Clinical Trials List
Protocol Number1512-0001
NCT Number(ClinicalTrials.gov Identfier)NCT06056024
Completed
2023-11-01 - 2025-09-12
Phase I
Not yet recruiting2
ICD-10C16.0
Malignant neoplasm of cardia
ICD-10C7A.092
Malignant carcinoid tumor of the stomach
ICD-10Z51.12
Encounter for antineoplastic immunotherapy
ICD-9151.0
Malignant neoplasm of cardia of stomach
Open-label Dose-finding Trial to Explore Safety, Pharmacokinetics, Pharmacodynamics, and Efficacy of BI 3706674 Given Orally as Monotherapy in Patients With Unresectable Metastatic KRAS Wild Type Amplified Gastric, Oesophageal, and Gastroesophagealjunction Adenocarcinoma
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Trial Applicant
Boehringer Ingelheim
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Sponsor
-
Trial scale
Multi-Regional Multi-Center
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Update
2026/03/01
Investigators and Locations
Co-Principal Investigator
- Chih-Hung Hsu 無
- 梁逸歆 無
- 陳國興 無
- Hsiang-Fong Kao 無
- 徐偉勛 無
- Kun-Huei Yeh 無
- Jih-Hsiang Lee 無
- 林昭文 無
The Actual Total Number of Participants Enrolled
0 Not yet recruiting
Co-Principal Investigator
The Actual Total Number of Participants Enrolled
0 Not yet recruiting
Condition/Disease
Solid Tumor, KRAS Mutation
Objectives
The main purpose is:
(Part A) Establishing the maximum tolerated dose (MTD),
(Part B) Determine the recommended dose for expansion (RDE), and
(Part C) Evaluating the efficacy of BI 3706674 monotherapy.
Secondary objectives were to document the safety and tolerability of BI 3706674, characterize the pharmacokinetics, and evaluate preliminary efficacy signals.
Test Drug
BI 3706674
Active Ingredient
BI 3706674
BI 3706674
BI 3706674
BI 3706674
BI 3706674
Dosage Form
FilmCoated tablets
Dosage
15 mg
50 mg
200 mg
50 mg
200 mg
Endpoints
Main evaluation indicators:
Dose Escalation (Part A)
Dose-limiting toxicity (DLT) occurred during MTD assessment
Dosage Confirmation (Part B)
Common Treatment Criteria for Adverse Events (CTCAE) Level 3 drug-related adverse events (AEs)
Dose Expansion (Part C)
Objective response (OR) is defined as a confirmed complete response (CR) or confirmed partial response (PR) from the first treatment to the earliest occurrence of disease progression, death, or trial discontinuation or completion. Best overall response (BOR).
Dose Escalation (Part A)
Dose-limiting toxicity (DLT) occurred during MTD assessment
Dosage Confirmation (Part B)
Common Treatment Criteria for Adverse Events (CTCAE) Level 3 drug-related adverse events (AEs)
Dose Expansion (Part C)
Objective response (OR) is defined as a confirmed complete response (CR) or confirmed partial response (PR) from the first treatment to the earliest occurrence of disease progression, death, or trial discontinuation or completion. Best overall response (BOR).
Inclution Criteria
Main inclusion criteria
‧Only the dose escalation portion for patients with pathologically confirmed locally advanced or metastatic GAC, EAC, and GEJAC with KRAS wt amplification, and confirmed disease progression despite at least 1 prior line of therapy: patients with KRAS wt amplification or Patients with advanced or metastatic recurrent or refractory solid tumors of any histology harboring a KRAS G12V mutation who have exhausted treatment options known to prolong survival with their disease.
‧At least one target lesion can be measured according to RECIST version 1.1 (radiated lesions do not qualify as target lesions unless progression of the lesion has been demonstrated after completion of radiotherapy) Dose escalation component only: OK if the trial sponsor and trial sponsor mutually agree Patients without measurable disease according to RECIST version 1.1 were included.
‧Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
‧Dose confirmation part only: Willing to receive tumor biopsies before and during treatment
‧Adequate organ function as defined in Section 3.3.2.
‧ Prior to administration of investigational treatment, all toxicities associated with prior anticancer therapy have resolved to CTCAE grade 1 (except alopecia and peripheral neuropathy must be CTCAE grade 2 and amenorrhea or menstrual irregularity can be any level)
‧Only the dose escalation portion for patients with pathologically confirmed locally advanced or metastatic GAC, EAC, and GEJAC with KRAS wt amplification, and confirmed disease progression despite at least 1 prior line of therapy: patients with KRAS wt amplification or Patients with advanced or metastatic recurrent or refractory solid tumors of any histology harboring a KRAS G12V mutation who have exhausted treatment options known to prolong survival with their disease.
‧At least one target lesion can be measured according to RECIST version 1.1 (radiated lesions do not qualify as target lesions unless progression of the lesion has been demonstrated after completion of radiotherapy) Dose escalation component only: OK if the trial sponsor and trial sponsor mutually agree Patients without measurable disease according to RECIST version 1.1 were included.
‧Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
‧Dose confirmation part only: Willing to receive tumor biopsies before and during treatment
‧Adequate organ function as defined in Section 3.3.2.
‧ Prior to administration of investigational treatment, all toxicities associated with prior anticancer therapy have resolved to CTCAE grade 1 (except alopecia and peripheral neuropathy must be CTCAE grade 2 and amenorrhea or menstrual irregularity can be any level)
Exclusion Criteria
Main exclusions:
‧Have received anti-cancer chemotherapy within 3 weeks of taking the trial drug for the first time
‧Have received anti-cancer hormone therapy or anti-cancer immunotherapy within 2 weeks of first taking the trial drug
‧Have ever been treated with RAS, MAPK or SOS1 target drugs
‧Have received anti-cancer chemotherapy within 3 weeks of taking the trial drug for the first time
‧Have received anti-cancer hormone therapy or anti-cancer immunotherapy within 2 weeks of first taking the trial drug
‧Have ever been treated with RAS, MAPK or SOS1 target drugs
The Estimated Number of Participants
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Taiwan
8 participants
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Global
146 participants
