Clinical Trials List
Protocol NumberBBI-4182-101
Active
2025-09-01 - 2027-05-31
Phase I/II
Recruiting6
ICD-10C16.0
Malignant neoplasm of cardia
ICD-10C7A.092
Malignant carcinoid tumor of the stomach
ICD-10Z51.12
Encounter for antineoplastic immunotherapy
ICD-9151.0
Malignant neoplasm of cardia of stomach
A first-in-human dose escalation and expansion trial of BDC-4182 as a single agent in patients with advanced gastric and gastroesophageal cancer in stage 1/2.
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Trial Applicant
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Sponsor
Novotech Clinical Research Taiwan Pty Ltd.
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Trial scale
Multi-Regional Multi-Center
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Update
2026/07/21
Investigators and Locations
Co-Principal Investigator
- Kun-Huei Yeh 無
- Chih-Hung Hsu 無
- 張端瑩 無
- Jih-Hsiang Lee 無
- Wei-Wu Chen 無
- 徐偉勛 無
- Hsiang-Fong Kao 無
- 吳宗哲 無
The Actual Total Number of Participants Enrolled
0 Recruiting
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
- Yi-Ping Hung 無
- Yun-Cheng Hsieh 無
- 林泰祺 無
- 姜乃榕 無
- Hung-Yuan Yu 無
- 郭懿萱 無
- 邱乃祈 無
- 唐振育 無
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
- Chang-Fang Chiu 無
- Chi-Ching Chen 無
- 鄭富銘 無
- 陳珈妤 無
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
The Actual Total Number of Participants Enrolled
0 Recruiting
Principal Investigator
Wen-Chi Chou
Co-Principal Investigator
The Actual Total Number of Participants Enrolled
0 Recruiting
Condition/Disease
Advanced gastric cancer, advanced gastroesophageal cancer
Objectives
Primary Objective: To investigate the safety and tolerability of BDC-4182 as a single agent in patients with advanced gastric and gastroesophageal cancer, and to define its Phase 2 Recommended Dosage-Induced (RP2D).
Secondary Objectives: To evaluate the preliminary antitumor activity of BDC-4182 as a single agent; to analyze the pharmacokinetic (PK) characteristics of BDC-4182 in patients with advanced gastric and/or gastroesophageal cancer; to evaluate the immunogenicity of BDC-4182 as a single agent.
Exploratory Objectives: To explore potential biomarkers in blood and tumor tissues related to BDC-4182 exposure, efficacy, or safety; to study and define CLDN18 expression in tumor tissues.
Test Drug
BDC-4182
Active Ingredient
BDC-4182
Dosage Form
Injectable frozen powder
Dosage
125mg/5mL
Endpoints
Incidence of AEs and SAEs according to NCI CTCAE version 5.0 classification; Incidence of dose-limiting toxicities (DLTs).
Inclution Criteria
To be eligible for inclusion in this trial, participants must meet all of the following criteria:
1. Be able to read and sign the informed consent form.
2. Be 18 years of age or older at the time of providing informed consent (or, if older than 18, the local consent age).
3. Have a disease that can be assessed according to the Responsive Evaluation Criteria in Solid Tumors (RECIST) version 1.1.
4. Participants must meet the following criteria:
a. Histologically/cytologically confirmed gastric or gastroesophageal cancer, metastatic (stage 4) or unresectable (stage 3).
b. Have experienced disease progression following local approved or standard therapies, or be unwilling or unable to tolerate standard therapies, in order to be eligible for inclusion.
5. Claudin 18 manifestation in the tumor
a. Incremental group:
i. Participants with unknown Claudin 18 manifestation may be included.
ii. If prior Claudin 18 IHC manifestation is known, the participant must have ≥ 1% of tumor cells showing Claudin 18 IHC ≥ 2+.
b. Supplemental group: Subjects must have ≥20% of their tumor cells exhibiting Claudin 18 expression and IHC ≥ 2+.
c. Consult your medical monitor as needed.
