GC/GEJCPhase 1/2HCB101 GC GEJNCT07680569
Phase Ib/IIa Open-label Study, to Evaluate Safety, Tolerability, and Antitumor Activity of HCB101 in Combination With Multiple Agents in Subjects With Advanced Gastric or Gastro-esophageal (GEJ) Adenocarcinoma
A Phase 1/2 study testing Zolbetuximab, Oxaliplatin + 5-Fluorouracil/Leucovorin and CAPOX (oxaliplatin/capecitabine) in people with GC/GEJC, run by Kaohsiung Medical University Chung-Ho Memorial Hospital.
Trial summary
This is an open-label, dose-escalation and dose-expansion phase Ib/IIa clinical study to evaluate the safety, tolerability, and preliminary efficacy of HCB101 in combination therapies in subjects with gastric or GEJ adenocarcinoma. A total of about 40 subjects will be enrolled in this study. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- GC/GEJC
- What is being tested?
- Zolbetuximab, Oxaliplatin + 5-Fluorouracil/Leucovorin and CAPOX (oxaliplatin/capecitabine)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- Jun 2026to Dec 2027
- 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
- Subjects are able to understand and willing to provide signed informed consent, which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol, including study visits and study-related procedures.
- Male and female subjects of ≥18 years of age, inclusive, at the time of signing the informed consent.
- With histologically/cytologically confirmed diagnosis of advanced gastric and gastro-esophageal adenocarcinoma as described below:
- Unresectable locally advanced, or metastatic HER2 (-) gastric or GEJ adenocarcinoma cancer, whose tumors are CLDN 18.2 positive (defined as ≥ 75% of tumor cells demonstrating moderate to strong membranous CLDN 18.2 immunohistochemical staining using an FDA-approved test ( http://www.fda.gov/CompanionDiagnostics).
- Must have at least 1 measurable lesion as defined by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1.
- Must have Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1 at Screening.
Show all 18Show fewer
- Have a life expectancy of ≥12 weeks (according to the Investigator's judgment).
- Have adequate organ function, as indicated by the following laboratory parameters below (had not received a blood transfusion, apheresis infusion, erythropoietin, granulocyte colony-stimulating factor, and other relevant medical support within 14 days before the administration of the first dose of study intervention).
- Absolute neutrophil count ≥1.5 × 109/L
- Platelets ≥100 × 109/L
- Hemoglobin ≥9.0 g/dL
- Total bilirubin ≤1.5 × upper limit of normal (ULN), <3.0 × ULN if known Gilbert's disease
- Alanine aminotransferase and aspartate aminotransferase ≤3× ULN and ≤5× ULN for subjects with liver metastasis
- Creatinine clearance ≥30 mL/min (using Cockcroft Gault equation)
- Coagulation: International normalized ratio (INR), prothrombin time (PT), and activated partial thromboplastin time (aPTT) ≤1.5× ULN (The INR applies only to subjects who do not receive therapeutic anticoagulation)
- Women of childbearing potential (WOCBP) must have a negative serum pregnancy test during the Screening Period (within 7 days before the first dose of the study intervention).
- Subjects must have tumors that are not microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR).
- Subjects must not have received any prior systemic anti-cancer and immune checkpoint inhibitor therapy.
Who cannot join
- Medical Conditions:
- With a known history of hypersensitivity to any components of the study intervention.
- Subjects who have other malignancies requiring treatment within 2 years before the first dose of study intervention will be excluded, except for radically treated locally curable basal or squamous cell skin cancer and other malignancies that have been treated with no relapse within 2 years.
- Primary tumor in the central nervous system (CNS), or active or untreated CNS metastases and/or carcinomatous meningitis. Subjects with previously treated brain metastases may participate, provided they are clinically stable for at least 28 days and have no evidence of new or enlarging brain metastases and no requirements for high-dose corticosteroids 14 days before dosing with study intervention. Subjects on low-dose corticosteroids (<20 mg prednisone or equivalent per day) may participate.
