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A Phase 1/1b, Open-label, Multicenter, Dose Escalation and Dose Expansion Study Evaluating the Safety, Tolerability, Pharmacokinetics, and Efficacy of KQB198 as Monotherapy and in Combination with Anticancer Agents in Participants with Advanced Hematologic Malignancies
Cancer Categories
Hematologic (Blood Cancers)
Karmanos Trial ID
2024-055
NCT ID
NCT06507306
Age Group
Adult
Scope
National
Phase
Phase I
Includes initial studies to determine the metabolism and pharmacologic actions of drugs in humans, the side effects associated with increasing doses, and to gain early evidence of effectiveness; may include healthy participants and/or patients.
Phase I
Principal Investigator
Jay
Yang, M.D.
Oncology - Hematology, Oncology - Medical
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Objective:
Primary Objective:
Part 1: To determine the safety, tolerability, and RP2D of KQB198 as monotherapy and in combination with dasatinib
Part 2, Cohort A: To evaluate the efficacy of KQB198 in combination with dasatinib and determine the OBD
Part 2, Cohort B: To evaluate the efficacy of KQB198 monotherapy and determine the OBD
Secondary Objective:
Part 1: To evaluate the efficacy of KQB198 as monotherapy and in combination with dasatinib
Part 2, Cohorts A and B: To evaluate the efficacy of KQB198 monotherapy and in combination with dasatinib
All Parts: To evaluate the safety and tolerability of KQB198 as monotherapy and in combination with dasatinib
All Parts: To evaluate the plasma pharmacokinetics (PK) of KQB198 alone or KQB198 and dasatinib when administered in combination
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Eligibility
Locations
Applicable Disease Site
Therapies | Drugs | Devices
Eligibility
Eligibility
Inclusion Criteria:
PART 1: Histologically confirmed diagnosis of a solid tumor malignancy with any of the following oncogenic mutations: EGFR, RAS, PTPN11, or SOS1 mutations, or inactivating mutations of NF1.
PART 1 (Osimertinib arm) and Part 2 Cohort A: Histologically confirmed diagnosis of NSCLC with activating EGFR mutation and progression on osimertinib
Part 3 Cohort A: Histologically confirmed diagnosis of NSCLC with exon 20 insertion EGFR mutation
Unresectable or metastatic disease
No available treatment with curative intent
Adequate organ function
Measurable disease per RECIST 1.1.
Exclusion Criteria:
Prior therapy with a similar mechanism of action to KQB198
History of intestinal disease, inflammatory bowel disease, major gastric surgery, or other gastrointestinal conditions likely to alter absorption of study treatment or result in inability to swallow
History of interstitial lung disease
Locations
Locations
Karmanos Cancer Institute - Detroit Headquarters
4100 John R
Detroit, MI 48201
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Phone:
1-800-527-6266
Karmanos Cancer Institute at Weisberg Cancer Center - Farmington Hills
31995 Northwestern Hwy
Farmington Hills, MI 48334
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Phone:
1-800-527-6266
Applicable Disease Site
Applicable Disease Site
Myeloid and Monocytic Leukemia
Therapies, Drugs, Devices
Therapies | Drugs | Devices
Therapies
Biological Therapy
Drugs
Dasatinib; KQB198
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