Phase 1 Study of BPI-442096 in Advanced Solid Tumor Patients

NCT05369312 | Unknown Phase 1

• 1 other identifier: BTP-661711
• Study Type: interventional
• Target: 230
• Locations: 1 country
• Sites: 5

Brief Summary

A first-in-human study to evaluate the safety, tolerability and maximum tolerated dose (MTD) and establish the recommended phase 2 dose (RP2D) of BPI-442096, a SHP2 inhibitor, in patients with advanced solid tumors.

Conditions

Solid Tumor; Non-small Cell Lung Cancer; Pancreatic Cancer; Colorectal Cancer

Outcome Measures

Primary Outcomes (2)

• The adverse events (AEs)

  Safety and tolerability will be assessed by monitoring frequency, duration and severity of adverse events (AEs).

  Through the Phase I, approximately 24 months

• Determine the recommended Phase II dose (RP2D)

  Number of subjects with dose limiting toxicity

  Through the Phase I, approximately 24 months

Secondary Outcomes (8)

• Cmax

  Through the Phase I, approximately 24 months

• Tmax

  Through the Phase I, approximately 24 months

• t1/2

  Through the Phase I, approximately 24 months

• AUC0-t

  Through the Phase I, approximately 24 months

• the objective response rate (ORR）

  Through the Phase I, approximately 24 months

Study Arms (2)

Dose Escalation

EXPERIMENTAL

Oral tablets taken in escalating levels to determine MTD/RP2D. Each treatment cycle will be 21 days in duration with BPI-442096 administered, once daily (QD).

Drug: BPI-442096

Dose Expansion

EXPERIMENTAL

Oral tablets administered at MTD/RP2D defined dose. Each treatment cycle will be 21 days in duration with BPI-442096 administered, once daily (QD)

Drug: BPI-442096

Interventions

BPI-442096 DRUG

Subjects will receive BPI-442096 until disease progression

Dose Escalation; Dose Expansion

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Signed informed consent;
• Age ≥18 and ≤75 years, male and female patients;
• Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0-1;
• Dose escalation phase: histologically or cytologically confirmed locally advanced or metastatic solid tumor patients (excluding HCC patients), who had disease progression after standard therapy, intolerable to standard therapy, refuse to standard therapy or for whom no standard therapy exists;
• Dose expansion phase: histologically or cytologically confirmed locally advanced non-small cell lung cancer, pancreatic cancer, colorectal cancer or other diagnosed solid tumor patients (excluding HCC patients), who had disease progression after standard therapy, intolerable to standard therapy, refuse to standard therapy or for whom no standard therapy exists;
• Evaluable lesion required for dose escalation phase and at least 1 measurable lesion as per RECIST v1.1 required for dose expansion phase;
• Dose expansion only: Patients must have confirmation of tumour mutation status (including KRAS G12, Class-3 BRAF, NF1 LOF mutations, RTK mutations, amplifications or rearrangements).
• Adequate organ function;

You may not qualify if:

• Patients who have previously received a SHP2 inhibitor;
• Inadequate wash-out of prior therapies described per protocol, which may include anti-tumor therapies, tumor adjuvant drugs, organ or stem cell transplantation, moderate or strong CYP3A inhibitor or inducer;
• Patients with severe or unstable systemic disease, unstable/symptomatic CNS metastasis, other malignant tumors, autoimmune disease, ILD, cardiac disease, bleeding or embolic disease, infectious disease, conditions affecting drug swallow and absorption, medical history leading to chronic diarrhea, etc;
• Pregnancy or lactation;
• Other conditions considered not appropriate to participate in this trial by the investigators.

Sponsors & Collaborators

• Betta Pharmaceuticals Co., Ltd.: lead

Study Sites (5)

Guangdong Provincial People's Hospital

Guangzhou, Guangdong, 510080, China

Location

The First Affiliated Hospital of Sun yat-sen university

Guangzhou, Guangdong, 510080, China

Location

Henan Tumor Hospital

Zhengzhou, Henan, 453100, China

Location

Zhongshan Hospital affiliated to Fudan University

Xuhui, Shanghai Municipality, 200032, China

Location

Zhejiang Cancer Hospital

Hangzhou, Zhejiang, 310004, China

Location

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung; Pancreatic Neoplasms; Colorectal Neoplasms

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Digestive System Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases; Intestinal Neoplasms; Gastrointestinal Neoplasms; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Study Officials

• Yilong Wu, Ph.D

  Guangdong Provincial People's Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yilong Wu, Ph.D

CONTACT

020-83525210; syylwu@live.cn

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 5, 2022
• First Posted: May 11, 2022
• Study Start: June 1, 2022
• Primary Completion: May 1, 2024
• Study Completion: May 1, 2025
• Last Updated: June 21, 2022

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (5)