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Clinical Trials List

Protocol NumberRMC-6291-001

NCT Number(ClinicalTrials.gov Identfier)NCT05462717

Active

2022-12-01 - 2026-06-30

Phase I

Not yet recruiting4

Recruiting1

ICD-10C34.90

Malignant neoplasm of unspecified part of unspecified bronchus or lung

ICD-10C34.91

Malignant neoplasm of unspecified part of right bronchus or lung

ICD-10C34.92

Malignant neoplasm of unspecified part of left bronchus or lung

ICD-10C7A.090

Malignant carcinoid tumor of the bronchus and lung

ICD-10Z51.12

Encounter for antineoplastic immunotherapy

ICD-9162.9

Malignant neoplasm of bronchus and lung, unspecified

Phase 1/1b, Multicenter, Open-Label, Dose Escalation and Dose Expansion Study of RMC-6291 Monotherapy in Subjects With Advanced KRASG12C Mutant Solid Tumors

Trial Applicant

CMIC Asia-Pacific
Sponsor
Trial scale

Multi-Regional Multi-Center
Update

2026/02/01

Investigators and Locations

Principal Investigator 夏和雄 Division of Hematology & Oncology

Taipei Tzu Chi Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Not yet recruiting

Principal Investigator 魏裕峰 Division of General Internal Medicine

E-DA Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator Chia-Chi Lin Division of Hematology & Oncology

National Taiwan University Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Not yet recruiting

Principal Investigator Yu-Min Yeh Division of General Internal Medicine

National Taiwan University Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Not yet recruiting

Principal Investigator 魏裕峰 Division of General Internal Medicine

E-DA Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Not yet recruiting

Condition/Disease

Non-Small Cell Lung Cancer (NSCLC) 、Colorectal Cancer (CRC)、 Pancreatic Ductal Adenocarcinoma 、Advanced Solid Tumor

Objectives

main target •To evaluate the safety and tolerability of RMC-6291 monotherapy in adult subjects with KRASG12C-mutant solid tumors. • RMC-6291 monotherapy is estimated for MTD and/or RP2DS in adult subjects with KRASG12C mutant solid tumors. secondary goals •To explore the pharmacokinetic properties of RMC-6291 in plasma following single and repeated dose administration. •Evaluation of preliminary anti-tumor effects of RMC-6291 monotherapy in KRASG12C mutant solid tumors. •Evaluate the effect of food on the pharmacokinetics of RMC-6291 monotherapy. exploratory goals •Assessing additional efficacy endpoints for RMC-6291 monotherapy in subjects with advanced KRASG12C mutant solid tumors. •Exploring predictive biomarkers in sealed tumor tissue and/or blood for RMC-6291 treatment response and resistance. •Exploring pharmacodynamic biomarkers in blood responsive to RMC-2691.

Test Drug

RMC-6291 Tablets 25/100 mg

Active Ingredient

RMC-6291
RMC-6291

Dosage Form

Tablet

Dosage

25mg
100mg

Endpoints

Incidence and severity of DLTs, TEAEs, treatment-related adverse events, SAEs and clinically significant laboratory test values, electrocardiograms, and vital sign changes.

Inclution Criteria

Inclusion Criteria:

Subject must be ≥18 years of age.
Subject must have pathologically documented, locally advanced or metastatic KRASG12C-mutated solid tumor malignancy (not amenable to curative surgery) that has previously been treated with standard-of-care therapies for respective tumor types, is intolerant to, or is considered ineligible for standard-of-care anticancer treatments.
ECOG performance status 0 or 1
Prior treatment with a KRASG12C (OFF) inhibitor allowed for dose escalation
Adequate organ function

Exclusion Criteria

Exclusion Criteria:

Primary central nervous system (CNS) tumors
Active brain metastases
Known impairment of GI function that would alter the absorption
Major surgical procedures within 28 days or non-study-related minor procedures within 7 days of treatment.
Prior therapy with KRASG12C (ON) inhibitor

The Estimated Number of Participants

Taiwan

15 participants
Global

222 participants