Safety and Efficacy of HCB101 in Combination With Multiple Agents in Patients With Advanced Solid Tumors
NCT ID: NCT06771622
Last Updated: 2026-02-04
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
PHASE1/PHASE2
500 participants
INTERVENTIONAL
2025-03-13
2029-01-01
Brief Summary
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Part-I: Dose-escalation phase (Phase Ib):
Part I uses a standard 3+3 dose-escalation design to characterize safety and tolerability and to determine the maximum tolerated dose (MTD) and/or recommended Phase II dose (RP2D) of HCB101 when administered in combination regimens. The study includes 14 planned cohorts (Cohorts 1-9, including sub-cohorts 3a-3d and 6a-6c).
Part-II: Dose-expansion phase (Phase IIa) Based on safety, tolerability, PK/PD, and emerging antitumor activity observed in Part-I (Phase Ib), selected dose levels, tumor types, and combination regimens will be further investigated in Part-II (Phase IIa).
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Cohort 3a: HCB101 + Bevacizumab + FOLFIRI/ mFOLFOX6
HCB101: QW Bevacizumab 5 mg/kg IV on D1, Q2W
FOLFIRI:
Irinotecan 180 mg/m2 IV on D1, Q2W Leucovorin 400 mg/m2 IV on D1, Q2W 5-FU 400 mg/m2 IV on D1, then 1200 mg/m2/day on D2 and D3 (total 2400 mg/m2), Q2W
mFOLFOX6: Oxaliplatin 85 mg/m2 IV on D1, Q2W Leucovorin 400 mg/m2 IV on D1, Q2W 5-FU 400 mg/m2 IV on D1, then 1200 mg/m2/day on D2 and D3 (total 2400 mg/m2), Q2W
HCB101
QW
Oxaliplatin
130 mg/m2 IV on Day 1, cycled every 21 days
Bevacizumab
5 mg/kg IV on Day 1, Repeat every 2 weeks;
Irinotecan
180 mg/m2 IV over 30-90 minutes on Day 1 every 2 weeks
Leucovorin
400 mg/m2 IV on Day 1 every 2 weeks
5-FU
400 mg/ m2 IV bolus on Day 1, followed by 1200 mg/m2/day x 2 days (total 2400 mg/m2 over 46-48 hours) IV continuous infusion Repeat every 2 weeks
Pembrolizumab
200 mg IV day 1; given every 21 days
Cohort 1: HCB101+Trastuzumab+Pertuzumab+CAPEOX
HCB101: QW Trastuzumab: 8 mg/kg IV loading dose on Day 1 of cycle 1, then 6 mg/kg IV every 21 days; Pertuzumab: 840 mg IV on Day 1, cycled every 21 days; Oxaliplatin: 130 mg/m2 IV on Day 1, cycled every 21 days; Capecitabine: 1000 mg/m2 PO BID on Days 1-14, cycled every 21 days;
HCB101
QW
Trastuzumab
8 mg/kg IV loading dose on Day 1 of cycle 1, then 6 mg/kg IV every 21 days;
Pertuzumab
840 mg IV on Day 1, cycled every 21 days;
Oxaliplatin
130 mg/m2 IV on Day 1, cycled every 21 days
Capecitabine
1000 mg/m2 PO BID on Days 1-14, Cycled every 21 days
Cohort 2: HCB101+Ramucirumab+Paclitaxel
HCB101: QW Ramucirumab: 8 mg/kg IV on Days 1 and 15, cycled every 28 days; Paclitaxel: 80 mg/m2 IV on Days 1, 8, and 15, cycled every 28 days;
HCB101
QW
Ramucirumab
8 mg/kg IV on Days 1 and 15, Cycled every 28 days
Paclitaxel
80 mg/m2 IV on Days 1, 8, and 15, Cycled every 28 days
Cohort 3b: HCB101 + Cetuximab + FOLFIRI/ mFOLFOX6
HCB101: QW Cetuximab 400 mg/m2 IV on D1, then 250 mg/m2, weekly
FOLFIRI:
Irinotecan 180 mg/m2 IV on D1, Q2W Leucovorin 400 mg/m2 IV on D1, Q2W 5-FU 400 mg/m2 IV on D1, then 1200 mg/m2/day on D2 and D3 (total 2400 mg/m2), Q2W
mFOLFOX6: Oxaliplatin 85 mg/m2 IV on D1, Q2W Leucovorin 400 mg/m2 IV on D1, Q2W 5-FU 400 mg/m2 IV on D1, then 1200 mg/m2/day on D2 and D3 (total 2400 mg/m2), Q2W
HCB101
QW
Oxaliplatin
130 mg/m2 IV on Day 1, cycled every 21 days
Cetuximab
