A Study of HFB200301 in Adult Patients With Advanced Solid Tumors


About this study

The purpose of this study is to test the safety and tolerability of HFB200301 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 dose of HFB200301 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 the participants have.

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:

- 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 3 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

- For soft tissue sarcoma and testicular germ cell tumor patients only: prior immune

- Therapeutic radiation therapy within the past 2 weeks

- Prior exposure to agents targeting the Tumor Necrosis Factor Receptor type 2 (TNFR2)

- 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 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 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, 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

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

Eligibility last updated 11/15/22. 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

Rochester, Minn.

Mayo Clinic principal investigator

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

Closed for enrollment

Contact information:

Cancer Center Clinical Trials Referral Office

(855) 776-0015

Jacksonville, Fla.

Mayo Clinic principal investigator

Hani Babiker, M.D.

Open for enrollment

Contact information:

Cancer Center Clinical Trials Referral Office

(855) 776-0015

Scottsdale/Phoenix, Ariz.

Mayo Clinic principal investigator

Mahesh Seetharam, M.D.

Closed for enrollment

Contact information:

Cancer Center Clinical Trials Referral Office

(855) 776-0015

More information


Publications are currently not available

Mayo Clinic Footer