A Phase 1 Study Evaluating the Safety, PK, and Clinical Effects of PT-112 in Subjects With Advanced Solid Tumors


About this study

The purpose of this study is to determine the maximum tolerated dose, and evaluate its safety, tolerability, preliminary clinical effects, and drug/body interactions.

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.

Key Inclusion Criteria:

- Pathologically confirmed advanced solid tumor for which standard therapy proven to
provide clinical benefit does not exist or is no longer effective.

- Eastern Collaborative Oncology Group (ECOG) Performance Status of 0-1.

- Progressive disease, either measurable on physical examination or imaging by Response
Evaluation Criteria in Solid Tumors (RECIST v1.1) or PCWG3 or by informative tumor

- Adequate organ function based on laboratory values.

- If there is a known history of brain metastases, either treated or untreated, the
disease must be stable.

- Willing and able to provide written Informed Consent and comply with the requirements
of the study.

Key Exclusion Criteria:

- Any cytotoxic chemotherapy within 21 days prior to initiation of study drug.

- Any immunomodulatory drug therapy, anti-neoplastic hormonal therapy, immunosuppressive
therapy, corticosteroids, or growth factor treatment within 14 days prior to
initiation of study drug.

- Presence of an acute or chronic toxicity of prior chemotherapy, that has not resolved
to ≤Grade 1, as determined by CTCAE v 4.0.

- Receipt of more than 3 prior regimens of cytotoxic chemotherapy for metastatic

- Bone marrow reserve which is not adequate for participation in this trial.

- Radiotherapy within 28 days prior to baseline.

- Fraction of radiotherapy to >25 % of bone marrow.

- Major surgery within 28 days prior to initiation of study drug.

- Active bacterial, viral, or fungal infection requiring systemic therapy.

- Known human immunodeficiency virus or acquired immunodeficiency syndrome related

- Clinically significant hearing impairment, as judged by the Principal Investigator.

- Uncontrolled cardiovascular abnormalities.

- Previous malignancy, except for non-squamous-cell carcinoma of skin or carcinoma
in-situ of the uterine cervix, unless the tumor was treated with curative intent more
than 2 years prior to study entry.

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

Eligibility last updated 9/7/22. 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

Brian Costello, M.D.

Open for enrollment

Contact information:

Cancer Center Clinical Trials Referral Office

(855) 776-0015

Jacksonville, Fla.

Mayo Clinic principal investigator

Roxana Dronca, M.D.

Open for enrollment

Contact information:

Cancer Center Clinical Trials Referral Office

(855) 776-0015

Scottsdale/Phoenix, Ariz.

Mayo Clinic principal investigator

Alan Bryce, M.D.

Open for enrollment

Contact information:

Cancer Center Clinical Trials Referral Office

(855) 776-0015

More information


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