400 mg/m2 first infusion, followed by 250 mg/m2 IV weekly;
Irinotecan
180 mg/m2 IV over 30-90 minutes on Day 1 every 2 weeks
Leucovorin
400 mg/m2 IV on Day 1 every 2 weeks
5-FU
400 mg/ m2 IV bolus on Day 1, followed by 1200 mg/m2/day x 2 days (total 2400 mg/m2 over 46-48 hours) IV continuous infusion Repeat every 2 weeks
Cohort 3c: HCB101 + Ramucirumab + FOLFIRI
HCB101: QW Ramucirumab 8 mg/kg IV on D1 and 15, Q4W
FOLFIRI:
Irinotecan 180 mg/m2 IV on D1, Q2W Leucovorin 400 mg/m2 IV on D1, Q2W 5-FU 400 mg/m2 IV on D1, then 1200 mg/m2/day on D2 and D3 (total 2400 mg/m2), Q2W
HCB101
QW
Ramucirumab
8 mg/kg IV on Days 1 and 15, Cycled every 28 days
Irinotecan
180 mg/m2 IV over 30-90 minutes on Day 1 every 2 weeks
Leucovorin
400 mg/m2 IV on Day 1 every 2 weeks
5-FU
400 mg/ m2 IV bolus on Day 1, followed by 1200 mg/m2/day x 2 days (total 2400 mg/m2 over 46-48 hours) IV continuous infusion Repeat every 2 weeks
Cohort 3d: HCB101 + mFOLFOX6
HCB101: QW
mFOLFOX6: Oxaliplatin 85 mg/m2 IV on D1, Q2W Leucovorin 400 mg/m2 IV on D1, Q2W 5-FU 400 mg/m2 IV on D1, then 1200 mg/m2/day on D2 and D3 (total 2400 mg/m2), Q2W
HCB101
QW
Oxaliplatin
130 mg/m2 IV on Day 1, cycled every 21 days
Leucovorin
400 mg/m2 IV on Day 1 every 2 weeks
5-FU
400 mg/ m2 IV bolus on Day 1, followed by 1200 mg/m2/day x 2 days (total 2400 mg/m2 over 46-48 hours) IV continuous infusion Repeat every 2 weeks
Cohort 4: HCB101 + Pembrolizumab/Toripalimab + albumin-bound paclitaxel
HCB101, QW Pembrolizumab 200 mg IV on D1, Q3W or Toripalimab 240 mg IV on D1, Q3W Albumin-bound paclitaxel 100 mg/m2 on D1, 8, 15, Q4W or 125 mg/m2 IV on D1, D8, Q3W
HCB101
QW
Toripalimab
240 mg/kg IV on Day 1 Cycled every 21 days
Albumin-bound paclitaxel
125 mg/m2 IV on day 1 and Day 8 Cycled every 21 days
Pembrolizumab
200 mg IV day 1; given every 21 days
Cohort 5: HCB101 + Pembrolizumab + CAPEOX
HCB101, QW Pembrolizumab 200 mg IV on D1, Q3W Oxaliplatin 130 mg/m2 IV on D1, Q3W Capecitabine 1000 mg/m2 PO BID on D1-14, Q3W
HCB101
QW
Oxaliplatin
130 mg/m2 IV on Day 1, cycled every 21 days
Capecitabine
1000 mg/m2 PO BID on Days 1-14, Cycled every 21 days
Pembrolizumab
200 mg IV day 1; given every 21 days
Cohort 6a: HCB101 + Pembrolizumab
HCB101, QW Pembrolizumab 200 mg IV on D1, Q3W
HCB101
QW
Pembrolizumab
200 mg IV day 1; given every 21 days
Cohort 6b: HCB101 + Pembrolizumab + Cetuximab
HCB101, QW Pembrolizumab 200 mg IV on D1, Q3W Cetuximab 400 mg/m2 IV on D1, then 250 mg/m2, QW
HCB101
QW
Cetuximab
400 mg/m2 first infusion, followed by 250 mg/m2 IV weekly;
Pembrolizumab
200 mg IV day 1; given every 21 days
Cohort 6c: HCB101 + Cetuximab
HCB101, QW Cetuximab 400 mg/m2 IV on D1, then 250 mg/m2, QW
HCB101
QW
Cetuximab
400 mg/m2 first infusion, followed by 250 mg/m2 IV weekly;
Cohort 7: HCB101 + Trastuzumab Deruxtecan
HCB101, QW Trastuzumab Deruxtecan 5.4 mg/kg IV on D1, Q3W
HCB101
QW
Trastuzumab deruxtecan
5.4 mg/kg IV on D1, Q3W
Cohort 8: HCB101 + Atezolizumab/Toripalimab + Bevacizumab
HCB101, QW Atezolizumab 1200 mg IV on D1, Q3W or Toripalimab 240 mg IV on D1, Q3W Bevacizumab 15 mg/kg IV on D1, Q3W
HCB101
QW
Bevacizumab
5 mg/kg IV on Day 1, Repeat every 2 weeks;
Toripalimab
240 mg/kg IV on Day 1 Cycled every 21 days
Atezolizumab
1200 mg IV on D1, Q3W
Cohort 9: HCB101 + Atezolizumab/Toripalimab + carboplatin + etoposide.