6. East Coast Cancer Clinical Research Partnership (ECOG) performance status score of 0 or 1.
7. Adequate organ function, defined as follows:
a. Hematology:
i. Absolute neutrophil count ≥ 1500 cells/mm3, and no granulocyte colony-stimulating factor (G-CSF)/filgrastim/pegfilgrastim support within 7 days of Day 1 of Cycle 1 (C1D1).
ii. Platelet count ≥ 75,000 cells/mm3.
iii. Hemoglobin ≥ 9 g/dL (and no blood transfusion within 7 days).
b. Kidneys: Creatinine clearance ≥ 50 mL/min, calculated using the Cockcroft-Gault formula: [(140 - age) × (body weight in kg) × (0.85 for females)] / [72 × (serum creatinine in mg/dL)].
c. Coagulation: Prothrombin time (PT) or international normalized ratio (INR) and activated partial thromboplastin time (aPTT) ≤ 1.5 times the upper limit of normal (ULN) (unless receiving anticoagulant therapy).
d. Liver:
i. Aspartate transaminase (AST) and alanine transaminase (ALT) ≤ 3 times the ULN (≤ 5 times the ULN if the subject has known liver metastases).
ii. Total bilirubin ≤ 1.5 times the ULN (an independent value > 1.5 times the ULN is acceptable if direct bilirubin < 35% of the total).
8. Life expectancy assessed by the trial administrator > 12 weeks. 9. Baseline albumin level ≥ 3.0 g/dL and no albumin infusion within the past 14 days.
10. Consent to pre-enrollment biopsy, with the trial administrator determining the risk to be acceptable. If biopsies cannot be safely obtained or are clinically infeasible, suitable stockpiled tumor specimens must be submitted. If stockpiled tumor specimens do not meet the above criteria, consultation with the medical monitor and consent are required before acceptance.
a. For subjects who have not received Claudin 18.2 targeted therapy, suitable tumor specimens are defined as paraffin blocks <12 months from the date of consent signing.
b. For subjects who have received Claudin 18.2 targeted therapy, suitable tumor specimens are defined as samples obtained after Claudin 18.2 targeted therapy and <12 months from the date of consent signing.
11. Women of childbearing potential (WOCBP) should use at least one of the following highly effective contraceptive methods (with an annual failure rate of less than 1%) during treatment and for one month after treatment completion:
a. Ovulation-suppressing estrogen- and progesterone-based hormonal contraceptives.
b. Ovulation-suppressing progesterone-only hormonal contraceptives.
c. Intrauterine devices (IUDs).
d. Vasectomy.
e. Abstinence.
f. Intrauterine hormone-releasing systems (IHMS).
g. Bilateral tubal ligation.
12. Men of childbearing potential who are partners of women of childbearing potential (WOCBP) must agree to use condoms in conjunction with a highly effective female contraceptive method (as described above) from the screening period until at least one month after the last dose of trial treatment. Furthermore, they must agree not to donate sperm during this period. Male partners will be considered fertile unless surgically sterilized with appropriate documentation.
1. Be able to read and sign the informed consent form.
2. Be 18 years of age or older at the time of providing informed consent (or, if older than 18, the local consent age).
3. Have a disease that can be assessed according to the Responsive Evaluation Criteria in Solid Tumors (RECIST) version 1.1.
4. Participants must meet the following criteria:
a. Histologically/cytologically confirmed gastric or gastroesophageal cancer, metastatic (stage 4) or unresectable (stage 3).
b. Have experienced disease progression following local approved or standard therapies, or be unwilling or unable to tolerate standard therapies, in order to be eligible for inclusion.
5. Claudin 18 manifestation in the tumor
a. Incremental group:
i. Participants with unknown Claudin 18 manifestation may be included.
ii. If prior Claudin 18 IHC manifestation is known, the participant must have ≥ 1% of tumor cells showing Claudin 18 IHC ≥ 2+.
b. Supplemental group: Subjects must have ≥20% of their tumor cells exhibiting Claudin 18 expression and IHC ≥ 2+.
c. Consult your medical monitor as needed.