- Clinically significant cardiovascular condition, including
- History of congestive heart failure (New York Heart Association Class >2), with only heart failure with preserved ejection fraction (HFpEF) included;
Show all 34Show fewer
- History of unstable angina within 6 months before the first dose of study intervention;
- New-onset angina or myocardial infarction within 6 months before the first dose of study intervention;
- New-onset of atrial fibrillation, supraventricular arrhythmia, or ventricular arrhythmia within 6 months before the first dose of study intervention and still in unstable condition and requiring treatment or intervention. History of atrial fibrillation, supraventricular arrhythmia, or ventricular arrhythmia will be allowed, provided the condition is stably controlled.
- History or presence of an abnormal ECG that, in the Investigator's opinion, is clinically meaningful (including QT interval corrected for heart rate using Fridericia's correction [QTcF] >470 msec at Screening, pacemaker installation, or previous diagnosis of congenital long QT syndrome).
- Any previous treatment-related toxicities which have not recovered to ≤ Grade 1 as evaluated by National Cancer Institute, Common Terminology Criteria for Adverse Events (NCI CTCAE) version 5.0 or baseline, except alopecia and anemia (Note: subjects with chronic Grade 2 toxicities which are well managed and stable may be eligible per the discretion of the Investigator, e.g., Grade 2 chemotherapy-induced neuropathy.)
- With known inherited or acquired bleeding disorders or bleeding diathesis.
- Have RBC transfusion dependence defined as requiring more than 2 units of RBC transfusions every 28 days over a period of 3 months before Screening.
- With a previously documented diagnosis of hemolytic anemia or Evans Syndrome in the last 3 months.
- Prior/Concomitant Therapy/Treatment
- Subjects who have undergone major surgery or radical radiotherapy within 28 days before the first dose of study intervention.
- Subjects who have undergone palliative radiotherapy within 14 days before the first dose of study intervention.
- Subjects who have used a radioactive drug (Strontium, Samarium, etc.) within 56 days before the first dose of the study intervention.
- Subjects who have undergone any investigational or approved systemic cancer therapy (including chemotherapy, immunotherapy, hormonal therapy, and herbal/alternative therapies with anti-cancer indications or targeted therapy) within 14 days or 5 half-lives, whichever is longer, before the first dose of the study intervention.
- Subjects who have used herbal medication within 14 days before the first dose of the study intervention.
- Subjects who are active using of vitamin K antagonist anticoagulant like warfarin. Use of low molecular weight heparin and factor Xa inhibitors will be permitted on a case-by-case basis. Daily low dose of aspirin use (≤ 100 mg/QD) is allowed.
- Subjects who have received any treatment targeting the CD47 or SIRPα pathway.
- Participation in another clinical study with an investigational product administered in the last 14 days or 5 half-lives (whichever is longer) before receiving the first dose of study intervention. An investigational device was used within 28 days before the first dose of study intervention.
- Reproductive and breastfeeding
- Women of reproductive potential who are unable to use effective contraception during treatment and for 6 months after the last dose.
- Women who are breastfeeding during treatment and for 6 months after the last dose.
- Infections:
- An uncontrolled acute infection, an active infection requiring systemic treatment, or subjects who have received systemic antibiotics within 14 days before the first dose of the study intervention (Note: prophylaxis use of systemic antibiotics treatment for upper tract infection is allowed as long as there is no violation of the requirement of concomitant medications).
- Known history of human immunodeficiency virus (HIV) infection and/or acquired immunodeficiency syndrome or positive HIV testing having CD4+ T-cell counts <350 cells/µL or subjects with unknown HIV infection status who are unwilling to undergo HIV testing.
- Known active hepatitis B or C. Subjects with hepatitis B virus surface antigen (HBsAg) or hepatitis C virus (HCV) antibody positive test results during Screening must be further tested for hepatitis B virus (HBV) deoxyribonucleic acid (DNA) titer (excluding subjects with a DNA titer of more than 2500 copies [cps]/mL or 500 IU/mL) and HCV ribonucleic acid (RNA) (excluding subjects with an HCV RNA concentration exceeding the lower detection limit of the assay) to exclude active hepatitis B or hepatitis C infection requiring treatment. Hepatitis B virus carriers, i.e., subjects with stable hepatitis B infection after drug treatment (DNA titer not exceeding 2500 cps/mL or 500 IU/mL) and hepatitis C infected subjects who received treatment and achieved sustained virologic response for at least 12 weeks can be enrolled. Note: If the lower detection limit of the HBV DNA assay is higher than 2500 cps/mL or 500 IU/mL, the subjects with an HBV DNA assay result lower than the lower detection limit of the assay can be enrolled.
