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Protocol # 22-281

Status

Recruiting

Description

This is an open-label, multicenter, and non-randomized Phase 1a/1b clinical study to evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics, and preliminary antitumor activity of BGB-24714 as monotherapy and in combination with chemotherapy in participants with advanced or metastatic solid tumors.

Condition

  • Solid Tumor, Adult

Interventions

  • BGB-24714
  • Paclitaxel

Phase

Phase 1

Study Type

Interventional

Further Study Details

Primary Outcome:

  • Dose Escalation: Number of participants with adverse events (AEs)
  • Dose Escalation: Maximum tolerated dose (MTD) of BGB-24714 as monotherapy and in combination with chemotherapy
  • Dose Escalation: Recommended Phase 2 dose (RP2D) of BGB-24714 as monotherapy and in combination with chemotherapy
  • Dose Expansion: Objective response rate (ORR)

Secondary Outcome:

  • Dose Escalation: Objective response rate (ORR)
  • Dose Expansion: Progression-free Survival (PFS)
  • Dose Expansion: Number of participants with adverse events
  • Duration of Response (DOR)
  • Disease Control Rate (DCR)
  • Plasma concentration of BGB-24714
  • Plasma Concentrations of BGB-24714 metabolite

Enrollment

244

Study Start Date

July 6, 2022

Eligibility

  • Gender:     All
  • Minimum age:     18 Years
  • Maximum age:     N/A
  • Healthy volunteers:     No

Sponsors

BeiGene

Source

BeiGene

Official title

A Phase 1 Study Investigating the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Preliminary Antitumor Activity of Second Mitochondrial-derived Activator of Caspases Mimetic BGB-24714 as Monotherapy and in Combination With Chemotherapy in Patients With Advanced or Metastatic Solid Tumors

Clinicaltrials.gov Identifier

NCT05381909

     

Source: Clinicaltrials.gov. Through our founding membership in the Dana-Farber/Harvard Cancer Center, an NCI-designated Comprehensive Cancer Center, these clinical trials are conducted at the Massachusetts General Hospital Cancer Center and may be available at other partner institutions.