Drugs / HCB101
Trials 4
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 11 trial | ||||||
| Phase 1 | NCT05892718 | Oct 2023 → May 2027 expected | non-Hodgkin lymphoma | FBD Biologics Limited | Recruiting | No outcome recorded |
| Phase 1/23 trials | ||||||
| Phase 1/2 | NCT07136545 | Aug 2025 → Dec 2026 expected | head and neck squamous cell carcinoma | Taipei Veterans General Hospital, Taiwan | Recruiting | No outcome recorded |
| Phase 1/2 | NCT07204574 | May → Dec 2025 overdue | — | Chang Gung Memorial Hospital | Recruiting | No outcome recorded |
| Phase 1/2 | NCT06771622 | Mar 2025 → Jan 2028 expected | — | FBD Biologics Limited | Active not recruiting | No outcome recorded |
News releases announcing trial results or a regulatory action · 28
| Date | Issuer | Release |
|---|---|---|
| 2026-09-23 | HanchorBio Inc. | Results HanchorBio Outlines Global Growth Strategy and Multi-Asset Pipeline at Second Annual R&D Day hanchorbio.com ↗
in response-evaluable patients receiving mid-dose HCB101 (5.12–8 mg/kg QW) alongside with ramucirumab and paclitaxel, the combination demonstrated an 80% confirmed objective response rate (ORR) and a 100% disease control rate (n=10 participants). |
| 2026-09-18 | HanchorBio Inc. | Results HanchorBio to Present Five Clinical Abstracts at CSCO 2026 hanchorbio.com ↗
Among 15 efficacy-evaluable patients, the overall objective response rate (ORR) was 60%, highlighted by an 80% ORR in the 5.12–8 mg/kg mid-dose cohorts with a maximum tumor reduction of −78.2%. |
| 2026-09-09 | HanchorBio Inc. | Regulatory HanchorBio Reaches Clinical Milestone for HCB101 as US FDA Allows Continued Treatment for Phase 1 Patient Experiencing Clinical Benefit hanchorbio.com ↗
The FDA determination enables a patient who experienced clinical benefit while receiving HCB101 in the Company’s Phase 1 study to continue treatment with HCB101 beyond the parent clinical trial. |
| 2026-09-07 | HanchorBio Inc. | Results HanchorBio Earns Dual KSMO/FACO 2026 Recognition for HCB101 and HCB301 hanchorbio.com ↗
Among 15 efficacy-evaluable patients, the 5.12–8 mg/kg mid-dose cohorts achieved an ORR of 80.0%, with broad and deep tumor shrinkage observed across patients. |
| 2026-09-01 | HanchorBio Inc. | Results HanchorBio to Present Pipeline Strategy at 2026 Jefferies APAC Healthcare Conference hanchorbio.com ↗
Updated clinical activity for HanchorBio’s lead SIRPα-based macrophage-directed immunotherapy, including an 80% objective response rate (ORR) in the 5.12–8 mg/kg mid-dose cohorts of second-line gastric/gastroesophageal junction (GC/GEJ) cancer treated with ramucirumab and paclitaxel. |
| 2026-07-22 | HanchorBio Inc. | Results HanchorBio Expands Clinical Evidence Supporting Its Macrophage-Directed Oncology Strategy hanchorbio.com ↗
Six achieved partial responses, with tumor reductions exceeding 30%, representing an objective response rate of 54.5% |
| 2026-06-30 | HanchorBio Inc. | Results HanchorBio Showcases HCB101 Myeloid-Enhancer Strategy in Gastric Cancer and HNSCC at JCA-AACR 2026 hanchorbio.com ↗
Across 15 efficacy-evaluable patients, dose-related antitumor activity was observed, including an 80% objective response rate in the mid-dose cohorts and a disease control rate of 93.3% across the overall cohort. |
| 2026-06-30 | HanchorBio Inc. | Regulatory HanchorBio Announces FDA Type C Meeting Minutes Supporting a Clear Development Path for HCB101 in Second-Line Gastric/GEJ Cancer hanchorbio.com ↗
In the meeting minutes, FDA indicated that the Company’s proposed staged Q2W combination regimen exploration in the ongoing Phase 1b/2a HCB101-201 multi-cohort study appears reasonable at the current stage of development, subject to full protocol submission and review. |
| 2026-06-13 | HanchorBio Inc. | Results HanchorBio Presents Two Oral Presentations at ESMO TAT Asia 2026 Highlighting Progress Across Its Next-Generation Immunotherapy Pipeline hanchorbio.com ↗
HCB101 also demonstrated linear pharmacokinetics and sustained CD47 receptor occupancy of ≥90% at doses ≥8 mg/kg. |