- Active tuberculosis or latent tuberculosis infection (LTBI).
- Known to have a history of alcoholism or drug abuse.
- Any other medical (e.g., Child-Pugh class B or C, pulmonary, metabolic, congenital, endocrinal or CNS disease, etc.), psychiatric, or social condition deemed by the Investigator to be likely to interfere with a subject's rights, safety, welfare or ability to sign informed consent, cooperate and participate in the study, or interfere with the interpretation of the results.
- Subjects with current pneumonitis or a history of severe pneumonitis, including but not limited to immune-related pneumonitis or radiation-induced pneumonitis.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
Yu-Chi Chang contact
About this study
This is an open-label, dose-escalation and dose-expansion phase Ib/IIa clinical study to evaluate the safety, tolerability, and preliminary efficacy of HCB101 in combination therapies in subjects with gastric or GEJ adenocarcinoma. A total of about 40 subjects will be enrolled in this study.
Part-I: Dose-Escalation Phase (Phase Ib)
Read more
This phase includes Screening, Treatment, and Follow-up Periods:
Screening Period: Screening period is up to 28 days (D-28 to D-1) prior to receiving the first dose of HCB101.
Treatment Period: This period includes repeat dosing treatment period (42 days per cycle). During the treatment period, subjects from different cohorts will receive HCB101 in combination therapy. Treatment will continue until one of the following occurs: unacceptable adverse event (AE), radiographic or clinically documented disease progression, withdrawal of consent, loss to follow-up, death, or termination of the study, whenever occurs first.
Follow-up Period: This period will include Safety and Survival Follow-up Visits. After the last dose in the study, subjects are required to undergo a Safety Follow-up Visit, which will take place 30 (±7) days after the last dose of HCB101, and they will also undergo the Survival Follow-up Visit every 8 weeks (±14 days).
The end of treatment (EOT) Visit will coincide with the subject has permanently terminated the study intervention. If the EOT Visit is performed within the time window for the Safety Follow-up Visit, re-examination is not required.
Dose Escalation Criteria The study includes four planned dose levels of HCB101(8 mg/kg, 12 mg/kg, 18 mg/kg and 24 mg/kg) The maximum tolerated dose (MTD) will be determined using the standard 3+3 method.
To enhance safety during dose escalation, a staggered dosing approach will be applied. The second subject in each dose level should receive treatment staggered by at least 5 days after the first subject has received the 1st dose, provided that no significant safety concerns have been observed.
- Dose Escalation: The trial begins with the lowest dose, escalating in a stepwise manner. The observation period for dose limiting toxicities (DLT) is from the start of the first dose to day 28 post-dose. The next dose cohort may proceed only after the previous cohort has completed the 28-day DLT observation period and it is confirmed that the subjects are safely tolerated.
- Initial Cohort: Each dose cohort initially enrols three subjects. If none of these three subjects experience a DLT during the observation period, the next dose cohort will be enrolled.
- One DLT in a Cohort (1/3): If one out of three subjects experience a DLT, an additional three subjects will be enrolled at that dose level, totally six subjects.
- Two or More DLTs (2+/6): If one or more of the additional three subjects experience a DLT (resulting in two or more DLTs at this dose level), dose escalation will stop, and the previous dose will be designated as the MTD, or the SRC may decide to use an intermediate dose for further investigation.
- No Additional DLTs (1/6): If none of the additional three subjects experience a DLT (resulting in one DLT out of six), the trial will proceed to the next higher dose level.
- Two or More DLTs in a Cohort (≥2/3): If two or more out of three subjects experience a DLT, dose escalation will conclude, and the previous dose will be considered the MTD, or the SRC may determine whether to use an intermediate dose for the next level of investigation.
- *Maximum Dose Level: If the dose escalation reaches the highest level of 24 mg/kg without establishing an MTD, the MTD and/or the (potential) RP2D or effective dose may be confirmed based on safety, tolerability and efficacy data obtained. Additionally, it may be decided whether new dose levels are required for further escalation studies.
