Clinical Trial 24357

• Overview

  Study Title:

  A Phase 1/1b Multiple Cohort Trial of ALTA3263 in Patients With Advanced Solid Tumors With KRAS Mutations

  Summary:

  The purpose of this study is to characterize the safety and tolerability of ALTA3263 in adults with advanced solid tumors with KRAS mutations.

  Objective:

  Phase 1/1b Cohorts Objectives: * To characterize the safety and tolerability of ALTA3263 monotherapy and combination regimens in patients with advanced solid tumor malignancies with KRAS mutations. * To evaluate the PK of ALTA3263 monotherapy and combination regimens. * To evaluate biologically relevant dose levels of ALTA3263 monotherapy and combination regimens. * To identify the RDE and/or recommended Phase 2 doses (RP2Ds) and regimens of ALTA3263 monotherapy and combination regimens. * To evaluate the clinical activity/efficacy of ALTA3263 monotherapy and combination regimens in the Phase 1/1b population.

• Treatments

  Therapies:

  Chemotherapy; Microtubule stabilizing agent; PD-1 monoclonal antibody; Targeted therapy EGFR monoclonal antibody; Topoisomerase I inhibitor; selective KRAS active-state inhibitor

  Medications:

  ALTA3263 (); Albumin-Bound Paclitaxel (); Alimta (Pemetrexed); CPT-11 (irinotecan); Camptosar (irinotecan); Cetuximab (); Erbitux (Cetuximab); Fluorouracil (); Gemzar (gemcitabine); Oxaliplatin (); Paraplatin (carboplatin); Pembrolizumab (Keytruda); Pemetrexed (); carboplatin (); cisplatin (); eloxatin (Oxaliplatin); gemcitabine (); irinotecan (); leucovorin ()

• Inclusion Criteria

  Inclusion Criteria:
  • Histologically confirmed diagnosis of a solid tumor malignancy harboring a KRAS mutation identified through molecular testing (NGS- or PCR-based) with a Clinical Laboratory Improvement Amendments-certified (or equivalent) diagnostic test.
  • Unresectable or metastatic disease.
  • Progressed on, intolerant to, or declined prior standard-of-care therapy (including targeted therapy, if applicable) appropriate to tumor type and stage.
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
  • Adequate organ function.

• Exclusion Criteria

  Exclusion Criteria:
  • Prior treatment with a KRAS inhibitor, certain exceptions are described in the full study protocol.
  • Known condition that prohibits the ability to swallow or absorb an oral medication.
  • Other inclusion/exclusion criteria may apply.

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