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
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.