Metastatic Colorectal CancerPhase 2NCT06039202
CA102N Combined With TAS-102 Compared to Bevacizumab Combined With TAS-102 in Subjects With Metastatic Colorectal Cancer
A Phase 2 study testing CA102N, TAS-102 and Bevacizumab in people with Metastatic Colorectal Cancer, run by Holy Stone Healthcare Co., Ltd at 1 site in United States.
Trial summary
HS-CA102N-103 is a Phase 2, randomized, open label study to evaluate efficacy, safety, and tolerability of CA102N combined with trifluridine/tipiracil (TAS-102) compared to bevacizumab combined with TAS-102 in subjects with metastatic colorectal cancer (mCRC) who failed the standard treatment (for eg, cancer that has… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Metastatic Colorectal Cancer
- What is being tested?
- CA102N, TAS-102 and Bevacizumab
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2027to Sep 2031
- 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
- Adults aged ≥20 years in Taiwan, and Korea, or those aged ≥18 years in the US, at the time the ICFs are signed. (Please follow local regulatory requirements if the legal age of consent for study participation is different).
- Have relapsed after, intolerant to, or are refractory to fluoropyrimidine-, oxaliplatin- and irinotecan-based chemotherapy, an anti-VEGF biological therapy, and if RAS wild-type, an anti-EGFR therapy.
- Eastern Cooperative Oncology Group performance status 0 to 1.
- Presence of at least one measurable lesion (minimum 10 mm) assessed by the Investigator per RECIST version 1.1. Lesions situated in a previously irradiated area are considered measurable if progression has been demonstrated in such lesions after the end of radiotherapy.
- Has a life expectancy of ≥3 months.
- Women of childbearing potential and men with partners of childbearing potential must agree to use a highly effective means of contraception from study entry through at least 6 months after the last dose of CA102N.
Who cannot join
- History of hypersensitivity or hepatotoxic reactions to nimesulide or to any excipient.
- History or presence of a bleeding tendency or disorder.
- History of gastrointestinal bleed or perforation related to previous nonsteroidal anti-inflammatory drugs (NSAIDs) or bevacizumab.
- Presence or history of recurrent peptic ulcer or hemorrhage (2 or more distinct episodes of proven ulceration or bleeding).
- History of cerebrovascular or other active bleeding.
- Myocardial infarction within the last 12 months prior to the first dose of study drug, severe/unstable angina, symptomatic congestive heart failure New York Heart Association Class III or IV.
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- History of a serious cardiac arrhythmia requiring treatment. Subjects whose arrhythmia is well-controlled (eg, by ablation or medical therapy) may be considered for enrollment after discussion with the study medical monitor.
- Has had clinically significant lung disease (eg, interstitial pneumonia, interstitial lung disease, pneumonitis, pulmonary fibrosis, and severe radiation pneumonitis) requiring continuous systemic corticosteroid treatment for 6 months before Screening or who are suspected to have such diseases by imaging at Screening.
- Ascites, pleural effusion, or pericardial fluid requiring drainage in last 4 weeks prior to Screening, or subject who continues to have a peritoneal/pleural/pericardial drainage catheter post-surgery at the time of informed consent signature.
- History of allogeneic transplantation requiring immunosuppressive therapy.
- Presence of uncontrolled infections.
- Known positive test for hepatitis B, hepatitis C or human immunodeficiency virus. Testing is not required for protocol eligibility. Subjects who have received curative therapy for HCV with no detectable viral load are not excluded.
- Has clinically active brain metastases, defined as untreated and symptomatic, or requiring therapy with steroids or anticonvulsants to control associated symptoms. Subjects with treated brain metastases that are no longer symptomatic and who require no treatment with steroids and stable brain metastases at least 3 months may be included in the study if they have recovered from the acute toxic effect of radiotherapy.
- Pregnant or breast feeding or intends to become pregnant during the study.
- Unresolved toxicity of greater than or equal to NCI-CTCAE (version 5.0) Grade 2 attributed to any prior therapies (excluding anemia, alopecia, skin pigmentation, and platinum-induced peripheral neurotoxicity).
- Has a concomitant medical condition that would increase the risk of toxicity or confine the interpretation of efficacy or safety in the opinion of the Investigator.
Trial locations and contacts
1 site in 1 country.