HCB101, QW Atezolizumab 1200 mg IV on D1, Q3W or Toripalimab 240 mg IV on D1, Q3W Carboplatin AUC=5, IV on D1, Q3W for 4 cycles Etoposide 100mg/m2, IV on D1, 2, 3, Q3W for 4 cycles
HCB101
QW
Toripalimab
240 mg/kg IV on Day 1 Cycled every 21 days
Carboplatin (AUC 5)
AUC=5, IV on D1, Q3W for 4\~6 cycles
Etoposide
100mg/m2, IV on D1, 2, 3, Q3W for 4\~6 cycles
Atezolizumab
1200 mg IV on D1, Q3W
Interventions
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HCB101
QW
Trastuzumab
8 mg/kg IV loading dose on Day 1 of cycle 1, then 6 mg/kg IV every 21 days;
Pertuzumab
840 mg IV on Day 1, cycled every 21 days;
Oxaliplatin
130 mg/m2 IV on Day 1, cycled every 21 days
Capecitabine
1000 mg/m2 PO BID on Days 1-14, Cycled every 21 days
Ramucirumab
8 mg/kg IV on Days 1 and 15, Cycled every 28 days
Paclitaxel
80 mg/m2 IV on Days 1, 8, and 15, Cycled every 28 days
Bevacizumab
5 mg/kg IV on Day 1, Repeat every 2 weeks;
Cetuximab
400 mg/m2 first infusion, followed by 250 mg/m2 IV weekly;
Irinotecan
180 mg/m2 IV over 30-90 minutes on Day 1 every 2 weeks
Leucovorin
400 mg/m2 IV on Day 1 every 2 weeks
5-FU
400 mg/ m2 IV bolus on Day 1, followed by 1200 mg/m2/day x 2 days (total 2400 mg/m2 over 46-48 hours) IV continuous infusion Repeat every 2 weeks
Toripalimab
240 mg/kg IV on Day 1 Cycled every 21 days
Albumin-bound paclitaxel
125 mg/m2 IV on day 1 and Day 8 Cycled every 21 days
Pembrolizumab
200 mg IV day 1; given every 21 days
Carboplatin (AUC 5)
AUC=5, IV on D1, Q3W for 4\~6 cycles
Etoposide
100mg/m2, IV on D1, 2, 3, Q3W for 4\~6 cycles
Atezolizumab
1200 mg IV on D1, Q3W
Trastuzumab deruxtecan
5.4 mg/kg IV on D1, Q3W
Eligibility Criteria
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Inclusion Criteria
2. Male and female subjects of ≥18 years of age, inclusive, at the time of signing the informed consent.
3. With histologically/cytologically confirmed diagnosis of advanced solid tumors as described below:
1\) Cohort 1- Gastric Cancer, HER-Positive (First-Line): 2) Cohort 2 - Gastric Cancer (Second-Line): 3) Cohort 3 - Colorectal Cancer (Second-Line): 4) Cohort 4 - Triple-Negative Breast Cancer (First-Line): 5) Cohort 5 - Gastric Cancer, HER2 Medium/Low/Negative (First-Line): 6) Cohort 6 - Head and Neck Squamous Cell Carcinoma: 7) Cohort 7 - Ovarian Cancer: 8) Cohort 8 - Hepatocellular Carcinoma: 9) Cohort 9 - Extensive-Stage Small Cell Lung Cancer: 4. 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).
Exclusion Criteria
2. Prior/Concomitant Therapy/Treatment:
1. Subjects who have undergone major surgery or radical radiotherapy within 28 days before the first dose of study intervention.
2. Subjects who have received systemic antitumor therapies within the following washout periods prior to the first dose of study intervention:
* 28 days for curative radiotherapy, immunotherapy, or targeted therapy, etc.
* 14 days for chemotherapy, palliative radiotherapy, endocrine therapy, or herbal medicine or traditional therapies with known or claimed antitumor activity.
3. Subjects who have used a radioactive drug (Strontium, Samarium, etc.) within 56 days before the first dose of the study intervention.
4. 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 in Mainland China; ≤ 81 mg QD in the United States) is allowed.
5. Subjects who have received any treatment targeting the CD47 or SIRPα pathway.
6. Subjects who have received or plan to receive live virus or bacterial vaccine within 28 days before the first dose of study intervention while the subject receives the study intervention.
3. Participation in another clinical study with an investigational product administered or investigational device used in the last 28 days (If half-life is not clear) or 5 half-lives (If half-life is clear, the longer time one prevails) before receiving the first dose of study intervention.
4. Subjects who have received any treatment targeting the CD47 or SIRPα pathway.
5. An uncontrolled acute infection.
6. Known to have a history of alcoholism or drug abuse.
7. 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.
18 Years
ALL
No
Sponsors
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FBD Biologics Limited
INDUSTRY
Responsible Party
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Locations
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Cancer Hospital of Shandong First Medical University
Jinan, Shandong, China
Countries
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Other Identifiers
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HCB101-201
Identifier Type: -
Identifier Source: org_study_id
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