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Solid CancerPhase 1/2NCT06771622

Safety and Efficacy of HCB101 in Combination With Multiple Agents in Patients With Advanced Solid Tumors

A Phase 1/2 study testing HCB101, Trastuzumab and Pertuzumab in people with Solid Cancer, run by FBD Biologics Limited at 1 site in China.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Solid Cancer
What is being tested?
HCB101, Trastuzumab and Pertuzumab
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
500 participants
Where
1 siteChina
Study dates
13 Mar 2025to 1 Jan 2029
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.
  • 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:
  • 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).

Who cannot join

  • 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:
  • 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.
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  • 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.

Trial locations and contacts

1 site in 1 country.

China1 site

  • Cancer Hospital of Shandong First Medical University

    Jinan, Shandong

Other trials in China

About this study

Official title: 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

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):

Read more

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).

Conditions
Solid Cancer

What participants receive

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

  • HCB101Drug

    QW

  • TrastuzumabDrug

    8 mg/kg IV loading dose on Day 1 of cycle 1, then 6 mg/kg IV every 21 days;

  • PertuzumabDrug

    840 mg IV on Day 1, cycled every 21 days;

  • OxaliplatinDrug

    130 mg/m2 IV on Day 1, cycled every 21 days

  • CapecitabineDrug

    1000 mg/m2 PO BID on Days 1-14, Cycled every 21 days

  • RamucirumabDrug

    8 mg/kg IV on Days 1 and 15, Cycled every 28 days

  • PaclitaxelDrug

    80 mg/m2 IV on Days 1, 8, and 15, Cycled every 28 days

  • BevacizumabDrug

    5 mg/kg IV on Day 1, Repeat every 2 weeks;

  • CetuximabDrug

    400 mg/m2 first infusion, followed by 250 mg/m2 IV weekly;