After all subjects in each dose level have completed the DLT assessment, the SRC will decide whether to proceed with dose escalation, explore intermediate/higher doses, terminate the dose escalation study, proceed with a dose extension study or adjust the tumor type for dose extension, etc., based on the data obtained on safety, tolerability and antitumor activity (if required), etc. The SRC may also adjust the dose and frequency of administration, etc.; the SRC may also decide during a dose escalation whether to adjust the tumor type enrolled. Based on the provision of a reasonable basis, appropriate methods may be used to combine the pre-adjustment data with the post-adjustment data, or with data obtained from studies conducted by HCB101.
During the dose-escalation phase, if a subject does not experience a Grade ≥ 2 AE related to the trial treatment (including HCB101 or in combination with standard-of-care drugs), intra-subject dose escalation is permitted after the DLT evaluation period. A maximum of two intra-individual dose escalations per subject is allowed.
- Conditions
- GC/GEJC
- Being tested
- Zolbetuximab, Oxaliplatin + 5-Fluorouracil/Leucovorin, CAPOX (oxaliplatin/capecitabine)
- Keywords
- HCB101, GC, GEJC
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ZolbetuximabBiological
First dose (C1D1) 800 mg/m2, followed by 400 mg/m2 every 2 weeks (Q2W) within a 42-day cycle.
Those who do not experience disease progression after 12 treatments (4 cycles) of mFOLFOX6 continued with zolbetuximab plus folinic acid and fluorouracil, at investigator discretion.
Zolbetuximab treatment will be continued until disease progression, unacceptable toxicity, or other discontinuation criteria are met.
Oxaliplatin + 5-Fluorouracil/LeucovorinDrug
Oxaliplatin 85 mg/m2 IV on Day 1, 15 and 29 of a 42-day cycle. Up to 12 treatments (4 cycles). Leucovorin 400 mg/m2 IV on Day 1, 15 and 29 of a 42-day cycle. After 12 treatments (4 cycles), patients are allowed to continue treatment at the investigator's discretion.
5-Fluorouracil (5-FU) 400 mg/m² given as a bolus and 2400 mg/m² continuous IV infusion over 46-48 hours on Day 1, 15 and 29 of a 42-day cycle.
After 12 treatments (4 cycles), patients are allowed to continue treatment at the investigator's discretion.
CAPOX (oxaliplatin/capecitabine)Drug
Oxaliplatin 130 mg/m2 IV on Day 1 and 22 of a 42-day cycle. Up to 8 treatments (4 cycles). Capecitabine 1000 mg/m² PO BID on Days 1-14 and Day 22-36 of a 42-day cycle. After 8 treatments (4 cycles), patients are allowed to continue treatment at the investigator discretion.
| Study group | Role | What they receive |
|---|---|---|
| HCB101+Zolbetuximab+mFOLFOX6 | Experimental | HCB101+Zolbetuximab+mFOLFOX6 Receives: Biological: Zolbetuximab; Drug: Oxaliplatin + 5-Fluorouracil/Leucovorin |
| HCB101+Zolbetuximab+CAPOX | Experimental | HCB101+Zolbetuximab+CAPOX Receives: Biological: Zolbetuximab; Drug: CAPOX (oxaliplatin/capecitabine) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number/incidence and percentage of subjects with AEs, SAEs and TEAEs.
To evaluate the safety and tolerability of HCB101 in combination with zolbetuximab and standard-of-care therapies.
Measured: From signing the ICF at Screening until 30 days after the last administration of the study intervention or Safety Follow-up Visit with an expected observation period of 2 years.
MTD or RP2D of HCB101 in combination therapy
To determine the MTD or RP2D of HCB101 in combination therapy
Measured: From 1st dose to Cycle 1 Day 28 (each cycle is 42 days).
Secondary outcomes (5)
Objective Response Rate (ORR)
To evaluate the preliminary antitumor activity and its duration of response of HCB101 in combination therapy
Measured: From first dose to best overall response of CR or PR, with an expected observation period of 2 years.
Progression-free survival (PFS)
To evaluate the preliminary antitumor activity and its duration of response of HCB101 in combination therapy
Measured: From first dose to disease progression or death, whichever occurs first, with an expected observation period of 2 years.
