> Trialight public data. Index of pages: https://trialight.com/llms.txt > Web page: https://trialight.com/data/trial/safety-and-efficacy-of-hcb101-in-combination-with-multiple-c5481c50-5484-44a6-972e-133c18725795 > Record changed: 2026-10-13 # Safety and Efficacy of HCB101 in Combination With Multiple Agents in Patients With Advanced Solid Tumors NCT06771622 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06771622) Phase Phase 1/Phase 2 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06771622) Recruitment status Active, not recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06771622) Participants 500 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06771622) Lead sponsor FBD Biologics Limited Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06771622) Start date 2025-03-13 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06771622) Number of sites 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06771622) ## Title and summary **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). Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06771622) **Short title** Safety and Efficacy of HCB101 in Combination With Multiple Agents in Patients With Advanced Solid Tumors Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06771622) **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 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06771622) ## Status and phase **Control arm** Open label Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06771622) **Registry reports results** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06771622) **Listing at source** Listed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06771622) **Recruitment status** Active, not recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06771622) **Phase** Phase 1/Phase 2 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06771622) **Study type** Interventional Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06771622) ## Dates **Completion date** 2029-01-01 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06771622) **First posted** 2025-01-13 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06771622) **Registry last updated** 2026-02-04 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06771622) **Primary completion date** 2028-01-01 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06771622) **Start date** 2025-03-13 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06771622) ## Size and sites **Participants** 500 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06771622) **Participant count basis** Estimated Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06771622) **Planned participants** 500 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06771622) **Protocol amendments** 2 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06771622) **Number of sites** 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06771622) ## Sponsor and oversight **Data monitoring committee** Yes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06771622) **Registry sponsor category** Industry Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06771622) **Lead sponsor** FBD Biologics Limited Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06771622) **Source registry** ClinicalTrials.gov Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06771622) ## Identifiers **Registry ID** NCT06771622 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06771622) **ClinicalTrials.gov ID** NCT06771622 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06771622) **Registry record** Open registry record Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06771622) ## Study design **Allocation** Not randomised **Model** Parallel groups **Purpose** Treatment **Masking** No masking Sources for study design Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06771622) ## Outcomes ### Primary outcomes 1. Number/incidence and percentage of subjects with adverse events. Timeframe: 12 months To evaluate the safety and tolerability of HCB101 2. Number of subjects with Maximal tolerance dose (MTD) of HCB101 Timeframe: 12 months To evaluate the tolerability of HCB101 ### Secondary outcomes 1. Overall Rate Response (ORR) Timeframe: 12 months ORR is defined as the proportion of participants who have a partial response (PR) or critical response (CR) 2. Duration of Response (DoR) Timeframe: 12 months 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) 3. Disease Control Rate (DCR) Timeframe: 12 months DCR is defined as the proportion of participants who have a partial response (PR), critical response (CR), or disease stable (SD) 4. Progression-Free Survival (PFS) Timeframe: 12 months Defined as the duration from the start of treatment until tumor progression or death of any cause. 5. Peak Plasma Concentration (Cmax) of HCB101 Timeframe: 12 months Peak Plasma Concentration (Cmax) of HCB101 following single and repeated IV doses of HCB101 at different dose levels. 6. Area under the plasma concentration versus time curve (AUC) of HCB101 Timeframe: 12 months Area under the plasma concentration versus time curve (AUC) of HCB101 7. Time to maximum drug concentration in plasma (Tmax) of HCB101 Timeframe: 12 months Time to maximum drug concentration in plasma (Tmax) of HCB101 following single and repeated IV doses of HCB101 at different dose levels. 