CC-95775 / BMS, Novo Nordisk - LARVOL DELTA

[VIRTUAL] CC-95775, a Reversible, Oral Bromodomain and Extra-Terminal (BET) Inhibitor in Patients With Advanced Solid Tumors (STs): Results of a Phase 1 Study (AACR-NCI-EORTC 2021) - No abstract available

Clinical • P1 data • Oncology • Solid Tumor

Study to Evaluate the Safety, Tolerability, Pharmacokinetic and Pharmacodynamic of CC-95775 in Subjects With Advanced Solid Tumors and Relapsed/Refractory Non-Hodgkin Lymphoma (clinicaltrials.gov) - P1b | N=24 | Completed | Sponsor: Celgene | Active, not recruiting ➔ Completed

Trial completion • Hematological Malignancies • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • Solid Tumor • GLI1 • MRI

Phase 1 Dose Escalation and Expansion Study to Determine Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of the BET Inhibitor FT-1101 As a Single Agent in Patients with Relapsed or Refractory Hematologic Malignancies (ASH 2019) - P1; "In xenograft and syngeneic models, FT-1101 achieved superior tumor growth inhibition (including regressions) relative to JQ1, another BET inhibitor (Millan 2015)...Most AML/MDS pts (n=80) received FT-1101 monotherapy; a small cohort (n=4) received FT-1101 200 mg QOW in combination with azacitidine... FT-1101, as monotherapy, shows acceptable safety, PK, and modest clinical activity in R/R AML/MDS and NHL pts. Intermittent (QOW) dosing within a tolerable range elicits PD activity (CCR1 suppression and HEXIM1 upregulation) consistent with preclinical observations indicating antitumor activity, and provides a rationale for testing FT-1101 in combination with standard therapies in AML/MDS and NHL."

Clinical • P1 data • PK/PD data • Acute Myelogenous Leukemia • Hematological Disorders • Hematological Malignancies • Leukemia • Lymphoma • Myelodysplastic Syndrome • Neutropenia • Non-Hodgkin’s Lymphoma • Oncology • Pneumonia • Respiratory Diseases • Septic Shock

Study to Evaluate the Safety, Tolerability, Pharmacokinetic and Pharmacodynamic of CC-95775 in Subjects With Advanced Solid Tumors and Relapsed/Refractory Non-Hodgkin Lymphoma (clinicaltrials.gov) - P1b; N=24; Active, not recruiting; Sponsor: Celgene; Trial primary completion date: Jul 2021 ➔ Oct 2021

Clinical • Trial primary completion date • Hematological Malignancies • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • Solid Tumor • GLI1 • MRI

Study to Evaluate the Safety, Tolerability, Pharmacokinetic and Pharmacodynamic of CC-95775 in Subjects With Advanced Solid Tumors and Relapsed/Refractory Non-Hodgkin Lymphoma (clinicaltrials.gov) - P1b; N=24; Active, not recruiting; Sponsor: Celgene; Recruiting ➔ Active, not recruiting; N=40 ➔ 24

Clinical • Enrollment change • Enrollment closed • Hematological Malignancies • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • Solid Tumor • GLI1

Safety and Efficacy of Bromodomain and Extra-Terminal Inhibitors for the Treatment of Hematological Malignancies and Solid Tumors: A Systematic Study of Clinical Trials. (PubMed, Front Pharmacol) - " We retrieved and reviewed published reports on the clinical trials of twelve BET inhibitors including AZD5153, ABBV-075, BMS-986158, CPI-0610, GSK525762, OTX-015, PLX51107, INCB054329, INCB057643, FT-1101, CC-90010, and ODM-207 for patients with hematological malignancies and solid tumors and summarized their published target genes. All BET inhibitors reviewed in our study exhibited exposure-dependent thrombocytopenia, which may limit their clinical application. Moreover, further efforts are necessary to explore the optimal dosing schemes and combinations to maximize the efficacy of BET inhibitors."

Clinical • Journal • Review • Fatigue • Hematological Malignancies • Infectious Disease • Neutropenia • Oncology • Pneumonia • Respiratory Diseases • Solid Tumor • Thrombocytopenia

Study to Evaluate the Safety, Tolerability, Pharmacokinetic and Pharmacodynamic of CC-95775 in Subjects With Advanced Solid Tumors and Relapsed/Refractory Non-Hodgkin Lymphoma (clinicaltrials.gov) - P1b; N=40; Recruiting; Sponsor: Celgene; Trial completion date: Jun 2023 ➔ Jul 2021; Trial primary completion date: Jun 2023 ➔ Jul 2021

Clinical • Trial completion date • Trial primary completion date • Hematological Malignancies • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • Solid Tumor

FORMA reports achievement of early-stage clinical development milestones for assets licensed exclusively to Boehringer Ingelheim and Bristol-Myers Squibb (Businesswire) - “FORMA Therapeutics, Inc…announced the achievement of clinical development milestones for two of its exclusively-licensed, clinical-stage products to Boehringer Ingelheim (BI) and Bristol-Myers Squibb Company…BI initiated a Phase 1 clinical trial for BI 1701963, a SOS1:KRAS inhibitor discovered in a partnership with FORMA that targets protein-protein interactions for the treatment of cancer…. BMS initiated an open-label, Phase 1B dose-escalation and expansion study to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of CC-95775 (formerly FT-1101) in patients with advanced or unresectable solid tumors.”

Licensing / partnership • New P1 trial

Study to Evaluate the Safety, Tolerability, Pharmacokinetic and Pharmacodynamic of CC-95775 in Subjects With Advanced Solid Tumors and Relapsed/Refractory Non-Hodgkin Lymphoma (clinicaltrials.gov) - P1b; N=40; Recruiting; Sponsor: Celgene; Not yet recruiting ➔ Recruiting

Clinical • Enrollment open

Study of a Novel BET Inhibitor FT-1101 in Patients With Relapsed or Refractory Hematologic Malignancies (clinicaltrials.gov) - P1; N=94; Completed; Sponsor: Forma Therapeutics, Inc.; Recruiting ➔ Completed; N=160 ➔ 94; Trial completion date: Oct 2019 ➔ Mar 2019; Trial primary completion date: Dec 2018 ➔ Mar 2019

Clinical • Combination therapy • Enrollment change • Trial completion • Trial completion date • Trial primary completion date