Clinical trial · Interventional
A Study of HFB301001 in Adult Patients With Advanced Solid Tumors
A Dose Escalation Study of HFB301001 (OX40 Agonist Antibody) in Adult Patients With Advanced Solid Tumors
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): The decision to discontinue the trial was made as part of a strategic review of the Sponsor's global development portfolio. It is not related to any safety concerns, efficacy findings, recruitment difficulties, or issues with trial conduct.
Summary
Brief summary (as posted)
The purpose of this study is to test the safety and tolerability of HFB301001 in patients with advanced cancers. There are two parts in this study. During the escalation part, groups of participants will receive increasing doses until a safe and tolerable doses of HFB301001 is determined. During the expansion part, participants will take the dose of study drug that was determined from the escalation part of the study and will be assigned to a group based on the type of cancer they have.
Conditions
Conditions (6)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Head and Neck Squamous Cell Carcinoma | Head and Neck Squamous Cell Carcinoma | ONTOLOGY_EXACT | 0.98 |
| Hepatocellular Carcinoma | Hepatocellular Carcinoma | ONTOLOGY_EXACT | 0.98 |
| Melanoma | Melanoma | ONTOLOGY_EXACT | 0.98 |
| Renal Cell Carcinoma | Renal Cell Carcinoma | CURATED_BROADER | 0.80 |
| Soft Tissue Sarcoma | Soft Tissue Sarcoma | ONTOLOGY_EXACT | 0.90 |
| Uterine Carcinosarcoma | Uterine Carcinosarcoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| HFB301001 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- HFB301001
- description
- Participants will receive HFB301001 via intravenous infusions
- interventionNames
- Drug: HFB301001
Primary outcomes (2)
- measure
- Number of participants with adverse events (AEs), serious AEs (SAEs), dose-limiting toxicities (DLTs), changes in laboratory values, vital signs and ECG parameters, and tolerability (dose interruptions, reductions, and dose intensity)
- timeFrame
- Cycle 1 Day 1 to 30 days after the last dose of HFB301001 (each cycle is 28 days)
- measure
- To determine a Recommended Phase 2 Dose (RP2D) during Dose Expansion
- timeFrame
- Cycle 1 Day 1 to 30 days after the last dose of HFB301001 (each cycle is 28 days)
Secondary outcomes (10)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria:
* Previously received the following lines of systemic therapy for the advanced/metastatic disease:
* Soft tissue sarcoma: at least 1 line of therapy
* Renal cell carcinoma: at least 2 lines of therapy;
* Uterine carcinosarcoma: at least 1 line of therapy;
* Hepatocellular carcinoma: at least 1 line of therapy
* Head and neck squamous cell carcinoma: at least 2 lines of therapy
* Melanoma:
* BRAF V600E mutant: must have received at least 2 lines of therapy
* BRAF V600E wild type: must have received at least 1 line of therapy
* Suitable site to biopsy at pre-treatment and on-treatment
* Measurable disease as determined by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 and immune-RECIST (iRECIST)
* Eastern Cooperative Oncology Group performance status of 0 or 1.
Exclusion Criteria:
* Systemic anti-cancer therapy within 2 weeks prior to start of study drug.
* For soft tissue sarcoma only: prior immune therapy or immune agonist antibodies
* For uterine carcinosarcoma patients only: prior immune therapy
* Therapeutic radiation therapy within the past 2 weeks
* Prior exposure to agents targeting the OX40 receptor;
* Active autoimmune disease requiring systemic treatment in the previous 2 years;
* Systemic steroid therapy (\>10 mg/day of prednisone or equivalent) or any immune suppressive therapy.
* Persisting toxicity of \>Grade 1 relating to prior anti cancer therapy with the following exceptions:
* All grades of alopecia are acceptable;
* Endocrine dysfunction on replacement therapy is acceptable.
* Severe or unstable medical condition, including uncontrolled diabetes, coagulopathy, or unstable psychiatric condition;
* Major surgery within 2 weeks of the first dose of study drug;
* History or presence of drug or non-drug induced interstitial lung disease or pneumonitis ≥Grade 2;
* History of allergic reactions attributed to compounds of similar chemical or biologic composition to monoclonal antibodies or any excipient of HFB301001;
* Known active malignancy, with the exception of the specific cancer under investigation in this trial, that required treatment within the previous 2 years.References
Publications (1)
- DERIVEDZhao J, Zhang D, Lu YY, Jin R, Li F, Zhang Z, Ni W, Gong N, Wang Y, Yin Z, Du Y, Ma W, Wang X, Zu L, Liu S, Yang K, Bai Y, Gan J, Adrian F, Hong Z, Zhang S, Chang Y, Wang Z, Jin X, Zhong J, Ge K, Peng S, Ding D, Zheng W, Xu S, Wang W, Schweizer L, Zhang H. HFB301001, an OX40-based immunotherapy, drives Treg clearance and CTL activation through optimized OX40 receptor clustering. J Immunother Cancer. 2026 Mar 30;14(3):e014185. doi: 10.1136/jitc-2025-014185. PMID 41912269