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Metastatic Colorectal Cancer (CRC)Phase 1NCT06825624

ARTEMIS-102: HS-20093 Combinations in Patients with Advanced Metastatic Colorectal Cancer

A Phase 1 study testing HS-20093, Bevacizumab and 5-FU in people with Metastatic Colorectal Cancer (CRC), run by Hansoh BioMedical R&D Company at 1 site in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial summary

HS-20093 is a fully humanized IgG1 antibody-drug conjugate (ADC) which specifically binds to B7-H3, a target wildly expressed on solid tumor cells. The objectives of this study are to investigate the safety, tolerability, pharmacokinetics and efficacy of HS-20093 in combination with other anti-cancer agents in… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Metastatic Colorectal Cancer (CRC)
What is being tested?
HS-20093, Bevacizumab and 5-FU
Could I receive a placebo?
No, everyone receives an active treatment
How many people
560 participants
Where
1 siteChina
Study dates
3 Oct 2024to 31 Dec 2026
Phase
Phase 1
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

  • At least age of 18 years at screening.
  • Histologically or cytologically confirmed, locally advanced or metastatic colorectal cancer.
  • Dose escalation part will enroll advanced metastatic colorectal cancer patients who have progressed on or intolerant to standard therapies.
  • Dose expansion part will enroll advanced metastatic colorectal cancer patients who have not received prior treatment for advanced/metastatic colorectal cancer.
  • At least one measurable lesion according to RECIST 1.1.
  • Eastern Cooperative Oncology Group (ECOG) Performance Status of 0~1.
Show all 10Show fewer
  • Life expectancy >= 12 weeks.
  • Men or women should be using adequate contraceptive measures throughout the study.
  • Females subjects must not be pregnant at screening or have evidence of non-childbearing potential.
  • Signed and dated Informed Consent Form.

Who cannot join

  • Treatment with any of the following:
  • Previous or current treatment with B7-H3 targeted therapy or ADCs with topoisomerase I inhibitors as the payload
  • Any cytotoxic chemotherapy, investigational agents and small molecule targeted therapy within 14 days prior to the first scheduled dose of HS-20093
  • Prior treatment with macromolecule anti-tumor therapy or other anticancer drugs within 28 days prior to the first scheduled dose of HS-20093
  • Radiotherapy with a limited field of radiation for palliation within 2 weeks, or patients received more than 30% of the bone marrow irradiation, or large-scale radiotherapy within 4 weeks prior to the first scheduled dose of HS-20093
  • Pleural or peritoneal effusion requiring clinical intervention. Pericardial effusion
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  • Major surgery within 4 weeks of the first dose of HS-20093
  • Spinal cord compression or brain metastases.
  • Treatment with drugs that are predominantly CYP3A4 strong inhibitors or inducers or sensitive substrates of CYP3A4 with a narrow therapeutic range within 7 days of the first dose of study drug; or requiring treatment with these drugs during the study.
  • Currently receiving drugs known to prolong QT interval or may cause torsade de pointe; or requiring treatment with these drugs during the study.
  • Any unresolved toxicities from prior therapy greater than Grade 2 according to Common Terminology Criteria for Adverse Events (CTCAE) 5.0 with the exception of stable hypothyroidism treated with hormone replacement therapy, alopecia or neurotoxicity.
  • History of other primary malignancies.
  • Inadequate bone marrow reserve or organ dysfunction
  • Evidence of cardiovascular risk.
  • Severe, uncontrolled or active cardiovascular diseases.
  • Diabetes ketoacidosis or hyperglycemia hypertonic occurring within 6 months before the first dose of the study drug.
  • Severe or poorly controlled hypertension.
  • Bleeding symptoms with apparent clinical significance or obvious bleeding tendency within 1 months prior to the first dose of HS-20093
  • Serious arteriovenous thrombosis events occurred within 3 months before the first dose.
  • Severe infections occurred within 4 weeks before the first dose.
  • Patients who have received continuous steroid treatment for more than 30 days within 30 days before the first dose, or need long-term (≥ 30 days) steroid treatment, or who have other acquired and congenital immunodeficiency diseases, or have a history of organ transplantation
  • The presence of active infectious diseases has been known before the first dose such as hepatitis B, hepatitis C, tuberculosis, syphilis, or human immunodeficiency virus HIV infection, etc.
  • Hepatic encephalopathy, hepatorenal syndrome, or Child-Pugh Grade B or more severe cirrhosis.
  • Other moderate or severe lung diseases that may interfere with the detection or treatment of drug-related pulmonary toxicity or may seriously affect respiratory function.
  • Previous history of serious neurological or mental disorders, including epilepsy, dementia or severe depression and any other status that may interfere in assessment.
  • Women who are breastfeeding or pregnant or planned to be pregnant during the study period.
  • 18. Vaccination or hypersensitivity of any level within 4 weeks prior to the first dose of HS-20093
  • History of severe hypersensitivity reaction, severe infusion reaction or allergy to recombinant human or mouse derived proteins.
  • Hypersensitivity to any ingredient of HS-20093.
  • Unlikely to comply with study procedures, restrictions, and requirements in the opinion of the investigator
  • Any disease or condition that, in the opinion of the investigator, would compromise subject safety or interfere with study assessments

