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

• Status: Recruiting
• Trial end date: 2021-10-31
• Target enrollment: 0
• Participant gender: Male

Summary

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 and is no longer enrolling. The Dose Expansion Phase currently has two cohorts: one for the study of PT-112 in patients with thymoma and thymic carcinoma, and the second in the study of PT-112 in metastatic castrate-resistant prostate cancer (mCRPC).

Condition or disease: Advanced Solid Tumors; Thymoma and Thymic Carcinoma; Metastatic Castrate Resistant Prostate Cancer (mCRPC) Intervention/treatment: Drug: PT-112 Injection Phase: Phase 1/2

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Phosplatin Therapeutics

Criteria

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 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.

• 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 disease.

• 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 illness.

• 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.