6. East Coast Cancer Clinical Research Partnership (ECOG) performance status score of 0 or 1.
7. Adequate organ function, defined as follows:
a. Hematology:
i. Absolute neutrophil count ≥ 1500 cells/mm3, and no granulocyte colony-stimulating factor (G-CSF)/filgrastim/pegfilgrastim support within 7 days of Day 1 of Cycle 1 (C1D1).
ii. Platelet count ≥ 75,000 cells/mm3.
iii. Hemoglobin ≥ 9 g/dL (and no blood transfusion within 7 days).
b. Kidneys: Creatinine clearance ≥ 50 mL/min, calculated using the Cockcroft-Gault formula: [(140 - age) × (body weight in kg) × (0.85 for females)] / [72 × (serum creatinine in mg/dL)].
c. Coagulation: Prothrombin time (PT) or international normalized ratio (INR) and activated partial thromboplastin time (aPTT) ≤ 1.5 times the upper limit of normal (ULN) (unless receiving anticoagulant therapy).
d. Liver:
i. Aspartate transaminase (AST) and alanine transaminase (ALT) ≤ 3 times the ULN (≤ 5 times the ULN if the subject has known liver metastases).
ii. Total bilirubin ≤ 1.5 times the ULN (an independent value > 1.5 times the ULN is acceptable if direct bilirubin < 35% of the total).
8. Life expectancy assessed by the trial administrator > 12 weeks. 9. Baseline albumin level ≥ 3.0 g/dL and no albumin infusion within the past 14 days.
10. Consent to pre-enrollment biopsy, with the trial administrator determining the risk to be acceptable. If biopsies cannot be safely obtained or are clinically infeasible, suitable stockpiled tumor specimens must be submitted. If stockpiled tumor specimens do not meet the above criteria, consultation with the medical monitor and consent are required before acceptance.
a. For subjects who have not received Claudin 18.2 targeted therapy, suitable tumor specimens are defined as paraffin blocks <12 months from the date of consent signing.
b. For subjects who have received Claudin 18.2 targeted therapy, suitable tumor specimens are defined as samples obtained after Claudin 18.2 targeted therapy and <12 months from the date of consent signing.
11. Women of childbearing potential (WOCBP) should use at least one of the following highly effective contraceptive methods (with an annual failure rate of less than 1%) during treatment and for one month after treatment completion:
a. Ovulation-suppressing estrogen- and progesterone-based hormonal contraceptives.
b. Ovulation-suppressing progesterone-only hormonal contraceptives.
c. Intrauterine devices (IUDs).
d. Vasectomy.
e. Abstinence.
f. Intrauterine hormone-releasing systems (IHMS).
g. Bilateral tubal ligation.
12. Men of childbearing potential who are partners of women of childbearing potential (WOCBP) must agree to use condoms in conjunction with a highly effective female contraceptive method (as described above) from the screening period until at least one month after the last dose of trial treatment. Furthermore, they must agree not to donate sperm during this period. Male partners will be considered fertile unless surgically sterilized with appropriate documentation.
Exclusion Criteria
Subjects meeting any of the following criteria will be excluded from the trial:
1. Known central nervous system (CNS) metastases, but acceptable if the patient is asymptomatic, clinically stable, and has not required steroid treatment for at least 14 days prior to the start of the trial.
2. Cardiac disease, including:
a. New York Heart Association Class II-IV congestive heart failure.
b. QT interval (QTcF) prolongation > 480 ms as corrected using the Fridricia formula on a 12-lead electrocardiogram (ECG).
c. Severe or uncontrolled arrhythmia within the 6 months prior to the start of the trial.
d. Myocardial infarction, unstable angina, or coronary angioplasty, stenting, or surgery within the 6 months prior to the start of the trial.
e. Severe or uncontrolled hypertension (systolic blood pressure ≥ 180 mmHg or diastolic blood pressure ≥ 120 mmHg) within the 6 months prior to the start of the trial. f. Symptomatic pericarditis or pericardial effusion within 6 months prior to the start of trial treatment.
