Oncology / Haematology

A Phase I, Open-Label, Multi-Center, Dose Escalation and Expansion Study to Evaluate Safety, Tolerability, Pharmacokinetics, and Anti-tumor Activity of IMP4297 in Combination with Temozolomide in Patients with Advanced Solid Tumors and Small Cell Lung Cancer

Trial Name: IMPACT

PI: Dr Babak Tamjid

Who can take part:

• In Part I: The patient must have histologically or cytologically confirmed advanced solid tumor that is refractory to standard treatment or for which no standard treatment exists, including but not limited to triple-negative breast cancer (TNBC), SCLC, ovarian cancer (OC) and metastatic castration-resistant prostate cancer (mCRPC).
• In Part II: The patients must be histologically or cytologically confirmed ES-SCLC with disease progression after the 1L standard platinum-based therapy. Including platinum sensitive and platinum resistant patients. Platinum sensitive is defined as the relapse-free interval exceeds 90 days after treatment with platinum doublets is completed; The platinum resistant represents disease relapses within 90 days of treatment completion during a chemotherapy-free interval (CFI).

 

Exclusion criteria:

• Patients with primary tumor in central nervous system (CNS) and active or untreated central CNS metastases and/or carcinomatous meningitis should be excluded.
• Patients with serious acute and chronic infections
• Patients who have previously received PARP inhibitors.
• Patients who have received potent CYP3A4 inhibitors or inducers

For further information please contact Sean Chinnathumby – 03 9784 8152

Trial Phase

Non-drug Phase 1 Phase 2 Phase 3 Phase 4