai Fosun Pharmaceutical Industrial Development 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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 102 participants (estimated)
Sponsor and investigators
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06936527
- Sponsor's protocol ID
- XS-03-II201
- Acronym
- XS-03-II201
- Status last verified
- Sep 2026
- First submitted
- 2 Apr 2025
- Last updated
- 25 Sep 2026
- Results posted
- No
- 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 25 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label, Multicenter Phase Ib/II Clinical Study: Aim to Valuate the Efficacy and Safety of XS-03 Comination With FOLFOX or FOLFIRI and Bevacizumab in Metastatic Colorectal Cancer Patients With RAS Mutation
- ClinicalTrials.gov ID
- NCT06936527
- Acronym / sponsor ID
- XS-03-II201 / XS-03-II201
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 102 participants (estimated)
- Lead sponsor
- Shanghai Fosun Pharmaceutical Industrial Development Co. Ltd.Industry (pharma, biotech, devices)
- Study start
- 23 May 2025 (actual)
- Primary completion
- 30 Apr 2028 (estimated)
- Study completion
- 30 Jul 2028 (estimated)
- First posted
- 20 Apr 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.
XS-03 in combination with FOLFOX or FOLFIRI and Bevacizumab for treatment of metastatic colorectal cancer patients with RAS mutation
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Experimental arm 1: XS-03 + FOLFOX/FOLFIRI + Bevacizumab | Experimental | Biological: Drug: XS-03, Biological: Bevacizumab, Drug: FOLFOX, Drug: FOLFIRIPhase 1b: XS-03 escalating orally Day 1 through Day 5 and Day 15 through Day 19 of each 28-day cycle in combination with FOLFOX or FOLFIRI and bevacizumab. FOLFOX (85 mg/m^2 oxaliplatin, 400 mg/m^2 leucovorin, 400 mg/m^2 bolus 5-fluorouracil (5-FU), and 2400 mg/m^2 continuous intravenous infusion 5-FU) , 5 mg/kg bevacizumab FOLFIRI (180 mg/m^2 irinotecan, 400 mg/m^2 leucovorin, 400 mg/m^2 bolus 5-fluorouracil (5-FU), and 2400 mg/m^2 continuous intravenous infusion 5-FU), 5 mg/kg bevacizumab |
| Experimental arm 2: XS-03 + FOLFOX/FOLFIRI + Bevacizumab | Experimental | Biological: Drug: XS-03Phase 2: XS-03 Recommended Phase 2 Dose (RP2D) and selected one more dosage orally Day 1 through Day 5 and Day 15 through Day 19 of each 28-day cycle in combinationwith FOLFOX or FOLFIRI and bevacizumab. FOLFOX (85 mg/m^2 oxaliplatin, 400 mg/m^2 leucovorin, 400 mg/m^2 bolus 5-fluorouracil (5-FU), and 2400 mg/m^2 continuous intravenous infusion 5-FU) , 5 mg/kg bevacizumab FOLFIRI (180 mg/m^2 irinotecan, 400 mg/m^2 leucovorin, 400 mg/m^2 bolus 5-fluorouracil (5-FU), and 2400 mg/m^2 continuous intravenous infusion 5-FU), 5 mg/kg bevacizumab |
| Comparator: FOLFOX/FOLFIRI + Bevacizumab | Active comparator | Biological: Biological: Bevacizumab, Drug: FOLFOX, Drug: FOLFIRIPhase 2: Comparator arm treat with FOLFOX or FOLFIRI + bevacizumab intravenously. FOLFOX (85 mg/m^2 oxaliplatin, 400 mg/m^2 leucovorin, 400 mg/m^2 bolus 5-fluorouracil (5-FU), and 2400 mg/m^2 continuous intravenous infusion 5-FU) , 5 mg/kg bevacizumab FOLFIRI (180 mg/m^2 irinotecan, 400 mg/m^2 leucovorin, 400 mg/m^2 bolus 5-fluorouracil (5-FU), and 2400 mg/m^2 continuous intravenous infusion 5-FU), 5 mg/kg bevacizumab |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Voluntarily participate in the clinical trial and sign the informed consent form.
- Age ≥18 and ≤ 75 years. No gender restrictions.
- Patients with histologically and/or cytologically confirmed metastatic colorectal cancer who are not suitable for surgical treatment.
- Advanced or metastatic colorectal cancer: Stage Ib patients must have received at least one prior systemic therapy; Stage II patients have no prior systemic therapy. For patients with previously neoadjuvant/adjuvant therapy, disease progression must occur no less than 6 months after the end of therapy to be eligible for inclusion.
- Documentation of RAS mutation. The previously gene test report issued by qualified testing institution is acceptable. BRAF status is not restricted.
Key exclusion criteria (21 listed)
- Patients with known high microsatellite instability (MSI-H) or mismatch repair deficiency (dMMR) primary or metastatic colorectal cancer and suitable for immune checkpoint inhibitor treatment assessed by investigators.