United States1 site
Banner MD Anderson Cancer Center
Gilbert, Arizona, 85234
About this study
Official title: A Phase 2, Randomized, Open Label Study to Evaluate Efficacy, Safety, and Tolerability of CA102N Combined With Trifluridine/Tipiracil (TAS-102) Compared to Bevacizumab Combined With TAS-102 in Subjects With Metastatic Colorectal Cancer (mCRC) Who Failed the Standard Treatment
HS-CA102N-103 is a Phase 2, randomized, open label study to evaluate efficacy, safety, and tolerability of CA102N combined with trifluridine/tipiracil (TAS-102) compared to bevacizumab combined with TAS-102 in subjects with metastatic colorectal cancer (mCRC) who failed the standard treatment (for eg, cancer that has relapsed after or is refractory to fluoropyrimidine, oxaliplatin and irinotecan-based chemotherapy).
Read the detailed description
HS-CA102N-103 is a Phase 2, randomized, open label study to evaluate efficacy, safety, and tolerability of CA102N combined with trifluridine/tipiracil (TAS-102) compared to bevacizumab combined with TAS-102 in subjects with metastatic colorectal cancer (mCRC) who failed the standard treatment (for eg, cancer that has relapsed after or is refractory to fluoropyrimidine, oxaliplatin and irinotecan-based chemotherapy).
In this study, the safety, tolerability, and PFS of CA102N in combination with TAS-102 compared to bevacizumab combined with TAS-102 will be evaluated in up to 100 subjects with metastatic colorectal cancer who have previously received fluoropyrimidine, oxaliplatin, and irinotecan-based chemotherapy, an anti-vascular endothelial growth factor (VEGF) biological therapy, and if RAS wild-type mCRC, an anti-epidermal growth factor receptor (EGFR) therapy.
- Conditions
- Metastatic Colorectal Cancer
- Being tested
- CA102N, TAS-102, Bevacizumab
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CA102NDrug
Also called Nim-HA cinjugate
CA102N is a covalently bound conjugate of the biological polymer sodium hyaluronate (NaHA) and nimesulide (Nim)
TAS-102Drug
Also called Trifluridine/tipiracil
TAS-102 is a cytotoxic combination treatment of 2 drugs: trifluridine, a thymidine-based nucleoside analogue, and tipiracil an inhibitor of thymidine phosphorylase.
BevacizumabBiological
Bevacizumab recombinant humanized monoclonal antibody that binds and neutralizes circulating vascular endothelial growth factor (VEGF)-A.
| Study group | Role | What they receive |
|---|---|---|
| CA102N plus Trifluridine/tipiracil (TAS-102) | Experimental | CA102N administered as 0.72 mg/kg of nimesulide equivalents on Days 1 and 15 of each 28-day cycle in combination with TAS-102 at 35 mg/m2/dose orally twice daily (BID) on Days 1 through 5 and Days 8 through 12 of each 28-day cycle. Administration sequence will be CA102N then TAS-102 (IV then oral) Receives: Drug: CA102N; Drug: TAS-102 |
| Bevacizumab plus Trifluridine/tipiracil (TAS-102) | Active comparator | bevacizumab 5 mg/kg on Days 1 and 15 of each 28-day cycle in combination with 35 mg/m2 of TAS-102 orally twice daily (BID) on Days 1 through 5 and Days 8 through 12 of each 28-day cycle. Administration sequence will be bevacizumab then TAS-102 (IV then oral) Receives: Drug: TAS-102; Biological: Bevacizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
To evaluate the efficacy of CA102N in combination with trifluridine/tipiracil (TAS-102) by progression free survival (PFS) rate.
Measured: 16 weeks after first treatment.
Number of subjects with treatment-related adverse events as assessed by NCI-CTCAE v5.0
Measured: one year after first treatment.
Secondary outcomes (4)
Disease control rate (DCR)
To evaluate the efficacy of CA102N in combination with trifluridine/tipiracil (TAS-102) by disease control rate.
Measured: 16 weeks after first treatment.
Overall response rate (ORR)
To evaluate the efficacy of CA102N in combination with trifluridine/tipiracil (TAS-102) by overall response rate.
Measured: 16 weeks after first treatment.
Maximum Plasma Concentration [Cmax] of CA102N when used in combination with trifluridine/tipiracil (TAS-102)
Measured: 16 weeks after first treatment.
To evaluate the efficacy of CA102N in combination with trifluridine/tipiracil (TAS-102) by overall survival (OS).