Overall Survival (OS)
To evaluate the preliminary antitumor activity and its duration of response of HCB101 in combination therapy
Measured: From first dose to death from any cause, with an expected observation period of 2 years.
Duration of Response (DOR)
To evaluate the preliminary antitumor activity and its duration of response of HCB101 in combination therapy
Measured: From first documented CR or PR to disease progression or death, with an expected observation period of 2 years.
Disease Control Rate (DCR)
To evaluate the preliminary antitumor activity and its duration of response of HCB101 in combination therapy
Measured: From first dose to best overall response of CR, PR, or SD, with an expected observation period of 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jul 2026
- Study startJun 2026 (estimated)
- Primary completionDec 2027 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GC/GEJCStudies 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
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kaohsiung Medical University Chung-Ho Memorial Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- FBD Biologics Limited, China Medical University Hospital, Chi Mei Medical Hospital
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07680569
- Sponsor's protocol ID
- KMUHIRB-F(I)-20250357
- Acronym
- HCB101 GC GEJ
- Status last verified
- Jun 2026
- First submitted
- 3 Jun 2026
- Last updated
- 2 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase Ib/IIa Open-label Study, to Evaluate Safety, Tolerability, and Antitumor Activity of HCB101 in Combination With Multiple Agents in Subjects With Advanced Gastric or Gastro-esophageal (GEJ) Adenocarcinoma
- ClinicalTrials.gov ID
- NCT07680569
- Acronym / sponsor ID
- HCB101 GC GEJ / KMUHIRB-F(I)-20250357
- Conditions
- GC/GEJC
- Keywords
- HCB101, GC, GEJC
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Kaohsiung Medical University Chung-Ho Memorial HospitalUniversity, hospital or other
- Collaborators
- FBD Biologics Limited, China Medical University Hospital, Chi Mei Medical Hospital
- Study start
- Jun 2026 (estimated)
- Primary completion
- Dec 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 2 Jul 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 is an open-label, dose-escalation and dose-expansion phase Ib/IIa clinical study to evaluate the safety, tolerability, and preliminary efficacy of HCB101 in combination therapies in subjects with gastric or GEJ adenocarcinoma. A total of about 40 subjects will be enrolled in this study.
Part-I: Dose-Escalation Phase (Phase Ib)
This phase includes Screening, Treatment, and Follow-up Periods:
Screening Period: Screening period is up to 28 days (D-28 to D-1) prior to receiving the first dose of HCB101.
Treatment Period: This period includes repeat dosing treatment period (42 days per cycle). During the treatment period, subjects from different cohorts will receive HCB101 in combination therapy. Treatment will continue until one of the following occurs: unacceptable adverse event (AE), radiographic or clinically documented disease progression, withdrawal of consent, loss to follow-up, death, or termination of the study, whenever occurs first.
Follow-up Period: This period will include Safety and Survival Follow-up Visits. After the last dose in the study, subjects are required to undergo a Safety Follow-up Visit, which will take place 30 (±7) days after the last dose of HCB101, and they will also undergo the Survival Follow-up Visit every 8 weeks (±14 days).
The end of treatment (EOT) Visit will coincide with the subject has permanently terminated the study intervention. If the EOT Visit is performed within the time window for the Safety Follow-up Visit, re-examination is not required.
Dose Escalation Criteria The study includes four planned dose levels of HCB101(8 mg/kg, 12 mg/kg, 18 mg/kg and 24 mg/kg) The maximum tolerated dose (MTD) will be determined using the standard 3+3 method.
To enhance safety during dose escalation, a staggered dosing approach will be applied. The second subject in each dose level should receive treatment staggered by at least 5 days after the first subject has received the 1st dose, provided that no significant safety concerns have been observed.
- Dose Escalation: The trial begins with the lowest dose, escalating in a stepwise manner. The observation period for dose limiting toxicities (DLT) is from the start of the first dose to day 28 post-dose. The next dose cohort may proceed only after the previous cohort has completed the 28-day DLT observation period and it is confirmed that the subjects are safely tolerated.
- Initial Cohort: Each dose cohort initially enrols three subjects. If none of these three subjects experience a DLT during the observation period, the next dose cohort will be enrolled.
