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A Dose Escalation Study of SHP2 Inhibitor in Patients With Solid Tumors Harboring KRAS of EGFR Mutations

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HUYABIO

Status and phase

Enrolling
Phase 1

Conditions

Solid Tumor
Cancer of Colon
Cancer of Pancreas
Cancer
Non Small Cell Lung Cancer
Pancreatic Cancer
Colorectal Cancer

Treatments

Drug: HBI-2376

Study type

Interventional

Funder types

Industry

Identifiers

NCT05163028
HBI-2376-101

Details and patient eligibility

About

A Phase 1 dose escalation study in patients with advanced solid tumors harboring KRAS or EGFR mutations to determine the maximum tolerated dose and recommended Phase II dose of HBI-2376 and characterize its pharmacokinetic profile.

Full description

A Phase 1, Open-Label, Dose Escalation of HBI-2376 in Patients with Advanced Malignant Solid Tumors Harboring KRAS or EGFR Mutations. The primary and secondary objectives are:

  1. To determine the MTD and recommended Phase 2 dose (RP2D), of HBI-2376 as an oral monotherapy for advanced solid tumors harboring KRAS or EGFR mutations
  2. To characterize the PK of HBI-2376 in subjects with advanced malignant solid tumors harboring KRAS or EGFR mutations

HBI-2376 is a SHP2 Inhibitor and will be dosed once daily throughout the escalation and expansion phase. Up to 42 subjects will be enrolled sequentially into the 3+3 dose escalation and monitored throughout the study for safety and tolerability. The dose escalation phase will consist of 6 cohorts, with doses ranging from 6 to 40mg. Once the MTD of RP2D is established, additional 6 subjects will be enrolled into the expansion phase at that dose level.

Enrollment

42 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

Key Inclusion Criteria:

  • Male or female at least 18 years of age at the time of signing the ICF prior to initiation of any study specific activities/procedures
  • Advanced malignant solid tumors with KRAS or EGFR mutations diagnosed by histology or cytology
  • Relapsed or refractory to, or intolerant of, or refuse approved or standard of care established therapy known to provide clinical benefit for disease
  • At least 1 measurable target lesion that meets the definition of RECIST v1.1
  • ECOG Performance Status of 0 or 1
  • Demonstrate adequate organ function
  • Must be able to swallow oral medications and must not have gastrointestinal abnormalities that significantly affect drug absorption

Key Exclusion Criteria:

  • History of another concurrent malignancy within 3 years prior to study entry, unless the malignancy was treated with curative intent and the likelihood of relapse is <5% in 2 years Note: Subjects with a history of squamous or basal cell carcinoma of the skin or carcinoma in the situ of the cervix may be enrolled
  • Untreated or symptomatic central nervous system (CNS) metastases Note: Subjects with asymptomatic treated CNS metastases are eligible provided they have been clinically stable and not requiring steroids for at least 4 weeks
  • Clinically significant cardiovascular disease, including stroke or myocardial infarction within 6 months
  • Any unresolved Grade 2 or greater toxicity from previous anti-cancer therapy, except alopecia, within 4 weeks of first study treatment administration
  • Active autoimmune diseases or history of autoimmune diseases that may relapse
  • Pregnant or nursing
  • Prior treatment with any SHP2 inhibitors
  • Any condition that required systemic treatment with either corticosteroids (>10 mg daily of prednisone or equivalent) or other immunosuppressive medication ≤14 days before the first study treatment administration
  • Treatment with other investigational drugs/devices within 4 weeks prior to first study treatment administration

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Sequential Assignment

Masking

None (Open label)

42 participants in 1 patient group

Dose Escalation and Expansion
Experimental group
Description:
HBI-2376 will be given orally in ascending doses (escalation cohort), until the maximum tolerated dose or recommended Phase 2 dose is reached. Up to 6 patients will then be enrolled in the expansion cohort at the recommended dose.
Treatment:
Drug: HBI-2376

Trial contacts and locations

12

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Central trial contact

John Ning, MD,PhD,FAIC

Data sourced from clinicaltrials.gov

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