3. Lung disease, including idiopathic pulmonary fibrosis, non-infectious interstitial lung disease, pneumonia, or chronic obstructive pulmonary disease (requiring daily treatment for dyspnea, continuous oxygen therapy, or hospitalization within the past 6 months).
4. Liver disease leading to symptomatic ascites, encephalopathy, coagulation disorders, esophageal/gastric varices, or persistent jaundice.
5. Known bowel obstruction or gastric outlet obstruction.
6. Arterial thrombotic event, stroke, or transient ischemic attack within 6 months prior to the start of trial treatment.
7. Bruising or uncontrolled bleeding within 7 days prior to the start of trial treatment.
8. Bone marrow transplant or solid organ transplant.
9. Infections, including:
a. Diseases requiring systemic therapy within 7 days prior to the start of trial treatment.
b. Viral respiratory infections requiring medical treatment within 7 days prior to the start of trial treatment.
c. Known human immunodeficiency virus (HIV) (Subjects with HIV who are receiving appropriate treatment may be eligible after discussion with a medical monitor).
d. Positive hepatitis B surface antibody (HBA) or hepatitis B core antibody (HCA) test within 3 months prior to screening or the start of trial treatment (subjects with positive HBA or HCA but negative PCR test are allowed).
e. Positive hepatitis C antibody (HCA) test and confirmatory RNA (RNA) test within 3 months prior to screening or the start of trial treatment. Exceptions include subjects (1) with a hepatitis C viral load below the detection limit and (2) having completed curative antiviral therapy or currently following antiviral therapy.
10. Autoimmune diseases requiring systemic disease modulation or immunosuppressive therapy (including autoimmune ocular diseases) within 2 years prior to the start of trial treatment. Exceptions include diseases treated only with replacement therapy (e.g., thyroxine).
11. Malignant tumors not included in this study within 2 years prior to the start of trial treatment. Exceptions include:
12. Any medical condition requiring systemic corticosteroids (orally >10 mg prednisone or equivalent daily) or other systemic immunosuppressive therapy within 28 days prior to the start of trial treatment. Exception: Intermittent or occasional use of inhaled or topical steroids is permitted.
13. History of an inflammatory eye disease requiring therapy within 3 months prior to the start of trial treatment.
14. Residual toxicities from prior treatment, including:
a. Treatment-related toxicities that have not resolved to Grade 1.
b. Grade 2 neuropathy.
Note: Exceptions to the above conditions include toxicities that do not pose a risk to vital organ systems (e.g., hair loss) or toxicities that are stabilized by alternative therapies (e.g., hypothyroidism).
15. Any investigational drug or standard anticancer therapy administered within 28 days prior to the start of trial treatment or within an estimated 5 elimination half-life, whichever is shorter.
16. Radiation therapy administered within 14 days prior to the start of trial treatment.
17. History of severe allergy to any component of BDC-4182.
18. Received a live/attenuated viral vaccine within 28 days prior to the start of trial treatment.
19. Major surgery performed within 28 days of the start of trial treatment (consult with your medical monitor).
20. Currently enrolled in another clinical trial, unless it is an observational (non-invasive) clinical trial or a follow-up phase of an invasive trial.
21. The subject was a breastfeeding mother or confirmed pregnant by a pregnancy test within 7 days prior to the start of trial treatment.
22. The subject is unwilling or unable to comply with the trial protocol.
1. Known central nervous system (CNS) metastases, but acceptable if the patient is asymptomatic, clinically stable, and has not required steroid treatment for at least 14 days prior to the start of the trial.