Measured: one year after first treatment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2023
- Study startDec 2027 (estimated)
- Primary completionOct 2030 (estimated)
- Study completionSep 2031 (estimated)
Why it stopped: Strategy under discussion
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Metastatic Colorectal CancerStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Up to 100 subjects will be enrolled in this study (including drop-out subjects), with 50 subjects assigned to each treatment arm. For arm 1, subjects will receive the assigned dose level of CA102N in combination with trifluridine/tipiracil (TAS-102). For Arm 2, subjects will receive bevacizumab in combination with trifluridine/tipiracil (TAS-102)
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Holy Stone Healthcare Co., Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06039202
- Sponsor's protocol ID
- HS-CA102N-103
- Status last verified
- Sep 2026
- First submitted
- 1 Sep 2023
- Last updated
- 18 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Pant S, Dragovich T, Lieu C, Jimeno A, Kundranda M, Menter D, Tchaparian E, Chen YC, Kopetz S. Phase 1 study of the safety, pharmacokinetics, and preliminary efficacy of CA102N as monotherapy and in combination with trifluridine-tipiracil in patients with locally advanced or metastatic solid tumors. Invest New Drugs. 2023 Feb;41(1):25-34. doi: 10.1007/s10637-022-01308-5. Epub 2022 Nov 4.
PubMed 36331676
Study at a glance
From the registry record, last updated by the sponsor on 18 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2, Randomized, Open Label Study to Evaluate Efficacy, Safety, and Tolerability of CA102N Combined With Trifluridine/Tipiracil (TAS-102) Compared to Bevacizumab Combined With TAS-102 in Subjects With Metastatic Colorectal Cancer (mCRC) Who Failed the Standard Treatment
- ClinicalTrials.gov ID
- NCT06039202
- Acronym / sponsor ID
- HS-CA102N-103
- Conditions
- Metastatic Colorectal Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- SuspendedReason stopped: Strategy under discussion
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Holy Stone Healthcare Co., LtdIndustry (pharma, biotech, devices)
- Study start
- Dec 2027 (estimated)
- Primary completion
- Oct 2030 (estimated)
- Study completion
- Sep 2031 (estimated)
- First posted
- 15 Sep 2023 (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.
HS-CA102N-103 is a Phase 2, randomized, open label study to evaluate efficacy, safety, and tolerability of CA102N combined with trifluridine/tipiracil (TAS-102) compared to bevacizumab combined with TAS-102 in subjects with metastatic colorectal cancer (mCRC) who failed the standard treatment (for eg, cancer that has relapsed after or is refractory to fluoropyrimidine, oxaliplatin and irinotecan-based chemotherapy).
Detailed description
HS-CA102N-103 is a Phase 2, randomized, open label study to evaluate efficacy, safety, and tolerability of CA102N combined with trifluridine/tipiracil (TAS-102) compared to bevacizumab combined with TAS-102 in subjects with metastatic colorectal cancer (mCRC) who failed the standard treatment (for eg, cancer that has relapsed after or is refractory to fluoropyrimidine, oxaliplatin and irinotecan-based chemotherapy).
In this study, the safety, tolerability, and PFS of CA102N in combination with TAS-102 compared to bevacizumab combined with TAS-102 will be evaluated in up to 100 subjects with metastatic colorectal cancer who have previously received fluoropyrimidine, oxaliplatin, and irinotecan-based chemotherapy, an anti-vascular endothelial growth factor (VEGF) biological therapy, and if RAS wild-type mCRC, an anti-epidermal growth factor receptor (EGFR) therapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Up to 100 subjects will be enrolled in this study (including drop-out subjects), with 50 subjects assigned to each treatment arm. For arm 1, subjects will receive the assigned dose level of CA102N in combination with trifluridine/tipiracil (TAS-102). For Arm 2, subjects will receive bevacizumab in combination with trifluridine/tipiracil (TAS-102)
| Arm | Type | Receives |
|---|---|---|
| CA102N plus Trifluridine/tipiracil (TAS-102) | Experimental | Drug: CA102N, Drug: TAS-102CA102N administered as 0.72 mg/kg of nimesulide equivalents on Days 1 and 15 of each 28-day cycle in combination with TAS-102 at 35 mg/m2/dose orally twice daily (BID) on Days 1 through 5 and Days 8 through 12 of each 28-day cycle. Administration sequence will be CA102N then TAS-102 (IV then oral) |
| Bevacizumab plus Trifluridine/tipiracil (TAS-102) | Active comparator | Drug: TAS-102, Biological: Bevacizumabbevacizumab 5 mg/kg on Days 1 and 15 of each 28-day cycle in combination with 35 mg/m2 of TAS-102 orally twice daily (BID) on Days 1 through 5 and Days 8 through 12 of each 28-day cycle. Administration sequence will be bevacizumab then TAS-102 (IV then oral) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Adults aged ≥20 years in Taiwan, and Korea, or those aged ≥18 years in the US, at the time the ICFs are signed. (Please follow local regulatory requirements if the legal age of consent for study participation is different).