  • IrinotecanDrug

    180 mg/m2 IV over 30-90 minutes on Day 1 every 2 weeks

  • LeucovorinDrug

    400 mg/m2 IV on Day 1 every 2 weeks

  • 5-FUDrug

    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

  • ToripalimabDrug

    240 mg/kg IV on Day 1 Cycled every 21 days

  • Albumin-bound paclitaxelDrug

    125 mg/m2 IV on day 1 and Day 8 Cycled every 21 days

  • PembrolizumabDrug

    200 mg IV day 1; given every 21 days

  • Carboplatin (AUC 5)Drug

    AUC=5, IV on D1, Q3W for 4~6 cycles

  • EtoposideDrug

    100mg/m2, IV on D1, 2, 3, Q3W for 4~6 cycles

  • AtezolizumabDrug

    1200 mg IV on D1, Q3W

  • Trastuzumab deruxtecanDrug

    5.4 mg/kg IV on D1, Q3W

Study groups in NCT06771622
Study groupRoleWhat they receive
Cohort 1: HCB101+Trastuzumab+Pertuzumab+CAPEOXExperimentalHCB101: 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;
Receives: Drug: HCB101; Drug: Trastuzumab; Drug: Pertuzumab; Drug: Oxaliplatin; Drug: Capecitabine
Cohort 2: HCB101+Ramucirumab+PaclitaxelExperimentalHCB101: 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;
Receives: Drug: HCB101; Drug: Ramucirumab; Drug: Paclitaxel
Cohort 3a: HCB101 + Bevacizumab + FOLFIRI/ mFOLFOX6ExperimentalHCB101: 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
Receives: Drug: HCB101; Drug: Oxaliplatin; Drug: Bevacizumab; Drug: Irinotecan; Drug: Leucovorin; Drug: 5-FU; Drug: Pembrolizumab
Cohort 3b: HCB101 + Cetuximab + FOLFIRI/ mFOLFOX6ExperimentalHCB101: 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
Receives: Drug: HCB101; Drug: Oxaliplatin; Drug: Cetuximab; Drug: Irinotecan; Drug: Leucovorin; Drug: 5-FU
Cohort 3c: HCB101 + Ramucirumab + FOLFIRIExperimentalHCB101: 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
Receives: Drug: HCB101; Drug: Ramucirumab; Drug: Irinotecan; Drug: Leucovorin; Drug: 5-FU
Cohort 3d: HCB101 + mFOLFOX6ExperimentalHCB101: 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
Receives: Drug: HCB101; Drug: Oxaliplatin; Drug: Leucovorin; Drug: 5-FU
Cohort 4: HCB101 + Pembrolizumab/Toripalimab + albumin-bound paclitaxelExperimentalHCB101, 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
Receives: Drug: HCB101; Drug: Toripalimab; Drug: Albumin-bound paclitaxel; Drug: Pembrolizumab
Cohort 5: HCB101 + Pembrolizumab + CAPEOXExperimentalHCB101, 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
Receives: Drug: HCB101; Drug: Oxaliplatin; Drug: Capecitabine; Drug: Pembrolizumab
Cohort 6a: HCB101 + PembrolizumabExperimentalHCB101, QW Pembrolizumab 200 mg IV on D1, Q3W
Receives: Drug: HCB101; Drug: Pembrolizumab
Cohort 6b: HCB101 + Pembrolizumab + CetuximabExperimentalHCB101, QW Pembrolizumab 200 mg IV on D1, Q3W Cetuximab 400 mg/m2 IV on D1, then 250 mg/m2, QW
Receives: Drug: HCB101; Drug: Cetuximab; Drug: Pembrolizumab
Cohort 6c: HCB101 + CetuximabExperimentalHCB101, QW Cetuximab 400 mg/m2 IV on D1, then 250 mg/m2, QW
Receives: Drug: HCB101; Drug: Cetuximab
Cohort 7: HCB101 + Trastuzumab DeruxtecanExperimentalHCB101, QW Trastuzumab Deruxtecan 5.4 mg/kg IV on D1, Q3W
Receives: Drug: HCB101; Drug: Trastuzumab deruxtecan
Cohort 8: HCB101 + Atezolizumab/Toripalimab + BevacizumabExperimentalHCB101, QW Atezolizumab 1200 mg IV on D1, Q3W or Toripalimab 240 mg IV on D1, Q3W Bevacizumab 15 mg/kg IV on D1, Q3W
Receives: Drug: HCB101; Drug: Bevacizumab; Drug: Toripalimab; Drug: Atezolizumab
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
Receives: Drug: HCB101; Drug: Toripalimab; Drug: Carboplatin (AUC 5); Drug: Etoposide; Drug: Atezolizumab

What is being measured

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

  1. Number/incidence and percentage of subjects with adverse events.

    To evaluate the safety and tolerability of HCB101

    Measured: 12 months

  2. Number of subjects with Maximal tolerance dose (MTD) of HCB101

    To evaluate the tolerability of HCB101

    Measured: 12 months

Secondary outcomes (8)

  1. Overall Rate Response (ORR)

    ORR is defined as the proportion of participants who have a partial response (PR) or critical response (CR)

    Measured: 12 months

  2. Duration of Response (DoR)

    DOR is defined as time from date of initial documentation of a response (PR or CR) to date of first documented evidence of progressive disease (PD)

    Measured: 12 months

  3. Disease Control Rate (DCR)

    DCR is defined as the proportion of participants who have a partial response (PR), critical response (CR), or disease stable (SD)

    Measured: 12 months

  4. Progression-Free Survival (PFS)

    Defined as the duration from the start of treatment until tumor progression or death of any cause.

    Measured: 12 months

  5. Peak Plasma Concentration (Cmax) of HCB101

    Peak Plasma Concentration (Cmax) of HCB101 following single and repeated IV doses of HCB101 at different dose levels.

    Measured: 12 months

  6. Area under the plasma concentration versus time curve (AUC) of HCB101

    Area under the plasma concentration versus time curve (AUC) of HCB101

    Measured: 12 months

  7. Time to maximum drug concentration in plasma (Tmax) of HCB101

    Time to maximum drug concentration in plasma (Tmax) of HCB101 following single and repeated IV doses of HCB101 at different dose levels.

    Measured: 12 months

  8. Terminal elimination half-life (t1/2) of HCB101

    Terminal elimination half-life (t1/2) of HCB101 following single and repeated IV doses of HCB101 at different dose levels.

    Measured: 12 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 Jan 2025
  2. Study start13 Mar 2025
  3. Primary completion1 Jan 2028 (estimated)
  4. Study completion1 Jan 2029 (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 1/2
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
500 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06771622
Sponsor's protocol ID
HCB101-201
Status last verified
Apr 2025
First submitted
8 Jan 2025
Last updated
4 Feb 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing HCB101, Trastuzumab and Pertuzumab in people with Solid Cancer, run by FBD Biologics Limited 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 4 inclusion and 15 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: under way, not looking for participants, as of the sponsor's last update on 4 Feb 2026. 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 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?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number/incidence and percentage of subjects with adverse events. (time frame: 12 months). 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?

On the ClinicalTrials.gov record for NCT06771622.

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 4 Feb 2026.

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