- One DLT in a Cohort (1/3): If one out of three subjects experience a DLT, an additional three subjects will be enrolled at that dose level, totally six subjects.
- Two or More DLTs (2+/6): If one or more of the additional three subjects experience a DLT (resulting in two or more DLTs at this dose level), dose escalation will stop, and the previous dose will be designated as the MTD, or the SRC may decide to use an intermediate dose for further investigation.
- No Additional DLTs (1/6): If none of the additional three subjects experience a DLT (resulting in one DLT out of six), the trial will proceed to the next higher dose level.
- Two or More DLTs in a Cohort (≥2/3): If two or more out of three subjects experience a DLT, dose escalation will conclude, and the previous dose will be considered the MTD, or the SRC may determine whether to use an intermediate dose for the next level of investigation.
- *Maximum Dose Level: If the dose escalation reaches the highest level of 24 mg/kg without establishing an MTD, the MTD and/or the (potential) RP2D or effective dose may be confirmed based on safety, tolerability and efficacy data obtained. Additionally, it may be decided whether new dose levels are required for further escalation studies.
After all subjects in each dose level have completed the DLT assessment, the SRC will decide whether to proceed with dose escalation, explore intermediate/higher doses, terminate the dose escalation study, proceed with a dose extension study or adjust the tumor type for dose extension, etc., based on the data obtained on safety, tolerability and antitumor activity (if required), etc. The SRC may also adjust the dose and frequency of administration, etc.; the SRC may also decide during a dose escalation whether to adjust the tumor type enrolled. Based on the provision of a reasonable basis, appropriate methods may be used to combine the pre-adjustment data with the post-adjustment data, or with data obtained from studies conducted by HCB101.
During the dose-escalation phase, if a subject does not experience a Grade ≥ 2 AE related to the trial treatment (including HCB101 or in combination with standard-of-care drugs), intra-subject dose escalation is permitted after the DLT evaluation period. A maximum of two intra-individual dose escalations per subject is allowed.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| HCB101+Zolbetuximab+mFOLFOX6 | Experimental | Biological: Zolbetuximab, Drug: Oxaliplatin + 5-Fluorouracil/LeucovorinHCB101+Zolbetuximab+mFOLFOX6 |
| HCB101+Zolbetuximab+CAPOX | Experimental | Biological: Zolbetuximab, Drug: CAPOX (oxaliplatin/capecitabine)HCB101+Zolbetuximab+CAPOX |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (18 listed)
- Subjects are able to understand and willing to provide signed informed consent, which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol, including study visits and study-related procedures.
- Male and female subjects of ≥18 years of age, inclusive, at the time of signing the informed consent.
- With histologically/cytologically confirmed diagnosis of advanced gastric and gastro-esophageal adenocarcinoma as described below:
- Must have at least 1 measurable lesion as defined by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1.
- Must have Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1 at Screening.
Key exclusion criteria (34 listed)
- Medical Conditions:
- Prior/Concomitant Therapy/Treatment
- Participation in another clinical study with an investigational product administered in the last 14 days or 5 half-lives (whichever is longer) before receiving the first dose of study intervention. An investigational device was used within 28 days before the first dose of study intervention.
