Clinical trial · Interventional
A Study Evaluating the Safety, Pharmacokinetics, and Clinical Effects of Intravenously Administered PT-112 Injection in Subjects With Advanced Solid Tumors and Subsequent Dose Expansion Cohorts
A Phase 1, Open-Label, Dose-Escalation Study Evaluating the Safety, Pharmacokinetics, and Clinical Effects of Intravenously Administered PT-112 Injection in Subjects With Advanced Solid Tumors and Subsequent Dose Expansion Cohorts
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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).
Conditions
Conditions (9)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Advanced Solid Tumors | Solid Neoplasm | CURATED_BROADER | 0.80 |
| CRPC | Castration-Resistant Prostate Carcinoma | ALIAS | 0.90 |
| Genital Neoplasms, Male | — | UNRESOLVED | — |
| mCRPC | — | UNRESOLVED | — |
| Metastatic Castrate-resistant Prostate Cancer | — | UNRESOLVED | — |
| Neoplasms by Site | Neoplasm by Site | ONTOLOGY_EXACT | 0.98 |
| Prostatic Neoplasms | Prostate Neoplasm | ALIAS | 0.90 |
| PT-112 | — | UNRESOLVED | — |
| Urogenital Neoplasms |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| PT-112 Injection | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- type
- EXPERIMENTAL
- label
- Arm 1: PT-112 injection
- description
- Arm 1: PT-112 Injection, administered by intravenous infusion, biweekly 360 mg/m2
- interventionNames
- Drug: PT-112 Injection
- type
- EXPERIMENTAL
- label
- Arm 2: PT-112 injection
- description
- Arm 2: PT-112 Injection, administered by intravenous infusion, biweekly 250 mg/m2
- interventionNames
- Drug: PT-112 Injection
- type
- EXPERIMENTAL
- label
- Arm 3: PT-112 injection
- description
- Arm 3: PT-112 Injection, administered by intravenous infusion, 360 mg/m2 for two doses, 250 mg/m2 for subsequent doses
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (1)
- DERIVEDKarp DD, Camidge DR, Infante JR, Ames TD, Price MR, Jimeno J, Bryce AH. Phase I study of PT-112, a novel pyrophosphate-platinum immunogenic cell death inducer, in advanced solid tumours. EClinicalMedicine. 2022 May 27;49:101430. doi: 10.1016/j.eclinm.2022.101430. eCollection 2022 Jul. PMID 35747193