A Phase 1, Open-Label, Study Evaluating the Safety, Pharmacokinetics, and Clinical Effects of Intravenously Administered PT-112 Injection in Subjects with Advanced Solid Tumors

NOT ENROLLING
Protocol # :
20-558
Conditions
Advanced Solid Tumors
CRPC
mCRPC
Metastatic Castrate-Resistant Prostate Cancer
PT-112
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Phase
I/II
Disease Sites
Healthy volunteer
Transplanted organ and tissue status, unspecified
Disease not specified
Neuroendocrine/Carcinoid
Gastroesophageal Junction
Gallbladder/Biliary
Other specified personal risk factors, not elsewhere classified
Lip, Oral Cavity and Pharynx
Esophagus
Stomach
Small Intestine
Colon
Rectum
Anus
Liver
Pancreas
Other Digestive Organ
Larynx
Lung
Other Respiratory and Intrathoracic Organs
Bones and Joints
Soft Tissue
Mycosis Fungoides
Other Skin
Breast
Cervix
Corpus Uteri
Ovary
Other Female Genital
Prostate
Other Male Genital
Urinary Bladder
Kidney
Other Urinary
Eye and Orbit
Brain and Nervous System
Thyroid
Unknown Sites
Ill-Defined Sites
Other Endocrine System
Multiple Myeloma
Donors
Kaposi's Sarcoma
Melanoma, Skin
Principal Investigator
Beltran, Himisha
Site Research Nurses
Aspinwall, Sheridan
Carey, Margaret, M.
Engel, Lauren, E.
Keller, Jennifer
Lagerstedt, Elizabeth
Leisner, Claire
Mingrino, Sage
Pace, Amanda
Salabao, Cristina
Theodore, Catherine
Walsh, Meghara

Trial Description

This is a Phase 1/2, open-label, multi-center, non-randomized, dose-escalation study to be
conducted in two parts: the Dose Escalation Phase and the Dose Expansion Phase. The Dose
Escalation Phase will determine the Maximum Tolerated Dose (MTD) and recommended Phase 2
dose(s) (RP2D) of PT-112 Injection and evaluate its safety and tolerability, and PK
(pharmacokinetics).

The Dose Escalation Phase is complete and no longer enrolling.

The Dose Expansion Phase has two cohorts: one cohort for the study of PT-112 in patients with
thymoma and thymic carcinoma (Cohort A), and one cohort for the study of PT-112 in metastatic
castrate-resistant prostate cancer (mCRPC) (Cohort D).

Eligibility Requirements

Key Inclusion Criteria:

- Male >/= 18 years of age

- Histologically or cytologically confirmed adenocarcinoma of the prostate.

- Document current evidence of metastatic castration-resistant prostate cancer (mCRPC),
where metastatic status is defined as having documented metastatic lesion(s) on either
bone scan or CT/MRI scan.

- Patients who have received at least three prior intended life-prolonging therapies for
metastatic disease.

- 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
marker(s).

- 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.

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.

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

- Radiotherapy within 14 days prior to baseline.

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

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

20-558