A Dose Escalation Study of HFB301001 in Adult Patients with Advanced Solid Tumors


About this study

The purpose of this study is to characterize the safety and tolerability of single agent HFB301001 and to determine recommended dose expansino (RDE(s) and a recommended Phase 2 dose (RP2D).

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

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

- 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 and 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.

Note: Other protocol defined Inclusion/Exclusion criteria may apply.

Eligibility last updated 1/19/23. Questions regarding updates should be directed to the study team contact.

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status Contact

Jacksonville, Fla.

Mayo Clinic principal investigator

Hani Babiker, M.D.

Open for enrollment

Contact information:

Cancer Center Clinical Trials Referral Office

(855) 776-0015

Rochester, Minn.

Mayo Clinic principal investigator

Konstantinos Leventakos, M.D., Ph.D.

Open for enrollment

Contact information:

Cancer Center Clinical Trials Referral Office

(855) 776-0015

Scottsdale/Phoenix, Ariz.

Mayo Clinic principal investigator

Mitesh Borad, M.D.

Open for enrollment

Contact information:

Cancer Center Clinical Trials Referral Office

(855) 776-0015

More information


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