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PhI/II PARP1 Selective Inhibitor IMP1734 in Pts w/AdvSolid Tumors

UCI Specialty Area: Cancer
Principal Investigator: Arash Rezazadeh Kalebasty
Official Title: A First-in-human, Phase I/II, Open-label, Multi-center, Dose-Escalation, Dose-optimization, and Dose-expansion Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Anti-tumor Activity of PARP1 Selective Inhibitor, IMP1734, as Monotherapy and in Combination in Participants with Advanced Solid Tumors
A Study On:
Corpus Uteri
Kidney
Other Male Genital
Other Urinary
Prostate

Study Description

The purpose of the study is to demonstrate similarity of PK between the proposed pembrolizumab biosimilar GME751, Keytruda-EU and Keytruda-US in participants with stage IIB, IIC or III melanoma who underwent complete resection of the tumor and, if applicable, dissection of affected lymph nodes, and require adjuvant treatment with pembrolizumab.

• The study duration for a participant will be approximately 28 weeks including screening.

• The treatment duration will be approximately 24 weeks (4 treatment cycles, each of 6 weeks duration).

• Participants will come to the study site every 6 weeks for treatment and for a final assessment. In Cycle 1 and Cycle 4, additional visits will be required for PK blood sampling.

Eligibility

  • Completely surgically resected (including sentinel node if applicable) stage IIB, IIC or III(A-D) cutaneous melanoma, classified per AJCC 8th edition (Keung and Gershenwald 2018)
  • Disease-free status (no loco-regional relapse or distant metastasis, no clinical evidence for brain metastases) as supported by surgical or pathological reports and post-surgical tumor imaging
  • Minimum 2 to maximum 13 weeks from final surgical resection to first study treatment with adequate wound healing (as per the Investigator’s judgement) from the surgery
  • Adverse effects resulting from prior radiotherapy or other antineoplastic therapy must have resolved to CTCAE grade 1 (or lower)
  • ECOG performance status of 0 or 1
  • Albumin tested within 10 days before first study treatment ≥25 g/L
  • Adequate organ function as per the Investigator’s clinical judgement and safety laboratory values that are specified below and were tested within 10 days before first study treatment.
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University of California, Irvine - Study Information Sheet

UCI Center for Clinical Research Potential Participant Database

Lead Researcher
Maheswari Senthil, MD
UCI Center for Clinical Research

In the instance of parental permission, “You” refers to “Your child.”

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