- Reproductive and breastfeeding
- Infections:
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 |
|---|---|---|
| ZolbetuximabFirst dose (C1D1) 800 mg/m2, followed by 400 mg/m2 every 2 weeks (Q2W) within a 42-day cycle. Those who do not experience disease progression after 12 treatments (4 cycles) of mFOLFOX6 continued with zolbetuximab plus folinic acid and fluorouracil, at investigator discretion. Zolbetuximab treatment will be continued until disease progression, unacceptable toxicity, or other discontinuation criteria are met. | Biological | HCB101+Zolbetuximab+CAPOX, HCB101+Zolbetuximab+mFOLFOX6 |
| Oxaliplatin + 5-Fluorouracil/LeucovorinOxaliplatin 85 mg/m2 IV on Day 1, 15 and 29 of a 42-day cycle. Up to 12 treatments (4 cycles). Leucovorin 400 mg/m2 IV on Day 1, 15 and 29 of a 42-day cycle. After 12 treatments (4 cycles), patients are allowed to continue treatment at the investigator's discretion. 5-Fluorouracil (5-FU) 400 mg/m² given as a bolus and 2400 mg/m² continuous IV infusion over 46-48 hours on Day 1, 15 and 29 of a 42-day cycle. After 12 treatments (4 cycles), patients are allowed to continue treatment at the investigator's discretion. | Drug | HCB101+Zolbetuximab+mFOLFOX6 |
| CAPOX (oxaliplatin/capecitabine)Oxaliplatin 130 mg/m2 IV on Day 1 and 22 of a 42-day cycle. Up to 8 treatments (4 cycles). Capecitabine 1000 mg/m² PO BID on Days 1-14 and Day 22-36 of a 42-day cycle. After 8 treatments (4 cycles), patients are allowed to continue treatment at the investigator discretion. | Drug | HCB101+Zolbetuximab+CAPOX |
Primary outcome
Number/incidence and percentage of subjects with AEs, SAEs and TEAEs.
Time frame: From signing the ICF at Screening until 30 days after the last administration of the study intervention or Safety Follow-up Visit with an expected observation period of 2 years.
To evaluate the safety and tolerability of HCB101 in combination with zolbetuximab and standard-of-care therapies.
MTD or RP2D of HCB101 in combination therapy
Time frame: From 1st dose to Cycle 1 Day 28 (each cycle is 42 days).
To determine the MTD or RP2D of HCB101 in combination therapy
5 secondary outcomes
Objective Response Rate (ORR)
Time frame: From first dose to best overall response of CR or PR, with an expected observation period of 2 years.
Progression-free survival (PFS)
Time frame: From first dose to disease progression or death, whichever occurs first, with an expected observation period of 2 years.
Overall Survival (OS)
Time frame: From first dose to death from any cause, with an expected observation period of 2 years.
Duration of Response (DOR)
Time frame: From first documented CR or PR to disease progression or death, with an expected observation period of 2 years.
Disease Control Rate (DCR)
Time frame: From first dose to best overall response of CR, PR, or SD, with an expected observation period of 2 years
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 2 Jul 2026.
- Individual participant dataSharing planned: Undecided
Related trials for GC/GEJC
Not yet recruitingPhase 3
A Study of Neoadjuvant-adjuvant Durvalumab and FLOT Chemotherapy Followed by Adjuvant Durvalumab in Chinese Patients With Resectable GC/GEJC.
Gastric, Esophagogastric Junction
Not yet recruitingPhase 2
Retlirafusp Alfa Combined With Zeprumetostat, Apatinib, and Chemotherapy as First-Line Treatment for Metastatic GC/GEJC
Gastric Cancer/Gastroesophageal Junction Adenocarcinoma
RecruitingPhase 1/2
A Clinical Study to Test if an Investigational Treatment Called BNT326 is Safe and Potentially Beneficial When Used Alone or in Combination With Other Investigational Treatments Such as BNT327, for People With Advanced Malignant Tumors
Advanced Solid Tumor
Not yet recruitingPhase 2
Trastuzumab Combined With Retlirafusp Alfa in Treating HER2（Human Epidermal Growth Factor Receptor 2） 2+/3+ Gastric/Gastroesophageal Junction Adenocarcinoma After First-line Systemic Therapy Failure
GC, GEJC
Active, not recruitingPhase 2
TremelImumab aNd Durvalumab For the Non-operatIve Management (NOM) of MSI-high Resectable GC/GEJC.
Gastric Cancer, Microsatellite Instability
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.
Yu-Chi Chang contact
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Zolbetuximab, Oxaliplatin + 5-Fluorouracil/Leucovorin and CAPOX (oxaliplatin/capecitabine) in people with GC/GEJC, run by Kaohsiung Medical University Chung-Ho Memorial Hospital.
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 18 inclusion and 34 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 2 Jul 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 I-Chen Wu (+886-7-3121101 ext. 7452, minicawu@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number/incidence and percentage of subjects with AEs, SAEs and TEAEs. (time frame: From signing the ICF at Screening until 30 days after the last administration of the study intervention or Safety Follow-up Visit with an expected observation period of 2 years.). 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 2 Jul 2026.