Solid Tumors Clinical Trial
Official title:
A Phase 1b/2, Open Label, Dose Escalation and Expansion Study of the Glutaminase Inhibitor Telaglenastat (CB-839) in Combination With CDK4/6 Inhibitor Palbociclib in Patients With Advanced or Metastatic Solid Tumors
Verified date | September 2022 |
Source | Calithera Biosciences, Inc |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 53 |
Est. completion date | September 24, 2021 |
Est. primary completion date | September 24, 2021 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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) - Part 2, Cohort 3: Advance KRAS-mutant Pancreatic Ductal Adenocarcinoma (PDAC) harboring a mutation or loss in CDKN2A (PDAC) and received treatment with one or more lines of systemic chemotherapy with FOLFIRINOX and/or gemcitabine/abraxane in the neoadjuvant, adjuvant, or metastatic disease setting or unable to receive standard of care chemotherapy Cohort 4 may be opened only if Cohort 3 achieves predefined criteria for efficacy -Part 2 Cohort 4: Advanced KRAS-mutant Pancreatic Ductal Adenocarcinoma (PDAC). ยท Histological or cytological diagnosis of advanced or metastatic KRAS-mutant with CDKN2A wild type (PDAC) and received treatment with one or more lines of systemic chemotherapy with FOLFIRINOX and/or gemcitabine/abraxane in the neoadjuvant, adjuvant, or metastatic disease setting or unable to receive standard of care chemotherapy. 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: 1. small molecule TKI therapy (including investigational) within 2 weeks or 5 half-lives prior to expected Cycle 1 Day 1 dose 2. any type of anti-cancer antibody or cytotoxic chemo within 4 weeks prior to Cycle 1 Day 1 Dose 3. radiation therapy for bone metastasis within 2 weeks prior or any other external radiation therapy within 4 weeks prior to C1D1 4. patients with clinically relevant ongoing complications from prior radiation therapy are not eligible |
Country | Name | City | State |
---|---|---|---|
United States | Emory, Winship Cancer Institute | Atlanta | Georgia |
United States | Northwestern University Feinberg School of Medicine | Chicago | Illinois |
United States | Rush University Medical Center | Chicago | Illinois |
United States | MD Anderson | Houston | Texas |
United States | University of Iowa Hospitals and Clinics | Iowa City | Iowa |
United States | University of Wisconsin Clinical Science Center | Madison | Wisconsin |
United States | Sarah Cannon Research Institute- Tennessee Oncology | Nashville | Tennessee |
United States | Regions Cancer care Center | Saint Paul | Minnesota |
United States | South Texas Accelerated Research Therapeutic, LLC | San Antonio | Texas |
United States | UCLA Hematology/Oncology | Santa Monica | California |
Lead Sponsor | Collaborator |
---|---|
Calithera Biosciences, Inc |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Safety and Tolerability of telaglenestat (CB-839) in combination with palbociclib: (CR) number of participants with treatment related adverse events | Number of participants with treatment related adverse events as assessed by CTCAE v5.0 | Start of treatment to 28 days post treatment | |
Primary | Maximum tolerated dose and/or Recommended Phase 2 Dose: | Incidence and nature of dose-limiting toxicities | Measured from Part 1 patients only within their first 28 day cycle | |
Secondary | Maximum plasma concentration of telaglenastat and palbociclib: | Non-compartmental method of analysis will be used to analyze the plasma concentrations | PKs are drawn on two different days (Day 8 and Day 15) during Cycle 1 | |
Secondary | Anti-tumor activity of telaglenestat and palbociclib: | Change in tumor size from baseline | Approximately every 8 weeks until disease progression, for approximately 18 months |
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