| 2026-06-10 | HanchorBio Inc. | Results HanchorBio Presents Late-Breaking Data at FOCIS 2026 Supporting Innate-Immune Product Engine Across Oncology and Autoimmune Disease hanchorbio.com ↗
HCB101 combined with ramucirumab and paclitaxel achieved an overall objective response rate (ORR) of 57.1% |
| 2026-06-01 | HanchorBio Inc. | Results HanchorBio Presents Two ASCO 2026 Abstracts Highlighting HCB101 Combination Activity and HCB301 First-in-Human Clinical Progress hanchorbio.com ↗
HanchorBio, Inc. (TWSE: 7827), a global clinical-stage biotechnology company advancing next-generation immunotherapies for oncology and autoimmune diseases, today announced updated clinical data for HCB101 and HCB301 presented at the 2026 Annual Meeting of the American Society of Clinical Oncology (ASCO) in Chicago. |
| 2026-05-18 | HanchorBio Inc. | Results HanchorBio Announces First Confirmed Partial Response in Colorectal Cancer Cohort of Ongoing HCB101-201 Combination Study hanchorbio.com ↗
In the ongoing colorectal cancer cohort, HCB101 has now demonstrated a first confirmed partial response in combination with standard-of-care therapy. |
| 2026-04-23 | HanchorBio Inc. | Results HanchorBio Presents Early Frontline Triple-Negative Breast Cancer Data for HCB101 Combination at GBCC 2026 hanchorbio.com ↗
The combination achieved an objective response rate (ORR) of 37.5% and a disease control rate (DCR) of 100%, with no unexpected safety signals observed to date. |
| 2026-04-22 | HanchorBio Inc. | Results HanchorBio Reports Head and Neck Cancer Data for HCB101, Including Durable Monotherapy Activity and Complete Response at Low Dose in Combination with PD-1 hanchorbio.com ↗
HanchorBio Reports Head and Neck Cancer Data for HCB101, Including Durable Monotherapy Activity and Complete Response at Low Dose in Combination with PD-1 |
| 2026-04-03 | HanchorBio Inc. | Results HanchorBio Signals “Backbone” Potential for HCB101 as SAB Aligns on Gastric Cancer Registrational Path hanchorbio.com ↗
In the ongoing HCB101-201 combination study, second-line gastric cancer demonstrated an overall objective response rate (ORR) of ~60% (9/15) across multiple dose cohorts, with higher activity observed at mid-dose levels (5.12 and 8 mg/kg), where ORR reached ~80% (8/10). |
| 2026-04-03 | HanchorBio Inc. | Results HanchorBio Reports Early Taiwan IIT Signal in 2L CRC With Sustained Disease Control Beyond 37 Weeks hanchorbio.com ↗
Among these three subjects, all achieved stable disease as the best observed response, and two remained on treatment with sustained disease control for more than 37 weeks (7.1 months). |
| 2026-04-01 | HanchorBio Inc. | Results HanchorBio Reports Preliminary First-Line HER2+ Gastric Cancer Data for HCB101, Demonstrating 83.3% ORR hanchorbio.com ↗
Among 6 efficacy-evaluable patients treated across multiple dose levels (5.12, 8, and 12 mg/kg), 5 achieved confirmed partial responses (PRs), yielding an objective response rate (ORR) of 83.3%. |
| 2026-03-20 | HanchorBio Inc. | Results HanchorBio Presents First Dedicated HCB101 Head and Neck Cancer Data in Oral Presentation at ICHNO 2026 hanchorbio.com ↗
The presentation highlighted emerging clinical findings from the ongoing HCB101-101 Phase 1a monotherapy study (NCT05892718), together with supportive early observations from an investigator-initiated study (SirH&N) in Taiwan. |
| 2026-03-16 | HanchorBio Inc. | Results HanchorBio Highlights Advancing HCB101 Clinical Program Across Monotherapy and Combination Settings at ESMO-TAT 2026 hanchorbio.com ↗
Collectively, these findings reinforce HCB101’s differentiated safety profile, sustained CD47 receptor occupancy, and early evidence of antitumor activity across multiple tumor types, especially in combination with established standard-of-care therapies. |
| 2026-03-05 | HanchorBio Inc. | Results HanchorBio Presents Dose-Dependent Tumor Responses and Deepening Tumor Shrinkage with HCB101 Triple Combination in Second-Line Gastric Cancer at the 11th Asia-Pacific Gastroesophageal Cancer Congress hanchorbio.com ↗
The poster highlights early findings supporting dose-dependent antitumor activity of HCB101 in combination with ramucirumab and paclitaxel in patients with advanced gastric adenocarcinoma who progressed after first-line therapy. |
