Safety and Efficacy of HCB101 in Combination With Multiple Agents in Patients With Advanced Solid Tumors
Phase Ib/IIa, Open-label, Multicenter, Dose Escalation, and Dose Expansion Study to Evaluate Safety, Tolerability, Pharmacokinetics, and Antitumor Activity of HCB101 in Combination With Multiple Agents in Subjects With Advanced Solid Tumors
1 other identifier
interventional
500
1 country
1
Brief Summary
This is a non-randomized, open-label, dose-escalation, and dose-expansion Phase Ib/IIa study to evaluate the safety, tolerability, PK, PD, and preliminary antitumor activity of HCB101 administered in combination with standard or approved anticancer therapies in subjects with advanced solid tumors. The trial includes a Part-I (Phase Ib) of the dose-escalation phase and a Part-II (Phase IIa) of the dose-expansion phase. 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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started Mar 2025
Typical duration for phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 8, 2025
CompletedFirst Posted
Study publicly available on registry
January 13, 2025
CompletedStudy Start
First participant enrolled
March 13, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
January 1, 2029
February 4, 2026
April 1, 2025
2.8 years
January 8, 2025
February 2, 2026
Conditions
Outcome Measures
Primary Outcomes (2)
Number/incidence and percentage of subjects with adverse events.
To evaluate the safety and tolerability of HCB101
12 months
Number of subjects with Maximal tolerance dose (MTD) of HCB101
To evaluate the tolerability of HCB101
12 months
Secondary Outcomes (8)
Overall Rate Response (ORR)
12 months
Duration of Response (DoR)
12 months
Disease Control Rate (DCR)
12 months
Progression-Free Survival (PFS)
12 months
Peak Plasma Concentration (Cmax) of HCB101
12 months
- +3 more secondary outcomes
Study Arms (14)
Cohort 1: HCB101+Trastuzumab+Pertuzumab+CAPEOX
EXPERIMENTALHCB101: 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
EXPERIMENTALHCB101: 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 3a: HCB101 + Bevacizumab + FOLFIRI/ mFOLFOX6
EXPERIMENTALHCB101: 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
Cohort 3b: HCB101 + Cetuximab + FOLFIRI/ mFOLFOX6
EXPERIMENTALHCB101: 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
Cohort 3c: HCB101 + Ramucirumab + FOLFIRI
EXPERIMENTALHCB101: 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
Cohort 3d: HCB101 + mFOLFOX6
EXPERIMENTALHCB101: 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
Cohort 4: HCB101 + Pembrolizumab/Toripalimab + albumin-bound paclitaxel
EXPERIMENTALHCB101, 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
Cohort 5: HCB101 + Pembrolizumab + CAPEOX
EXPERIMENTALHCB101, 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
Cohort 6a: HCB101 + Pembrolizumab
EXPERIMENTALHCB101, QW Pembrolizumab 200 mg IV on D1, Q3W
Cohort 6b: HCB101 + Pembrolizumab + Cetuximab
EXPERIMENTALHCB101, QW Pembrolizumab 200 mg IV on D1, Q3W Cetuximab 400 mg/m2 IV on D1, then 250 mg/m2, QW
Cohort 6c: HCB101 + Cetuximab
EXPERIMENTALHCB101, QW Cetuximab 400 mg/m2 IV on D1, then 250 mg/m2, QW
Cohort 7: HCB101 + Trastuzumab Deruxtecan
EXPERIMENTALHCB101, QW Trastuzumab Deruxtecan 5.4 mg/kg IV on D1, Q3W
Cohort 8: HCB101 + Atezolizumab/Toripalimab + Bevacizumab
EXPERIMENTALHCB101, QW Atezolizumab 1200 mg IV on D1, Q3W or Toripalimab 240 mg IV on D1, Q3W Bevacizumab 15 mg/kg IV on D1, Q3W
Cohort 9: HCB101 + Atezolizumab/Toripalimab + carboplatin + etoposide.
EXPERIMENTALHCB101, 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
Interventions
QW
8 mg/kg IV loading dose on Day 1 of cycle 1, then 6 mg/kg IV every 21 days;
840 mg IV on Day 1, cycled every 21 days;
130 mg/m2 IV on Day 1, cycled every 21 days
1000 mg/m2 PO BID on Days 1-14, Cycled every 21 days
8 mg/kg IV on Days 1 and 15, Cycled every 28 days
80 mg/m2 IV on Days 1, 8, and 15, Cycled every 28 days
5 mg/kg IV on Day 1, Repeat every 2 weeks;
400 mg/m2 first infusion, followed by 250 mg/m2 IV weekly;
180 mg/m2 IV over 30-90 minutes on Day 1 every 2 weeks
400 mg/m2 IV on Day 1 every 2 weeks
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
240 mg/kg IV on Day 1 Cycled every 21 days
125 mg/m2 IV on day 1 and Day 8 Cycled every 21 days
200 mg IV day 1; given every 21 days
AUC=5, IV on D1, Q3W for 4\~6 cycles
100mg/m2, IV on D1, 2, 3, Q3W for 4\~6 cycles
1200 mg IV on D1, Q3W
Eligibility Criteria
You may qualify if:
- Subjects are able to understand and willing to provide signed informed consent.
- 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 solid tumors as described below:
- \) 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).
You may not qualify if:
- With a known history of hypersensitivity to any components of the study intervention.
- 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 received systemic antitumor therapies within the following washout periods prior to the first dose of study intervention:
- days for curative radiotherapy, immunotherapy, or targeted therapy, etc.
- days for chemotherapy, palliative radiotherapy, endocrine therapy, or herbal medicine or traditional therapies with known or claimed antitumor activity.
- Subjects who have used a radioactive drug (Strontium, Samarium, etc.) within 56 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 in Mainland China; ≤ 81 mg QD in the United States) is allowed.
- Subjects who have received any treatment targeting the CD47 or SIRPα pathway.
- 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.
- 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.
- Subjects who have received any treatment targeting the CD47 or SIRPα pathway.
- An uncontrolled acute infection.
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Cancer Hospital of Shandong First Medical University
Jinan, Shandong, China
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 8, 2025
First Posted
January 13, 2025
Study Start
March 13, 2025
Primary Completion (Estimated)
January 1, 2028
Study Completion (Estimated)
January 1, 2029
Last Updated
February 4, 2026
Record last verified: 2025-04
Data Sharing
- IPD Sharing
- Will not share