- Previously received bevacizumab and its biosimilar therapy. (Only for phase II)
- Central nervous system metastases which are symptomatic or require therapy.
- Imaging shows major blood vessel invasion (such as the aorta, pulmonary artery, pulmonary vein, vena cava, etc.).
- Adverse events and/or complications that caused by previous antitumor therapy have not recovered to baseline level or ≤ CTCAE grade 1.
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 |
|---|---|---|
| Drug: XS-03, Biological: Bevacizumab, Drug: FOLFOX, Drug: FOLFIRIXS-03 orally Bevacizumab intravenously FOLFOX intravenously FOLFIRI intravenously | Biological | Experimental arm 1: XS-03 + FOLFOX/FOLFIRI + Bevacizumab |
| Drug: XS-03XS-03 orally | Biological | Experimental arm 2: XS-03 + FOLFOX/FOLFIRI + Bevacizumab |
| Biological: Bevacizumab, Drug: FOLFOX, Drug: FOLFIRIBevacizumab intravenously FOLFOX intravenously FOLFIRI intravenously | Biological | Comparator: FOLFOX/FOLFIRI + Bevacizumab |
Primary outcome
Phase 1b: Number of participants with Dose-limiting Toxicities (DLTs) in experimental arm of XS-03 in combination with FOLFOX or FOLFIRI and Bevacizumab
Time frame: up to day 28
Dose-limiting toxicities were defined as events related to XS-03 that were considered an adverse reaction or suspected adverse reaction during the first cycle of treatment
Phase 1b: Determine the Maximum Tolerated Dose (MTD) in experimental arm of XS-03 in combination with FOLFOX or FOLFIRI and Bevacizumab
Time frame: up to day 28
MTD is defined as at most 1 patient out of 6 experiencing DLT
Phase 2: Objective Response Rate (ORR) of two experimental arms and comparator arm
Time frame: up to 18 months after first dose of last patient
Defined as the percentage of participants that achieve a best overall response of complete response (CR) or partial response (PR) (per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 criteria)
15 secondary outcomes
Phase 1b: Objective Response Rate (ORR) of all treated participants
Time frame: up to 18 months after first dose of last patient
Duration of response (DOR) of all treated participants
Time frame: up to 18 months after first dose of last patient
Progression-free survival (PFS) of treated participants
Time frame: up to 18 months after first dose of last patient
Overall survival (OS) of treated participants
Time frame: up to 18 months after first dose of last patient
Number of Participants With Adverse Events (AEs) of treated participants
Time frame: up to 28 days after last dose of study drug
Number of Participants With Clinically Significant Change From Baseline in safety monitoring
Time frame: up to 28 days after last dose of study drug
Number of Participants With dose adjustment
Time frame: up to 28 days after last dose of study drug
Time to Reach Maximum Peak Plasma Concentration (Tmax)
Time frame: From pre-dose on day 1 of cycle 1 to day 5 of cycle 3 (28-day cycle length)
Maximum Plasma Concentration(Cmax)
Time frame: From pre-dose on day 1 of cycle 1 to day 5 of cycle 3 (28-day cycle length)
Area under the plasma concentration versus time curve from time zero to the last measurable concentration(AUC0-t)
Time frame: From pre-dose on day 1 of cycle 1 to day 5 of cycle 3 (28-day cycle length)
Elimination Half-life (T1/2)
Time frame: From pre-dose on day 1 of cycle 1 to day 5 of cycle 3 (28-day cycle length)
Systemic Clearance From Plasma Following Extravascular Administration (CL/F)
Time frame: From pre-dose on day 1 of cycle 1 to day 5 of cycle 3 (28-day cycle length)
The volume of distribution(Vd/F)
Time frame: From pre-dose on day 1 of cycle 1 to day 5 of cycle 3 (28-day cycle length)
Average concentration at steady state(Cavg,ss)
Time frame: From pre-dose on day 1 of cycle 1 to day 5 of cycle 3 (28-day cycle length)
Minimum observed concentration at steady state(Cmin,ss)
Time frame: From pre-dose on day 1 of cycle 1 to day 5 of cycle 3 (28-day cycle length)
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 25 Sep 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site 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 Drug: XS-03, Biological: Bevacizumab, Drug: FOLFOX, Drug: FOLFIRI, Drug: XS-03 and Biological: Bevacizumab, Drug: FOLFOX, Drug: FOLFIRI in people with Colorectal Cancer and Metastatic Colorectal Cancer With RAS Mutation, run by Shanghai Fosun Pharmaceutical Industrial Development 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 11 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: enrolling by invitation, as of the sponsor's last update on 25 Sep 2026. 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 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?
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?
Phase 1b: Number of participants with Dose-limiting Toxicities (DLTs) in experimental arm of XS-03 in combination with FOLFOX or FOLFIRI and Bevacizumab (time frame: up to day 28). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 25 Sep 2026.