| 2026-02-19 | HanchorBio Inc. | Results HanchorBio Presents Monotherapy and Combination Clinical Data for HCB101 at AACR Immuno-Oncology 2026 hanchorbio.com ↗
Across both monotherapy and combination settings, HCB101 is demonstrating a consistent and differentiated clinical profile – cytopenia-sparing safety, sustained receptor occupancy, and early dose-dependent activity signals, |
| 2026-02-13 | HanchorBio Inc. | Regulatory HanchorBio Receives FDA Orphan Drug Designation for HCB101 in Gastric Cancer hanchorbio.com ↗
HanchorBio, Inc. (TPEx: 7827), a global clinical-stage biotechnology company advancing next-generation immunotherapies for oncology and autoimmune diseases, today announced that the U.S. Food and Drug Administration (FDA) granted Orphan Drug Designation (ODD) to HCB101 for the treatment of gastric cancer. |
| 2026-01-09 | HanchorBio Inc. | Results HanchorBio Reports High Objective Response Rate with HCB101 Combination in Second-Line Gastric Cancer Following ASCO-GI 2026 Poster Presentation hanchorbio.com ↗
HanchorBio, Inc. (TPEx: 7827), a global clinical-stage biotechnology company advancing next-generation immunotherapies for oncology and autoimmune diseases, today reported updated clinical data from its ongoing Phase Ib/IIa study evaluating HCB101 in combination with ramucirumab and paclitaxel in patients with previously treated gastric cancer. |
| 2025-12-09 | HanchorBio Inc. | Results HanchorBio Presents First-in-Human Data of HCB101 Monotherapy in Relapsed/Refractory Non-Hodgkin Lymphoma at ASH 2025 hanchorbio.com ↗
The accepted abstract (#3299) features a focused sub-analysis from HanchorBio’s ongoing multinational, open-label Phase 1 study (NCT05892718) evaluating HCB101 monotherapy across solid and hematologic malignancies, highlighting results from the R/R NHL cohort. |
| 2025-07-17 | HanchorBio Inc. | Regulatory HanchorBio Receives Third Taiwan TFDA Approval for HCB101 Combination Therapy in Advanced Gastric Cancer hanchorbio.com ↗
today announced that the Taiwan Food and Drug Administration (TFDA) has approved a third investigator-initiated trial (IIT) evaluating HCB101 in combination with zolbetuximab and chemotherapy |
| 2025-06-03 | HanchorBio Inc. | Results HanchorBio Presents Promising Phase 1 HCB101 Data at ASCO 2025 – Confirmed Partial Response Observed in Solid Tumor and Lymphoma Patients hanchorbio.com ↗
The data, featured in a poster session, demonstrated favorable safety, high CD47 receptor occupancy, and early clinical signs of anti-tumor activity, including confirmed partial response (PR) in patients with head and neck cancer (HNSCC) and marginal zone lymphoma. |
| 2025-04-15 | HanchorBio Inc. | Regulatory HanchorBio Announces Second Taiwan TFDA Approval for HCB101 Combination Therapy in Advanced Head and Neck Cancer hanchorbio.com ↗
This marks the second TFDA-approval IIT of HCB101 in combination with standard-of-care (SOC) therapies, following the recently announced IIT approval for a metastatic colorectal cancer (mCRC) study. |
| 2025-03-24 | HanchorBio Inc. | Regulatory HanchorBio Announces Taiwan TFDA Approval for HCB101 Combination Therapy in Advanced Colorectal Cancer hanchorbio.com ↗
HanchorBio Inc., a global biotechnology company developing innovative immuno-biomedicines to address significant unmet medical needs in oncology, today announced that the Taiwan Food and Drug Administration (TFDA) has approved an investigator-initiated trial (IIT) evaluating HCB101 in combination with cetuximab or bevacizumab and FOLFOX or FOLFIRI for advanced or metastatic colorectal cancer (CRC). |
All press releases naming this drug 40 releases
Evidence & citations 3 cited values
Every value below carries the sentence it was read from. 4 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | HCB101 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT05892718 ↗ |
| Modality | Protein / enzyme biologic | “Fc-fusion Protein Targeting SIRPα-CD47 Pathway” NCT05892718 ↗ |
| Route | Intravenous | “HCB101 administered via. intravenous (IV) infusion.” NCT05892718 ↗ |