2. Cardiac disease, including:
a. New York Heart Association Class II-IV congestive heart failure.
b. QT interval (QTcF) prolongation > 480 ms as corrected using the Fridricia formula on a 12-lead electrocardiogram (ECG).
c. Severe or uncontrolled arrhythmia within the 6 months prior to the start of the trial.
d. Myocardial infarction, unstable angina, or coronary angioplasty, stenting, or surgery within the 6 months prior to the start of the trial.
e. Severe or uncontrolled hypertension (systolic blood pressure ≥ 180 mmHg or diastolic blood pressure ≥ 120 mmHg) within the 6 months prior to the start of the trial. f. Symptomatic pericarditis or pericardial effusion within 6 months prior to the start of trial treatment.
3. Lung disease, including idiopathic pulmonary fibrosis, non-infectious interstitial lung disease, pneumonia, or chronic obstructive pulmonary disease (requiring daily treatment for dyspnea, continuous oxygen therapy, or hospitalization within the past 6 months).
4. Liver disease leading to symptomatic ascites, encephalopathy, coagulation disorders, esophageal/gastric varices, or persistent jaundice.
5. Known bowel obstruction or gastric outlet obstruction.
6. Arterial thrombotic event, stroke, or transient ischemic attack within 6 months prior to the start of trial treatment.
7. Bruising or uncontrolled bleeding within 7 days prior to the start of trial treatment.
8. Bone marrow transplant or solid organ transplant.
9. Infections, including:
a. Diseases requiring systemic therapy within 7 days prior to the start of trial treatment.
b. Viral respiratory infections requiring medical treatment within 7 days prior to the start of trial treatment.
c. Known human immunodeficiency virus (HIV) (Subjects with HIV who are receiving appropriate treatment may be eligible after discussion with a medical monitor).
d. Positive hepatitis B surface antibody (HBA) or hepatitis B core antibody (HCA) test within 3 months prior to screening or the start of trial treatment (subjects with positive HBA or HCA but negative PCR test are allowed).
e. Positive hepatitis C antibody (HCA) test and confirmatory RNA (RNA) test within 3 months prior to screening or the start of trial treatment. Exceptions include subjects (1) with a hepatitis C viral load below the detection limit and (2) having completed curative antiviral therapy or currently following antiviral therapy.
10. Autoimmune diseases requiring systemic disease modulation or immunosuppressive therapy (including autoimmune ocular diseases) within 2 years prior to the start of trial treatment. Exceptions include diseases treated only with replacement therapy (e.g., thyroxine).
11. Malignant tumors not included in this study within 2 years prior to the start of trial treatment. Exceptions include:
12. Any medical condition requiring systemic corticosteroids (orally >10 mg prednisone or equivalent daily) or other systemic immunosuppressive therapy within 28 days prior to the start of trial treatment. Exception: Intermittent or occasional use of inhaled or topical steroids is permitted.
13. History of an inflammatory eye disease requiring therapy within 3 months prior to the start of trial treatment.
14. Residual toxicities from prior treatment, including:
a. Treatment-related toxicities that have not resolved to Grade 1.
b. Grade 2 neuropathy.
Note: Exceptions to the above conditions include toxicities that do not pose a risk to vital organ systems (e.g., hair loss) or toxicities that are stabilized by alternative therapies (e.g., hypothyroidism).
15. Any investigational drug or standard anticancer therapy administered within 28 days prior to the start of trial treatment or within an estimated 5 elimination half-life, whichever is shorter.
16. Radiation therapy administered within 14 days prior to the start of trial treatment.
17. History of severe allergy to any component of BDC-4182.
18. Received a live/attenuated viral vaccine within 28 days prior to the start of trial treatment.
19. Major surgery performed within 28 days of the start of trial treatment (consult with your medical monitor).
20. Currently enrolled in another clinical trial, unless it is an observational (non-invasive) clinical trial or a follow-up phase of an invasive trial.
21. The subject was a breastfeeding mother or confirmed pregnant by a pregnancy test within 7 days prior to the start of trial treatment.
22. The subject is unwilling or unable to comply with the trial protocol.
The Estimated Number of Participants
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Taiwan
16 participants
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Global
122 participants