Trial locations and contacts

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

Ying Yuan contact

Yuanying1999@zju.org.cn

China1 site, 1 recruiting

  • The Second Affiliated Hospital Zhejiang University

    Hangzhou, Zhejiang

    Recruiting

Other trials in China

About this study

Official title: ARTEMIS-102: a Phase Ib Study of HS-20093 Combination Therapy to Evaluate the Safety, Tolerability, Pharmacokinetics and Efficacy in Patients with Advanced Metastatic Colorectal Cancer

HS-20093 is a fully humanized IgG1 antibody-drug conjugate (ADC) which specifically binds to B7-H3, a target wildly expressed on solid tumor cells. The objectives of this study are to investigate the safety, tolerability, pharmacokinetics and efficacy of HS-20093 in combination with other anti-cancer agents in patients with advanced metastatic colorectal cancer.

Read the detailed description

This is a phase 1b, open-label, multi-center, dose-escalation and expansion, phase 1b study in Chinses subjects with advanced metastatic colorectal cancer. This study is in design allowing assessment of safety, tolerability, pharmacokinetics and efficacy of HS-20093 in combination with other anti-cancer agents.

A total of 5 combination-treatments will be carried out in 5 cohorts. The target population of dose escalation part is patients have progressed on or intolerant to available standard therapies, and the dose expansion part will enroll patients who have not received treatment for advanced metastatic colorectal cancer.

All patients will be carefully followed for adverse events during the study treatment and for 90 days after the last dose of study drug. Subjects will be permitted to continue therapy with assessments for progression if the product is well tolerated and sustained clinical benefit exists.

Being tested
HS-20093, Bevacizumab, 5-FU, Leucovorin, Capecitabine
Keywords
Metastatic Colorectal Cancer (mCRC), B7-H3, antibody-drug conjugate (ADC), HS-20093
Medical subject headings
Colorectal Neoplasms

What participants receive

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

  • HS-20093Drug

    administered as an IV infusion

  • BevacizumabDrug

    administered as an IV infusion

  • 5-FUDrug

    administered as an IV infusion

  • LeucovorinDrug

    administered as an IV infusion

  • CapecitabineDrug

    administered orally

  • OxaliplatinDrug

    administered as an IV infusion

Study groups in NCT06825624
Study groupRoleWhat they receive
Arm1ExperimentalHS-20093 and Bevacizumab
Receives: Drug: HS-20093; Drug: Bevacizumab
Arm 2ExperimentalHS-20093, Bevacizumab and 5-fluorouracil (5-FU), Leucovorin
Receives: Drug: HS-20093; Drug: Bevacizumab; Drug: 5-FU; Drug: Leucovorin
Arm 3ExperimentalHS-20093, Bevacizumab and 5-fluorouracil (5-FU)
Receives: Drug: HS-20093; Drug: Bevacizumab; Drug: 5-FU
Arm 4ExperimentalHS-20093, Bevacizumab and capecitabine
Receives: Drug: HS-20093; Drug: Bevacizumab; Drug: Capecitabine
Arm 5ExperimentalHS-20093, Bevacizumab, Oxaliplatin and 5-fluorouracil (5-FU), Leucovorin
Receives: Drug: HS-20093; Drug: Bevacizumab; Drug: 5-FU; Drug: Leucovorin; Drug: Oxaliplatin

What is being measured

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

  1. Maximum tolerated dose (MTD) for combination-treatments

    To determine the MTD for further evaluation of HS-20093 with other anti-cancer agents in subjects with metastatic colorectal cancer

    Measured: Up to day 21 (arm 1/3/4) or 28 (arm 2/5) from the first dose

Secondary outcomes (11)

  1. Incidence and severity of adverse events (AEs)

    AE assessed by investigator exclusively related to subject's underlying disease or medical condition [graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE), Version 5.0]. Any untoward medical occurrence in a clinical study participant, whether or not considered related to the medicinal product. Incidence and severity of AEs are assessed according to vital signs, laboratory variables, physical examination, electrocardiogram, etc.

