A Phase I Clinical Study of QLC1101 in Patients With Advanced Solid Tumors

NCT06403735 | Recruiting Phase 1

• 1 other identifier: QLC1101-101
• Study Type: interventional
• Target: 250
• Locations: 1 country
• Sites: 5

Brief Summary

QLC1101 is a selective reversible inhibitor of KRAS G12D, with the dosage form of capsules and administration route of oral administration. In the first-in-humans (FIH) study, the sponsor will explore the safety, tolerability, pharmacokinetics (PK), and preliminary efficacy of QLC1101 in subjects with advanced solid tumors harboring a KRAS G12D mutation. The FIH study includes dose escalation, PK expansion, and efficacy expansion.

Conditions

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

Outcome Measures

Primary Outcomes (3)

• Dose limiting toxicity (DLT)

  Subjects in this phase will be treated with single oral administration of QLC1101, observed for 4 days, and if tolerant, treated with repeated oral administration of QLC1101 twice daily for 21 consecutive days. After completing the DLT observation (the 25 days after the first dose as the DLT observation period), the subject will continue to receive repeated-dose treatment of Cycle 2 and subsequent cycles.

  25 days after the first dose

• MTD (or MAD)

  the maximum tolerated dose (MTD) or maximum administered dose (MAD, if MTD fails to be determined) of QLC1101 monotherapy

  1 year

• RP2D

  the recommended phase II dose of QLC1101 monotherapy

  1.5 years

Secondary Outcomes (2)

• Preliminary efficacy endpoints

  3 years

• Preliminary efficacy endpoints

  3 years

Study Arms (1)

QLC1101

EXPERIMENTAL

patients with advanced solid tumors harboring a KRAS G12D mutation were administrated with QLC1101 orally in a total of 6 dose groups at 100,200,400,600,900, and 1200 mg BID

Drug: QLC1101

Interventions

QLC1101 DRUG

QLC1101 is an innovative small molecule inhibitor targeting KRAS G12D with independent intellectual property rights developed by Qilu Pharmaceutical Co., Ltd.QLC1101 can prevent GTP/GDP nucleotide exchange and/or the formation of KRAS G12D/GTP/RAF1 complex and inhibit mutant KRAS-dependent signal transduction by specifically binding to the KRAS G12D target, thereby inhibiting the generation of KRAS G12D mutant tumors.

QLC1101

Eligibility Criteria

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

You may qualify if:

• Patients with histologically confirmed advanced (metastatic or unresectable) solid tumors harboring a KRAS G12D mutation. Sign the ICF.
• Those who fail or are unable to tolerate standard treatment, lack standard treatment, or refuse to receive standard treatment;
• Those who are able to swallow and retain oral medication and must not have any clinically significant gastrointestinal abnormality that may alter absorption;
• Subjects who have at least one measurable lesion documented by computed tomography (CT) and/or magnetic resonance imaging (MRI) as confirmed by the investigator per the RECIST v1.1 criteria.
• ECOG PS score: 0 or 1;
• Expected survival time ≥ 3 months;
• Adequate organ function at screening:

You may not qualify if:

• Previously treated with inhibitors against KRAS G12D mutation;
• The period of time prior to the first dose of investigational product should be at least 28 days from previous treatment or at least 5 half-lives
• Known immediate or delayed hypersensitivity or idiosyncratic reaction to the ingredients of the preparation used in the trial;
• Presence of other active malignant tumors in addition to primary tumors;
• Presence of serious lung diseases at screening;
• Clinically significant gastrointestinal disorders or other conditions that seriously interfere with drug absorption;
• Severe hereditary or acquired hemorrhagic diathesis or coagulation disorders;
• Complicated with clinically significant cardiovascular and cerebrovascular disorders;
• History of allogeneic hematopoietic stem cell transplantation or organ transplantation (except corneal transplantation);
• Presence of known mental disorders, epilepsy, dementia, or alcohol and drug abuse that may affect the compliance with study requirements;
• the investigator determines that participation in the study is not in the best interest of the subject.

Sponsors & Collaborators

• Qilu Pharmaceutical Co., Ltd.: lead

Study Sites (5)

The First Affiliated Hospital of Guangdong Pharmaceutical University

Guangzhou, Guangdong, 510699, China

NOT YET RECRUITING

Harbin Medical university cancer hospital

Harbin, Heilongjiang, 150081, China

NOT YET RECRUITING

Jiangxi Cancer Hospital

Nanchang, Jiangxi, 330029, China

NOT YET RECRUITING

Shanghai east hospital

Shanghai, Shanghai Municipality, 200000, China

RECRUITING

Yunnan Cancer Hospital

Kunming, Yunnan, 650118, China

NOT YET RECRUITING

MeSH Terms

Conditions

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

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 10, 2024
• First Posted: May 8, 2024
• Study Start: April 25, 2024
• Primary Completion (Estimated): May 31, 2026
• Study Completion (Estimated): April 30, 2027
• Last Updated: May 8, 2024

Record last verified: 2024-04

Locations

CN (5)