- Have relapsed after, intolerant to, or are refractory to fluoropyrimidine-, oxaliplatin- and irinotecan-based chemotherapy, an anti-VEGF biological therapy, and if RAS wild-type, an anti-EGFR therapy.
- Eastern Cooperative Oncology Group performance status 0 to 1.
- Presence of at least one measurable lesion (minimum 10 mm) assessed by the Investigator per RECIST version 1.1. Lesions situated in a previously irradiated area are considered measurable if progression has been demonstrated in such lesions after the end of radiotherapy.
- Has a life expectancy of ≥3 months.
Key exclusion criteria (16 listed)
- History of hypersensitivity or hepatotoxic reactions to nimesulide or to any excipient.
- History or presence of a bleeding tendency or disorder.
- History of gastrointestinal bleed or perforation related to previous nonsteroidal anti-inflammatory drugs (NSAIDs) or bevacizumab.
- Presence or history of recurrent peptic ulcer or hemorrhage (2 or more distinct episodes of proven ulceration or bleeding).
- History of cerebrovascular or other active bleeding.
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 |
|---|---|---|
| CA102NAlso: Nim-HA cinjugateCA102N is a covalently bound conjugate of the biological polymer sodium hyaluronate (NaHA) and nimesulide (Nim) | Drug | CA102N plus Trifluridine/tipiracil (TAS-102) |
| TAS-102Also: Trifluridine/tipiracilTAS-102 is a cytotoxic combination treatment of 2 drugs: trifluridine, a thymidine-based nucleoside analogue, and tipiracil an inhibitor of thymidine phosphorylase. | Drug | Bevacizumab plus Trifluridine/tipiracil (TAS-102), CA102N plus Trifluridine/tipiracil (TAS-102) |
| BevacizumabBevacizumab recombinant humanized monoclonal antibody that binds and neutralizes circulating vascular endothelial growth factor (VEGF)-A. | Biological | Bevacizumab plus Trifluridine/tipiracil (TAS-102) |
Primary outcome
To evaluate the efficacy of CA102N in combination with trifluridine/tipiracil (TAS-102) by progression free survival (PFS) rate.
Time frame: 16 weeks after first treatment.
Number of subjects with treatment-related adverse events as assessed by NCI-CTCAE v5.0
Time frame: one year after first treatment.
4 secondary outcomes
Disease control rate (DCR)
Time frame: 16 weeks after first treatment.
Overall response rate (ORR)
Time frame: 16 weeks after first treatment.
Maximum Plasma Concentration [Cmax] of CA102N when used in combination with trifluridine/tipiracil (TAS-102)
Time frame: 16 weeks after first treatment.
To evaluate the efficacy of CA102N in combination with trifluridine/tipiracil (TAS-102) by overall survival (OS).
Time frame: one year after first treatment.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Sep 2026.
- Results publication: PubMed 36331676Pant S, Dragovich T, Lieu C, Jimeno A, Kundranda M, Menter D, Tchaparian E, Chen YC, Kopetz S. Phase 1 study of the safety, pharmacokinetics, and preliminary efficacy of CA102N as monotherapy and in combination with trifluridine-tipiracil in patients with locally advanced or metastatic solid tumors. Invest New Drugs. 2023 Feb;41(1):25-34. doi: 10.1007/s10637-022-01308-5. Epub 2022 Nov 4.
- The result of phase I studyLink provided by the sponsor.
- 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. This study is not recruiting at the moment.
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 2 study testing CA102N, TAS-102 and Bevacizumab in people with Metastatic Colorectal Cancer, run by Holy Stone Healthcare Co., Ltd at 1 site in United States.
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 6 inclusion and 16 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: paused, as of the sponsor's last update on 18 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 United States. 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?
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?
To evaluate the efficacy of CA102N in combination with trifluridine/tipiracil (TAS-102) by progression free survival (PFS) rate. (time frame: 16 weeks after first treatment.). 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 NCT06039202, which also lists 1 linked publication.
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 Sep 2026.