Testing HFB200301 alone and with Tislelizumab in patients with advanced cancers
A Phase 1a/1b, Open-Label, Multi-Center, Dose Escalation and Expansion Study of HFB200301 (TNFR2 Agonist Antibody) as a Single Agent and in Combination With Tislelizumab (Anti-PD-1 Antibody) in Adult Patients With Advanced Solid Tumors
This study is testing a new cancer treatment called HFB200301, both on its own and with another drug called tislelizumab, to see how safe it is for adults with advanced solid tumors.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 170 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | HiFiBiO Therapeutics Industry-sponsored |
| Drugs / interventions | tislelizumab, radiation, prednisone |
| Locations | 10 sites (Scottsdale, Arizona and 9 other locations) |
| Trial ID | NCT05238883 on ClinicalTrials.gov |
What this trial studies
This study aims to evaluate the safety and tolerability of HFB200301, both as a standalone treatment and in combination with tislelizumab, in adults suffering from advanced solid tumors. It consists of two parts: an escalation phase where increasing doses of HFB200301 will be administered to determine the maximum tolerated dose, followed by an expansion phase where participants will receive the established dose based on their specific cancer type. The study will include a screening period, a treatment period where the drug will be administered, and a follow-up period to monitor outcomes.
Who should consider this trial
Good fit: Ideal candidates are adults with advanced gastric cancer, renal cell carcinoma, melanoma, sarcoma, or testicular germ cell tumors who have previously received multiple lines of systemic therapy.
Not a fit: Patients who have not undergone prior systemic therapy or those with early-stage cancers may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could provide a new therapeutic option for patients with advanced solid tumors who have limited treatment alternatives.
How similar studies have performed: Other studies have shown promise with similar combination therapies, indicating potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria:
* Previously received the following lines of systemic therapy for the advanced/metastatic disease:
* Gastric cancer: at least 2 lines of therapy
* Renal 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
* Sarcoma: at least 1 line of therapy
* Testicular germ cell tumor: at least 2 lines of therapy
* Cervical cancer: at least 2 lines of therapy
* Mesothelioma: at least 2 lines of therapy
* Non-small cell lung cancer: at least 2 lines of therapy
* Head and neck squamous cell carcinoma: at least 2 lines 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 or modified RECIST (mRECIST) for mesothelioma
* 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 or within 4 weeks for immune-oncologic therapy
* For soft tissue sarcoma and testicular germ cell tumor patients only: prior immune therapy
* Therapeutic radiation therapy within the past 2 weeks
* Prior exposure to agents targeting the Tumor Necrosis Factor Receptor type 2 (TNFR2) 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 ≤ 14 days before first dose
* Persisting toxicity of ≥Grade 2 (≥Grade 1 for diarrhea) 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 4 weeks of the first dose of study drug
* History or presence of drug or non-drug induced interstitial lung disease or pneumonitis ≥Grade 2. For combination only: non-small cell lung cancer patients, mesothelioma or patients with significantly impaired pulmonary function or who require supplemental oxygen at baseline must undergo an assessment of pulmonary function at screening
* History of allergic reactions, immune related reactions, or cytokine release syndrome (CRS) attributed to compounds of similar chemical or biologic composition to monoclonal antibodies or any excipient of HFB200301
* Using sensitive substrates of major cytochrome P450 (CYP450) enzymes
* Known active malignancy, with the exception of the specific cancer under investigation in this trial, that required treatment within the previous 2 years
* For combination only:
* Prior randomization in a tislelizumab study regardless of the treatment arm, until the primary and key secondary endpoints of the study have read out
* Hypersensitivity to tislelizumab or any of its excipients.
Where this trial is running
Scottsdale, Arizona and 9 other locations
- Mayo Clinic — Scottsdale, Arizona, United States (Active_not_recruiting)
- USC/Norris Comprehensive Cancer Center — Los Angeles, California, United States (Recruiting)
- Mayo Clinic — Jacksonville, Florida, United States (Recruiting)
- Mayo Clinic — Rochester, Minnesota, United States (Active_not_recruiting)
- Washington University School of Medicine — Saint Louis, Missouri, United States (Recruiting)
- The University of Texas, MD Anderson Cancer Center — Houston, Texas, United States (Terminated)
- NEXT Virginia Cancer Specialists — Fairfax, Virginia, United States (Recruiting)
- Hospital Universitario Vall d'Hebron — Barcelona, Spain (Recruiting)
- Hospital Universitario 12 de Octubre — Madrid, Spain (Recruiting)
- Hospital Clinico Universitario de Valencia — Valencia, Spain (Recruiting)
Study contacts
- Study coordinator: Edward Steele, Clinical Trial Manager
- Email: e.steele@medpace.com
- Phone: +1(513)579-9911
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.