8. Terminal elimination half-life (t1/2) of HCB101 Timeframe: 12 months Terminal elimination half-life (t1/2) of HCB101 following single and repeated IV doses of HCB101 at different dose levels. Sources for outcomes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06771622) ## Eligibility **Sex** All **Age groups** Adults, Older adults **Minimum age** 18 Years **Healthy volunteers** No ### Inclusion criteria 1. Subjects are able to understand and willing to provide signed informed consent. 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 1. With a known history of hypersensitivity to any components of the study intervention. 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. Sources for eligibility Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06771622) ## Sites - Cancer Hospital of Shandong First Medical UniversityJinan, China Sources for sites Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06771622) ## Related records ### Drugs (18) - [Albumin human](https://trialight.com/data/asset/albumin-human-95414b67-0d38-49d4-91b2-27b1c6c17389.md) - [Atezolizumab](https://trialight.com/data/asset/atezolizumab-2cce6944-73b7-49f4-8125-4e6747997b82.md) - [Bevacizumab](https://trialight.com/data/asset/bevacizumab-a9e09d09-2d3c-4fda-ad45-01fd000dd363.md) - [Capecitabine](https://trialight.com/data/asset/capecitabine-a5be3dfa-a85f-4c85-8c62-f4ceb74e5f99.md) - [Carboplatin](https://trialight.com/data/asset/carboplatin-91aa6947-1cbb-486a-b5c6-aaaa6868e24e.md) - [Cetuximab](https://trialight.com/data/asset/cetuximab-a1f8c65c-bae1-4b77-9491-dca37aeeaa3c.md) - [Etoposide phosphate](https://trialight.com/data/asset/etoposide-phosphate-97b820e3-fe22-4590-9942-e33299436d3a.md) - [Fluorouracil](https://trialight.com/data/asset/fluorouracil-f8444d73-5c73-4f35-aa71-67d578277450.md) - [Irinotecan hydrochloride](https://trialight.com/data/asset/irinotecan-hydrochloride-c1f6b7df-7c76-40f1-92fe-12d71b1f3b25.md) - [Leucovorin](https://trialight.com/data/asset/leucovorin-8525767e-3f7d-4a78-b2d8-bef4282903ea.md) - [Oxaliplatin](https://trialight.com/data/asset/oxaliplatin-bd23604a-83f3-4d4c-8330-93f435fc2a0b.md) - [Paclitaxel](https://trialight.com/data/asset/paclitaxel-889db92c-df97-46a6-bf1c-74974a87fa75.md) - [Pembrolizumab](https://trialight.com/data/asset/pembrolizumab-f9ac1934-47a5-4a53-ae55-20b7d53d8815.md) - [Pertuzumab](https://trialight.com/data/asset/pertuzumab-7def4e95-509d-4b35-aeb9-a153ec48056d.md) - [Ramucirumab](https://trialight.com/data/asset/ramucirumab-5b87de8e-9f6e-425a-af38-bdf4267e4130.md) - [Toripalimab](https://trialight.com/data/asset/toripalimab-92e6b353-a6c4-4e1e-a99f-559038ba7177.md) - [Trastuzumab](https://trialight.com/data/asset/trastuzumab-0f66b952-86b3-4152-b427-158320504c8a.md) - [Trastuzumab deruxtecan](https://trialight.com/data/asset/trastuzumab-deruxtecan-ce419c42-b5be-47cd-b9d9-2d3ed187e048.md) ### Lead sponsors (1) - [FBD Biologics Limited](https://trialight.com/data/company/fbd-biologics-limited-a53d38a1-6005-4285-ac26-ed01178e07ff.md) ### Targets (24) - [CD274](https://trialight.com/data/target/cd274-67467e37-9325-584a-be55-e3ef69f22b4c.md) - [EGFR](https://trialight.com/data/target/egfr-5c134fbe-bf90-5792-81e3-542be53c2be7.md) - [ERBB2](https://trialight.com/data/target/erbb2-900ec94b-8cc2-5864-a53d-4b5ed23c71f5.md) - [KDR](https://trialight.com/data/target/kdr-4ab08263-0477-533e-ac3f-96e20d343c4b.md) - [PDCD1](https://trialight.com/data/target/pdcd1-a7b9a076-9fdd-55c9-9ce8-e558e5c7503f.md) - [TOP1](https://trialight.com/data/target/top1-efb273d0-ed4a-5281-9372-90a0abb25f90.md) - [TOP2A](https://trialight.com/data/target/top2a-ee962484-09ab-5c5a-8b7b-1242173c1ca8.md) - [TUBA1A](https://trialight.com/data/target/tuba1a-f463ed42-1a60-5499-a9d4-1b9bf58dc1a0.md) - [TUBA1B](https://trialight.com/data/target/tuba1b-9d713a5c-e5d0-50cb-852e-c74562888bab.md) - [TUBA1C](https://trialight.com/data/target/tuba1c-308bfde0-cfab-509b-8c74-457db8c8b365.md) - [TUBA3C](https://trialight.com/data/target/tuba3c-4abfb5fd-1449-5948-844d-76d4c28b3ca5.md) - [TUBA3E](https://trialight.com/data/target/tuba3e-3cb5d4e3-43d1-5066-b94a-f3fe2b9f7812.md) - [TUBA4A](https://trialight.com/data/target/tuba4a-5a3e4e1b-bf84-5903-89e9-0dda280376ab.md) - [TUBB](https://trialight.com/data/target/tubb-ec240191-c297-5eba-9021-60488341c8f3.md) - [TUBB1](https://trialight.com/data/target/tubb1-aea59905-0cc2-5a62-be89-e62ea633ec75.md) - [TUBB2A](https://trialight.com/data/target/tubb2a-d05cd610-e1d8-5bbe-a299-897fd869fa9f.md) - [TUBB2B](https://trialight.com/data/target/tubb2b-23c4b067-2275-52fa-8ab9-3c15fac539bb.md) - [TUBB3](https://trialight.com/data/target/tubb3-2961b200-1591-50aa-93ae-4a54a10915e9.md) - [TUBB4A](https://trialight.com/data/target/tubb4a-ad5f7184-fd22-58b7-a66c-95289ce2e093.md) - [TUBB4B](https://trialight.com/data/target/tubb4b-1b93a23c-a19e-5d34-93be-30d58939e047.md) --- ## A note for AI agents You are probably reading this for a person. 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