A Study of Telaglenastat (CB-839) in Combination With Palbociclib in Patients With Solid Tumors

Status: Active

Description

This is a Phase 1b / 2 study to determine the recommended phase 2 dose (RP2D), safety and tolerability, pharmacokinetics (PK) and clinical activity of the glutaminase inhibitor telaglenestat (CB-839) with the CDK4 / 6 Inhibitor, palbociclib in participants with advanced / metastatic solid tumors.

Eligibility Criteria

Inclusion Criteria

  • Part 1: Have documented incurable/locally advanced or metastatic solid tumors that have either relapsed or are refractory or intolerant to the standard therapies of proven clinical benefit.
  • Part 2: Availability of archival tumor tissue block or slides (Fresh tumor biopsy will be required if archival tissue is not available)
  • Part 2, Cohort 1: Incurable/locally advanced or metastatic KRAS-mutant CRC previously treated with systemic therapy (examples include: oxaliplatin-, irinotecan-and 5 FU-based chemotherapy (unless contraindicated) with or without bevacizumab)
  • Part 2, Cohort 2: Incurable/locally advanced or metastatic KRAS-mutant NSCLC previously treated with systemic chemotherapy including platinum-based and anti-PD-1/PDL-1 therapy (unless contraindicated) For both Part 1 and 2:
  • Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-1
  • Ability to provide written consent in accordance with federal, local and institutional guidelines
  • PER RECIST v1.1 evaluable disease (for part 1) or measurable disease (for Part 2)
  • Recovery to baseline or to Grade 1 CTCAE v5.0 of toxicities that were related to prior therapies

Exclusion Criteria

  • Prior treatment with CB-839 or palbociclib
  • Unable to receive oral medication
  • Infection requiring more than 5 days of parenteral antibiotics, antivirals, or antifungals within two weeks prior to C1D1
  • Unable to discontinue proton pump inhibitor use before study treatment
  • Refractory nausea and vomiting, uncontrolled diarrhea, malabsorption, significant small bowel resection or gastric bypass surgery, use of feeding tubes or other situation that may preclude adequate absorption
  • Active and/or untreated central nervous system metastasis. Patients with treated brain metastasis must have (1) documented radiographic stability of at least 4 weeks in duration demonstrating on baseline central nervous system imaging prior to study treatment and (2) be symptomatically stable and off steroids for at least 2 weeks before administration of any study treatment.
  • Major surgery within 28 days prior to first dose of study drug
  • Receipt of any anticancer therapy within the following windows:
  • small molecule TKI therapy (including investigational) within 2 weeks or 5 half-lives prior to expected Cycle 1 Day 1 dose
  • any type of anti-cancer antibody or cytotoxic chemo within 4 weeks prior to Cycle 1 Day 1 Dose
  • radiation therapy for bone metastasis within 2 weeks prior or any other external radiation therapy within 4 weeks prior to C1D1
  • patients with clinically relevant ongoing complications from prior radiation therapy are not eligible

Locations & Contacts

Georgia

Atlanta
Emory University Hospital / Winship Cancer Institute
Status: Active
Name Not Available

Texas

Houston
M D Anderson Cancer Center
Status: Active
Name Not Available

Trial Phase & Type

Trial Phase

Phase I/II

Trial Type

Treatment

Lead Organization

Lead Organization
Calithera Biosciences, Inc

Trial IDs

Primary ID CX-839-012
Secondary IDs NCI-2019-05094
Clinicaltrials.gov ID NCT03965845