    Measured: From the first dose through 90 days post end of treatment

  2. Objective response rate (ORR) determined by investigators

    Objective tumor response for target lesions will be assessed by imaging/measurement compared with the overall tumor burden at baseline. ORR is evaluated by the number of participants with best overall response of CR and PR (Confirmed CR/PR assessment require at least 1 repeat).

    Measured: From the first dose up to PD or withdrawal from study, whichever came first, assessed up to 24 months

  3. Disease control rate (DCR) determined by investigators

    Objective tumor response for target lesions will be assessed by imaging/measurement compared with the overall tumor burden at baseline. DCR was evaluated by the number of participants with best overall response of CR, PR and stable disease (SD) [Confirmed CR/PR assessment require at least one repeat (≥4 weeks); SD shall be assessed at least 5 weeks after the first dose].

    Measured: From the first dose up to PD or withdrawal from study, whichever came first, assessed up to 24 months

  4. Duration of response (DoR) determined by investigators

    DoR was defined as the period from the first occurrence of CR or PR to PD or death from any cause. If no PD or death after CR/PR, the cut-off date of progression-free survival (PFS) would be used [Confirmed CR/PR assessment require at least one repeat (≥4 weeks)].

    Measured: From the first dose up to PD or death, whichever came first, assessed up to 24 months

  5. Progression-free survival (PFS) determined by investigators according to RECIST 1.1

    PFS was defined as the time from random assignment or first dose to PD or death from any cause.

    Measured: From the first dose up to PD or death, whichever came first, assessed up to 24 months

  6. Overall survival (OS)

    OS was defined as the time from random assignment or first dose to death from any cause.

    Measured: From the first dose up to death, whichever came first, assessed up to 24 months

  7. Observed maximum plasma concentration (Cmax) of HS-20093

    Cmax will be obtained after administration of the first dose of HS-20093

    Measured: From pre-dose to study completion, assessed up to 24 months

  8. Time to reach maximum plasma concentration (Tmax) of HS-20093

    Tmax will be obtained after administration of the first dose of HS-20093

    Measured: From pre-dose to study completion, assessed up to 24 months

  9. Terminal half-life (T1/2) of HS-20093 following the first dose

    T1/2 will be obtained after administration of the first dose of HS-20093

    Measured: From pre-dose to study completion, assessed up to 24 months

  10. Area under plasma concentration versus time curve from zero to last sampling time (AUC0-t) following the first dose of HS-20093

    Area under the plasma concentration versus time curve from time zero to the last sampling time when the concentration was no less than the lower limit of quantification (LLQ). AUC0-t was calculated according to the mixed log-linear trapezoidal rule.

    Measured: From pre-dose to study completion, assessed up to 24 months

  11. Percentage of participants with antibodies to HS-20093 in serum

    Serum samples were collected for the determination of anti-drug antibody (ADA) at designated time points.

    Measured: From pre-dose to study completion, assessed up to 24 months

Timeline

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

  1. First posted13 Feb 2025
  2. Study start3 Oct 2024
  3. Primary completion31 Oct 2026 (estimated)
  4. Study completion31 Dec 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
560 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06825624
Sponsor's protocol ID
HS-20093-105
Status last verified
Feb 2025
First submitted
9 Feb 2025
Last updated
13 Feb 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing HS-20093, Bevacizumab and 5-FU in people with Metastatic Colorectal Cancer (CRC), run by Hansoh BioMedical R&D Company 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 10 inclusion and 31 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 13 Feb 2025. 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 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.

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 Ying Yuan (Yuanying1999@zju.org.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Maximum tolerated dose (MTD) for combination-treatments (time frame: Up to day 21 (arm 1/3/4) or 28 (arm 2/5) from the first dose). 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 NCT06825624.

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 13 Feb 2025; AzTrials last refreshed its copy on 7 Nov 2026.

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